K Number
K004005
Device Name
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
Manufacturer
Date Cleared
2001-10-12

(290 days)

Product Code
Regulation Number
878.5040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.
Device Description
The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.
More Information

Not Found

No
The summary describes a system for ultrasound-assisted tissue removal and lipoplasty, focusing on mechanical and ultrasonic components and clinical study results comparing it to suction-assisted lipoplasty. There is no mention of AI, ML, image processing, or any data-driven algorithms.

Yes
The device is indicated for the liquefication and aspiration of soft tissues and subcutaneous fatty deposits for aesthetic body contouring and surgical applications, which are therapeutic interventions.

No
The device is used for liquefaction and aspiration of soft tissues and fatty deposits, which are therapeutic procedures, not diagnostic ones.

No

The device description explicitly lists multiple hardware components including an ultrasonic generator, handpiece, foot pedal, cannulae, and tubing sets, indicating it is a hardware-based system.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical procedure involving the liquefaction and aspiration of soft tissues and fatty deposits within the body for therapeutic and aesthetic purposes.
  • Device Description: The components listed are all instruments used for surgical intervention (ultrasonic generator, handpiece, cannulae, etc.).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.

IVD devices are typically used to analyze samples like blood, urine, or tissue to detect diseases, conditions, or infections. The Mentor Contour Genesis System is a surgical device used for direct intervention on the patient's body.

N/A

Intended Use / Indications for Use

The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Product codes

OPB, MUU

Device Description

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissues, localized subcutaneous fatty deposits

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

A clinical study was conducted to compare ultrasound-assisted lipoplasty (UAL) to suction-assisted lipoplasty (SAL). A total of 366 subjects were enrolled in the study; of these, 180 were UAL patients and 186 were SAL patients. For the primary safety measures, the proportions of subjects reporting any adverse event were similar between the two treatments (18.8% for UAL and 19.9% for SAL). The statistical analysis indicated that the proportion in the UAL group was equivalent to that in the SAL group. For the secondary effectiveness measures, subjects in the UAL group reported an overall satisfaction rate of 90.3%, compared with 95.2% in the SAL group. Subjects in the UAL group had a statistically significant improvement in their feelings towards each body area treated, a statistically significant improvement in self-esteem as measured by the Rosenberg Self-Esteem scale and the Body Esteem scale, and a statistically significant improvement in body contour measurements as assessed by a masked reviewer. Very few differences were seen between UAL and SAL in these effectiveness measures.

Key Metrics

proportions of subjects reporting any adverse event were similar between the two treatments (18.8% for UAL and 19.9% for SAL).
overall satisfaction rate of 90.3% for UAL, compared with 95.2% in the SAL group.

Predicate Device(s)

K970471

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.

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June 8, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

Mentor Corp. Donna Crawford Manager, Corporate Regulatory Affairs 201 Mentor Dr. Santa Barbara, California 93111

Re: K004005

Trade/Device Name: Mentor Ultrasound-Assisted Tissue Removal System (current), Mentor Contour Genesis System (proposed) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB

Dear Donna Crawford:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 12, 2001. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

OCT 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna A. Crawford Director, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive Santa Barbara, California 93111

Re: K004005

Trade/Device Name: Mentor® Contour Genesis System Regulation Number: 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: July 17, 2001 Received: July 17, 2001

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Donna A. Crawford

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and a your finding of substantial equivalence of your device to a legally promated predicated. " ceresults 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, up

Image /page/2/Picture/5 description: The image shows a close-up of a handwritten symbol or character. It features a curved line resembling a loop or hook at the top, connected to a more angular or jagged line at the bottom. The symbol is drawn with thick, dark strokes, suggesting the use of a marker or pen.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(K) Number : K004005

Device Name:

Mentor® Contour Genesis System

Indications for Use:

The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery aspiration of both assubs in conlications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

(Division Sign-Off)

(Division Sign-On)
Division of General, Restorative Division of General Devices

510(k) Number K004005

0000009

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K00 4005 (P. 1 of 2)

OCT 1 2 2001

510(k) SUMMARY

Date:

December 22, 2000

Submitter:

Donna A. Crawford Director, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111 Phone: 805-879-6304 Fax: 805-879-6015

| Trade or Proprietary

Name:Mentor® Contour Genesis System
---------------------------------------------------------------

Common or usual name: Ultrasound-assisted lipoplasty system

Description and Intended Use of Device:

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.

The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Substantial Equivalence:

The Mentor Contour Genesis System is substantially equivalent to the Mentor Ultrasound-Assisted Tissue Removal System which was cleared under 510(k) K970471 for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

The primary difference is that the Contour Genesis System is also indicated for the liquefication and aspiration of subcutaneous fatty deposits for the purposes of aesthetic body contouring.

A clinical study was conducted to compare ultrasound-assisted lipoplasty (UAL) to suction-assisted lipoplasty (SAL). A total of 366 subjects were enrolled in the study; of these, 180 were UAL patients and 186 were SAL patients. For the primary safety

5

Koo4005 (P.2 of 2)

measures, the proportions of subjects reporting any adverse event were similar between the two treatments (18.8% for UAL and 19.9% for SAL). The statistical analysis indicated that the proportion in the UAL group was equivalent to that in the SAL group. For the secondary effectiveness measures, subjects in the UAL group reported an overall satisfaction rate of 90.3%, compared with 95.2% in the SAL group. Subjects in the UAL group had a statistically significant improvement in their feelings towards each body area treated, a statistically significant improvement in self-esteem as measured by the Rosenberg Self-Esteem scale and the Body Esteem scale, and a statistically significant improvement in body contour measurements as assessed by a masked reviewer. Very few differences were seen between UAL and SAL in these effectiveness measures.