(14 days)
A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).
Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.
Non-implanted electrical stimulator for urinary incontinence
This document is an FDA 510(k) clearance letter and an "Indications for Use" statement for the Omnistim® Continence+ Pelvic Floor Stimulation System. Unfortunately, this type of regulatory document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and the underlying study data.
Regulatory clearance for medical devices like this often relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring new, extensive clinical trials that would generate the detailed performance metrics you've requested.
Therefore, I cannot provide the following information based on the text provided:
- A table of acceptance criteria and the reported device performance: This document specifies the intended use but not specific performance metrics or their acceptance criteria.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a physical stimulator, not an AI algorithm).
- The type of ground truth used: Not applicable or available.
- The sample size for the training set: Not applicable or available.
- How the ground truth for the training set was established: Not applicable or available.
What the document does tell us:
- Device Name: Omnistim® Continence+ Pelvic Floor Stimulation System
- Regulation Number: 21 CFR 876.5320
- Regulation Name: Non-implanted electrical continence device
- Regulatory Class: II
- Product Code: KPI
- Indications for Use: A non-implanted electrical stimulator for urinary incontinence, intended to retrain urinary continence mechanisms by electrical stimulation to pelvic floor musculature and surrounding structures. Indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence. It aims to improve urethral sphincter closure, strengthen pelvic floor muscles, and inhibit the detrusor muscle through reflexive mechanisms to improve urinary control.
- Approval Status: Received 510(k) clearance, deemed substantially equivalent to legally marketed predicate devices.
To get the type of detailed study information you're asking for, you would typically need to consult the full 510(k) submission summary (if available publicly, often redacted), peer-reviewed publications about the device, or clinical trial reports, which are not part of this FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Accelerated Care Plus % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K093600
Trade/Device Name: Omnistim® Continence+ Pelvic Floor Stimulation System Regulation Number: 21 CFR 876.5320 Regulation Name: Non-implanted electrical continence device Regulatory Class: II Product Code: KPI Dated: November 19, 2009 Received: November 20, 2009
DEC - 4 2009
Dear Mr. Lehtonen:
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); medical device reporting of medical
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device-related adverse events} (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pre-market (510K) Notification Submission
Revision 4 02/12/09
Section 4 - Indications for use
510(k) Number (if known):
Classification Name/Code:
Also, irrigated [T
KO93600
Device Name:
Non-Implanted Electrical Continence Device
Omnistim® Continence+ Pelvic Floor Stimulation System
Model Numbers:
300100A
Indications for Use:
A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).
Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
Page 5 of 17
§ 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).