ELPHA 4 CONTI

K032988 · Danmeter A/S · KPI · Dec 3, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032988
• Device Name: ELPHA 4 CONTI
• Applicant: Danmeter A/S
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system. Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.

Device Story

ELPHA 4 Conti is a non-implanted electrical continence device; delivers electrical stimulation to pelvic floor muscles via vaginal probe. Intended to strengthen pelvic floor muscles and activate central nervous system to reduce urinary incontinence in adult females. Operated by patient or clinician; used for stress and urge incontinence management. Device provides electrical pulses to stimulate muscle contraction; clinical benefit derived from improved muscle tone and neuromuscular activation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Non-implanted electrical stimulator; utilizes vaginal probe for delivery of electrical pulses to pelvic floor muscles. Class II device under 21 CFR 876.5320.

Indications for Use

Indicated for adult females with stress or urge urinary incontinence to strengthen pelvic floor muscles via vaginal probe electrical stimulation.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

DEC - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Hanne Nielsen Quality Manager Danmeter A/S Kildemosevej 13 DK-5000 Odense C DENMARK

Re: K032988

Trade/Device Name: ELPHA (Model; 4 Conti) Regulation Number: 21 CFR§ 876.5320 Regulation Name: NonImplanted Electrical Continence Device Regulatory Class: II Product Code: 78 KPI Dated: September 18, 2003 Received: October 2, 2003

Dear Ms. Nielsen:

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 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) This letter will anow you to oogh manis of substantial equivalence of your device to a legally prematication. The PDF intents of 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 If you desire specific acvice to: your and 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 Additionally, 101 questions on the personation entitled, "Miso, please note the regulation entitled, "Misbranding Other of Compliance at (201) soation" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respensional Consumer Assistance at its toll-free number [phone] or Mandiacturers, Theoriational act 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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## Indications for Use

KO32988 510(k) Number (if known):

Device Name: ELPHA 4 Conti

Indications For Use:

Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system.

Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.

Danmeter A/S September 18, 2003

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leppan

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

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