The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.

Device Description

The Mentor Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.

AI/ML Overview

This document describes the validation of the Mentor Resterilizable Gel Breast Implant Sizer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility: Materials used in the Sizer must meet the requirements of ISO 10993 for biological safety.	"All materials passed the requirements of ISO 10993 for biocompatibility."
Physical Properties after Repeated Use: The Sizers must maintain their physical characteristics after ten cleanings, sterilizations, and insertions. This includes meeting design specifications.	"All physical characteristics passed the acceptance criteria as defined in the protocol. These results confirmed that the Sizer met the design specifications after ten cleanings, sterilizations and insertions."
Cleaning and Sterilization Effectiveness: The recommended cleaning and sterilization procedures must achieve a minimum sterility assurance level (SAL) of 10⁻⁶.	"The results of this qualification provide documented evidence that Mentor's cleaning and sterilization procedures as recommended in the labeling achieve a minimum sterility assurance level of 10⁻⁶."

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

The document does not explicitly state the sample size used for the test set in the material biocompatibility or physical properties testing. It mentions "materials being used" and "the Sizers."

The data provenance is prospective, as these tests were conducted specifically for the device's clearance. The country of origin is USA, as the manufacturer is Mentor Corporation, located in Santa Barbara, CA and Irving, TX.

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

This information is not provided in the document. The studies described are technical performance tests (biocompatibility, physical integrity, sterilization effectiveness) which typically rely on standardized laboratory testing protocols rather than expert medical interpretation of results for "ground truth."

4. Adjudication Method:

The document does not describe an adjudication method as it's not relevant for the types of technical performance tests conducted.

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

An MRMC comparative effectiveness study was not performed or described. The device is a physical breast implant sizer, not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.

6. Standalone Performance:

Standalone performance for the device was performed. The studies focused on the intrinsic properties and performance of the Sizer itself (biocompatibility, physical durability, sterilization effectiveness) without human interaction as part of the primary measurement.

7. Type of Ground Truth Used:

The ground truth used for these studies was based on:

Standardized laboratory testing protocols and established thresholds: For biocompatibility (ISO 10993), physical properties (design specifications and defined acceptance criteria in a protocol), and sterilization effectiveness (achieving a minimum SAL of 10⁻⁶). This is a form of empirical measurement against defined standards.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device validation. Training sets are typically used for machine learning algorithms. This device is a physical medical device, and its validation relies on engineering and biological safety testing, not AI model training.

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

As there is no training set for a physical device, this question is not applicable.

Summary

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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 pointing in all directions. To the right of the symbol, the word "MENTOR" is written in bold, uppercase letters. Below "MENTOR", the word "CORPORATION" is written in smaller, uppercase letters.

201 Mentor Drive Santa Barbara, CA 93111 USA (805) 879-6000

www.mentorcorp.com

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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:	K062421	OCT 1 0 2006
Contact Person:	Nicola SelleySenior Director, Clinical and Regulatory AffairsMentor Corporation201 Mentor DriveSanta Barbara, CA 93111
Telephone:	805-879-6301
Fax:	805-879-6095

Date Prepared:

Device Name and Classification

Trade Name:	Mentor Resterilizable Gel Breast Implant Sizer
Common Name:	Volume Sizer for Breast Implants
Classification Name:	Not Classified
Product Code:	MRD

Manufacturer

Mentor Texas 3041 Skyway Circle North Irving, TX 75038

Device Description

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K062421

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Substantial Equivalence Claim

The Mentor Resterilizable Sizer is substantially equivalent to the Mentor Sterile Saline Sizer which received clearance under 510(k) K010709. The primary differences are that the Mentor Sterile Saline Sizer is provided sterile, for one differences are may and is filled with saline. The Mentor Resterilizable Gel Sizer is provided non-sterile, can be resterilized and reused up to ten times, and is filled with silicone gel.

Indications for Use

The Mentor Restelizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.

Summary of Testing

The materials being used in the Sizer were tested for biological safety. All materials passed the requirements of ISO 10993 for biocompatibility.

A design verification study was performed to assess the physical properties of the Sizers after ten cleanings, sterilizations, and insertions. All physical characteristics passed the acceptance criteria as defined in the protocol. These results confirmed that the Sizer met the design specifications after ten cleanings, sterilizations and insertions.

A qualification of the cleaning and sterilization procedures as recommended in the labeling was performed. The results of this qualification provide documented evidence that Mentor's cleaning and sterilization procedures as recommended in the labeling achieve a minimum sterility assurance level of 10 °.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2006

Mentor Corporation % Ms. Nicola Selley Sr. Director, Clinical & Regulatory Affairs 201 Mentor Drive Santa Barbara, California 93111

Re: K062421

K002421
Trade/Device Name: Mentor Resterilizable Gel Breast Implant Sizer Regulatory Class: Unclassified Product Code: MRD Dated: August 16, 2006 Reccived: August 22, 2006

Dear Ms. Selley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 510(x) prematice is substantially equivalent (for the indications for relerenced above and nave acterifical arted with the devices marketed in interstate commerce use stated in the encreasing management date of the Medical Device Amendments, or to devices that provision in May 20, 1770, inc ondeations with the provisions of the Federal Food, Drug, and Cosmetic liave occh rooms. In accerarioval of a premarket approval application (PMA). You may, Act (Act) that do not require approval controls provisions of the Act. The general therefore, mainer the devroe, subject seasing for annual registration. listing of devices. good controls provibions in alabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (600 abor of the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff thay be subject to saterial 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 I rease of advised that I Dr Crisedants over device complies with other requirements of the Act that 1-07-1 has made a acterimandians administered by other Federal agencies. You must comply or any I cacal statues and regalares. Including, but not limited to: registration and listing (21 CFR Part with an the Act 3 requirements, merading, current on the requirements as set forth in the 807), laboring (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. Nicola Selley

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Harbare Buem

Mark N. Melkerson 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

K062421 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Mentor Resterilizable Gel Breast Implant Sizer

Indications For Use:

The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary The Menton Restentizable Ool Broad Implant 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)

Barbara Bueltmann

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K062421

Regulation Number and Section

N/A