← Product Code MRD · K062421 # MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421) _Mentor Corporation · MRD · Oct 10, 2006 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K062421 ## Device Facts - **Applicant:** Mentor Corporation - **Product Code:** MRD - **Decision Date:** Oct 10, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU ## Indications for Use 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 Story Silicone elastomer device filled with silicone gel; designed for temporary intraoperative placement in surgically prepared breast pocket. Used by surgeons to evaluate appropriate size and shape of MemoryGel™ breast implants prior to permanent implantation. Provided non-sterile; requires sterilization before use; reusable up to ten times. Benefits include improved intraoperative assessment of implant fit. ## Clinical Evidence Bench testing only. Biocompatibility testing per ISO 10993 passed. Design verification study confirmed physical properties met specifications after ten cleaning, sterilization, and insertion cycles. Cleaning and sterilization procedures validated to achieve a minimum sterility assurance level of 10^-6. ## Technological Characteristics Silicone elastomer shell; silicone gel fill. Reusable (up to 10 cycles). Sterilization required prior to use. Biocompatibility per ISO 10993. ## Predicate Devices - Mentor Sterile Saline Sizer ([K010709](/device/K010709.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 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 Page 1 of 2 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 Selley
Senior Director, Clinical and Regulatory Affairs
Mentor Corporation
201 Mentor Drive
Santa 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 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. {1}------------------------------------------------ K062421 Page 2 of 2 ## 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 °. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ **510(k) Number** K062421 --- **Source:** [https://fda.innolitics.com/device/K062421](https://fda.innolitics.com/device/K062421) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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