The Smith & Nephew, Inc., Endoscopy Division Limited Reuse Endoscopic Surgery Blades as indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the blade by healthcare facilities.

Device Description

Limited reuse instrument consisting of several concentric tubes and various tip designs. The blades are used to resect and remove tissue endoscopically. The inner blade is driven by a motor. Tissue is removed by suction through the inner diameter of the inner blade.

AI/ML Overview

The provided text is a 510(k) summary for Limited Reuse Endoscopic Surgery Blades and the FDA's response letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance (algorithm only) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document focuses on regulatory approval based on substantial equivalence to a previously approved device (K955914) and highlights a "validated sterilization method and inclusion of test data showing that burr devices will meet all performance and safety standards when run at 8000 rpm" as the modification. While this implies performance and safety tests were conducted, the specific acceptance criteria and results are not detailed in this summary.

Summary

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Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599

Smith = Nephew

97i676

JUN 27 1997

510(k) Summarv Smith & Nephew, Inc., Endosopy Division Limited Reuse Endoscopic Surgery Blades

Substantial Equivalence :

The Smith & Nephew, Inc., Endosopy Division Limite Reuse Endoscopic Surgery Blades were originaly determined to be substantially equivalent to predicate devices under 510(k) K955914.

Predicate Device :

The modification to the devices referenced in this 510(k) notification as compared to the predicate devices is the addition of a validated sterilization method and inclusion of test data showing that burr devices will meet all performance and safety standards when run at 8000 rpm.

Summary of Device Function :

Intended Use of Device :

Indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the healthcare facilities.

Comparison of Technological Characteristics of Predicate Device :

The design and function of the items refered to in this 510(k) notification are identical to those listed in the previous limited reuse endoscopic surgery blade 510(k)s submitted by The Smith & Nephew, Inc., Endosopy Division.

Elizabeth A. Ryan

Regulatory Affairs

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 1997

Ms. Elizabeth A. Ryan Regulatory Affairs Smith & Nephew, Inc ... Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810

Re: K971676 Trade Name: Limited Reuse Endoscopic Blades Regulatory Class: II

Product Code: HRX Dated: May 6, 1997 Received: May 7, 1997

Dear Ms. Ryan:

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, Farts 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 (OS) 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

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Page 2 - Ms. Elizabeth A. Ryan

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.

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.

Stephen Rhode

A 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: K971676

Device Name : Limited Reuse Endoscopic Surgery Blades

Indications for Use :

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-the-Counter

(Optional Format 1-2-96)

Huston Oliveles

(Division Sign-Off) Division of General Restoral Restoration . Devices 510(k) Number_

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.