(98 days)
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 Implanted.
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 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 sterile and is for single use only. The Sizer should not be resterilized.
The provided text is a 510(k) summary for the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. It outlines the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing and performance data.
However, the request asks for specific details about the acceptance criteria and the study proving the device meets these criteria, particularly in the context of an AI medical device. The provided FDA document does not pertain to an AI medical device. Instead, it describes a physical medical device (a breast implant sizer). Therefore, many of the requested points, such as AI-specific performance metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance), and details about training/test sets for an AI model, are not applicable to this document.
The document discusses biocompatibility testing and physical performance data for the sizer device. I will extract the relevant "acceptance criteria" and "device performance" information from the provided text as best as possible, mapping it to the closest available information, while explicitly noting when requested information is not present or not applicable due to the nature of the device described.
Device: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
Type of Device: Physical Medical Device (not an AI medical device)
Acceptance Criteria and Reported Device Performance
The provided document details non-clinical testing for biological safety (biocompatibility) and physical properties. The acceptance criteria are implicitly that the device "passed" these tests or showed "no significant effects."
| Acceptance Criteria Category | Specific Test/Property | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO Agarose Overlay and ISO Elution) | Device passes cytotoxicity requirements. | Passed |
| Sensitization (Maximization Method) | Device passes sensitization requirements. | Passed | |
| Intracutaneous Reactivity | Device passes intracutaneous reactivity requirements. | Passed | |
| Acute Systemic Toxicity | Device passes acute systemic toxicity requirements. | Passed | |
| Hemocompatibility (Direct Contact and Extraction) | Device passes hemocompatibility requirements. | Passed | |
| Pyrogenicity - Material Mediated | Device is non-pyrogenic. | Non-pyrogenic. | |
| Pyrogenicity - Limulus Amebocyte Lysate (LAL) | Device is non-pyrogenic. | Non-pyrogenic. | |
| Genotoxicity (Bacterial Reverse Mutation Assay) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Unscheduled DNA Synthesis Assay in Mammalian Cells In Vitro) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Micronucleus Cytogenetic Assay in Mice) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Implantation | Device is non-irritating. | Non-irritating. | |
| Immunotoxicity | No significant effects on immunological response. | No significant effects of the test articles on the immunological response. | |
| Autoantibody Production | No significant differences for serum IFN-γ levels among treatment groups. | No significant differences were found for the serum IFN-γ levels among the treatment groups of this experiment. | |
| Adjuvancy | Unlikely to cause an adjuvant effect in humans. | Unlikely that silicone gels cause an adjuvant effect in humans. | |
| Reproductive Toxicity/Teratogenicity | Does not cause reproductive or teratogenic effects. | Did not cause reproductive or terotogenic effects. | |
| Chronic Toxicity/Carcinogenicity | Not considered to be carcinogenic. | Not considered to be carcinogenic. | |
| Physical Performance | Shell/Patch Joint Strength | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. |
| Shell Elongation | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Shell Tension Set | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Shell Break Force | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Gel Cohesiveness | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Microbiological Safety | Bioburden Testing | Verification of device microbiological safety. | Conducted to verify device microbiological safety. (No specific "passed" or "failed" for Bioburden, but implied by overall conclusion that "all physical characteristics passed the acceptance criteria.") |
| Routine LAL Testing | Verification of device microbiological safety. | Conducted to verify device microbiological safety. (No specific "passed" or "failed" for LAL, but implied by overall conclusion that "all physical characteristics passed the acceptance criteria.") |
Study Details (as applicable to a physical device, not an AI device)
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state sample sizes for each specific test. It mentions "test articles" (e.g., "Intact, smooth and Siltex MemoryGel breast implants" for cytotoxicity) which implies physical samples were used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be laboratory-based performance and biocompatibility testing of manufactured units, rather than human subject data or image data. It refers to established standards (e.g., EN ISO 10993-1, FDA Guidance).
- Retrospective or Prospective: Not applicable in the context of device design verification; these are laboratory tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to physical and biological testing metrics, not interpretation of clinical data by experts for ground truth establishment. Biocompatibility results are typically determined by laboratory assays and objective measurements against established standards, not expert consensus. The "ground truth" for physical properties would be engineering specifications and measurements.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for image-based or clinical human-in-the-loop studies (e.g., for AI). For physical device testing, results are typically determined by validated testing methods and equipment.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical breast implant sizer, not an AI device. No human-in-the-loop studies involving AI assistance are described.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The type of ground truth used:
- For Biocompatibility: Laboratory test results, conducted according to ISO 10993 standards and FDA guidance, measuring specific biological responses (e.g., cytotoxicity, sensitization).
- For Physical Performance: Engineering specifications and objective physical measurements (e.g., strength, elongation, break force, cohesiveness). This leverages testing conducted to qualify the device as an implant, implying adherence to implant design specifications.
-
The sample size for the training set:
- Not applicable. This refers to a physical device, not an AI model requiring a training set. The "training" for this device is its manufacturing process and design.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of an AI model for this physical device. The device's "ground truth" for its design and manufacturing would be established through established engineering principles, material science, and quality control processes. The document states that the testing "leverages the testing conducted to qualify the device as an implant" and confirms it "meets implant design specifications."
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September 6, 2024
Mentor Worldwide LLC Alicia Botham Senior Program Lead 31 Technology Drive Irvine, California 92614
Re: K241552
Trade/Device Name: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer Regulatory Class: Unclassified Product Code: MRD Dated: May 24, 2024 Received: May 31, 2024
Dear Alicia Botham:
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" (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).
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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 Rule"). 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).
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Sincerely,
Simeerery',
Alicia Hemphill -S Hemphill -S Hemphill -S Hemphill -S
Alicia Hemphill -S Hemphill -S - Date: 2024.09.06 21:10:36 Date: 2024.09.06 21:10:36 -05'00'
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
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Indications for Use
510(k) Number (if known) K241552
Device Name
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
Indications for Use (Describe)
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 Implanted.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K241552)
Contact Person: Alicia Botham Senior Program Lead, Regulatory Affairs Mentor Worldwide LLC 31 Technology Drive Irvine, CA 92618
Telephone: 828-775-0302
Email: ABotham1@its.jnj.com
May 31, 2024 Date Prepared:
Device Name and Classification
| Trade Name | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer |
|---|---|
| Common Name | Volume Sizer for Breast Implants |
| Product Code | MRD – Mammary Sizer |
| Device Classification Regulation | Unclassified, Pre-Amendment |
| Classification Panel | General and Plastic Surgery |
| Premarket Review | Office of Health Technology 4 (Surgical and InfectionControl Devices)Division of Health Technology 4B (Infection Control andPlastic and Reconstructive Surgery) |
Predicate Device
MENTOR™ MemoryGel™ Resterilizable Gel Sizer, K062421
This predicate has not been subject to a design-related recall.
Device Description
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 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
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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™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ Enhance Breast Implant to be implanted.
Comparison of Technological Characteristics with the Predicate Device:
The MENTOR™ MemoryGel™ Enhance (SZUHE) Single Use Gel Sizer is substantially equivalent to the MENTOR™ Resterilizable Gel Sizer which received clearance under 510(k) K062421. The primary differences are the Mentor Resterilizable Gel Sizer is provided non-sterile, can be resterilized and reused up to ten times. The MENTOR™ MemoryGel™ Enhance Gel Breast Implant Sizer is provided sterile and is for single use only.
| MENTOR™ MemoryGel™ Enhance SingleUse Gel Sizer (under review) | Mentor Resterilizable Gel Sizer510(k) K062421 | |
|---|---|---|
| Indication for Use | The Sizer is only indicated for singleuse for temporary insertionintraoperatively to evaluate the sizeand shape of the MemoryGel™Enhance Breast Implant to beimplanted. | The Mentor Resterilizable Gel BreastImplant Sizer is indicated for temporaryinsertion intraoperatively to evaluatethe size and shape of the MemoryGel™Breast Implant to be implanted. |
| Shell | Polydimethylsiloxane andPhenyl Polydimethylsiloxane(Low Bleed Layer)Heat Cured | Polydimethylsiloxane andPhenyl Polydimethylsiloxane(Low Bleed Layer)Heat Cured |
| Low Bleed Patch | PolydimethylsiloxanePhenyl Polydimethylsiloxane(Low Bleed Layer)Heat Cured | PolydimethylsiloxanePhenyl Polydimethylsiloxane(Low Bleed Layer)Heat Cured |
| Pad Printing | PolydimethylsiloxaneMoisture Cured | PolydimethylsiloxaneMoisture Cured |
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| Filler | Silicone Gel(prefilled) | Silicone Gel(prefilled) |
|---|---|---|
| Sterilization | Provided Sterile(Dry Heat) | Provided Non-sterile(with cleaning and sterilizationinstructions) |
| Use | Single Use Only | Up to 10 times use |
Device Component Comparison for Predicate and Proposed Device(s)
| Component | MENTOR™ MemoryGel™ MC, M+, HP,UHP Resterilizable Gel Breast ImplantSizer | MENTOR™ MemoryGel™Enhance Single Use GelSizer | PatientContacting |
|---|---|---|---|
| (Predicate) | (Proposed) | ||
| Silicone Shell | Polydimethylsiloxane | Same as predicate | Yes |
| Dimethyl: MED-6649 | |||
| Diphenyl: MED-6609 | |||
| Silicone gel | 1 Part Pre-Mix Restricted Gel: GEL1-8109 | Nusil MED3-6300-1Unrestricted Gel | No |
| Low BleedPatch | Polydimethylsiloxane | Same as predicate | No |
| Dimethyl: MED-6649 | |||
| Diphenyl: MED-6609 | |||
| Patch Disk | MED-4735 | Same as predicate | No |
| Disk | MED-4735 | Same as predicate | No |
| Dip Coat | Dow Corning 92-009 | Same as predicate | Yes |
| Black SiliconeInk | Silicone CF3-1008-2 | Same as predicate | Yes |
| ShellThickness | Minimum thickness is 0.009" | Same as predicate | N/A |
Summary of Non-Clinical Testing:
Biocompatibility
The MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is currently categorized as a limited (<24hrs) tissue contacting device as per EN ISO 10993-1 (2020) and FDA Guidance for Industry "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
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(2023). The materials being used in the Sizer were tested for biological safety. All materials passed the requirements of ISO 10993 for biocompatibility.
The device was first qualified as a breast implant and therefore, testing conducted to qualify the device as an implant can be applied to the device used as a sizer. Per the Design Verification Plan, the only difference between the device as an implant the device as a sizer (the subject of this application), is device labelling as well as pad printing to read "SINGLE USE ONLY" and "NOT FOR IMPLANT."
| Test | Test Article | Results |
|---|---|---|
| Cytotoxicity Study (ISOAgarose Overlay and ISOElution) | Intact, smooth and SiltexMemoryGel breast implants | Passed |
| Sensitization(MaximizationMethod) | MemoryGel smooth shell,textured shell and siliconegel | Passed |
| Intracutaneous Reactivity | Smooth and SiltexMemoryGel breast implants | Passed |
| Acute Systemic Toxicity | Smooth and SiltexMemoryGel breast implants | Passed |
| Hemocompatibility (DirectContact and Extraction) | Siltex and smoothMemoryGel breast implants | Passed |
| Pyrogenicity - MaterialMediated | Smooth and SiltexMemoryGel breast implants | Non-pyrogenic. |
| PyrogenicityーLimulusAmebocyte Lysate (LAL) | Smooth MemoryGel BreastImplants | Non-pyrogenic |
| Genotoxicity - BacterialReverse Mutation Assay | Smooth MemoryGel breastimplant | Negative for genotoxic activity |
| Genotoxicity - UnscheduledDNA Synthesis Assay inMammalian Cells In Vitro | Smooth MemoryGel breastimplant | Negative for genotoxic activity |
| Genotoxicity - ChromosomeAberrations in ChineseHamster Ovary (CHO) Cells | Smooth MemoryGel breastimplant | Negative for genotoxic activity |
| Genotoxicity - MicronucleusCytogenetic Assay in Mice | Siltex MemoryGel breastimplant | Negative for genotoxic activity |
| Implantation | Siltex MemoryGel BreastImplant | Non-irritating |
| Immunotoxicity | Smooth and SiltexMemoryGel breast implants | No significant effects of the testarticles on the immunologicalresponse |
Summary of Toxicology and Biocompatibility Testing & Results Considered for the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
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| Autoantibody Production | Smooth MemoryGel BreastImplant Shell | No significant differences werefound for the serum IFN-γ levelsamong the treatmentgroups of this experiment. |
|---|---|---|
| Adjuvancy | Siltex MemoryGel BreastImplant Shell and Gel | Unlikely that silicone gels cause anadjuvant effect in humans |
| ReproductiveToxicity/Teratogenicity | Smooth MemoryGel BreastImplant Shell, SiltexMemoryGel Breast ImplantShell and Gel | Did not cause reproductive orterotogenic effects |
| ChronicToxicity/Carcinogenicity | Smooth MemoryGel BreastImplant Shell, SiltexMemoryGel Breast ImplantShell and Gel | Not considered to be carcinogenic |
Performance Data
Mentor conducted design verification to assess the physical properties of the Sizers, which leverages the testing conducted to qualify the device as an implant. The following tests were performed: Shell/Patch Joint Strength, Shell Elongation, Shell Tension Set, Shell Break Force, and Gel Cohesiveness. In addition, Bioburden Testing and Routine LAL Testing were conducted to verify device microbiological safety. All physical characteristics passed the acceptance criteria as defined in the protocol. These results confirm that the device meets implant design specifications, and therefore qualifies the device to be used as a sizer for temporary intraoperative use by means of substantial equivalence to the predicate device.
Summary and Conclusion
The combination of successful performance testing (passing all acceptance criteria), unchanged indications for use, and unchanged technological characteristics, demonstrate substantial equivalence of the proposed device to the predicate device. The conclusions drawn from the nonclinical testing (discussed above) demonstrate that the subject device (K241552) is as safe, as effective and performs as well as or better than the predicate device (MENTOR™ Resterilizable Gel Breast Implant Sizer, K062421).
N/A