INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY

K031605 · Smith & Nephew, Inc. · HRX · Jun 18, 2003 · Orthopedic

Device Facts

• Record ID: K031605
• Device Name: INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
• Applicant: Smith & Nephew, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids through the ioint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

Device Story

Microprocessor-based fluid management system for arthroscopic surgery; regulates irrigation fluid delivery to maintain intra-articular pressure and joint distention. Operates via electronic pressure control loop between control unit and tube cassette. Hermes-Ready™ feature adds communication interface for voice and pendant control of pressure, mode, suction, and power functions when integrated with Hermes™ Digital O.R. Center. Used in surgical settings by clinicians to improve visualization during procedures.

Clinical Evidence

Bench testing only; verification and validation data demonstrate device safety and performance as intended.

Technological Characteristics

Microprocessor-based control unit; electronic pressure control loop; tube cassette interface; communication interface for Hermes™ Digital O.R. Center integration; supports voice and pendant control inputs.

Indications for Use

Indicated for patients undergoing arthroscopic joint surgery requiring irrigation fluid flow regulation to maintain intra-articular pressure, distention, and visualization.

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 InteliJET™ Fluid Management System

Reference Devices

• Hermes™ Digital O.R. Center

Submission Summary (Full Text)

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031605

JUN 1 8 2003

Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: [phone] Fax: [phone]

Smith = Nephew

Endoscopy Division

### Exhibit C

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.

# InteliJETTM Fluid Management System Hermes-Ready™

Date Prepared: May 21, 2003

# A. Submitter's Name:

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

# B. Company Contact

Janice Haselton Regulatory Affairs Specialist II Phone: [phone] Fax: [phone]

### C. Device Name

| Trade Name: | InteliJETT™ Fluid Management System Hermes-Ready™ |
|----------------------|---------------------------------------------------|
| Common Name: | Arthroscopic Fluid Management System |
| Classification Name: | Arthroscopes |

### D. Predicate Devices

The Smith & Nephew InteliJET™ Fluid Management System Hermes-Ready™ is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew InteliJETTM Fluid Management System.

#### E. Description of Device

The Smith & Nephew InteliJETTM Fluid Management System Hermes-Ready™ is a microprocessor-based system designed for controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube casssette. The addition of the Hermes Ready™ feature will enable voice and pendant

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control of the pressure, mode, suction, and on/off functions when used in conjunction with a Hermes™ Digital O.R. Center.

#### Intended Use r.

The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids through the ioint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

# G. Comparison of Technological Characteristics

The Smith & Nephew InteliJET™ Fluid Management System Hermes-Ready™ has the same technological characteristics and intended use as the predicate device, the Smith & Nephew InteliJET™ Fluid Management System. The addition of a communication interface for voice activation with the Hermes™ Control Center offers the surgeon direct communications without changing the intended use or features of the Smith & Nephew InteliJET™ Fluid Management 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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUN 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031605

Trade/Device Name: InteliJET™ Fluid Management System Hermes-Ready™ Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 21, 2003 Received: May 22, 2003

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 Muy 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. Janice Haselton

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark A Milliken

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

| 510(k) Number (if known): | k031605 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: __ InteliJET™ Fluid Management System Hermes-Ready™

Indications For Use:

The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

(PLEASE DO NOT 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) √
OR
(Division Sign-Off)
Division of General Restorative
Over-The-Counter Use **__**

Division of General, Restorative and Neurological Dev

510(k) Number

InteliJet TM Fluid Management System HERMES - Ready TM Page 14 of 8