(98 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a silicone sizer, with no mention of AI or ML technology.
No
This device is a sizer used temporarily during surgery to determine the appropriate implant size, not to treat a medical condition or restore a function.
No
Explanation: The device is a sizer used for temporary intraoperative placement to evaluate the size and shape of a breast implant. It does not diagnose a medical condition or disease.
No
The device description clearly states it is a "silicone elastomer device, filled with silicone gel," indicating it is a physical object and not software.
Based on the provided information, the MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer 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.
- Device Function: The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is a physical device used intraoperatively (during surgery) to temporarily evaluate the size and shape of a breast implant pocket. It is inserted directly into the body, not used to test a sample taken from the body.
- Intended Use: The intended use clearly states it's for "temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implanted." This is a surgical tool, not a diagnostic test.
Therefore, this device falls under the category of a surgical instrument or implant accessory, not an in vitro diagnostic device.
N/A
- Intended Use / 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 shape and size of the MemoryGel™ Enhance Breast Implanted.- Product codes (comma separated list FDA assigned to the subject device)
MRD - 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 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 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. - Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found - Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062421 - Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found - Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
- Product codes (comma separated list FDA assigned to the subject device)
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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).
2
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
3
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)
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 (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 Infection |
| Control Devices) | |
| Division of Health Technology 4B (Infection Control and | |
| Plastic 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
5
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 Single
Use Gel Sizer (under review) | Mentor Resterilizable Gel Sizer
510(k) K062421 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Sizer is only indicated for single
use for temporary insertion
intraoperatively to evaluate the size
and shape of the MemoryGel™
Enhance Breast Implant to be
implanted. | 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. |
| Shell | Polydimethylsiloxane and
Phenyl Polydimethylsiloxane
(Low Bleed Layer)
Heat Cured | Polydimethylsiloxane and
Phenyl Polydimethylsiloxane
(Low Bleed Layer)
Heat Cured |
| Low Bleed Patch | Polydimethylsiloxane
Phenyl Polydimethylsiloxane
(Low Bleed Layer)
Heat Cured | Polydimethylsiloxane
Phenyl Polydimethylsiloxane
(Low Bleed Layer)
Heat Cured |
| Pad Printing | Polydimethylsiloxane
Moisture Cured | Polydimethylsiloxane
Moisture Cured |
6
| Filler | Silicone Gel
(prefilled) | Silicone Gel
(prefilled) |
|---------------|--------------------------------|---------------------------------------------------------------------------|
| Sterilization | Provided Sterile
(Dry Heat) | Provided Non-sterile
(with cleaning and sterilization
instructions) |
| 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 Implant
Sizer | MENTOR™ MemoryGel™
Enhance Single Use Gel
Sizer | Patient
Contacting |
|-----------------------|----------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------|
| | (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 MED3-6300-1
Unrestricted Gel | No |
| | | | |
| Low Bleed
Patch | 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 Silicone
Ink | Silicone CF3-1008-2 | Same as predicate | Yes |
| | | | |
| Shell
Thickness | 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 (