(47 days)
The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.
The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.
I am unable to provide a description of the acceptance criteria and study as the provided text does not contain that information. The document is a 510(k) summary for a medical device (evadri Bladder Control System), which primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.
The document includes:
- Sections 1-6: Details about the sponsor, device name, predicate devices, detailed description of the evadri Bladder Control System (including technological characteristics for stimulation and biofeedback).
- Section 7: A conclusion stating that the device is safe and effective and substantially equivalent to identified predicate devices.
- FDA Letter: A letter from the FDA confirming the 510(k) clearance and the device's substantial equivalence.
- Statement of Intended Use: A reiteration of the device's intended use.
There is no mention of specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a performance study within the provided text.
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K050483
Page 1 of 2
Hollister Incorporated evadri Bladder Control System
510(k) Summary
1. Sponsor's name, Address and Contact Person
Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville IL. 60048 Contact Person Joseph S. Tokarz Director, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847) 680-2849 Ph: (847) 918-3860 Fax:
Date Summary Prepared - February 21, 2005
2. Name of Device:
evadri Bladder Control System
3. Name of Predicate Device(s)
- InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) ■
- Pathway CTS 2000 pelvic Floor Training System ( K001515 and K023906) 피
4. Description of Device
er The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.
5. Statement of Intended Use
The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.
6. Statement of Technological Characteristics of the Device
Stimulation:
| Frequency (Hz) | 10, 12.5, 20, 50, 100, 200 |
|---|---|
| Pulse width (msec) | 0.3, 1 |
| Pulse Type | Balanced, biphasic, no dc component |
| Pulse Amplitude (VDC) | 0-30, 1% or 5% increments |
| ON period (seconds) | 1-80 in 1 second increments |
| Off period (seconds) | 0-80 in 1 second increments |
| Session Duration (minutes) | 1-30 in 1 minute increments |
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K050483
Page 2 of 2
Hollister Incorporated Evadri System
Biofeedback:
| Measurement channels | Adjustable, 2 channels of EMG, 2 channels of pressure orcombination of EMG and pressure. |
|---|---|
| EMG Sensitivity (micro volts) | 0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500 |
| EMG bandwidth | 20-500Hz (channel 1), 100-500Hz (channel 2) |
| EMG signal processing | Root Mean Squared (RMS) |
| EMG detection | Bipolar |
| Pressure sensitivity (cmH2O) | 0-10, 0-25, 0-50, 0-100, and 0-350 |
| Work periods (seconds) | 1-80 in 1 second increments |
| Rest periods (seconds) | 0-80 in 1 second increments |
| Session Duration (minutes) | 1-60 minutes in 1 minute increments |
Instrumentation Unit:
Power
Power rating Overall current protection Overall Dimensions Approximate weight
AC to DC power adapter, isolated, 115/230 VAC switch able input, 6VDC output 20VA 3 ampere fuse 100 x 70 x 130mm 81bs
7. Conclusion
Based upon the information presented within this pre-market notification it is concluded that the evadri Dasod upon the mistmation pe and effective for its intended use and the device is substantially equivalent to the identified predicate devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
APR 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph S. Tokarz Director Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K050483 Trade/Device Name: evedri Bladder Control System Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: February 21, 2005 Received: February 24, 2005
Dear Mr. Tokarz:
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 (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 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 icter with anow you've ough finding of substantial equivalence of your device to a legally premaired notification: "The FDF maning sification 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 ac no is 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" (21 CFR Also, production other general information on your responsibilities under the Act from the 807.77). Tourmal Manufacturers, International and Consumer 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. Hogdon
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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Hollister Incorporated evadri Bladder Control System
Statement of Intended Use
510(k) Number (if Known): Device Name:
evadri Bladder Control System
Intended Use:
The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or I hic evadi Hiadder Colubor System is intences to perfect electromyographic biofeedback) incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR
Over-the-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nancy C. Brodon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 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).