(89 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical, non-electronic device used for temporary sizing during surgery. There is no mention of any computational or data processing capabilities, let alone AI/ML.
No
The device is described as a "sizer" used for temporary insertion to evaluate the size and shape of breast implants. Its function is to aid in the surgical procedure of implant placement, not to treat or prevent a disease or condition itself.
No
Explanation: The device is used intraoperatively to evaluate the size and shape of breast implants before implantation. It aids in surgical planning but does not diagnose a disease or condition.
No
The device description explicitly states that the device is a "silicone elastomer device, filled with silicone gel," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the MENTOR™ Gel Breast Implant Sizer is designed for temporary insertion intraoperatively (during surgery) into the surgically prepared breast pocket. Its purpose is to help the physician evaluate the size and shape of a breast implant before it is permanently implanted.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical tool used within the body during a surgical procedure.
Therefore, the function and intended use of this device fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The MENTOR™ MemoryGel™ 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.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
Product codes
MRD
Device Description
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative 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 sterile and can be used out of the box for the initial use. The Gel Sizer is 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.
The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative 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.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast pocket
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
MENTOR™ has completed the performance qualification (PQ) for the use of the alternate MED6-6605 for the Dip Coat application process located in MENTOR™ Irving, Texas Site. The PQ acceptance criteria defined in the PQ Protocol were satisfactorily met.
In Process Visual Inspection: Yield ≥ Product Target Yield, Result: PASS, In Process Visual inspection on each of the lots showed a Yield above the Product Target Yield.
Visual Inspection after 2X Sterilization Process: C=0 / 100% Pass, Result: PASS, Visual inspection after 2X Sterilization Process showed 100% acceptable Dip Coat.
As a result of this qualification activity, it is concluded that the Dip Coat process using MED6-6605 has successfully passed PQ activities based on the acceptance criteria. This PQ established with objective evidence the Dip Coat Process, under anticipated conditions, can consistently produce products that meet all predetermined requirements. Based on the satisfactory results, it can be concluded that alternate material MED6-6605 is suitable material for Dip Coat application and can be released for commercial manufacturing once the regulatory approvals are obtained.
MENTOR™ has conducted Sizers Reprocessing Product Lifetime testing to verify that MED6-6605 (NuSil™ Technology) can adequately function as a suitable Dip Coat material and perform as intended over the product lifetime of MENTOR™ gel sizers manufactured at MENTOR™ Texas. Based on the satisfactory results, it can be concluded that alternate material MED6-6605 functioned as a suitable dispersion coating (dip coat) material over the expected product lifetime of MENTOR™ gel sizers manufactured by MENTOR™ Texas.
Criteria for Success Requirements: Visual examination, Acceptance Criteria: The dip coat on each device shall maintain full integrity and adherence of the dipcoat to the substrate posterior side of the sizer., Test Results: PASS.
Criteria for Success Requirements: Visual examination, Acceptance Criteria: There shall be no evidence of leakage of gel or like fluid in and around the dip coat at the injection hole site., Test Results: PASS.
Criteria for Success Requirements: Visual examination, Acceptance Criteria: Dip coat shall show no sign of cracking, delamination, or any leakage from fill hole., Test Results: PASS.
There was no evidence of dip coat failure, nor were any leakages detected at the dip coat injection site of any of the test samples. Therefore, MED6-6605 successfully functioned as a suitable dispersion coating (dip coat) material over the expected product lifetime of MENTOR™ gel sizers manufactured by MENTOR™ Texas.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
January 13, 2025
Mentor Worldwide, LLC Saakshi Arora-Tice Senior Regulatory Affairs Program Lead 31 Technology Drive Irvine. California 92614
Re: K243271
Trade/Device Name: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTORTM MemoryGel™ Enhance Single Use Gel Sizer Regulatory Class: Unclassified Product Code: MRD
Dated: November 14, 2024 Received: November 14, 2024
Dear Saakshi Arora-Tice:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Alicia Hemphill - Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary (K243271)
| Contact Person: | Saakshi Arora-Tice
Senior Regulatory Affairs Program Lead
Mentor Worldwide LLC
31 Technology Drive
Irvine, CA 92618 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 908-707-3561 |
| Email: | sarorati@its.jnj.com |
| Date Prepared: | January 8, 2025 |
Device Name and Classification
| Trade Name | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer (K131853)
MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer (K151055)
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Volume Sizer for Breast Implants |
| Product Code | MRD |
| Device
Classification
Regulation | Unclassified, Pre-Amendment |
| Classification Panel | General and Plastic Surgery |
| Premarket Review | Office of Health Technology 4 (Surgical and Infection Control Devices)
Division of Health Technology 4B (Infection Control and Plastic and
Reconstructive Surgery) |
Predicate Device
The predicate device referenced in this submission is the previously cleared device that utilized the original dip coat material. The devices have the same technological characteristics as the predicate device(s). The only difference is the Dip Coat component which is changing from Krayden / Dow DC 92-009 to NuSil MED6-6605 material on all Sizers manufactured at the MENTOR™ Texas.
Device Description
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative 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 sterile and can be used out of the box for the initial use. The Gel Sizer is 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.
The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative 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.
5
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
Indications for Use
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implanted.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
Comparison of Technological Characteristics with the Predicate Device
MENTOR™ is changing the current material for the Dip Coat component from Krayden / Dow DC 92-009 to NuSil™'s MED6-6605 material on all Gel Implants and Sizers manufactured at the MENTOR™ Texas. The table below compares the current Dip Coat DC 92-009 from Krayden/Dow Corning and the proposed material MED6-6605 from Nusil™. The devices have the same technological characteristics as the predicate device(s). The only difference is the Dip Coat component which is changing from Krayden / Dow DC 92-009 to NuSil MED6-6605 material on all Sizers manufactured at the MENTOR™ Texas.
| Characteristic | Description | From (Gel Sizers current design/state) | To (Gel Sizers proposed design/state) |
|---|---|---|---|
| Indications for Use | Indications for Use | a) MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer | |
| The Gel Sizer is indicated for use for temporary insertion intra- | |||
| operatively to evaluate the size and shape of the MemoryShape™ Breast Implant to be implanted. |
b) MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer
The Sizer is indicated for temporary insertion intraoperatively to
evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
c) MENTOR™ MemoryGel™ Enhance Singe Use Gel Sizer
The Sizer is indicated for temporary insertion intraoperatively to
evaluate the size and shape of the MemoryGel™ Enhance Breast
Implant to be implanted. Prior to using the Gel Sizer, the physician
should be familiar with all the literature associated with the
MemoryGel™ Enhance Breast Implant to be implanted. | No Change |
| Sterilization | Dry Heat Sterilization | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer, MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer | No Change |
| | | Temp: 236°F Min/ 251°F Max | No Change |
| | | Time: 34 hrs. Min/ 38 hrs. Max | No Change |
| | | MENTOR™ MemoryGel™ Enhance Singe Use Gel Sizer
Temp: 236°F Min/ 251°F Max
Time: 48 hrs. Min/ 52 hrs. Max | No Change |
| Material | RTV Dispersion Coating | Supplier: Krayden/Dow Corning
Materials: DC 92-009 | Supplier: NuSil™
Materials:
MED6-6605 |
Table 1: Comparison of Technological Characteristics with the Predicate Device
6
| Characteristic | Description | From (Gel Sizers current design/state) | To (Gel Sizers
proposed
design/state) |
|----------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------|
| | Device Contact
Materials for
Dip Coat
Applied to
Outside
Surface of TX
Devices | Patch Disk
Materials: MED4735 | No Change |
| | | Patch Fill- Reinforced
Materials: MED4750 Silicone | No Change |
| | | Silicone Gel (MemoryShape Family)
Materials: MED3-6309-1, Cohesive III (1:1 Mixed Gel) | No Change |
| | | Silicone Gel (MemoryGel Family)
Materials: GEL1-8109, 1-Part Pre-Mix Gel | No Change |
| | Indirect / Non-
contact TX
Device
Materials with
Dip Coat | Shell
Material: MED-6649 (Dimethyl), MED-6609 (Diphenyl) | No Change |
| | | Low Bleed Patch
Material: MED-6649 (Dimethyl), MED-6609 (Diphenyl) | No Change |
Summary of Non-Clinical Testing
Biocompatibility
MENTOR™ has completed a Biological Evaluation Matrix (BEM) focusing on a proposed material change and identifies and characterizes the materials based on their type and the duration of patient contact. The Dip Coat has direct patient contact for either a limited duration (≤ 24 hours) for sizers or long-term (>30 days) for implants. Regardless of the device's size, all devices use about the same amount (1-2 drops,