WORRY-REMOVER IRRIGATOR

K030056 · Corisen Group, Ltd. · HED · Apr 22, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030056
• Device Name: WORRY-REMOVER IRRIGATOR
• Applicant: Corisen Group, Ltd.
• Product Code: HED · Obstetrics/Gynecology
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5900
• Device Class: Class 1

Indications for Use

WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.

Device Story

The WORRY-REMOVER™ IRRIGATOR is a hand-squeezed bottle system for vaginal irrigation. It features a one-way liquid valve to prevent backflow of fluid into the bottle, preventing contamination, and a one-way air valve to prevent negative pressure buildup. The user manually controls the flow speed by squeezing the bottle. The device is intended for over-the-counter use for general feminine hygiene, providing a method for vaginal cleansing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-squeezed bottle system; includes one-way liquid valve and one-way air valve; manual operation; non-powered.

Indications for Use

Indicated for general feminine hygiene applications as a vaginal douche apparatus. Intended for over-the-counter use.

Regulatory Classification

Identification

A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.

Predicate Devices

• La Joie Vaginal Cleaner Container (K000736)
• Peri-Bottle (K902830)

Submission Summary (Full Text)

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APR 2 2 2003

Ko 30056

## VII. 510(k) Summary

| Submitter | Corisen Group, Ltd.<br>575 Charring Cross Drive, Suite 100<br>Westerville, OH 43081<br>Telephone: [phone]<br>Date Prepared: April 2, 2003 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | WORRY-REMOVER™ IRRIGATOR |
| Device Classification | DOUCHE APPRATUS, VAGINAL, THERAPEUTIC |
| Common/Usual Name | Vaginal Irrigator |
| Predicate Devices | La Joie Vaginal Cleaner Container (K000736);<br>Peri-Bottle (K902830) |
| Device Description | The irrigating-bottle is hand-squeezed to force the<br>cleaning solution to slowly and completely flow into<br>the vaginal cavity. The one-way liquid valve permits<br>the fluid to flow only from the bottle into the vaginal<br>cavity but not back to the bottle, preventing<br>contaminations of the solution and bottle. The one-<br>way air valve permits air to flow into the bottle to<br>prevent production of negative pressure within the<br>bottle. The flow speed of the liquid is controlled by<br>the user's hand. This system makes the process of<br>vaginal irrigation much easier, neater, and more<br>relaxing than using some other types of irrigators. |
| Intended Use | WORRRY-REMOVER™ IRRIGATOR is designed for<br>use as a vaginal douche apparatus for general<br>feminine hygiene applications. |
| Comparison to<br>Predicate Device | The indication for use of WORRRY-REMOVER™ Irrigator are substantially equivalent to the previously<br>cleared La Joie Vaginal Cleaner Container (K000736) and Peri-Bottle (K902830). |
| Conclusion | WORRRY-REMOVER™ Irrigator is substantially equivalent to the predicate devices. |

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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2003

Ms. Pamela Shen Vice President Corisen Group, Ltd. 575 Charring Cross Drive, Suite 100 WESTERVILLE OH 43081

## Re: K030056

Trade/Device Name: WORRY-REMOVER™ Irrigator Regulation Number: 21 CFR 884.5900 Regulation Name: Therapeutic vaginal douche apparatus

Regulatory Class: II Product Code: 85 HED Dated: March 10, 2003 Received: March 13, 2003

Dear Ms. Shen:

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 t 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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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## Indication for Use IV.

510(k) Number (if known): K030056

WORRRY-REMOVER™ IRRIGATOR Device Name:

## Indications for Use:

The WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.

(Please do not write below this line – continue on another page if needed)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

.

OR Over-The-Counter Use: レ

unter Use:

Danith Regner

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(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .