(59 days)
No
The document describes a mechanical shaver handpiece and its intended use in orthopedic surgery. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The comparison to a predicate device from 1995 further suggests a lack of advanced computational technology.
No
The device is used to resect tissue and bur bone, which are surgical procedures, not therapeutic ones in and of themselves. Therapeutic devices typically administer treatment rather than remove tissue.
No
The device is used to resect tissue and bur bone, which are therapeutic actions, not diagnostic ones. Its described function focuses on surgical intervention rather than disease detection or assessment.
No
The device description explicitly states it is a "Shaver handpiece, constructed of a motor housing with a coupling mechanism for securing cutters and burs to the handpiece, valve for suction control, tapered fitting for attaching suction tubing to the handpiece and cable for connecting the shaver to the TPS". This describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used by surgeons to "resect tissue and bur bone" in various orthopedic joints. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical handpiece with a motor, coupling mechanism for cutters/burs, suction control, and a cable for connection. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical instrument used for mechanical tissue and bone removal during orthopedic procedures.
N/A
Intended Use / Indications for Use
Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in the following orthopedic joints: Knee Shoulder Ankle Elbow Wrist Hip Temporamandibular. The Total Performance System Shaver Handpiece will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
Product codes
HRX
Device Description
The Total Performance System Shaver handpiece, constructed of a motor housing with a coupling mechanism for securing cutters and burs to the handpiece, valve for suction control, tapered fitting for attaching suction tubing to the handpiece and cable for connecting the shaver to the TPS is equivalent in intended use, safety and effectiveness to existing shaver marketed by Smith & Nephew Dyonics per 510(k)953096.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Shoulder Ankle Elbow Wrist Hip Temporamandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Total Performance Shaver Packaging is validated per ASTM standards 4169, D999, D775, F88, D3078. The Total Performance Shaver Electrical safety is validated per IEC 601-1 and IEC 601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Stryker®
2590 Walsh Avenue Santa Clara, CA 95051
OCT 2 4 1997
(408) 567-9100 1-800-435-0111 Fax
K973195 Device Name: Arthroscope and accessories CFR 888.1100 Class II Current Classification Name Surgical instruments motors/accessories Expanded Classification Name : CFR 878.4820 Class I Common and Usual Name Surgical Shaver : Total Performance System Shaver Proprietary Name : Device Sponsor . Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 FDA Registration No. 2936485 Regulatory Classification Class II
SUMMARY OF SAFETY AND EFFECTIVENESS FOR TPS SHAVER HANDPIECE
:
The Total Performance System Shaver Handpiece is substantially equivalent to the Smith & Nephew Dyonics EP-1 Shaver 510(k) 953096.
The Total Performance System Shaver handpiece, constructed of a motor housing with a coupling mechanism for securing cutters and burs to the handpiece, valve for suction control, tapered fitting for attaching suction tubing to the handpiece and cable for connecting the shaver to the TPS is equivalent in intended use, safety and effectiveness to existing shaver marketed by Smith & Nephew Dyonics per 510(k)953096.
The Powered instrumentation technology utilized in this device is equivalent to existing marketed products. Power modality, intended used, mode of operation, cutting technique, methods of sterilization and safety risks are substantially equivalent. The Total Performance Shaver Packaging is validated per ASTM standards 4169, D999, D775, F88, D3078. The Total Performance Shaver Electrical safety is validated per IEC 601-1 and IEC 601-1-2.
The Stryker Total Performance System Shaver does not raise any new safety and efficacy concerns when compared to a similar device marketed by Dyonics. Therefore, the Stryker Total Performance System Shaver is substantially equivalent to the Smith & Nephew Dyonics EP-1 shaver.
E.t.
Eric Finley Design Engineer
Enclosure
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized image of a human face in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Mr. Eric Finley Design Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K973195
Trade Name: Total Performance System Shaver Regulatory Class: II Product Code: HRX Dated: August 15, 1997 Received: August 26, 1997
Dear Mr. Finley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Eric Finley
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K97317J
Page 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ N/A
TOTAL PERFORMANCE SYSTEM SHAVER HANDPIECE Device Name:
Indications For Use:
Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee Shoulder Ankle Elbow Wrist Hip Temporamandibular.
The Total Performance System Shaver Handpiece will be used to resect tissue and bur bone.
Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
(PLÉASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| Labels | Values |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | X |
| 510(k) Number | K973195 |
| Over-The-Counter Use |