(26 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a gel sizer for breast implants, with no mention of AI or ML.
No
The device is a sizer used to evaluate the appropriate size and shape of a breast implant for temporary intraoperative placement, not to treat or cure a disease or condition.
No
The device is a sizer used to determine the correct size and shape of a breast implant, not to diagnose a medical condition or disease.
No
The device description clearly describes a physical, resterilizable gel sizer, which is a 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Mentor Resterilizable MemoryShape™ Gel Sizer is a physical device used intra-operatively (during surgery) to help a physician determine the correct size and shape of a breast implant by temporarily placing it in the breast pocket. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted." This is a surgical aid, not a diagnostic test.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
Product codes
MRD
Device Description
The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative 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 non-sterile to be sterilized prior to initial use and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intra-operatively used by a physician.
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)
Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. This testing was performed as required by the risk analysis and in accordance with design control procedures. The testing that was performed is summarized as follows:
- Elongation ●
- Tension Set .
- Break Force
- Patch to Shell Joint Testing
- Gel Cohesion
- Gel Penetration
All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Mentor MemoryShape " Resterilizable Gel Sizer
K131853
5.0 510(k) Summary
JUL 1 7 2013
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor MemoryShape™ Resterilizable Gel Sizer device is provided below.
| Device Common Name: | Sizer, Mammary, Breast Implant Volume |
|---|---|
| Device Proprietary Name: | Mentor MemoryShape™ Resterilizable Gel Sizer |
| Submitter: | MENTOR Worldwide LLC |
| 201 Mentor Drive | |
| Santa Barbara, CA 93111 | |
| Contact: | Manchi Cheung |
| Regulatory Project Manager | |
| 201 Mentor Dr. | |
| Santa Barbara, CA 93111 | |
| Phone: 805-879-6790 | |
| mcheung3@its.jnj.com | |
| Date Prepared: | June 20, 2013 |
| Classification | |
| Regulation: | Unclassified, Pre-Amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | MRD |
| Predicate Device: | K062421, Mentor Resterilizable Gel Breast Implant Size |
Indication for Use:
The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
Device Description:
The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative 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 non-sterile to be sterilized prior to initial use and 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.
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K131853 page 2/2
Special 510(k) Premarket Notification
Mentor MemoryShape" Resterilizable Gel Sizer
Technological Characteristics
The proposed modifications to the already cleared Mentor Resterilizable Gel Sizer include minor configuration changes to device shape and volume, gel fill, and addition of orientation marks. No new technological characteristics were introduced as a result of the proposed modifications.
Performance Data:
Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. This testing was performed as required by the risk analysis and in accordance with design control procedures. The testing that was performed is summarized as follows:
- Elongation ●
- Tension Set .
- Break Force
- Patch to Shell Joint Testing
- Gel Cohesion
- Gel Penetration
All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device is substantially equivalent to the predicate device.
Substantial Equivalence:
This 510(k) describes minor changes to the design of the Mentor Resterilizable Gel Breast Implant Sizer. There have been no changes to the indications for use or the intended use. The changes do not raise different questions of safety or effectiveness and results of non-clinical performance evaluations demonstrate that the proposed device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines extending from the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2013
Mentor Worldwide LLC % Ms. Manchi Cheung Regulatory Project Manager 201 Mentor Drive Santa Barbara, California 93111
Re: K131853
Trade/Device Name: Mentor MemoryShape™ Resterilizable Gel Breast Implant Sizer Regulatory Class: Unclassified Product Code: MRD . Dated: June 20, 2013 Received: June 21, 2013
Dear Ms. Cheung:
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 (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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Manchi Cheung
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson, M.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.0
K131853 510(k) Number (if known):
Device Name: Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer
Indications For Use:
The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape" breast implant to be implanted.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
David Krause -S
(Division Sign-Off) Division of Surgical Devic સ 53 510(k) Number K13
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