(30 days)
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.
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 document describes a 510(k) premarket notification for the MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer STERILE. It compares this device to a predicate device (MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer, K131853) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "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." However, the specific quantitative acceptance criteria for each test are not provided in this document. The document lists the types of tests performed:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Elongation | (Not specified in document) | Met pre-determined criteria |
| Tension Set | (Not specified in document) | Met pre-determined criteria |
| Break Force | (Not specified in document) | Met pre-determined criteria |
| Patch to Shell Joint Testing | (Not specified in document) | Met pre-determined criteria |
| Gel Cohesion | (Not specified in document) | Met pre-determined criteria |
| Stability | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
| Sterilization | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
| Packaging | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical performance test. It only mentions that "non-clinical performance testing was conducted." The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is a medical device for surgical sizing, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set. The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications, verified by laboratory testing.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert interpretation, which is not applicable to the non-clinical performance testing described here.
5. 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
N/A. This device is a physical surgical sizer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance testing is based on engineering specifications and established material science properties. The tests (Elongation, Tension Set, Break Force, Patch to Shell Joint Testing, Gel Cohesion, Stability, Sterilization, and Packaging) are designed to confirm that the physical and mechanical characteristics of the device meet predetermined quality and safety standards.
8. The Sample Size for the Training Set
N/A. This is a physical medical device undergoing performance testing, not a machine learning model requiring a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As mentioned above, a training set is not applicable here.
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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
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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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 SizerSTERILE |
| 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 SizerSTERILE (Gel Sizer) is designed for temporary intra-operativeplacement in the surgically prepared breast pocket. The Gel Sizer isused to evaluate the appropriate breast implant size and shape foreach patient prior to implantation of a MemoryShape™ (contourshape) breast implant. The Gel Sizer is provided sterile and can be usedout of the box for the initial use. The Gel Sizer is then resterilized 9additional times for a total of 10 uses. The MemoryShape™ sizers areoffered in various sizes to match the corresponding MemoryShape™breast implants. These gel sizers contain raised orientation marks onthe anterior and posterior of the device to help the physician withplacement. |
| Indications for Use: | The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizeris indicated for temporary insertion intra-operatively to evaluate thesize and shape of the MemoryShape™ breast implant to be implanted. |
| Technological Characteristics: | The proposed device, MENTOR® MemoryShape™ Resterilizable GelBreast Implant Sizer STERILE, and the predicate device, MENTOR®MemoryShape™ Resterilizable Gel Breast Implant Sizer, are made ofthe same materials, are made with the same component parts, and areoffered in the same range of styles, dimensions, and fill volume. Boththe proposed device and the predicate device can be used a total of 10times. |
| The proposed device is provided sterile and can be used out of the boxfor the initial use, while the predicate device is provided non-sterileand must be sterilized prior to initial use. For all subsequent uses, bothdevices must be cleaned and sterilized prior to use. | |
| The proposed device is packaged in sterile barrier packaging and has ashelf life of five (5) years. | |
| Performance Data: | Non-clinical performance testing was conducted in order todemonstrate substantial equivalence with the predicate device. Thetesting that was performed is summarized as follows:x Elongationx Tension Setx Break Forcex Patch to Shell Joint Testingx Gel Cohesion |
| All non-clinical performance testing results met their pre-determinedacceptance criteria, thus demonstrating that the modified device issubstantially equivalent to the predicate device. In addition, stability,sterilization, and packaging data demonstrate that the changes to thedevice do not raise different questions of safety or effectiveness. | |
| Conclusions: | The proposed device, MENTOR® MemoryShape™ Resterilizable GelBreast Implant Sizer STERILE, is substantially equivalent to thepredicate device, MENTOR® MemoryShape™ Resterilizable Gel BreastImplant Sizer. There have been no changes to the intended use andindications 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 oreffectiveness. Results of non-clinical performance evaluationsdemonstrate that the proposed device is substantially equivalent tothe predicate device. |
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N/A