(70 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called ELPHA 4 Conti, a non-implanted electrical continence device. It does not contain the specific information required to answer the prompt regarding acceptance criteria and the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text.
The document does not describe:
- Any acceptance criteria.
- Any specific study performed to prove device performance.
- Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The letter merely states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses.
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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (800) 638-2041 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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 876.5320 Nonimplanted electrical continence device.
(a)
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).(b)
Classification. Class II (performance standards).