(116 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics associated with AI/ML models strongly suggest this is a physical aid for self-examination, not an AI/ML-powered device.
No.
The device is described as an aid for performing self-breast examinations, facilitating detection rather than treatment or prevention of disease. Its function is to assist in examination, not to provide therapy.
No
The device is described as an "aid for performing breast-self examinations" and helps "detecting abnormalities," but it does not make a diagnosis. The predicate devices are also for self-examination.
No
The device description explicitly states it is made of conformable polyurethane and filled with a non-toxic lubricant, indicating it is a physical device, not software-only.
Based on the provided information, the BeMitt™ Self Breast Exam 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.
- BeMitt™ Function: The BeMitt™ is a physical aid used externally on the breast to facilitate a self-examination. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it's an "aid for performing breast-self examinations," which is a physical examination technique.
Therefore, the BeMitt™ falls under the category of a medical device used for physical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BeMitt™ Self Breast Exam is indicated as an aid for performing breast-self examinations.
Product codes (comma separated list FDA assigned to the subject device)
IZH
Device Description
The BeMitt™ Self Breast Exam is indicated as an aid for performing breastself examinations. The device is made of conformable polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
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)
Not Found
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.
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.
0
BeMitt™Breast Self Examination Aid 510(k) Submission
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
-
- Submitter's name, address, telephone number, contact person:
Beth Bromberg President DJA Distributors, LLC 2225 E. Flamingo Road, Suite 204 Las Vegas, Nevada 89119
- Submitter's name, address, telephone number, contact person:
UCT 26 2007
Phone: (702) 733-9650 Fax: (702) 431-7824
Email:
Date prepared: 13 June 2007
- Name of the device, including the trade or proprietary name if applicable, the 2) Common or usual name, and the classification name, if known:
Common/Usual Name
BeMitt™ Self Breast Exam
Proprietary Name
BeMitt™ Self Breast Exam
Classification Names
Mammographic X-ray system (892.1710; IZH, regulatory class II)
- Identification of the predicate or legally marketed device: 3)
DJA Distributors, LLC. believes that the BeMitt™ Self Breast Exam is substantially equivalent to the previously cleared My Breast Friend device from MBF Sales, LLC (Rockville, MD). The predicate 510(k) number is K023390, and Sensa Touch Breast Self Exam Glove from Sante Feminine LTD (Smyrna, Ga). The predicate 510(k) is K042250.
BeMitt
Page 4.1
1
Device Description: 4)
The BeMitt™ Self Breast Exam is indicated as an aid for performing breastself examinations. The device is made of conformable polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
The BeMitt™ Self Breast Exam is designed to comply with the standards listed below:
Premarket Notification 510(k): Regulatory Requirements for Medical Devices, HHS Publication FDA 95-4158 (1995).
BeMitt™ Self Breast Exam will be cleared and/or approved by the following agency:
U.S. Food and Drug Administration (FDA)
న) Intended Use:
The BeMitt™ Self Breast Exam is indicated as an aid for performing breastself examinations.
- Performance Standards: (()
DJA Distributors, LLC. is not aware of any special controls or performance standards established for this device under sections 513 or 514 of the Food, Drug and Cosmetic Act.
7) Conclusion statements:
In summary, BeMitt™ Self Breast Exam meets or exceeds all safety requirements for a device in its regulatory class and is found to be identical in materials and functionality when compared to the stated predicate devices.
BeMitt
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol that resembles a stylized eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UC) 26 2007
DJA Distributors, LLC c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K071787
Trade Name: BeMitt™ Breast Self Exam Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: October 10, 2007 Received: October 11, 2007
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: KOF1787
Device Name: BeMitt™ Self Breast Exam
Indications For Use:
The BeMitt™ Self Breast Exam is indicated as an aid for performing breast-self examinations.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrency of CDRH, Office of Device Evaluation (ODE)
Herbert Penner
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071787 Page 3.1
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