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 Description

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. 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria in the manner typically expected for medical device evaluations involving performance metrics, clinical trials, or expert assessments.

Instead, the document is a 510(k) premarket notification for the "DETRUSAN 500 Incontinence Therapy System." It focuses on demonstrating substantial equivalence to a predicate device (K994109) rather than presenting new clinical study data with specific acceptance criteria and performance outcomes.

Here's a breakdown of why the requested information cannot be extracted from this document:

No Acceptance Criteria or Reported Device Performance Table: The document compares the technological characteristics of the Detrusan 500 to a predicate device. This comparison focuses on technical specifications (e.g., voltage, frequency, pulse width) and intended use, not on predefined acceptance criteria for clinical efficacy or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, accuracy, or symptom improvement rates.
No Sample Sizes, Data Provenance, Expert Information, or Adjudication Method for a Test Set: Since there is no described study to prove efficacy against acceptance criteria, there's no mention of a test set, its sample size, data origin, the number or qualifications of experts, or any adjudication method. The document is a technical comparison for regulatory submission.
No Multi-Reader Multi-Case (MRMC) or Standalone Study: The document does not describe either a MRMC comparative effectiveness study or a standalone algorithm-only study. It's a premarket notification for a physical therapeutic device, not an AI or diagnostic imaging device that would typically undergo such studies.
No Ground Truth Type: As there's no study described for performance evaluation, there's no mention of the type of ground truth used (e.g., pathology, outcomes data). The "ground truth" in this context would generally refer to a physician's diagnosis of incontinence, which the device treats, but the document doesn't detail how the device's effectiveness is measured against such a truth.
No Training Set Sample Size or Ground Truth Establishment for Training Set: The Detrusan 500 is an electrical stimulator, not a machine learning model. Therefore, there is no "training set" in the sense of data used to train an algorithm. The device has preprogrammed follow-ups and frequencies, which are likely based on established physiological principles and previous clinical experience with similar devices, rather than a machine learning training process.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use. It does not provide the details of a study that establishes acceptance criteria and proves device performance against those criteria in the way your request describes for a typical performance evaluation study.

Summary

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AUG 3 2000

K994109 PG. 1 of 4

DETRUSAN 500

Version July 2000

Incontinence Therapy System

Safety and Effectiveness Summary

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

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:

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)

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StimulationCharacteristics	Proposed devicePRS 9300 (K930530/C)	Predicate deviceDetrusan 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,Balanced, Biphasic;	Square Symmetrical,Balanced, Biphasic;
Charge Pulse at 500 Ω	60 µC/phase;net charge/pulse=0	64 µC/phase;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%of "On" time (no down ramp)	1/12th of the intensity (V)
Duty Cycle	On (sec): 1-80 in 1sec increm.Off (sec): 0-80 in 1 sec increm.	On (sec): 1-60 in1sec.incremOff (sec:0-60 in 1 sec.increm
Session Duration (min)	0-301 minute increments	0-301 minute increments
Programmable Features	Not by PatientBy Physician: Pulse width,Frequency, Duty Cycle,Session length	Not by Patient!By Physician: Pulse width,Frequency, Duty Cycle,Session length, Programs

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Current DensityCondition: Full outputSettings, 100 Hz, pulseWidth at 500 Ω (nominal)	Probe9595 - 0.003 $A /cm^2$Probe9596 - 0.018 $A /cm^2$	Probe 185_50530.00403 $A / cm^2$Probe 185_50560.01640 $A / cm^2$
Power DensityCondition: Full outputSettings, 100 Hz, pulse	Probe9595 - 0.047 $W/cm^2$Probe9596 - 0.239 $W/cm^2$	Probe 185_50530.12 $W / cm^2$Probe 185_50560.12 $W/cm^2$
EMR	Engineering models ofPRS9300 have been testedand shown to comply withEN 5501 and IEC 801-3emissions and immunity,respectively	engineering models ofDetrusan have beentested as shown by theEMR Report includedfirst 510K proposal.(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 (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-5597 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:

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

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)

Over-The Counter Use

(Optional Format 1 -2 - 96

Regulation Number and Section

§ 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).