Contents
- 888.4150 Calipers for clinical use.
- 888.4200 Cement dispenser.
- 888.4210 Cement mixer for clinical use.
- 888.4220 Cement monomer vapor evacuator.
- 888.4230 Cement ventilation tube.
- 888.4300 Depth gauge for clinical use.
- 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
- 888.4510 Manual surgical instrument for appropriate patient selection for orthopedic implant.
- 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.
- 888.4520 Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.
- 888.4540 Orthopedic manual surgical instrument.
- 888.4560 Intraoperative surgical angle measurement tool.
- 888.4580 Sonic surgical instrument and accessories/attachments.
- 888.4600 Protractor for clinical use.
- 888.4800 Template for clinical use.
- 888.5850 Nonpowered orthopedic traction apparatus and accessories.
- 888.5890 Noninvasive traction component.
- 888.5895 Wearable vibration device for orthopedic use.
- 888.5940 Cast component.
- 888.5960 Cast removal instrument.
- 888.5980 Manual cast application and removal instrument.
Subpart E · Subpart E—Surgical Devices
888.4150Calipers for clinical use.#
(a)Identification. A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4200Cement dispenser.#
(a)Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4210Cement mixer for clinical use.#
(a)Identification. A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§ 888.3027).
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4220Cement monomer vapor evacuator.#
(a)Identification. A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027).
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4230Cement ventilation tube.#
(a)Identification. A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (§ 888.3027).
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4300Depth gauge for clinical use.#
(a)Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4505Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.#
(a)Identification. Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. The special controls for this device are:
(1)Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.
(2)The patient contacting components of the device must be demonstrated to be biocompatible.
(3)Labeling must include:
(i)Identification of implant(s) and instruments which have been validated for use together; and
(ii)Validated methods and instructions for reprocessing any reusable parts.
888.4510Manual surgical instrument for appropriate patient selection for orthopedic implant.#
(a)Identification. This device is an orthopedic manual surgical instrument used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for the orthopedic implant in terms of geometry, surgical technique and use of the device.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Technical specifications regarding geometry of the instruments must be identified and validated to demonstrate that the instruments accurately measure the critical geometry for patient selection of the intended orthopedic implant.
(2)The use of the instruments is validated to demonstrate that the measurement process does not alter the patient anatomy which is being measured.
(3)The patient contacting components of the device must be demonstrated to be biocompatible.
(4)Labeling must include:
(i)Identification of orthopedic implant(s) and instruments which have been validated for use together; and
(ii)Validated methods and instructions for reprocessing any reusable parts.
888.4515Orthopedic manual surgical instrumentation for use with total disc replacement devices.#
(a)Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2)The patient contacting components of the device must be demonstrated to be biocompatible.
(3)Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4)Labeling must include:
(i)Identification of implant(s) and instruments which have been validated for use together; and
(ii)Validated methods and instructions for reprocessing any reusable parts.
888.4520Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.#
(a)Identification. Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices are non-powered hand-held devices designed specifically for use with non-fusion spinous process spacer devices and interface with the associated implant for the purpose of inserting, positioning, or removing the implant. This type of device includes instruments specific to the geometry of the implant.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2)The patient contacting components of the device must be demonstrated to be biocompatible.
(3)Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4)Labeling must include:
(i)Identification of implant(s) and instruments which have been validated for use together; and
(ii)Validated methods and instructions for reprocessing any reusable parts.
888.4540Orthopedic manual surgical instrument.#
(a)Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4560Intraoperative surgical angle measurement tool.#
(a)Identification. An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of system-level accuracy and validation of procedural accuracy in simulated use.
(2)Usability testing must demonstrate that the intended user(s) can correctly use the device based on the instructions for use.
(3)The patient-contacting components of the device must be demonstrated to be biocompatible.
(4)Performance testing must support the sterility and shelf-life of the device.
(5)Software verification, validation, and hazard analysis must be performed.
(6)Performance data must demonstrate the electrical safety, electromagnetic compatibility, and wireless coexistence of the device.
(7)Labeling must include:
(i)A detailed summary of the device technical parameters;
(ii)Information regarding limitations of the clinical significance of the device output;
(iii)A detailed summary of the accuracy and precision of the device;
(iv)Validated methods and instructions for reprocessing of any reusable components; and
(v)The shelf-life of the device.
888.4580Sonic surgical instrument and accessories/attachments.#
(a)Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
888.4600Protractor for clinical use.#
(a)Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.4800Template for clinical use.#
(a)Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.5850Nonpowered orthopedic traction apparatus and accessories.#
(a)Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
888.5890Noninvasive traction component.#
(a)Identification. A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
888.5895Wearable vibration device for orthopedic use.#
(a)Identification. A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the reduction in loss of bone strength or bone mineral density. Testing must evaluate patient risks, including regional pain, dizziness, blurred vision, muscle weakness, difficulty with balance, headache, and nausea. The testing must include a minimum of 1 year of follow-up.
(2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be provided:
(i)Characterization of the designed outputs of the device;
(ii)Demonstration of the reliability and reproducibility of device output; and
(iii)Validation that vibration characteristics received by the patient are within safe physiologic limits.
(3)The patient-contacting components of the device must be demonstrated to be biocompatible.
(4)Performance data must be provided to demonstrate the electrical safety, mechanical safety, thermal safety, battery safety, and electromagnetic compatibility of the device.
(5)Software verification, validation, and hazard analysis must be performed.
(6)Human factors or usability evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use.
(7)Labeling must include the following:
(i)A summary of the clinical performance testing with the device, including clinical outcomes and observed adverse events;
(ii)Information regarding limitations of the clinical significance of the clinical performance testing;
(iii)Instructions on duration and frequency of use, and when to discontinue use of the device; and
(iv)Instructions for device maintenance, including appropriate cleaning of any reusable components and safe disposal of the device.
888.5940Cast component.#
(a)Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
888.5960Cast removal instrument.#
(a)Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
888.5980Manual cast application and removal instrument.#
(a)Identification. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
United States Government work; public domain under 17 U.S.C. § 105.