← Product Code [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE) · K971303

# INSTEAD, SOFTCUP (K971303)

_Ultrafem, Inc. · HHE · Jun 6, 1997 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K971303

## Device Facts

- **Applicant:** Ultrafem, Inc.
- **Product Code:** [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE.md)
- **Decision Date:** Jun 6, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5400
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for 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.

## Device Story

INSTEAD Softcup is a feminine protection device designed to collect menstrual fluid. It functions as a physical barrier/receptacle inserted into the vaginal canal. The device is intended for over-the-counter use by women during menstruation. It serves as an alternative to traditional absorbent products like tampons or pads, aiming to prevent leakage and staining of clothing. The device is a passive, non-electronic, mechanical product.

## Clinical Evidence

No clinical data provided; device is a mechanical feminine protection product.

## Technological Characteristics

Mechanical feminine protection cup; non-electronic; no software or active components.

## Regulatory Identification

A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

## Special Controls

*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.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 6 1997

Ultrafem, Inc.
% Mr. Peter S. Reichertz
Arent Fox Kintner Plotkin & Kahn
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036-5339

Re: K971303
INSTEAD® Softcup - Feminine Protection Cup
Dated: April 7, 1997
Received: April 8, 1997
Regulatory class: II
21 CFR §884.5400/Product code: 85 HHE

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
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:

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)

Dalev L. Lathing
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971303

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑
(Optional Format 1-2-96)

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