LIMITED REUSE ENDOSCOPIC BLADES

K971676 · Smith & Nephew, Inc. · HRX · Jun 27, 1997 · Orthopedic

Device Facts

• Record ID: K971676
• Device Name: LIMITED REUSE ENDOSCOPIC BLADES
• Applicant: Smith & Nephew, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Limited reuse endoscopic surgery instrument consisting of concentric tubes and various tip designs. Device connects to a motor to drive an inner blade; tissue is resected and removed via suction through the inner blade diameter. Used by surgeons in endoscopic procedures to remove soft and osseous tissue from articular cavities. Modification includes validated sterilization method and performance testing at 8000 rpm.

Clinical Evidence

Bench testing only; no clinical data provided. Testing confirmed performance and safety standards at 8000 rpm.

Technological Characteristics

Limited reuse endoscopic instrument; concentric tube design; motor-driven inner blade; suction-based tissue removal; validated for sterilization; tested for operation at 8000 rpm.

Indications for Use

Indicated for endoscopic resection of soft and osseous tissue in large and small articular cavities.

Regulatory Classification

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.

Predicate Devices

• K955914

Submission Summary (Full Text)

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# Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: [phone] 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 :

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.

#### 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 [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/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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# 510(k) Number: K971676

Device Name : Limited Reuse Endoscopic Surgery Blades

Indications for Use :

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-the-Counter

(Optional Format 1-2-96)

Huston Oliveles

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