SMITH & NEPHEW ARTHROSCOPE

K072675 · Smith & Nephew, Inc. · HRX · Oct 15, 2007 · Orthopedic

Device Facts

• Record ID: K072675
• Device Name: SMITH & NEPHEW ARTHROSCOPE
• Applicant: Smith & Nephew, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew line of rigid Arthroscopes/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 Arthroscopes/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

Smith & Nephew Arthroscope is a reusable rigid endoscope used for illumination and visualization of joint spaces, nasal cavities, and the nasal pharynx. Device consists of an objective lens and optical relay train to transfer images. Operated by physicians in clinical or surgical settings. Provides direct visualization to assist in diagnostic and operative procedures, including removal of loose bodies and soft tissue in the hip joint. Benefits include minimally invasive access to internal anatomical structures for examination and treatment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Rigid arthroscope/endoscope. Optical design features objective lens and relay train for image transfer. Reusable. Sterilization via various methods. No software or electronic components.

Indications for Use

Indicated for patients requiring diagnostic or operative arthroscopic procedures, or endoscopic examination and treatment of nasal cavities and nasal pharynx. 4mm diameter models are 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 Arthroscope (K043395)

Submission Summary (Full Text)

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K072675

# 007 1 5 2007

## 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 Arthroscope

Date Prepared:

# A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

### B. Company Contact

Janice Haselton Sr. Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

#### C. Device Name

| Trade Name: | Smith & Nephew Arthroscope |
|----------------------|----------------------------|
| Common Name: | Arthroscope |
| Classification Name: | Arthroscope |

### D. Predicate Devices

The current line of Smith & Nephew Arthroscopes serves as the predicate device for this submission (K043395).

#### E. Description of Device

Smith & Nephew Arthroscopes are reusable devices and are sterilized using a variety of sterilization methods. Arthroscopes are used by being inserted into an artificial opening of the human body to provide illumination and visualization of a joint space. The optical design of the standard arthroscope consists of the objective lens which creates the image and transfers it through the optical train by means of identical relays that maintain the image quality with very little degradation.

#### F. Intended Use

The Smith & Nephew line of rigid Arthroscopes/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.

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In addition, the Smith & Nephew 4 mm diameter rigid Arthroscopes/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.

# G. Comparison of Technological Characteristics

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

# H. Summary Performance Data

All verification 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

OCT 1 5 2007

Smith & Nephew, Inc. % Ms. Janice Haselton Sr. Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K072675

Trade/Device Name: Smith & Nephew Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 20, 2007 Received: September 21, 2007

Dear Ms. Haselton:

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

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Page 2 - Ms. Janice Haselton

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.

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 vour 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,

F.2
Mark N. Melkerson
Director
DES
0,2
101001

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

510(k) Number (if known): K072675

Device Name: Smith & Nephew Arthroscope

Indications For Use: The line of rigid Arthroscopes/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 Arthroscopes/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 _____________________________________________________________________________________________________________________________________________________________ (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)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072626

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