The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.

Device Description

The LySonix Aspiration Pump System is a stand-alone version of the aspiration 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 text is a 510(k) summary for the LySonix Aspiration Pump System (K980454). This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not detail specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) in the context of a performance study for the LySonix Aspiration Pump System. The primary "performance" discussed is its functional equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or data provenance is mentioned as there is no performance study described in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. No ground truth establishment is mentioned as there is no performance study described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is mentioned as there is no performance study described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This is a physical medical device (aspiration pump), not an AI/ML software device. Therefore, an MRMC study with human readers would not be applicable or expected.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. However, the device can operate as a "stand-alone aspiration system" or with the LySonix 2000 Ultrasonic Surgical System, implying its functional independence. This is not "standalone performance" in the context of an AI algorithm evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is mentioned as there is no performance study described.

8. The sample size for the training set

Cannot be provided. No training set is mentioned as there is no AI/ML component or performance study described in this 510(k) summary.

9. How the ground truth for the training set was established

Cannot be provided. No training set ground truth is mentioned.

Summary of what is present in the document:

This 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device rather than providing a detailed performance study with acceptance criteria and results.

Device Name: LySonix Aspiration Pump System
Intended Use: For the suction or aspiration of fluids and tissue during surgical procedures. It can operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
Substantial Equivalence Claim: The LySonix Aspiration Pump System is equivalent to the aspiration component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials, and performance.
Regulatory Class: Class II
Product Code: BTA and JCX

The document indicates that the FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that, for a device of this type (an aspiration pump), the performance demonstration relied on showing it functions comparably to an already approved device, rather than requiring a detailed clinical performance study with specific acceptance criteria as you might see for a diagnostic device or AI software.

Summary

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K980454

510(k) SUMMARY

MAR 1 8 1900

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

Submitted by:	Ronald F. LagerquistRegulatory Affairs ManagerLySonix Inc.1170 Mark AvenueCarpinteria, CA 93013Telephone: (805) 684-0409
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FAX:

February 4, 1998 Date Prepared:

Device Name:

・・

Proprietary Name: LySonix Aspiration Pump System

Common Name: Aspiration Pump

Indication for Use:

(805) 684-0170

Device Description:

Substantial Equivalence:

· The LySonix Aspiration Pump System is equivalent to the aspiration component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance.

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Image /page/1/Picture/1 description: The image shows the seal of the United States Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads, representing health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K980454 LySonix Aspiration Pump System Trade Name: Requlatory Class: II Product Code: BTA and JCX Dated: February 4, 1998 Received: February 5, 1998

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent dețermination 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 requlation may result in requlatory 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 - Mr. Lagerquist

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,

R. Slyter Rhodes
Galen M. Witter, Ph.D.

M. Witten, Ph.D., M.D. irector ivision of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant:

LySonix, Inc.

510(k) Number:

K980454

LySonix Aspiration Pump System Device Name:

Indications For Use:

The LySonix Aspiration System is intended for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a standalone aspiration system.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. studying the image, I see that it is a text block. I will reproduce the text in markdown format. The text is: (Division Sign-Off) Division of General Restorative Devices 510(k) Number. K980454

Prescription Use X Per 21 CFR 801.109

Over-the-Counter

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.