(274 days)
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.
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.
The UroVal BRS System is used to record and display electromyogram (EMG) signals and determine latency time intervals of the bulbocavernous reflex (BCR).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for the UroVal BRS System's performance in terms of specific EMG signal parameters or BCR latency measurements. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through conformity with recognized standards and a comparative clinical trial.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety Standards | Adherence to biological evaluation standards for medical devices (ISO 10993-1, -5, -10) | The UroVal BRS System is stated to meet these standards. |
| Electrical Safety Standards | Adherence to general requirements for basic safety and essential performance of medical electrical equipment (IEC 60601-1, -1-2, -1-4) | The UroVal BRS System is stated to meet these standards. |
| Functional Equivalence | To acquire EMG signals for display and analysis and determine BCR latency time intervals. | The device's description and intended use confirm these functions. |
| Clinical Performance Equivalence | Performance is substantially equivalent to predicate devices (MLS MA-300 System and The Prometheus Group CTS 2000 System). | A clinical trial compared the UroVal BRS System to the CTS 2000, and the conclusion is that it performs safely and effectively and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "a clinical trial" but does not provide the number of participants or cases included in this trial.
- Data Provenance: The study was a "clinical trial," which implies prospective data collection. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study focuses on comparing the device's performance to a predicate device, not on establishing a new ground truth based on expert consensus. The "ground truth" implicitly would be the measurements obtained from the predicate device (CTS 2000).
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of comparing device measurements, a formal adjudication process involving multiple experts to resolve discrepancies in the test set ground truth would likely not be relevant, as the predicate device's output serves as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No, the document describes a clinical trial comparing the UroVal BRS System to the CTS 2000 ("The UroVal BRS System performance was compared to the CTS 2000 in a clinical trial"). This is a device-to-device comparison, not an MRMC study evaluating human reader performance with and without AI assistance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an MRMC study with AI assistance.
6. Standalone (Algorithm Only) Performance:
- Was standalone performance done? Yes, the clinical trial compared the UroVal BRS System (algorithm/device only) directly against the predicate device (CTS 2000), which can be considered a standalone assessment of its measurement capabilities. The comparison concluded that the UroVal BRS System "performs safely and effectively, and is substantially equivalent to the predicate devices."
7. Type of Ground Truth Used:
The ground truth used for the comparison was the performance of a legally marketed predicate device, specifically the CTS 2000. This implies that the measurements (EMG signals, BCR latency) obtained from the CTS 2000 were considered the reference "truth" against which the UroVal BRS System's measurements were compared.
8. Sample Size for the Training Set:
This information is not provided. The document describes a medical device, not a machine learning or AI algorithm that would typically have a separate training set. The UroVal BRS System itself performs the measurements.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a separate training set for an AI algorithm. The device's underlying principles are based on established physiological measurements and comparisons to existing, validated devices.
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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:
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| 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 forin vitro cytotoxicity |
| ISO 10993-10 | (2002) | Biological Evaluation of Medical Devices: Part 10: Testsfor irritation and delayed-type hypersensitivity |
| IEC 60601-1 | (2006) | Medical Electrical Equipment -Part 1: GeneralRequirements for basic safety and essential performance |
| IEC 60601-1-2 | (2001) | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety: Collateral Standard:Electromagnetic Compatibility -- Requirements and Tests |
| IEC 60601-1-4 | (2000) | Medical Electrical Equipment - Part 1-4: GeneralRequirements 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.
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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.
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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
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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
§ 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).