The Mentor Ultrasound Assisted Tissue Removal System indications for use are the ultrasonic liquefication and aspiration of soft tissue.
The Mentor Ultrasound Assisted Tissue Removal System is indicated for use for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

Device Description

The principles of operation and technology incorporated in the Mentor Tissue Removal System are equivalent to ultrasonic surgical aspirator systems which use ultrasonic energy to liquefy selected tissues. The Mentor TRS performs the functions of ultrasonic tissue liquefication, irrigation/infiltration and aspiration. The user interface consists of digital and bar displays of manually controlled parameters. The system is controlled by the handpiece mounted switches or by traditional footpedal controls. The handpiece contains a piezoelectric transducer and connects by cable to the control module. The handpiece converts the electrical signal into ultrasonic mechanical vibrations which are amplified by the titanium cannula. The cannula may be used by itself or together with a stainless steel sheath which provides a path for irrigation. The irrigation and aspiration functions may be performed simultaneously or independently. The Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a "stand alone" unit used in conjunction with existing aspiration and irrigation equipment.

AI/ML Overview

This 510(k) summary (K970471) for the Mentor Ultrasound Assisted Tissue Removal System does not contain the specific acceptance criteria or a detailed study report proving the device meets acceptance criteria as typically expected for performance claims. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested details cannot be directly extracted from the provided text.

Based on the provided information, here's what can be stated:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document. The submission focuses on establishing substantial equivalence to predicate devices, implying that its performance characteristics are presumed to be similar without explicitly stating new acceptance criteria or presenting a performance study.
Sample size used for the test set and the data provenance: Not applicable. There is no mention of a test set or associated data provenance in this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is not discussed.
Adjudication method for the test set: Not applicable. There is no mention of a test set or adjudication.
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: Not applicable. This device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic or interpretative system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical tool, not an algorithm. The "Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a 'stand alone' unit used in conjunction with existing aspiration and irrigation equipment," refers to its operational flexibility as a hardware component, not standalone algorithmic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study with ground truth is detailed.
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Key takeaway from the document:

The submission for the Mentor Ultrasound Assisted Tissue Removal System (K970471) focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Morwel Corporation Ultra-Safe Ultrasonic Aspiration System (K962525) and the Valleylab CUSA System (K910696). The argument for safety and effectiveness is based on the device's "principles of operation and technology incorporated... are equivalent to ultrasonic surgical aspirator systems" and are "similar to other surgical devices with suction, ultrasound and irrigation functions which FDA has found to be substantially equivalent to pre-amendment devices."

The FDA's letter concurs with the substantial equivalence finding, allowing the device to be marketed. This type of 510(k) submission typically relies on comparing features, indications for use, and technological characteristics to predicates rather than presenting de novo performance study results with predefined acceptance criteria.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol resembling a four-pointed star with arrows at each point, followed by the word "MENTOR" in bold, uppercase letters. Below "MENTOR" is the word "CORPORATION" in smaller, uppercase letters.

JUL 17 159:

Executive Offices

5425 Hollister Avenue

Santa Barbara, CA 93111

(805) 681-6000

510(k) SUMMARY

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

The assigned 510(k) number is: K970471

Submitted by: Clarke Scherff Director Regulatory Affairs/Quality Assurance Mentor Corporation 5425 Hollister Avenue Santa Barbara, CA 93111

Telephone: (805) 681-6000 FAX: (805) 681-6004

Date Prepared: February 6, 1997

Device Name

Proprietary Name: Mentor Ultrasound Assisted Tissue Removal System

Common Name: Ultrasonic Surgical Aspirator

Indication for Use

The Mentor Tissue Removal System indications for use are the ultrasonic liquefication and aspiration of soft tissue. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..............................................................................................................

Device Description

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

510 Summary Page 2 of 2

The system is controlled by the handpiece mounted switches or by traditional footpedal controls. The handpiece contains a piezoelectric transducer and connects by cable to the control module. The handpiece converts the electrical signal into ultrasonic mechanical vibrations which are amplified by the titanium cannula. The cannula may be used by itself or together with a stainless steel sheath which provides a path for irrigation. The irrigation and aspiration functions may be performed simultaneously or independently.

The Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a "stand alone" unit used in conjunction with existing aspiration and irrigation equipment.

Substantial Equivalence Claim

The principles of operation and technology incorporated in the Mentor Tissue Removal System are similar to other surgical devices with suction, ultrasound and irrigation functions which FDA has found to be substantially equivalent to pre-amendment devices as outlined in the following table:

. . . . .

Table 1

Manufacturer	Product	510(k) Number
Morwel Corporation	Ultra-Safe UltrasonicAspiration System	K962525
Valleylab	Valleylab CUSA System	K910696

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Clarke Scherff Vice President Quality and Regulatory Assurance Mentor Corporation 5425 Hollister Avenue Santa Barbara, California 93111

JUL 17 1997

Re: K970471

Trade Name: Mentor Ultrasound Assisted Tissue Removal System Regulatory Class: II Product Code: LFL Dated: May 16, 1997 Received: May 19, 1997

Dear Mr. Scherff:

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

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

Page 2 - Mr. Clarke Schreff

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.

to all
Salli M. White, Ph.D., M.P.

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

{4}------------------------------------------------

510(k) Number (if known): K970471

Device Name: MENTOR Ultrasound Assisted Tissue Removal System

Indications For Use:

The Mentor Ultrasound Assisted Tissue Removal System is indicated for use for the " . liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

to colle 8

neral Restorative D

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

0000008

Regulation Number and Section

N/A