SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS

K050580 · Smith & Nephew Endoscopy, Inc. · HRX · Apr 20, 2005 · Orthopedic

Device Facts

• Record ID: K050580
• Device Name: SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Smith & Nephew InteliJET™ Fluid Management Systems are indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Device Story

Microprocessor-controlled fluid management system for arthroscopic surgery; delivers irrigation fluid to surgical site. Operates via electronic pressure control loop between control unit and tube cassette. Used in OR by surgical staff to maintain intra-articular pressure, ensuring uniform distension and clear visualization. Output allows surgeons to maintain stable joint environment during procedures. Benefits include improved visualization and consistent fluid delivery.

Clinical Evidence

Bench testing only. Verification and validation data demonstrate device is safe and effective and performs as intended.

Technological Characteristics

Microprocessor-controlled irrigation pump; electronic pressure control loop; tube cassette interface. Intended for arthroscopic joint surgery. Class II device (21 CFR 888.1100).

Indications for Use

Indicated for use during arthroscopic joint surgery (knee, shoulder, hip, small joints) to regulate irrigation fluid flow and maintain intra-articular pressure for distension 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

• FMS SOLO (K002040)
• Arthroscopic Pump A115 (K033927)
• NeXtra™ Arthroscopic Pump and Shaver System (K041824)

Submission Summary (Full Text)

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

078 749 1599 Fax

K050580

Page 1 of 2

We are smith&nephew

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

APR 2 0 2005

510(K) SUMMAN I OF SHEET PARTE LE 1 11.12 LE LEFR 807.92 upon
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 InteliJET™ Fluid Management Systems

Date Prepared: March 2, 2005

### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

### B. Company Contact

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

### C. Device Name

Smith & Nephew InteliJET™ Fluid Management Systems Trade Name: Arthroscopic Fluid Management System Common Name: Classification Name: Arthroscopes

### D. Predicate Devices

The Smith & Nephew InteliJET™ Fluid Management Systems are substantially I he offinal ce replied intental Scientific Technology to the following legally marketed devices in commercial distribution: K002040: FMS SOLO, Future Medical Systems K033927: Arthroscopic Pump A115, World of Medicine K041824: NeXtra™ Arthroscopic Pump and Shaver System

#### Description of Device E.

The Smith & Nephew InteliJETTM Fluid Management Systems are microprocessor-I he Shiftil to replied for controlled delivery of irrigation fluid during intra-

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articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube cassette.

#### Intended Use F.

The Smith & Nephew InteliJET™ Fluid Management Systems are indicated for use I he Simul to Nephon int surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

## G. Comparison of Technological Characteristics

The Smith & Nephew InteliJET™ Fluid Management Systems have the same The Smith & Nophen Internation as the predicate devices, the Arthroscopic Pump A115, FMS SOLO, and NeXtra™ Arthroscopic Pump and Shaver System. In addition, 1 MB SOLO; and Neritew InteliJET™ Fluid Management System and predicate device are intended for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints.

### H. Summary Performance Data

All verification and validation data demonstrate that the devices are safe and effective and performs as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2005

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

Re: K050580

KU30580
Trade/Device Name: Smith and Nephew InteliJET™ Fluid Management System Smith and Nephew InteliJETTM Fluid Management System-HERMES

Ready Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 4, 2005 Received: March 7, 2005

Dear Ms. Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pe me substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) to regally names of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in assee approval of a premarket approval application (PMA). and Cosment Act (71ct) that ac not requent of the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (660 are 2) trols. Existing major regulations affecting your device (100 it may be subject to sach additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of counts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease of advised that I Dri of issually of our device complies with other requirements of the Act that IDA has made a decemmants in as administered by other Federal agencies. You must of any I cochal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Her S requirements, we spective requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quarty bystems (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) This letter will anow you to begin halfieling of substantial equivalence of your device to a legally prematket notification. "The I Drivinanig sification 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Colliact the Office of Compullies as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Octisahttp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050580

### Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew InteliJET™ Fluid Management System

Indications For Use:

The Smith & Nephew InteliJET™ Fluid Management System is indicated for use during I he Smill & Nepliew michs D - - 1 This wof irrigation fluids in the knee, shoulder, hip arthroscopic joint surgery to regalation in pressure for uniform distension and clear visualization of the surgical site.

Device Name: Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready

Indications For Use:

The Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready is The Smith & Neptlew meets 21 - 1 int surgery to regulate flow of irrigation fluids in multated for use daring artist over por to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

rative 341000

Smith & Nephew, Inc.
InteliJET™ F M S
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