The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the LySonix Suction/Aspiration and Infusion Cannulas. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections (e.g., acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

The core of this 510(k) is to show that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying that it would perform similarly and thus be as safe and effective. It does not contain a study designed to quantify the performance of the device against predefined acceptance criteria in the way one might find for a diagnostic or AI device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Material Composition	Not explicitly stated but implied to be "biocompatible metal" (stainless steel) for cannulas and aluminum for handles, matching predicates.	LySonix cannulas are stainless steel, handles are aluminum.
Technological Characteristics	Implied to be "same technological characteristics" as predicate devices.	"No new technology is being introduced... design is similar to the predicate Suction Aspiration Cannulas already on the market." This includes lengths, diameters, and tip shapes/styles within the same ranges.
Intended Use	Same as predicate devices: for suction of fluids/tissue and infusion of fluids during surgical procedures.	"instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures."
Sterility	Non-sterile, with predicate devices also offered non-sterile (and some as sterile options).	Provided non-sterile.

Note: The 510(k) process for this type of device relies heavily on substantial equivalence to existing devices, rather than establishing new performance metrics. Performance is assumed to be acceptable if it matches that of the legally marketed predicate devices.

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

Not Applicable / Not Provided: This 510(k) summary does not describe a performance study with a test set of data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison of design, materials, and intended use to predicate devices. There is no "test set" of patient data in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable / Not Provided: There was no "ground truth" derived from expert review of a test set, as this device submission does not involve a diagnostic or AI algorithm requiring such validation.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: No test set or expert adjudication was performed for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No: This document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) to assess the impact of the device on human reader performance. This product is a surgical tool, not a diagnostic device.

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

Not Applicable: This product is a physical surgical instrument (cannulas), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

Not Applicable: For this type of medical tool that is claiming substantial equivalence, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. There is no specific outcome data, pathology, or expert consensus used as ground truth for a new performance claim, as no new performance claim is being made.

8. The Sample Size for the Training Set

Not Applicable / Not Provided: This submission does not involve a machine learning or AI model, so there is no "training set."

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

Not Applicable / Not Provided: As there is no training set, this question is not relevant.

Summary

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K472958

510(k) SUMMARY LYSONIX SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION CANNULAS

SFF 9 9 1007

I. NAME OF SUBMITTER

LySonix, Inc. 1170 Mark Avenue Carpinteria, CA 93013

Contact person: Michael Sarrasin, JD (805) 684-0409 phone (805) 684-0170 fax

II. DEVICE NAME AND CLASSIFICATION

LySonix Suction/Aspiration Cannulas (TTD Delta Scavenger Proprietary Name: Cannulas) LySonix Infusion Cannulas (Infusion Diamond Cannulas) Common or Usual Name: Suction/Aspiration Cannulas Infusion/irrigation Cannulas Classification: Class II

Endoscope and accessories; 21 CFR 876.1500 Vacuum-powered suction apparatus; CFR 880.6740

III. PREDICATE DEVICES

The LySonix Suction/Aspiration Cannulas and Infusion Cannulas are substantially equivalent to suction and infusion cannula devices in commercial distribution by the following companies:

Ultra-Safe Ultrasonic Aspirator System (including suction cannulas); Morwel Corporation, Tucson, AZ; 510(k) number K962525
Suction Tips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520
Endo-Pool Suction Cannulas and Irrigation Probes: Davol. Inc., Cranston, RJ: 510(k) numbers K914526 and 926479
Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936
Byron Suction Tips; Byron Medical Corporation, Tucson, AZ 510(k) number K861878

IV. DESCRIPTION

The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The

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Suction and Infusion Cannulas are each available in three cannula lengths and four diameters.

The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile

V. INTENDED USE

The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.

The LySonix Suction and Infusion Cannulas are inserted under the skin during various types of surgical procedures and may be connected to a suction or aspiration apparatus if desired. The Suction Cannula can then be used to suction out waste fluids or aspirate unwanted tissue. The Infusion Cannulas are used to infuse fluids such as medications or saline during surgery. The Suction/Aspiration and Infusion cannulas are not indicated for use with any specific surgical specialty, but are considered general surgical tools.

VI. TECHNOLOGICAL CHARACTERISTICS

The LySonix Suction and Infusion Cannulas have the same technological characteristics as their predicate devices.

The materials used in all the came. All the manufacturers of these cannulas provide the devices in stainless steel, a biocompatible metal. The handles of the LySonix cannulas are ahulminum, as are handles provided by the predicate devices.

No new technology is being introduced in the design of the LySonix Cannulas and the design of the cannulas is similar to the predicate Suction Aspiration Cannulas already on the market. The lengths and diameters of the LySonix Suction and Infusion Cannulas are within the same ranges as those of the predicate devices, and the choice of tip shapes and styles are the same standard designs as the choices provided by the predicate devices. The predicate devices provide for a variety of handles of the LySonix cannulas do not differ in technology or design. All the devices are provided non-sterile, with some of the predicate devices also being offered as a sterile option.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. M.J. Sarrasin, J.D. Vice President, Regulatory and Legal Affairs LySonix, Inc. 1170 Mark Avenue Carpinteria, California 93013

SEP 1 9 1997

Re: K972958

Trade Name: LySonix Suction/Aspiration and Infusion Cannulas Regulatory Class: I Product Code: FGY Dated: August 8, 1997 Received: August 11, 1997

Dear Mr. Sarrasin:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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. M.J. Sarrasin, J.D.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972958

Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

Applicant: LYSONIX, INC.

510(k) Number (if known): N/A*

Device Name: LYSONIX SUCTION/ASPIRATION AND INFUSION CANNULAS

Indications For Use:

100

The LySonix Cannulas are instruments used for suction of thids and tissue and for infusion of fluids during a variety of surgical procedures.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Div. of General, Restorative and Neurological Devices)
Division Sign-Off
510(k) Number	K972958

Prescription UsePer 21 CFR 801.109	✓	OR	Over-the-Counter
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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.