The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist and jaw, also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

The Smith & Nephew, Inc., Endoscopy Division sterile, disposable Endoscopic Surgery Blades as indicated for use during arthroscopic resection of soft and osseous tissue in various large and small articular cavities including the hip joint. Blades which are size-appropriate are indicated for use in the following joints : shoulder, knee, elbow, ankle, wrist, jaw and the hip joint.

Device Description

The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are to be used for illumination and visualization of joint spaces during arthroscopic procedures. Sterile, disposable Endoscopic Surgery Blades consist 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

This submission for Smith & Nephew, Inc. Endoscopy Division Arthroscopes and Accessories, Endoscopic Surgery Blades, and Manual Instruments is a 510(k) premarket notification. This type of submission claims substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and conducting a new study to prove those criteria are met.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document is essentially a regulatory filing for a medical device seeking market clearance based on its similarity to existing approved devices.

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: These are not defined because the submission is based on substantial equivalence. The "performance" is implicitly deemed equivalent to the predicate devices.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth, Training Set, Ground Truth for Training Set: These are elements of a de novo study or a clinical trial to establish safety and efficacy. A 510(k) submission based on substantial equivalence to predicate devices typically relies on existing data or design specifications of the predicate devices, rather than new, independent studies with these specific parameters.

The Summary of Device Function and Comparison of Technological Characteristics of Predicate Device sections effectively serve as the "proof" in a 510(k) context – they argue that the new devices are so similar to already approved ones that they can be considered equally safe and effective.

In summary, the provided document is a 510(k) submission, which asserts substantial equivalence to predicate devices, and therefore does not include the detailed study design and results necessary to answer the questions about acceptance criteria and study data.

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

510(k) Summary Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories

Substantial Equivalence :

Smith+Nephew /K971253

The arthroscopes listed in this 510(k) are the same arthroscopes currently marketed by Smith & Nephew, Inc., Endoscopy Division. These arthroscopes are all considered size-appropriate for use within the hip joint as well as all other previously approved indications. Endoscopic Surgery Blades are similar to product currently marketed under 510(k) #K900070. Manual Instruments are longer versions of product currently marketed under 510(k) #K904284 or those that are Class I, exempt devices.

Predicate Device :

The devices in this 510(k) submission were originally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941036, #K934299, #K912453, #K833587, and #K900070.

Summary of Device Function :

Intended Use of Device :

The Smith & Nephew, Inc., Endoscopy Division sterile, disposable Endoscopic Surgery Blades as indicated for use during arthroscopic resection of soft and osseous tissue in various large and small articular cavities including the hip joint. Blades which are sizeappropriate are indicated for use in the following joints : shoulder, knee, elbow, ankle, wrist, jaw and the hip joint.

Comparison of Technological Characteristics of Predicate Device :

The design and functions of each of the items listed in this 510(k) notification are similar to those listed in the previous 510(k)s.

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) of the United States. The seal features a stylized eagle with three stripes extending from its wing, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN | 3 | 197

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

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Re: K971253

Trade Name: Arthroscopes & Accessories, Endoscopic Surgery Blades, Manual Instruments Regulatory Class: II Product Code: HRX Dated: March 31, 1997 Received: April 3, 1997

Dear Ms. Ryan:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they May be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices in the Eederal Register. Please note: this response to your premarket notification submissions 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 - Ms. Elizabeth A. Ryan

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

[signature]

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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510(k) Number : K971253 . . . . . . . . . . . . . . . . . . .

Device Name : Arthroscopes and Accessories, Sterile Disposable Endoscopic Surgery Blades, and Manual Instruments

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Indications for Use :

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

Concurrence of CDRH, Office of Device Evaluation (QDE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971253

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter
		(Optional Format 1-2-96)

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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.