(78 days)
This menstrual cup has the same intended use as the predicate menstrual cup. The DivaCup™ is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA letter to a company, Diva International, Inc., regarding the 510(k) premarket notification for "The DivaCup Menstrual Solution."
The letter primarily discusses:
- The FDA's determination of substantial equivalence for the device.
- Classification of the device (Class II, Menstrual cup).
- Applicable regulations and general controls.
- Contact information for various FDA offices.
- An "Indications For Use" statement for The DivaCup, which states it "has the same intended use as the predicate menstrual cup" and "is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow."
There is no mention of specific performance metrics, acceptance criteria, study methodologies, sample sizes for training or test sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (e.g., MRMC studies).
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
Ms. Francine Chambers President and Official Correspondent Diva International, Inc. P.O. Box 25089 1375 Weber Street E Kitchener, Ontario CANADA N2A 4A5
Re: K021356
Trade/Device Name: The DivaCup Menstrual Solution Regulation Number: 21 CFR §884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: 85 HHE Dated: April 24, 2002 Received: April 29, 2002
Dear Ms. Chambers:
This letter corrects our substantially equivalent letter dated July 16, 2002, regarding the Indications for Use form. Your device is an over-the-counter device. We have included the corrected Indications for Use form.
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.
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Page 2 - Ms. Francine Chambers
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
for
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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Aug Q6 02 12:58p
Page 1 of 1
510(k) Number (if known): K 021356
Device Name: The DivaCup - Menstrual Solution
1
Indications For Use:
This menstrual cup has the same intended use as the predicate menstrual cup. The DivaCup™ is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use X
(Optional Format 3-10-98)
§ 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.