(59 days)
For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.
Not Found
While the provided text is an FDA 510(k) clearance letter for the INSTEAD Softcup, it does not contain the detailed clinical study information required to answer your specific questions about acceptance criteria and study findings.
FDA 510(k) clearances determine substantial equivalence to a predicate device, which often relies on demonstrating similar performance characteristics, but the submission itself is a separate document that would contain the detailed study results. The letter only states that the device is "substantially equivalent" to previously marketed devices.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need to analyze the underlying 510(k) summary document or the full 510(k) submission, which is not included in the provided snippets.
If you were to provide a document that describes the clinical performance and testing conducted for the INSTEAD Softcup, I could attempt to extract the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ultrafem, Inc. % Mr. Peter S. Reichertz … Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, N.W.
Washington, D.C. 20036-5339
Re: K971303
JUN - 6 1997
INSTEAD® Softcup - Feminine Protection Cup ................. Dated: April 7, 1997 Received: April 8, 1997 Regulatory class: II 21 CFR §884.5400/Product code: 85 HHE
વદ્ધન
Dear Mr. Reichertz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductive, Abdominal. Ear. Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K971303
Device Name: INSTEAD ® Softcup® Feminine Protection Cup
Indications For Use: Use: - - - - - -
For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dotar attim
(Division Sign-Off)
Division of Reproductive, Abdominai, ENT,
and Radiological Devices 11971303 510(k) Number_
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use X (Optional Format 1-2-96)
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.