(174 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for treating symptoms of Female Sexual Arousal Disorder (FSAD), which qualifies it as a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is "Indicated for women with the following symptoms of Female Sexual Arousal Disorder (FSAD): difficulty with arousal (and lubrication), sexual desire and ability to achieve orgasm." This indicates it's used to address existing symptoms, not to diagnose them.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes treating symptoms of Female Sexual Arousal Disorder (FSAD) by addressing issues with arousal, lubrication, desire, and orgasm. This is a therapeutic or treatment-oriented use, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), performing tests in vitro (outside the body), or providing diagnostic information about a disease or condition.
- Anatomical Site: The anatomical site is the clitoral area, which aligns with a device intended for direct interaction with the body for therapeutic purposes, not for analyzing samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. The description of the Enhance CSA does not fit this definition.
N/A
Intended Use / Indications for Use
The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Arousal Disorder (FSAD): problems with arousal (and lubrication), sexual desire and ability to achieve orgasm.
Product codes
NBV
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5970 Clitoral engorgement device.
(a)
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.(b)
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.”
0
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.
1
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 (800) 638-2041 or (301) 443-6597 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
2
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