MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS

K020947 · Smith & Nephew, Inc. · FRN · Apr 17, 2002 · General Hospital

Device Facts

• Record ID: K020947
• Device Name: MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
• Applicant: Smith & Nephew, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for Use

The Dyonics InteliJET Reusable Cannulas are indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

Device Story

Dyonics InteliJET Reusable Cannulas function as surgical access portals during arthroscopic procedures. Cannulas connect to the InteliJET Fluid Management System to facilitate irrigation fluid flow into the joint space. This maintains intra-articular pressure, ensuring uniform distention and clear visualization of the surgical site for the surgeon. Used in clinical OR settings by surgeons; device enables fluid management integral to arthroscopic visualization.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993-1:1997.

Technological Characteristics

Reusable cannulas for arthroscopic fluid management. Material modified to meet ISO 10993-1:1997 biocompatibility standards. Designed for use with the InteliJET Fluid Management System.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures of the knee, shoulder, and small joints requiring irrigation fluid flow regulation for joint distention and visualization.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Dyonics InteliJET Reusable Cannulas (K020947)

Submission Summary (Full Text)

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APR 1 7 2002

K020947

# Exhibit D

510(k) Summary Dvonics InteliJET Reusable Cannulas Date Prepared: March 21, 2002

### Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: [phone] Telefax: 978-749-1599

## Smith - Nephew

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92.

### A. Submitter

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 USA

## B. Company Contact

Deborah Connors Regulatory Affairs Manager

### C. Device Name

Dvonics InteliJET™ Reusable Cannulas Trade Name: cannula for arthroscopy pump Common Name: Classification Name: Infusion Pump

#### D. Predicate Devices

The predicate device for this submission are the currently cleared Dyonics InteliJET Reusable Cannulas.

#### E. Description of Device

The Dyonics InteliJET Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJET Reusable Cannulas are designed to work in conjunction with the InteliJET Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

#### F. Intended Use

The Dyonics InteliJET Reusable Cannulas are indicated for use with the Intel.JET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

#### রে. Comparison of Technological Characteristics

The basic technologies, design and function of the Dyonics InteliJET Reusable Cannulas is not changed by the material modification described in this Premarket Notification Submission. The new material has been demonstrated to meet the requirements for biocompatibility established in ISO 10993-1: 1997. This change raises no new issues of safety and effectiveness.

Duinh (Sinn)

Deborah Connors Regulatory Affairs Manager

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 7 2002

Smith & Nephew, Inc. Endoscopy Division Ms. Deborah Connors Regulatory Affairs Manager 160 Dascomb Road Andover, Massachusetts 01810

Re: K020947

Trade Name: Dyonics InteliJET™ Reusable Cannulas Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 22, 2002 Received: March 25, 2002

Dear Ms. Connors:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave renewed your 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 May 20, 1970, the chargence 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, (Ave) that do flor require sphiect to the general controls provisions of the Act. The general thereols, maintons of the Act include requirements for annual registration, listing of devices, controlly provisions or actice, 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 11 your device 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. Deborah Connors

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 1.00 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 859. Additionally, for questions on the promotion and advertising of Compliance at [phone] - 115ce of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general informational 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,

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 Statement

ﺗ

| 510(k) Number<br>(if known) | KO20947 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Dyonics InteliJET Reusable Cannulas |
| Indications for Use | The Dyonics InteliJET Reusable Cannulas are indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints 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)

| | Miriam C. Provost |
|---------------|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K020947 |

| Prescription Use (Per 21 CFR 801.109) <div></div> | OR <div></div> Over-The-Counter Use |
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