(59 days)
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.
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 provided document is a 510(k) premarket notification for a medical device (Stryker Total Performance System Shaver). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study in the same way a new, novel device might.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially related to AI-driven performance metrics, ground truth, and expert evaluation, is not applicable to this document. The document describes a comparison study to a predicate device rather than a performance study against predefined objective criteria.
However, I can extract the information relevant to this specific type of submission:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)
For this 510(k) submission, the "acceptance criteria" are effectively the demonstration of substantial equivalence to a legally marketed predicate device. The "device performance" is established by showing that the new device has "equivalent intended use, safety and effectiveness" and does not raise "any new safety and efficacy concerns" compared to the predicate.
| Acceptance Criteria (Demonstrated) | Reported Device Performance (Claimed) |
|---|---|
| Intended Use Equivalence | The Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in orthopedic joints (Knee, Shoulder, Ankle, Elbow, Wrist, Hip, Temporomandibular) to resect tissue and bur bone, which is equivalent to the predicate. |
| Safety and Effectiveness Equivalence | The device is equivalent in safety and effectiveness to the Smith & Nephew Dyonics EP-1 Shaver (510(k) 953096). Power modality, intended use, mode of operation, cutting technique, methods of sterilization, and safety risks are substantially equivalent. |
| No New Safety/Efficacy Concerns | The Stryker Total Performance System Shaver does not raise any new safety and efficacy concerns when compared to the Dyonics device. |
| Packaging Validation | Validated per ASTM standards 4169, D999, D775, F88, D3078. |
| Electrical Safety Validation | Validated per IEC 601-1 and IEC 601-1-2. |
| Material/Construction Equivalence | Constructed of a motor housing with a coupling mechanism for securing cutters and burs, valve for suction control, tapered fitting for attaching suction tubing, and cable for connecting to the TPS, consistent with existing marketed shavers. |
| Technological Equivalence | The powered instrumentation technology utilized in this device is equivalent to existing marketed products; it does not introduce new technological characteristics that raise new questions of safety or effectiveness. |
Since this is a substantial equivalence claim for a mechanical surgical device from 1997, the following points are largely not applicable as they relate to modern AI/software device evaluation:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There isn't a "test set" in the context of AI performance evaluation. The substantial equivalence relies on comparison of design, materials, technological characteristics, and intended use against a predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no "ground truth" establishment in the AI sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical surgical shaver, not an AI diagnostic/interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Comparison for Substantial Equivalence):
The "study" in this context is the company's analysis and comparison of its Total Performance System Shaver Handpiece to the predicate device, the Smith & Nephew Dyonics EP-1 Shaver (510(k) 953096). This is a retrospective comparison based on existing market data, regulatory filings, and technical specifications of the predicate device, along with internal testing of the new device against relevant industry standards.
- Comparison Basis: The Stryker shaver was compared to the predicate device based on:
- Intended Use
- Power Modality
- Mode of Operation
- Cutting Technique
- Methods of Sterilization
- Safety Risks
- Construction and Components
- Technological Equivalence
- Safety Testing:
- Packaging: Validated per ASTM standards 4169, D999, D775, F88, D3078.
- Electrical Safety: Validated per IEC 601-1 and IEC 601-1-2.
The conclusion of this comparison was that the Stryker Total Performance System Shaver is substantially equivalent to the Smith & Nephew Dyonics EP-1 Shaver, meaning it is considered equally safe and effective for its intended use.
{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 |
§ 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.