(89 days)
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.
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.
The provided text is a 510(k) summary for the MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer, MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer, and MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. The primary change described is a material change for the Dip Coat component from Krayden / Dow DC 92-009 to NuSil MED6-6605.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides two tables outlining acceptance criteria and results for:
- Dip Coat Process PQ Testing (Table 4): This assesses the manufacturing process of applying the new dip coat material.
- Sizers Reprocessing Product Lifetime Testing (Table 5): This evaluates the durability and integrity of the new dip coat material over the expected device lifetime.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Dip Coat Process PQ Testing (Table 4) | |||
| In Process Visual Inspection | Yield ≥ Product Target Yield | "In Process Visual inspection on each of the lots showed a Yield above the Product Target Yield." | PASS |
| Visual Inspection after 2X Sterilization Process | C=0 / 100% Pass | "Visual inspection after 2X Sterilization Process showed 100% acceptable Dip Coat." | PASS |
| Sizers Reprocessing Product Lifetime Testing (Table 5) | |||
| Visual examination (Dip coat integrity) | The dip coat on each device shall maintain full integrity and adherence of the dipcoat to the substrate posterior side of the sizer. | "PASS" (Implied: The dip coat maintained full integrity and adherence.) | PASS |
| Visual examination (Leakage) | There shall be no evidence of leakage of gel or like fluid in and around the dip coat at the injection hole site. | "PASS" (Implied: No evidence of leakage of gel or like fluid.) | PASS |
| Visual examination (Cracking/Delamination) | Dip coat shall show no sign of cracking, delamination, or any leakage from fill hole. | "PASS" (Implied: Dip coat showed no sign of cracking, delamination, or any leakage from fill hole.) | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for the "Dip Coat Process PQ Testing" or the "Sizers Reprocessing Product Lifetime testing." For the PQ testing, it mentions "each of the lots" and "100% acceptable Dip Coat," suggesting all manufactured units in the tested lots were visually inspected. For the lifetime testing, it refers to "any of the test samples."
- Data Provenance: The studies were conducted by MENTOR™ as part of their performance qualification and product lifetime testing for their manufacturing process in MENTOR™ Texas. This is an internal, prospective study to validate a material change.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This submission concerns mechanical and material performance, not diagnostic accuracy requiring human expert interpretation for ground truth. Therefore, there were no human experts used to establish a ground truth as would be relevant for an AI/CADe device. The ground truth for performance was established by measurable engineering and material integrity criteria.
4. Adjudication Method for the Test Set:
Not applicable, as no human expert interpretation or adjudication was involved for establishing ground truth performance for this type of device and material change. The criteria were objective (e.g., visual inspection for yield, integrity, and absence of leakage/cracking).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is not a comparative effectiveness study for human readers with and without AI assistance. The device is a breast implant sizer, and the studies focus on the physical performance and biocompatibility of a material change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This submission is not for an algorithm or AI device. It is for a physical medical device (breast implant sizer).
7. The Type of Ground Truth Used:
The ground truth used for these performance studies is based on objective engineering and material integrity criteria. This includes:
- Visual inspection for manufacturing yield.
- Visual inspection for dip coat integrity (adherence, absence of cracking, delamination).
- Detection of leakage.
- Biocompatibility test results (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity) against established standards and historical data for similar materials.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set. The studies are physical performance tests of a material.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.
{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 - < Digitally signed by Alicia Hemphill -S
Date: 2025.01.13 12:11:08 -0600'
Alicia Hemphill Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
MENTOR™ MemoryShape TM Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer:
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
ndications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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-TiceSenior Regulatory Affairs Program LeadMentor Worldwide LLC31 Technology DriveIrvine, 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 |
| DeviceClassificationRegulation | 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 andReconstructive 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 SizerThe 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 SizerThe Sizer is indicated for temporary insertion intraoperatively toevaluate the size and shape of the MemoryGel™ breast implant to be implanted.c) MENTOR™ MemoryGel™ Enhance Singe Use Gel SizerThe Sizer is indicated for temporary insertion intraoperatively toevaluate the size and shape of the MemoryGel™ Enhance BreastImplant to be implanted. Prior to using the Gel Sizer, the physicianshould be familiar with all the literature associated with theMemoryGel™ 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 SizerTemp: 236°F Min/ 251°F MaxTime: 48 hrs. Min/ 52 hrs. Max | No Change | ||
| Material | RTV Dispersion Coating | Supplier: Krayden/Dow CorningMaterials: 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 Sizersproposeddesign/state) |
|---|---|---|---|
| Device ContactMaterials forDip CoatApplied toOutsideSurface of TXDevices | Patch DiskMaterials: MED4735 | No Change | |
| Patch Fill- ReinforcedMaterials: 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 TXDeviceMaterials withDip Coat | ShellMaterial: MED-6649 (Dimethyl), MED-6609 (Diphenyl) | No Change | |
| Low Bleed PatchMaterial: 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, <0.02 grams) of Dip Coat material. The proposed alternative is NuSiI™ MED6-6605 - RTV Silicone, which is already used in other MENTOR™ Saline-Filled and Spectrum Adjustable Breast Implants and Saline Sizers. These implants were first approved by the US FDA on May 10, 2000 (PMA Number P990075) and are marketed outside the US (CE mark in 1995) with no significant safety issues related to the silicone.
MENTOR™ has also conducted a Biocompatibility and Toxicology Risk assessment for the proposed sizer devices dip coated with MED6-6605. The proposed dip coat material MED6-6605 is already used in other MENTOR™ Saline-Filled and Spectrum Adjustable Breast Implants and Saline Sizers. A detailed biocompatibility risk assessment was conducted on these devices which concluded that these devices present no significant biocompatibility risk when used as long-term implants or limitedduration sizers. Based on existing chemical, biological data and history of clinical use, Spectrum and Saline filled Breast Implants and Sizers present no significant risk of adverse biologic reactions in patients.
Table 2 provides a summary of the biological tests of the dipcoat material (MED6-6605) which is already used in MENTOR™ saline-filled implants and sizers (P990075). Table 3 provides a summary of the biological tests of the sizer (other than dipcoat material).
| Test | Test Article | Result |
|---|---|---|
| Cytotoxicity, Elution | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Device - cut samples) | No evidence of cell lysis or toxicity |
| Cytotoxicity, Direct | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Shell - outside surface) | Slight evidence of cell lysis andtoxicity |
| Sensitization | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Shell) | No evidence of sensitization |
| Irritation/ Intracutaneous Reactivity | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Device - cut samples) | No evidence of irritation |
| Pyrogenicity, Material-mediatedpyrogenicity | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Device - cut samples) | Non-pyrogenic |
| Acute Systemic Toxicity | MENTOR™ Saline-Filled and Spectrum™Mammary Prostheses (Device - cut samples) | No evidence of systemic toxicity |
Table 2: Summary of Toxicology and Biocompatibility Testing & Results Applicable to Dip Coat as used in MemoryGel. MemoryShape & MemoryGel Enhance Sizers
{7}------------------------------------------------
| Implant Sizers | ||
|---|---|---|
| Test | Test Article | Result |
| Cytotoxicity - Elution | MENTORTM MemoryGelTM Resterilizable GelBreast Implant Sizer | No evidence of cell lysis or toxicity |
| Sensitization | MENTORTM MemoryGelTM Resterilizable GelBreast Implant Sizer | No evidence of sensitization |
| Irritation/ IntracutaneousReactivity | MENTORTM MemoryGelTM Resterilizable GelBreast Implant Sizer | No evidence of irritation for SC extract Slightedema/erythema for SO extract PrimaryIrritation Index was negligible |
| Material mediatedpyrogenicity | MENTORTM MemoryGelTM Resterilizable GelBreast Implant Sizer | Non-pyrogenic |
| Acute Systemic Toxicity | MENTORTM MemoryGelTM Resterilizable GelBreast Implant Sizer | No mortality or evidence of systemictoxicity |
| Endotoxin Mediatedpyrogenicity | MENTORTM MemoryGelTM Resterilizable GelBreast Implant SizerMENTORTM MemoryShapeTM ResterilizableGel Breast Implant Sizer | Non-pyrogenic: all lots passed |
Table 3: Summary of Toxicology and Biocompatibility Testing & Results Conducted for Gel Breast Implant Sizers
Performance Data
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 (see Table 4).
| Attribute Requirement | Acceptance Criteria | PASS/FAIL & Result / Conclusion |
|---|---|---|
| In Process VisualInspection | Yield ≥ Product TargetYield | PASSIn Process Visual inspection on each of the lots showed a Yieldabove the Product Target Yield |
| Visual Inspection after 2XSterilization Process | C=0 / 100% Pass | PASSVisual inspection after 2X Sterilization Process showed 100%acceptable Dip Coat. |
Table 4: Summary of testing and conclusions of the Dip Coat Process PQ Testing
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 (see Table 5), 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 SuccessRequirements | Acceptance Criteria | Test Results(PASS/FAIL)? |
|---|---|---|
| Visual examination | The dip coat on each device shall maintain full integrity and adherence of thedipcoat to the substrate posterior side of the sizer. | PASS |
| There shall be no evidence of leakage of gel or like fluid in and around the dipcoat at the injection hole site. | PASS | |
| Dip coat shall show no sign of cracking, delamination, or any leakage from fillhole. | PASS |
Table 5: Summary of testing and conclusions of the Sizers Reprocessing Product Lifetime testing
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
{8}------------------------------------------------
dispersion coating (dip coat) material over the expected product lifetime of MENTOR™ gel sizers manufactured by MENTOR™ Texas.
Summary and Conclusion
The combination of successful performance testing (passing all acceptance criteria), biocompatibility, unchanged indications for use, and unchanged technological characteristics, demonstrate substantial equivalence of the proposed devices to the predicate devices. The conclusions drawn from the nonclinical testing (discussed above) demonstrate that the proposed sizer devices dip coated with MED6-6605 from Nusil™ is as safe, as effective and performs as well as the predicate devices dip coated with DC 92-009 from Krayden/ Dow.
N/A