(290 days)
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.
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 provided text describes a 510(k) premarket notification for the Mentor® Contour Genesis System, a device for ultrasound-assisted lipoplasty. It references a clinical study conducted to demonstrate substantial equivalence to a predicate device. However, the document does not present specific acceptance criteria in a table format with reported device performance against those criteria. It also doesn't detail the study information in the structured way requested.
Based on the information provided, here's what can be extracted and inferred, along with the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative or tabular format. Instead, it compares the new device (UAL) to a predicate device (SAL) based on safety and effectiveness measures.
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance (Mentor® Contour Genesis System - UAL) | Reference / Comment |
|---|---|---|
| Safety: Similar proportion of subjects reporting any adverse event compared to SAL. | Proportion of subjects reporting any adverse event: 18.8%. This was statistically equivalent to the SAL group. | The study aimed to show equivalence in safety outcomes. |
| Effectiveness (Overall Satisfaction): Similar overall satisfaction rate compared to SAL. | Overall satisfaction rate: 90.3% | Compared to 95.2% in the SAL group. While not explicitly stated as 'equivalent,' the narrative implies it was considered acceptable for substantial equivalence. |
| Effectiveness (Improved feelings towards treated body area): Statistically significant improvement. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
| Effectiveness (Improved self-esteem): Statistically significant improvement as measured by Rosenberg Self-Esteem scale and Body Esteem scale. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
| Effectiveness (Improved body contour measurements): Statistically significant improvement as assessed by a masked reviewer. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set:
- Total subjects enrolled: 366
- UAL patients (test group): 180
- SAL patients (control group): 186
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical study comparing two treatments for a 510(k) submission, it is highly likely to be a prospective study. The country of origin is not specified, but typically for FDA submissions, studies are often conducted in the US or follow international clinical trial standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document mentions "a masked reviewer" assessed body contour measurements.
- It does not specify the number of experts (beyond "a masked reviewer"), their qualifications (e.g., radiologist with X years of experience), or how they established the 'ground truth' for other measures like satisfaction or self-esteem (which are patient-reported outcomes).
4. Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For patient-reported outcomes like satisfaction and self-esteem, adjudication is typically not applicable as the patient's report is the primary data. For body contour measurements, "a masked reviewer" implies a single assessment, not a consensus or adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This study was a clinical comparative effectiveness study, but specifically comparing device performance (UAL vs. SAL lipoplasty), not a multi-reader multi-case study comparing human readers with and without AI assistance.
- Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this document as it's not an AI device.
6. Standalone (Algorithm Only) Performance:
- This is not an AI device, so standalone algorithm performance is not applicable. The study evaluates the performance of a medical device (Mentor® Contour Genesis System) used by a surgeon.
7. Type of Ground Truth Used:
- Primary Safety Measures: Adverse events (patient-reported and/or clinician-observed).
- Secondary Effectiveness Measures:
- Patient-reported overall satisfaction.
- Patient-reported feelings towards each body area treated.
- Patient-reported self-esteem (using Rosenberg Self-Esteem scale and Body Esteem scale).
- Body contour measurements as assessed by a masked reviewer.
8. Sample Size for the Training Set:
- The document describes a clinical study to compare the device, which serves as the test set for demonstrating equivalence. It does not mention a separate training set for the device itself. This device is a physical medical system (ultrasonic generator, handpiece, etc.), not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- As this is not an AI/ML device, a separate training set and its associated ground truth establishment are not applicable.
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June 8, 2021
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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 ProprietaryName: | 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
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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.
§ 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.