(153 days)
K062141-MammoPad Radiolucent Cushion
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a foam solution used for grip during mammography, with no mention of AI or ML.
No
The device aids in positioning during radiologic visualization, but it does not directly treat or diagnose a medical condition. It facilitates the imaging process rather than providing therapeutic benefit.
No
Explanation: The device, MammoGRIP, is described as aiding in positioning during radiologic visualization of the breast by providing a tacky surface for better grip. It is explicitly stated that it facilitates breast positioning for optimal viewing by a mammography machine. This function is related to image acquisition and patient comfort, not to the interpretation or analysis of medical images to diagnose a condition.
No
The device description clearly states it is a "non-medicated, 0.1% benzalkonium chloride foam solution," indicating it is a chemical product, not software.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- MammoGRIP's Function: MammoGRIP is a topical solution applied to the technician's hands to improve grip during breast positioning for mammography. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it "aids in positioning during radiologic visualization of the breast." This is a physical aid for a medical procedure, not a diagnostic test performed on a sample.
- Device Description: The description details a foam solution applied to hands for better grip, not a test kit or analytical instrument.
Therefore, based on the provided information, MammoGRIP falls under the category of a medical device used to facilitate a diagnostic imaging procedure, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
MammoGRIP aids in positioning during radiologic visualization of the breast.
Product codes (comma separated list FDA assigned to the subject device)
IZH
Device Description
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.
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
technician
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)
The MammoGRIP device meets the following biocompatibility standards: • Intracutaneous Injection Test (Irritation) per ISO 10993-10 • Kligman Maximization Test (Sensitivity) per ISO 10993-10 The following characteristics are verified for each lot: pH, appearance, odor, and benzylkonium chloride content. In addition, radiolucency of the MammoGRIP device has been demonstrated.
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.
K062141-MammoPad Radiolucent Cushion
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
§ 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.
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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 Huffman |
Medical Research Manager, Regulatory | |
NAMSA | |
4050 Olson Memorial Hwy. | |
Suite 450 | |
Minneapolis, MN 55422 | |
Phone: +1-763-588-9857 | |
Fax: +1-763-287-3836 | |
ehuffman@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 Cushion |
This predicate device has not been subject to a design-related | |
recall. | |
Device Description: | 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. | |
Indications for Use: | MammoGRIP aids in positioning during radiologic |
visualization of the breast. | |
Comparison of the | |
Technological | |
Characteristics with | |
the Predicate | |
Device: | The MammoGRIP device is similar to the MammoPad device |
in the following ways: | |
• Each of the devices is intended to be used as an aid to | |
positioning during radiologic visualization of the | |
breast. | |
• Each of the devices is radiolucent. | |
• Each of the devices is provided non-sterile. | |
The MammoGRIP device is different from the predicate | |
device in the following ways: | |
• Physical Form | |
Performance Data: | The MammoGRIP device meets the following |
biocompatibility standards: | |
• Intracutaneous Injection Test (Irritation) per ISO 10993-10 | |
• Kligman Maximization Test (Sensitivity) per ISO 10993-10 | |
The following characteristics are verified for each lot: pH, | |
appearance, odor, and benzylkonium chloride content. In | |
addition, radiolucency of the MammoGRIP device has been | |
demonstrated. | |
Conclusion: | The data provided in this submission support the safety of the |
MammoGRIP device and demonstrate that the MammoGRIP | |
device is substantially equivalent to the predicate device | |
which is currently marketed for the same intended use. |
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