The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Device Description

The LySonix Irrigation System is a stand-alone version of the irrigation component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.

AI/ML Overview

The provided documents are a 510(k) summary and the FDA's clearance letter for the LySonix Irrigation System. These documents confirm that the device is substantially equivalent to a predicate device, but they do not contain the specific details required to answer your request about acceptance criteria and a study proving device performance.

Here's why and what information is missing:

510(k) Summary Purpose: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing intended use, technological characteristics, and performance data from studies (if applicable) to show that the new device is as safe and effective as the predicate. It does not typically include detailed reports of individual studies, their methodologies, acceptance criteria, or ground truth establishment.
Missing Information: The documents do not include:
- A table of acceptance criteria.
- Specific reported device performance against such criteria.
- Details about a study's sample size for a test set, data provenance, number or qualifications of experts, adjudication methods.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used, training set size, or how ground truth for the training set was established.

What the document does state regarding performance, but without the requested detail:

Substantial Equivalence: The key "proof" in a 510(k) submission like this is the demonstration of substantial equivalence. The document states: "The LySonix Irrigation System is equivalent to the irrigation component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance." (Page 0)
This statement implies that the performance of the LySonix Irrigation System was assessed and found to be on par with its predicate, but it doesn't describe how that performance was assessed, what specific metrics were used, or what acceptance criteria were applied in any study.

To answer your request comprehensively, one would need access to the full 510(k) submission, which would contain detailed testing protocols, results, and analyses. The summary provided here is a high-level overview for public disclosure, not the full technical report.

Summary

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

Image /page/0/Picture/0 description: The image shows a black and white graphic. The graphic is composed of a black semi-circle in the upper right corner and a black shape that resembles an arrow pointing to the left in the bottom left corner. The background is white.

K 974233

1170 Mark Avenue Carpinteria California 93013 Tel: 805-684-0409 Fax: 805-684-0170 Toll Free: 888-597-6649

510(k) SUMMARY FEB - 3 1998

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

Ronald F. Lagerquist Submitted by: Regulatory Affairs Manager LySonix Inc. 1170 Mark Avenue Carpinteria, CA 93013

Telephone: (805) 684-0409 (805) 684-0170 FAX:

November 10, 1997 Date Prepared:

Device Name:

Proprietary Name: LySonix Irrigation System

Common Name: Irrigation Pump

Indication for Use:

The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Device Description:

Substantial Equivalence:

The LySonix Irrigation System is equivalent to the irrigation component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance.

000038

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald F. Lagerquist Regulatory Affairs Manager LySonix, Incorporated 1170 Mark Avenue Carpinteria, California 93013

FEB - 3 1998

Re: K974233 Trade Name: LySonix Irrigation System Regulatory Class: II Product Code: GBX Dated: November 10, 1997 Received: November-12, 1997 ----

Dear Mr. Lagerquist:

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, Drug, 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-requirements-, 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

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

Page 2 - Mr. Lagerquist

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

2 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}------------------------------------------------

INDICATIONS FOR USE

Applicant:

LySonix, Inc.

510(k) Number:

Device Name:

K 974233

LySonix Irrigation System

Indications For Use:

The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

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

Concurrence of CDRH Office of Device Evaluation (QDE)

Pioleea

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974233

Prescription Use
Per 21 CFR 801.109

Over-the-Counter

Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.