The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.

Device Description

The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided non-sterile to be sterilized prior to initial use and then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.

AI/ML Overview

This document describes the validation of the Mentor MemoryShape™ Resterilizable Gel Sizer, which is a device used to evaluate the appropriate size and shape of breast implants during surgery. The validation process focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Elongation	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.
Tension Set	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.
Break Force	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.
Patch to Shell Joint Testing	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.
Gel Cohesion	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.
Gel Penetration	Not explicitly stated, implied to meet pre-determined criteria	All non-clinical performance testing results met their pre-determined acceptance criteria.

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

The document does not specify a distinct "test set" in the context of clinical data for human or image-based evaluation. The performance data is derived from non-clinical performance testing (physical and material properties). Therefore, the concept of sample size for human users or geographical data provenance is not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance is established through physical and material property testing, not expert human evaluation of clinical outcomes or images.

4. Adjudication Method for the Test Set

Not applicable. There is no human-based "test set" or adjudication process described. The performance is determined by meeting pre-determined engineering and material science criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes the testing of a physical medical device (an implant sizer), not a diagnostic or AI-driven system that would involve human readers or comparative effectiveness studies with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This document describes the testing of a physical medical device. The concept of an "algorithm only" or a "standalone" performance for human-in-the-loop systems is not relevant.

7. Type of Ground Truth Used

The ground truth used for this study is based on pre-determined engineering and material science specifications and standards. These specifications define the acceptable physical and chemical properties of the device components.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The testing described is for the physical attributes of the product.

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

Not applicable. As there is no training set for an AI/ML algorithm, the ground truth establishment for such a set is not relevant. The "ground truth" for the device's performance is founded on established engineering best practices and material science principles.

Summary

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Mentor MemoryShape " Resterilizable Gel Sizer

K131853

5.0 510(k) Summary

JUL 1 7 2013

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor MemoryShape™ Resterilizable Gel Sizer device is provided below.

Device Common Name:	Sizer, Mammary, Breast Implant Volume
Device Proprietary Name:	Mentor MemoryShape™ Resterilizable Gel Sizer
Submitter:	MENTOR Worldwide LLC201 Mentor DriveSanta Barbara, CA 93111
Contact:	Manchi CheungRegulatory Project Manager201 Mentor Dr.Santa Barbara, CA 93111Phone: 805-879-6790mcheung3@its.jnj.com
Date Prepared:	June 20, 2013
ClassificationRegulation:	Unclassified, Pre-Amendment
Panel:	General & Plastic Surgery
Product Code:	MRD
Predicate Device:	K062421, Mentor Resterilizable Gel Breast Implant Size

Indication for Use:

The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.

Device Description:

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K131853 page 2/2

Special 510(k) Premarket Notification

Mentor MemoryShape" Resterilizable Gel Sizer

Technological Characteristics

K131853

The proposed modifications to the already cleared Mentor Resterilizable Gel Sizer include minor configuration changes to device shape and volume, gel fill, and addition of orientation marks. No new technological characteristics were introduced as a result of the proposed modifications.

Performance Data:

Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. This testing was performed as required by the risk analysis and in accordance with design control procedures. The testing that was performed is summarized as follows:

Elongation ●
Tension Set .
Break Force
Patch to Shell Joint Testing
Gel Cohesion
Gel Penetration

All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device is substantially equivalent to the predicate device.

Substantial Equivalence:

This 510(k) describes minor changes to the design of the Mentor Resterilizable Gel Breast Implant Sizer. There have been no changes to the indications for use or the intended use. The changes do not raise different questions of safety or effectiveness and results of non-clinical performance evaluations demonstrate that the proposed device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines extending from the figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 17, 2013

Mentor Worldwide LLC % Ms. Manchi Cheung Regulatory Project Manager 201 Mentor Drive Santa Barbara, California 93111

Re: K131853

Trade/Device Name: Mentor MemoryShape™ Resterilizable Gel Breast Implant Sizer Regulatory Class: Unclassified Product Code: MRD . Dated: June 20, 2013 Received: June 21, 2013

Dear Ms. Cheung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Manchi Cheung

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S

Mark N. Melkerson, M.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4.0

K131853 510(k) Number (if known):

Device Name: Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer

Indications For Use:

The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape" breast implant to be implanted.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

David Krause -S

K131853

(Division Sign-Off) Division of Surgical Devic સ 53 510(k) Number K13

Page 11 of 86

Regulation Number and Section

N/A