(30 days)
Not Found
No
The device description and performance studies focus on material properties and physical characteristics, with no mention of AI/ML or data processing.
No.
The device is a sizer used for temporary intra-operative evaluation of breast implant size and shape, not for treating a disease or condition.
No
The device is used to evaluate the size and shape of a breast implant during surgery, not to diagnose a medical condition or disease. It aids in the surgical procedure rather than in diagnosis.
No
The device description clearly states it is a physical gel sizer designed for temporary intra-operative placement and resterilization, indicating it is a hardware device.
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.
- Device Function: The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is a physical device used intra-operatively (during surgery) to help a physician determine the appropriate size and shape of a breast implant. It is temporarily inserted into the breast pocket.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It is a tool for physical evaluation and sizing.
Therefore, the function and intended use of this device clearly fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The MENTOR MemoryShape Resterlizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape breast implant to be implanted.
Product codes (comma separated list FDA assigned to the subject device)
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.
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
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)
Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. The testing that was performed is summarized as follows:
x Elongation
x Tension Set
x Break Force
x Patch to Shell Joint Testing
x Gel Cohesion
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. In addition, stability, sterilization, and packaging data demonstrate that the changes to the device do not raise different questions of safety or effectiveness.
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.
MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer (K131853)
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
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping profiles creating a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Mentor Worldwide LLC Ms. Sarah McManus Associate Director, Regulatory Affairs 201 Mentor Drive Santa Barbara, California 93111
Re: K151055
Trade/Device Name: MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer STERILE Regulatory Class: Unclassified Product Code: MRD Dated: April 17, 2015 Received: April 20, 2015
Dear Ms. McManus:
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
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151055
Device Name
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
Indications for Use (Describe)
The MENTOR MemoryShape Resterlizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape breast implant to be implanted.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Sponsor: | Mentor Worldwide, LLC. |
|---|---|
| 201 Mentor Drive | |
| Santa Barbara, CA 93111 | |
| Contact: | Sarah McManus |
| Associate Director Regulatory Affairs | |
| Phone: 908-218-2954 | |
| Fax: 908-218-2595 | |
| Email: smcmanu3@its.jnj.com | |
| Date of Submission: | 17 April 2015 |
| Proprietary Name: | MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer |
| STERILE | |
| Common Name: | Sizer, Mammary, Breast Implant Volume |
| Regulation: | Unclassified, pre-amendment |
| Regulatory Class: | Unclassified |
| Product Code: | MRD |
| Predicate Device: | MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer |
| (K131853) | |
| 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. | |
| Indications for Use: | The MENTOR® MemoryShape™ Resterilizable 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. | |
| Technological Characteristics: | The proposed device, MENTOR® MemoryShape™ Resterilizable Gel |
| Breast Implant Sizer STERILE, and the predicate device, MENTOR® | |
| MemoryShape™ Resterilizable Gel Breast Implant Sizer, are made of | |
| the same materials, are made with the same component parts, and are | |
| offered in the same range of styles, dimensions, and fill volume. Both | |
| the proposed device and the predicate device can be used a total of 10 | |
| times. | |
| The proposed device is provided sterile and can be used out of the box | |
| for the initial use, while the predicate device is provided non-sterile | |
| and must be sterilized prior to initial use. For all subsequent uses, both | |
| devices must be cleaned and sterilized prior to use. | |
| The proposed device is packaged in sterile barrier packaging and has a | |
| shelf life of five (5) years. | |
| Performance Data: | Non-clinical performance testing was conducted in order to |
| demonstrate substantial equivalence with the predicate device. The | |
| testing that was performed is summarized as follows: | |
| x Elongation | |
| x Tension Set | |
| x Break Force | |
| x Patch to Shell Joint Testing | |
| x Gel Cohesion |
|
| | 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. In addition, stability,
sterilization, and packaging data demonstrate that the changes to the
device do not raise different questions of safety or effectiveness. |
| Conclusions: | The proposed device, MENTOR® MemoryShape™ Resterilizable Gel
Breast Implant Sizer STERILE, is substantially equivalent to the
predicate device, MENTOR® MemoryShape™ Resterilizable Gel Breast
Implant Sizer. There have been no changes to the intended use and
indications for use. The device materials, component parts,
dimensions, styles, and volumes remain unchanged. |
| | The changes to the device do not raise different questions of safety or
effectiveness. Results of non-clinical performance evaluations
demonstrate that the proposed device is substantially equivalent to
the predicate device. |
4