SMITH & NEPHEW VIDEOARTHROSCOPE

K043395 · Smith & Nephew, Inc. · HRX · Jan 12, 2005 · Orthopedic

Device Facts

• Record ID: K043395
• Device Name: SMITH & NEPHEW VIDEOARTHROSCOPE
• Applicant: Smith & Nephew, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew line of rigid Multimode VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Smith & Nephew 4.0mm diameter rigid Video Athroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Device Story

Reusable rigid VideoArthroscope; provides illumination and visualization for arthroscopic and ENT procedures. Device features mechanical focus mechanism; available in various diameters, lengths, and viewing angles (0° to 110°). Used by physicians in clinical/surgical settings to visualize internal anatomy; output viewed via connected video system. Facilitates diagnostic and operative interventions, including removal of loose bodies and soft tissue in hip joints. Benefits include enhanced visualization for minimally invasive surgical procedures.

Clinical Evidence

Bench testing only. Verification and validation data demonstrate device safety and effectiveness.

Technological Characteristics

Rigid endoscope; mechanical focus mechanism; variable diameters, lengths, and viewing angles (0°-110°). Reusable. Manufactured under Quality System. No software or electronic signal processing described.

Indications for Use

Indicated for patients undergoing diagnostic or operative arthroscopic procedures, or endoscopic examination and treatment of nasal cavities and nasal pharynx. 4.0mm diameter models indicated for removal of loose bodies and soft tissue in the hip joint.

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

• Smith & Nephew VideoArthroscope (K971253)

Submission Summary (Full Text)

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K 043395

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Smith & Nephew VideoArthroscope

Date Prepared: December 7, 2004

- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

## B. Company Contact

Kathleen Burns Regulatory Affairs Associate Phone: [phone] [phone] Fax:

## C. Device Name

Smith & Nephew VideoArthroscope Trade Name: Common Name: Arthroscope Classification Name: Arthroscope

## D. Predicate Devices

The current Smith & Nephew VideoArthroscope serves as the predicate device for this submission (K971253).

#### E. Description of Device

The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device is available in a variety if diameters, lengths, and with direction of view ranging from 0° to 110° and incorporates a mechanical focus mechanism.

#### F. Intended Use

The Smith & Nephew line of rigid Multimode VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

In addition, the Smith & Nephew 4.0mm diameter rigid Video Athroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

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# G. Comparison of Technological Characteristics

The Smith & Nephew VideoArthroscope has the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and is manufactured under a Quality System.

## H. Summary Performance Data

All verification and validation data demonstrates that the device is safe and effective and performs as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

Ms. Kathleen Burns Regulatory Affairs Associate Smith & Nephew, Inc. 150 Minuteman, Road Andover, Massachusetts 01810

Re: K043395

Trade/Device Name: Smith & Nephew VideoArthroscope Regulation Number: 21 CFR 888.1100, 21 CFR 874.4760 Regulation Name: Arthroscope, Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: HRX, EOB Dated: December 8, 2004 Received: December 10, 2004

Dear Ms. Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Kathleen Burns

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Device Name: Smith & Nephew VideoArthroscope

Indications For Use: The Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

In addition, the Smith & Nephew 4 mm diameter rigid VideoArthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden
(Division Sign-Off) for

Division of General, Restora and Neurological Devices

510(k) Number K043395