DETRUSAN 500

K994109 · Innovamed USA, Inc. · KPI · Aug 3, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994109
• Device Name: DETRUSAN 500
• Applicant: Innovamed USA, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge, Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.

Device Story

Detrusan 500 is a mains-powered electrical stimulator for incontinence therapy; delivers AC voltage output to vaginal or anal probes. Device features preprogrammed CPU; allows physician adjustment of pulse width (10-400 us), frequency (1-100 Hz), and duty cycle. Output limited to 80 mA. Used in clinical settings; operated by healthcare professionals. Stimulates pelvic floor muscles and inhibits detrusor muscle to improve sphincter closure; aids in treating urinary incontinence. Output parameters are physician-controlled; patient cannot modify programs.

Clinical Evidence

Bench testing only. Evidence includes electrical characterization, output power measurements at 500 Ohm, and EMR testing for emissions and immunity per EN 5501 and IEC 801-3 standards. No clinical trial data provided.

Technological Characteristics

Mains-powered electrical stimulator; provides AC output up to 30V. Current limited to 80mA. Adjustable pulse width (10-400 us) and frequency (1-100 Hz). Waveform: square, symmetrical, balanced, biphasic. Uses vaginal and anal probes. Connectivity: standalone. Software: preprogrammed CPU for stimulation control. EMR compliance: EN 5501, IEC 801-3.

Indications for Use

Indicated for patients with acute, ongoing, or chronic Urge, Stress, or Mixed Urinary Incontinence. Used to improve urethral sphincter closure, strengthen pelvic floor, and inhibit detrusor muscle via reflexive mechanisms.

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).

Predicate Devices

• Detrusan 500 Incontinence Therapy System (K994109)

Reference Devices

• Vaginal Probes (K990041)
• Anal Probes (K993721)
• PRS 9300 (K930530/C)

Submission Summary (Full Text)

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AUG 3 2000

# K994109 PG. 1 of 4

# DETRUSAN 500

Version July 2000

# Incontinence Therapy System

# Safety and Effectiveness Summary

1. Submitters Name:

Innovamed-USA, Inc. 1140 Lee Blvd. Suite 101 Lehigh Acres FL 33936

Establishment Registration No: Owner Operator ID:

106 43 903 96 47

# 2. Name of Device:

Detrusan 500 Device Class ll

## 3. Name of Predicate Devices:

Detrusan 500 Incontinence Therapy System. K 994109

### 4. Description of the Device:

#### l List of Components

Detrusan 500 incontinence Therapy system comes with the external electric stimulator unit and vaginal and anal electrodes (Probes made by "Laborie Medical Technologies") Vaginal Probes K 990041 Anal Probes K 993721 Approved by FDA.

Page 1

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#### Electric Characterization:

Detrusan 500 is a Main net powered electrical stimulator, which provides output stimulus to the probes. The Device can be adjusted to deliver AC voltages in the range up to 30 Volts. The current is depended on the resistor of the patient as standard measuring level at 500 Ohm- 60 mA limited by hardware and software up to 80 mA. Frequencies are adjustable 1 to 100 Hz

The pulse width is adjustable 10 to 400 us. 12 preprogrammed follow-ups and frequencies as well as pulse width adjustments are available by calling program number. The Device is constant Voltage stabilized.

### Intended Use:

The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge. Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.

### 5. Statement of Indented Use

The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge, Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.

# 6. Statement of technology Characteristics:

A list of comparison shows the difference of the Detrusan 500 and a legally premarket device (k930530/C), - see next Page.

Page 2

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PG. 3 OF 4

# DETRUSAN 500

Version July 2000

# Comparison of the Technological Characteristics of the PRS 9300(K930530C) and the Predicate Device Detrusan 500 (K9039647)

יין

| Stimulation<br>Characteristics | Proposed device<br>PRS 9300 (K930530/C) | Predicate device<br>Detrusan 500 (K994109) |
|--------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of Incontinence | Treatment of Incontinence |
| Control | Laptop Computer | Preprogrammed CPU |
| Output (nominal) | 0 to 30 VDC ?! | 0 to 30 VAC |
| Waveform: | Square, Symmetrical,<br>Balanced, Biphasic; | Square Symmetrical,<br>Balanced, Biphasic; |
| Charge Pulse at 500 Ω | 60 µC/phase;<br>net charge/pulse=0 | 64 µC/phase;<br>net charge/pulse=0 |
| Frequency | 12.5,20,50,100 Hz | 1 - 100 Hz |
| Peak Pulse Intensity | 30 VDC ?! | 30 VAC |
| Pulse with | 0.3, 1 ms | 0.01 - 0.4 ms |
| Ramps | 20%, 40%, 60%, 80%, 100%<br>of "On" time (no down ramp) | 1/12th of the intensity (V) |
| Duty Cycle | On (sec): 1-80 in 1sec increm.<br>Off (sec): 0-80 in 1 sec increm. | On (sec): 1-60 in1sec.increm<br>Off (sec:0-60 in 1 sec.increm |
| Session Duration (min) | 0-30<br>1 minute increments | 0-30<br>1 minute increments |
| Programmable Features | Not by Patient<br>By Physician: Pulse width,<br>Frequency, Duty Cycle,<br>Session length | Not by Patient!<br>By Physician: Pulse width,<br>Frequency, Duty Cycle,<br>Session length, Programs |

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| Current Density<br>Condition: Full output<br>Settings, 100 Hz, pulse<br>Width at 500 Ω (nominal) | Probe9595 - 0.003 $A /cm^2$<br>Probe9596 - 0.018 $A /cm^2$ | Probe 185_5053<br>0.00403 $A / cm^2$<br>Probe 185_5056<br>0.01640 $A / cm^2$ |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Power Density<br>Condition: Full output<br>Settings, 100 Hz, pulse | Probe9595 - 0.047 $W/cm^2$<br>Probe9596 - 0.239 $W/cm^2$ | Probe 185_5053<br>0.12 $W / cm^2$<br>Probe 185_5056<br>0.12 $W/cm^2$ |
| EMR | Engineering models of<br>PRS9300 have been tested<br>and shown to comply with<br>EN 5501 and IEC 801-3<br>emissions and immunity,<br>respectively | engineering models of<br>Detrusan have been<br>tested as shown by the<br>EMR Report included<br>first 510K proposal.<br>(K994109) |

Measurement conditions: of Detrusan: Range 1: Output Power = 30.V Range2: Full Output Settings 100Hz, = max. Pulse with 400 µs = max at 500KΩ

*

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2000 AUG

Mr. Ernest H. Czadilek President InnovaMed-USA, Inc. 1140 Lee Blvd., Suite 101-103 P.O. Box 1361 Lehigh Acres, FL 33936

Re: K994109 Detrusan 500 Incontinence Therapy System Dated: May 27, 2000 Received: May 31, 2000 Requlatory Class: Il 21 CFR §876.5320/Procode: 78 KPI

### Dear Mr. Czadilek:

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 legally marketed predicate idevices 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 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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 not fied any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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" (21CFR 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/odrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): K 99 41 09

Device Name: DETRUSAN 500 Version May 27, 2000

Indications for Use:

The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge, Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1 -2 - 96