(274 days)
Not Found
No
The summary describes a device that records and displays EMG signals and calculates latency times. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used to acquire and display EMG signals and determine latency time intervals for diagnostic purposes (assessing neurogenic sacral dysfunction), not to treat a condition.
Yes
The device "acquires EMG signals for display and analysis" and is used "to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence." This process of acquiring and analyzing signals to assess a medical condition falls under the definition of a diagnostic device.
No
The device description explicitly mentions hardware components such as a probe with a disposable tip and pregelled surface electrodes, indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The UroVal BRS System acquires and displays electrical signals (EMG) from the body. It does not analyze biological specimens (blood, tissue, etc.) outside of the body.
- Intended Use: The intended use is to assess neurogenic sacral dysfunction by acquiring and analyzing EMG signals, which is a physiological measurement taken directly from the patient.
Therefore, based on the provided information, the UroVal BRS System falls under the category of a physiological monitoring or diagnostic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
IKN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
SEP 1. 2009
510(k) Summary
Submitter
UroVal, Inc. Debbie Folkerts Vice President 1220 E. Marlatt Ave Manhattan KS 66502 USA Telephone: (785)-539-1787 Fax: (785)-539-0890
Date Prepared Sept 8, 2009
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:
Evaluation and Testing |
|---------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5 | (1999) | Biological Evaluation of Medical Devices: Part 5: Tests for
in vitro cytotoxicity |
| ISO 10993-10 | (2002) | Biological Evaluation of Medical Devices: Part 10: Tests
for irritation and delayed-type hypersensitivity |
| IEC 60601-1 | (2006) | Medical Electrical Equipment -Part 1: General
Requirements for basic safety and essential performance |
| IEC 60601-1-2 | (2001) | Medical Electrical Equipment - Part 1-2: General
Requirements for Safety: Collateral Standard:
Electromagnetic Compatibility -- Requirements and Tests |
| IEC 60601-1-4 | (2000) | Medical Electrical Equipment - Part 1-4: General
Requirements for Safety: Collateral Standard:
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 (800) 638-2041 or (240) 276-3150 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