(48 days)
My Breast Friend Breast Self-exam Pad is indicated as an aid for performing breast selfexamination.
The My Breast Friend Breast Self-exam Pad is a thin polyurethane bladder containing a small quantity of silicone and air fluids. The very thin nature of the material allows the pad to conform to the patient's breast tissue and for the patient to observe a reduction in friction. The very thin and flexible bladder provides easy sliding between the upper and lower surfaces of the bladder and allows the patient to sense subtle tissue density variations.
The provided text is related to a 510(k) submission for the "My Breast Friend Breast Self-exam Pad." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting novel performance studies and acceptance criteria as would be required for new device approvals.
Therefore, the document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or the other requested information such as sample sizes, expert qualifications, or ground truth establishment.
Instead, the submission states:
- Performance Standard: "No mandatory or voluntary standards are applicable."
- Substantial Equivalence: "The My Breast Friend Self-exam Pad is substantially equivalent to the currently marketed devices, Sensor Pad (K973450) and Aware Pad (K991469)."
The FDA's letter confirms their review and determination of substantial equivalence based on the indications for use. This pathway implies that the new device's safety and effectiveness are considered equivalent to a legally marketed predicate device, and thus, extensive new clinical performance data demonstrating specific acceptance criteria are not typically required in the same way as for a PMA or novel device.
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510(K) SUMMARY
KO23390
This Summary was prepared in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. General Information
- I Device Name and classification: My Breast Friend Breast Self-exam Pad - Class II
- l Submitter's Name: MBF Sales LLC
- 트 Contact Name and address: Eduardo March AAC Consulting Group Inc. 7361 Calhoun Place, Suite 500 Rockville. MD 20855
2. Performance Standard:
No mandatory or voluntary standards are applicable.
3. Substantial Equivalence:
The My Breast Friend Self-exam Pad is substantially equivalent to the currently marketed devices, Sensor Pad (K973450) and Aware Pad (K991469).
4. Indications for Use:
The My Breast Friend Self-exam Pad is indicated as an aid for performing breast self-examination.
5. Technological Characteristics:
The My Breast Friend Breast Self-exam Pad is a thin polyurethane bladder containing a small quantity of silicone and air fluids. The very thin nature of the material allows the pad to conform to the patient's breast tissue and for the patient to observe a reduction in friction. The very thin and flexible bladder provides easy sliding between the upper and lower surfaces of the bladder and allows the patient to sense subtle tissue density variations.
Date Prepared: 30 September 2002
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2002
MBF Sales LLC % Mr. Eduardo March Senior Consultant AAC Consulting Group 7361 Calhoun Place Suite 500 ROCK VILLE MD 20855-2765 Re: K023390
Trade/Device Name: My Breast Friend Self-exam Pad Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IXH Dated: October 7, 2002 Received: October 9, 2002
Dear Mr. March:
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) NUMBER (If known): _ KO 2 3390
My Breast Friend Breast Self-exam Pad Device Name:
Indications for Use:
My Breast Friend Breast Self-exam Pad is indicated as an aid for performing breast selfexamination.
(Please do not write below this line - Continue on other page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the Counter Use
David A. Jepson
Division Sign-Off
Sign-om
Division of Reproductive, Abdominal,
and Radiological Devices K023390
510(k) Number..........
§ 892.1940 Radiologic quality assurance instrument.
(a)
Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.