ELPHA 2000 CONTI

K964738 · Dan Med, Inc. · KPI · Aug 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964738
• Device Name: ELPHA 2000 CONTI
• Applicant: Dan Med, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• 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 2000 CONTI is an electrical muscle stimulator designed for pelvic floor rehabilitation. Device delivers electrical stimulation to pelvic floor muscles via a vaginal probe. Primary function is strengthening pelvic floor musculature and activating the central nervous system to treat stress and urge urinary incontinence in adult females. Operated by clinician or patient under prescription; used in clinical or home settings. Output consists of controlled electrical pulses; clinical benefit is reduction of urinary incontinence symptoms through muscle conditioning.

Clinical Evidence

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

Technological Characteristics

Electrical muscle stimulator; utilizes vaginal probe for delivery of electrical stimulation to pelvic floor muscles. Device operates via electrical energy source. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for adult females with stress or urge urinary incontinence to strengthen pelvic floor muscles and activate the central nervous system 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 14 1997

Mr. Thomas Sandgaard
DanMed, Inc.
747 Sheridan Boulevard, S.7A
Lakewood, Colorado 80214

Re: K964738
Elpha 2000 Conti
Dated: June 28, 1997
Received: July 7, 1997
Regulatory class: II
21 CFR §876.5320/Product code: 78 KPI

Dear Mr. Sandgaard:

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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and .nat, through periodic QS 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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmanain.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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510(k) Number (if known): K964738

Device Name: *Elpha 2000 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.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The Counter Use ☐

Robert R. Nathig
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964738

(Optional Format 1-2-96)