ENHANCE CLITORAL STIMULATION AID

K043480 · Gynavations, Inc. · NBV · Jun 8, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K043480
• Device Name: ENHANCE CLITORAL STIMULATION AID
• Applicant: Gynavations, Inc.
• Product Code: NBV · Obstetrics/Gynecology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5970
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Arousal Disorder: lack of sexual arousal (and lubrication), sexual desire and ability to achieve orgasm.

Device Story

Enhance Suction Cup Clitoral Stimulation Aid (CSA) is a mechanical device designed to assist women with symptoms of Female Sexual Arousal Disorder. The device utilizes suction to promote clitoral engorgement. It is intended for over-the-counter use by the patient. By facilitating blood flow to the clitoral area, the device aims to improve sexual arousal, lubrication, and the ability to achieve orgasm.

Technological Characteristics

Mechanical clitoral engorgement device; suction-based stimulation mechanism; classified under 21 CFR 884.5970 (Product Code: NBV).

Indications for Use

Indicated for women experiencing symptoms of Female Sexual Arousal Disorder, specifically lack of sexual arousal (including lubrication), sexual desire, and ability to achieve orgasm.

Regulatory Classification

Identification

A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.

Special Controls

*Classification.* Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a logo or emblem. It features a stylized bird-like figure with three curved lines representing its body and wings. The text "Department of Health & Human Services" is arranged in a circular fashion around the bird-like figure.

JUN 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

David Gloth, M.D. President Gynavations, Inc. 665 Salem Street MALDEN MA 02148

Re: K043480

Trade/Device Name: Enhance Suction Cup Clitoral Stimulation Aid Regulation Number: 21 CFR §884.5970 Regulation Name: Clitoral engorgement device Regulatory Class: II Product Code: NBV Dated: May 3, 2005 Received: May 4, 2005

Dear Dr. Gloth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your boarded by the program intelly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholorate) to regary ment date of the Medical Device Amendments, or to devices that have been ready 20, 1770, and chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmod in about all of a premarket approval application (PMA). You may, therefore, market the do inot require approval or a 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 It your device is olashiloa (soo avel additional controls. Existing major regulations affecting your Apployal), it thay of below 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 I least be advisou mat i Dr. I on 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 I cacal states and regulations assessment insted to registration and listing (21 CFR Part 807); labeling Act 3 requirements, invading, but notes in active requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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) I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket noutication. The PDA maing of backannal vice 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 If you desire spective advice for your device of our of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification who Allso, please note the regulation entired, "Theoration on your responsibilities under the Act from the 807.97). You may outer general meethal manufacturer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Indications for Use

510(k) Number (if known): K043480

Device Name: Enhance Suction Cup Clitoral Stimulation Ald

Indications For Use:

The Enhance CSA is Indicated for women with the following symptoms of Female Sexual The Liminee OOA Is nanodious a (and lubrication), sexual desire and ability to achieve orgasm.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The- Counter Use V - (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
Division Sign-Off

Tivision of Reproductive, Abdominal, and Radiological Devices 510(k) Number