(153 days)
MammoGRIP aids in positioning during radiologic visualization of the breast.
MammoGRIP™ is a non-medicated, 0.1% benzalkonium chloride foam solution intended to be used during mammography to facilitate breast positioning. When MammoGRIP is applied to the technician's hands, it imparts a slightly tacky or sticky surface while it is still damp, thereby allowing the technician to have a better grip of the dry breast tissue for optimal positioning in the field of view of the mammography machine. MammoGRIP is intended to be used with standard mammogram positioning techniques.
The provided text is a 510(k) summary for the MammoGRIP device. It does not describe a study involving an AI algorithm or its performance. Instead, it describes a device that aids in breast positioning during mammography by making a technician's hands slightly tacky. The acceptance criteria and "study" mentioned refer to biocompatibility tests and verification of physical characteristics for this accessory, not an AI performance study.
Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.
Here's what can be extracted based on the provided text, interpreted in the context of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Intracutaneous Injection | Device meets ISO 10993-10 (Irritation) |
| Biocompatibility: Kligman Maximization Test | Device meets ISO 10993-10 (Sensitivity) |
| pH | Verified for each lot |
| Appearance | Verified for each lot |
| Odor | Verified for each lot |
| Benzylkonium Chloride Content | Verified for each lot |
| Radiolucency | Demonstrated (specifics not provided beyond "demonstrated") |
2. Sample size used for the test set and the data provenance
The text describes biocompatibility tests (assays) and quality control verifications for the physical characteristics of the device. These are not "test sets" in the context of clinical performance data for an AI system. The sample size for these tests is not specified in the document, nor is the data provenance in terms of country of origin or retrospective/prospective nature, as these are typically laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" here would relate to the outcome of biological responses to the material (biocompatibility) or the physical/chemical properties of the product. These are assessed by laboratory procedures, not by expert interpretation of clinical data in the way an AI would be evaluated.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" are used for expert consensus on clinical findings. For biocompatibility tests, results are typically determined by standardized laboratory protocols.
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
No. This is not an AI device, and no MRMC study was conducted or is relevant for this type of accessory.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm.
7. The type of ground truth used
For biocompatibility, the ground truth is established by the biological response observed in standardized assays. For physical characteristics, the ground truth is the measured physicochemical properties of the formulation.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
Women's Imaging Solutions Enterprises, LLC Erika Huffman Prin. Medical Research Manager 4050 OLSON MEMORIAL HIGHWAY MINNEAPOLIS MN 55422
Re: K152038
Trade/Device Name: MammoGRIP Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic X-Ray System (accessory) Regulatory Class: II Product Code: IZH Dated: December 14, 2015 Received: December 16, 2015
Dear Ms. Huffman:
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 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.
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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" (21 CFR 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,
Robert Ocks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152038
Device Name MammoGRIP
Indications for Use (Describe)
MammoGRIP aids in positioning during radiologic visualization of the breast.
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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6.0 510(k) Summary
| Submitter: | MammoGRIP LLC |
|---|---|
| Contact Person: | Erika HuffmanMedical Research Manager, RegulatoryNAMSA4050 Olson Memorial Hwy.Suite 450Minneapolis, MN 55422Phone: +1-763-588-9857Fax: +1-763-287-3836ehuffman@namsa.com |
| Date Prepared: | July 17, 2015 |
| Trade Name: | MammoGRIP™ |
| Common Name: | Mammography positioning aid |
| Classification Name: | Accessory to X-Ray Mammographic System,21 CFR Part 892.1710 |
| Regulatory Class: | Class II |
| Product Code: | IZH |
| Predicate Device: | K062141-MammoPad Radiolucent CushionThis predicate device has not been subject to a design-relatedrecall. |
| Device Description: | MammoGRIP™ is a non-medicated, 0.1% benzalkoniumchloride foam solution intended to be used duringmammography to facilitate breast positioning. WhenMammoGRIP is applied to the technician's hands, it imparts aslightly tacky or sticky surface while it is still damp, therebyallowing the technician to have a better grip of the dry breasttissue for optimal positioning in the field of view of themammography machine. MammoGRIP is intended to be usedwith standard mammogram positioning techniques. |
| Indications for Use: | MammoGRIP aids in positioning during radiologicvisualization of the breast. |
| Comparison of theTechnologicalCharacteristics withthe PredicateDevice: | The MammoGRIP device is similar to the MammoPad devicein the following ways:• Each of the devices is intended to be used as an aid topositioning during radiologic visualization of thebreast.• Each of the devices is radiolucent.• Each of the devices is provided non-sterile. |
| The MammoGRIP device is different from the predicatedevice in the following ways:• Physical Form | |
| Performance Data: | The MammoGRIP device meets the followingbiocompatibility standards:• Intracutaneous Injection Test (Irritation) per ISO 10993-10• Kligman Maximization Test (Sensitivity) per ISO 10993-10The following characteristics are verified for each lot: pH,appearance, odor, and benzylkonium chloride content. Inaddition, radiolucency of the MammoGRIP device has beendemonstrated. |
| Conclusion: | The data provided in this submission support the safety of theMammoGRIP device and demonstrate that the MammoGRIPdevice is substantially equivalent to the predicate devicewhich is currently marketed for the same intended use. |
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§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.