SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS

K980092 · Smith & Nephew, Inc. · FRN · Mar 9, 1998 · General Hospital

Device Facts

• Record ID: K980092
• Device Name: SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
• Applicant: Smith & Nephew, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 9, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for Use

The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics 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 are surgical instruments used to establish portals during arthroscopic procedures. They function as conduits for irrigation fluids when used with the InteliJet Fluid Management System. The system regulates fluid flow to maintain intra-articular pressure, ensuring uniform joint distention and clear visualization for the surgeon. Used in OR settings by surgeons; the device facilitates the surgical workflow by providing stable access and fluid management, directly benefiting the patient by enabling clear visualization during minimally invasive joint surgery.

Clinical Evidence

No clinical data. Evidence consists of bench testing, specifically biocompatibility and flow curve analysis.

Technological Characteristics

Reusable cannula for arthroscopic fluid management. Mechanical device; no energy source or software. Materials modified from predicate; validated via biocompatibility and flow performance testing.

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 Cannula (K980042)

Submission Summary (Full Text)

{0}------------------------------------------------

K980042

510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics InteliJet™ Reusable Cannula

#### Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. elephone: 508-749-1000

# Smiths = Nephew

# Substantial Equivalence:

The material change defined in this premarket notification submission has no impact on the designed safety and efficacy of the Dyonics InteliJet Reusable Cannula. This conclusion is supported by the following testing: biocompatibility and flow curve analysis.

## Predicate Device:

The predicate device for this submission is the currently marketed Dyonics InteliJet Reusable Cannula.

### Summary of Device Function:

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.

#### Intended Use of Device:

The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics 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.

# Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Dyonics InteliJet Cannulas are not changed by the material modification described in this Premarket Notification Submission. The material modification defined in this submission raises no new issues of safety and effectiveness.

Subnah J. Connor

Deborah J. Connors Sr. Regulatory Affairs Specialist

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, rendered in black lines. The eagle is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1998

Ms. Deborah J. Connors Senior, Requlatory Affairs Specialist Endoscopy Division Smith & Nephew, Incorporated 160 Dascomb Road Andover, Massachusetts 01810

K980092 Re: Trade Name: Smith & Nephew Dyonics Intelijet Reusable Cannulas Requlatory Class: II Product Code: FRN Dated: January 8, 1998 Received: January 9, 1998

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Connors

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

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

Enclosure

{3}------------------------------------------------

K980092 510(k) Number :

Device Name : Smith & Nephew, Inc., 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 WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion Sign Off

(Division General Restorative Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)