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 Description

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.

AI/ML Overview

This submission is for a material change to an existing device, the Dyonics InteliJet Reusable Cannula. The 510(k) summary indicates that the change "has no impact on the designed safety and efficacy" of the device.

Here's an analysis of the provided information, noting what can be extracted and what is not available due to the nature of this particular 510(k) summary (which focuses on a material change to an already approved device rather than a de novo submission):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maintain designed safety and efficacy after material change	Supported by biocompatibility and flow curve analysis

2. Sample Size Used for the Test Set and Data Provenance

Specific sample sizes for the "biocompatibility and flow curve analysis" are not provided in this summary. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of 510(k) submission. A material change primarily relies on engineering and scientific testing (biocompatibility, flow analysis) rather than clinical expert ground truth for medical image analysis or diagnostic performance. No experts were used in this context.

4. Adjudication Method

This information is not applicable. No expert adjudication was performed for this type of testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a material change submission for a cannula.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This device is a mechanical cannula, not an algorithm, so this type of study isn't relevant.

7. Type of Ground Truth Used

The "ground truth" for this material change involved engineering and scientific measurements corresponding to the device's functional and safety characteristics. Specifically:

Biocompatibility: Likely involved testing against relevant ISO standards to ensure the new material is not toxic or reactive.
Flow Curve Analysis: Involved measuring fluid flow properties through the cannula to ensure it meets the original design specifications for maintaining intra-articular pressure and fluid delivery.

8. Sample Size for the Training Set

This information is not applicable. This is a hardware device, not an AI or machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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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:

Intended Use of Device:

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

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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.

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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)

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).