UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1

K083679 · Uroval · IKN · Sep 11, 2009 · Physical Medicine

Device Facts

• Record ID: K083679
• Device Name: UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
• Applicant: Uroval
• Product Code: IKN · Physical Medicine
• Decision Date: Sep 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

Device Story

UroVal BRS System records and displays electromyogram (EMG) signals to assess neurogenic sacral dysfunction; determines latency time intervals of bulbocavernous reflex (BCR). System utilizes probe with single-use disposable tip to evoke BCR response and trigger EMG recording; uses pregelled surface electrodes for muscle activity monitoring. Operated by healthcare professionals in clinical settings. System provides report generation capabilities; output used by clinicians to evaluate sacral nerve function and assist in diagnosing incontinence conditions.

Clinical Evidence

Performance compared to the CTS 2000 predicate in a clinical trial. Data demonstrates substantial equivalence based on device characteristics and performance metrics.

Technological Characteristics

Diagnostic electromyograph; uses pregelled surface electrodes and probe with disposable tip. Complies with ISO 10993-1, -5, -10 (biocompatibility); IEC 60601-1 (safety); IEC 60601-1-2 (EMC); and IEC 60601-1-4 (programmable electrical medical systems).

Indications for Use

Indicated for patients requiring assessment of neurogenic sacral dysfunction, including urinary and fecal incontinence. For use by or under the direction of a healthcare professional.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

• MLS MA-300 System (K000220)
• The Prometheus Group CTS 2000 System (K001515)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 1. 2009

#### 510(k) Summary

#### Submitter

UroVal, Inc. Debbie Folkerts Vice President 1220 E. Marlatt Ave Manhattan KS 66502 USA Telephone: [phone] Fax: [phone]

Date Prepared Sept 8, 2009

K083679

42

# Name of Device

| Common Name: | EMG System |
|----------------------|------------------------------|
| Proprietary Name: | UroVal BRS System |
| Classification Name: | Electromyography, Diagnostic |
| Regulation: | 21 CFR 890.1375 |
| Class: | Class II |
| Product Code: | IKN |

### Predicate Devices

The UroVal BRS System is substantially equivalent in intended use, function and basic composition to the currently marketed MLS MA-300 System (K000220), and The Prometheus Group CTS 2000 System (K001515).

#### Device Description

The UroVal BRS System is used to record and display electromyogram (EMG) signals. In addition, the BRS System will determine latency time intervals of the bulbocavernous reflex (BCR). The UroVal BRS System also has report generation capabilities.

The UroVal BRS System uses a probe, with a single use disposable tip to evoke a BCR response, and activate recording and timing of EMG signals.

The UroVal BRS System uses pregelled surface electrodes to monitor the muscle activity.

## Intended Use

To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

## Technological Characteristics

The UroVal BRS System has similar technological characteristics to the currently marketed predicate devices listed above. The UroVal BRS System meets standards:

{1}------------------------------------------------

| ISO 10993-1 | (2003) | Biological Evaluation of Medical Devices: Part 1:<br>Evaluation and Testing |
|---------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5 | (1999) | Biological Evaluation of Medical Devices: Part 5: Tests for<br>in vitro cytotoxicity |
| ISO 10993-10 | (2002) | Biological Evaluation of Medical Devices: Part 10: Tests<br>for irritation and delayed-type hypersensitivity |
| IEC 60601-1 | (2006) | Medical Electrical Equipment -Part 1: General<br>Requirements for basic safety and essential performance |
| IEC 60601-1-2 | (2001) | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Safety: Collateral Standard:<br>Electromagnetic Compatibility -- Requirements and Tests |
| IEC 60601-1-4 | (2000) | Medical Electrical Equipment - Part 1-4: General<br>Requirements for Safety: Collateral Standard:<br>Programmable electrical medical systems |

2/2

## Performance Data (non-clinical or clinical)

The UroVal BRS System performance was compared to the CTS 2000 in a clinical trial, and is substantially equivalent to the predicate devices based on the device characteristics, descriptive data, compliance with standards, and indications for use.

### Conclusion

The technological characteristics and performance data for the UroVal BRS System demonstrates it performs safely and effectively, and is substantially equivalent to the predicate devices.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped with a cross. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

SEP 1 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

UroVal % RCRI. Inc. Ms. Sharon Iverson Regulatory Project Director 5353 Wavzata Boulevard, Suite 505 Minneapolis, Minnesota 55416

Re: K083679

Trade Name: UroVal BRS System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: IKN Dated: September 3, 2009 Received: September 4, 2009

Dear Ms. Iverson;

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Sharon Iverson

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number: K083679

UroVal BRS System Device Name:

Indications For Use:

To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

Prescription Use X AND/OR (21 CFR 801 .Subpart D)

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083679