STRYKER HIP ARTHOROSCOPY SET

• K Number: K982375
• Device Name: STRYKER HIP ARTHOROSCOPY SET
• Manufacturer: Stryker Endoscopy
• Date Cleared: 1998-10-02 ( 87 days)
• Product Code: HRX
• Regulation Number: 888.1100
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K963524 , K971253 , K926212
• Predicate For: K012605 , K012635

Intended Use

The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

Device Description

The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.

AI/ML Overview

This document is a 510(k) premarket notification for the Stryker Hip Arthroscopy Set, seeking clearance from the FDA for commercial marketing. It does not include data from a study to prove the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that Stryker is asserting their device is as safe and effective as devices already on the market, not necessarily that it has met specific, novel performance benchmarks through a new study.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be answered from the provided text.

Here's an analysis of what can be extracted:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness.
   • Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy) is reported for the Stryker Hip Arthroscopy Set itself. The document states: "The Stryker Hip Arthroscopy Set introduces no new risks to health as compared with existing commercially available devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. No new performance study in a test set is described.

3. 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. No new performance study is described that would require establishing ground truth from experts. The safety and effectiveness statement mentions "orthopedic surgeons now performing various hip arthroscopic procedures," but this is in the context of device design considerations, not as part of a formal ground truth establishment for a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No new performance study is described.

5. 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 medical device (arthroscope and instruments), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. No new performance study is described.

8. The sample size for the training set:

   • Not applicable. No machine learning or AI algorithm development is described.

9. How the ground truth for the training set was established:

   • Not applicable. No machine learning or AI algorithm development is described.

Summary based on the provided text:

The Stryker Hip Arthroscopy Set is cleared based on demonstrating substantial equivalence to predicate devices (Karl Storz arthroscopes, Smith & Nephew, Karl Stroz, and Arthrex manual instruments). The clearance does not rely on a new clinical study with specific acceptance criteria and performance data for this particular device. Instead, the assumption is that since the device has similar technological characteristics and indications for use as previously cleared devices, it poses no new safety or effectiveness concerns.

Summary

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stryker
OCT 2 1998

2590 Walsh Avenue Santa Clara, CA 95051

982375

[phone] 408) 567-2505 Fax

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (REVISED)

Stryker Endos Joy

Applicant:

2590 Walsh Avenue Santa Clara, CA 95051 [phone]

Device Identification:

Common Name: Arthroscope and Accessories

Trade Name: Stryker Hip Arthroscopy Set

Contact:

Baltazar Acosta Hip Project Coordinator [phone]

Carlos Gonzalez Regulatory Affairs [phone]

Device Description: The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.

Indications: The Hip Arthroscopy Set is used for illumination and visualization of the deep confines of the hip joint. The Hip Arthroscopy Set is made size/length appropriate, and is indicated for use in approaching the hip joint for diagnostic evaluation and resection of various diseased soft tissues, debridement of cartilaginous tissues, and the removal of loose and foreign bodies in the hip joint.

Substantial Equivalence Statement: Stryker hip arthroscopes are claimed substantially equivalent (SE) to commercially available arthroscopes made by Karl Storz and cleared under K963524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex, cleared under K971253, K963524, and K926212 respectively.

Safety and Effectiveness: The Hip Arthroscopy Set is made size length appropriate, reflecting desirable characteristics as described by orthopedic surgeons now performing various hip arthroscopic procedures. The Stryker Hip Arthroscopy Set introduces no new risks to health as compared with existing commercially available devices.

Signed: Baltazar Acosta
Baltazar Acosta
Hip Project Coordinator

Signed: Carlos Gonzalez
Carlos Gonzalez
Regulatory Affairs

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1998

Baltazar Acosta Hip Project Coordinator Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K982375 Trade Name: Stryker Hip Arthoroscopy Set Regulatory Class: II Product Code: HRX Dated: June 2, 1998 Received: July 7, 1998

Dear Mr. Acosta:

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 legally marketed predicate 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.

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Page 2 - Baltazar Acosta

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

C. Sadie McWitter, Ph.D., M.D.

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

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Page 1 of 1

510(k) Number: K982375

Device Name: Stryker Hip Arthroscopy Set

Revised Indications For Use: (Revised)

The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801 109)

OR

Over the Counter Use	________________
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	(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	1982375

Regulation Number and Section

§ 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.