(269 days)
The PBI MyoVision 3G WireFree™ Systems are indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.
The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer.
The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education.
The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the
static surface EMG scanners (ScanVision™),
dynamic surface EMG scanner (DynaVision™),
range of motion inclinometers (FlexVision™), and
thermograph (ThermoVision™).
Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI).
The provided document (K123399) by Precision Biometrics Inc. for their MyoVision 3G WireFree™ System does not include acceptance criteria or a study that directly proves device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled devices.
This submission is a 510(k) Premarket Notification for a diagnostic electromyography device, which relies on demonstrating substantial equivalence to a legally marketed predicate device (Fasstech, Insight Millennium III (K023209)). The summary focuses on technological character differences and non-clinical performance data to support this equivalence.
Here's an analysis based on the information provided, specifically addressing the questions concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics for device performance in the document. The submission focuses on compliance with established standards (like those from AAMI, IEC, ISO) and demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Instead of specific performance metrics against acceptance criteria, the document states: "Performance testing per standardized methods and PBI test protocols for bench data was conducted and provides support that the MyoVision 3G WireFree™ System is substantially equivalent to currently marketed predicate devices." And "Non-clinical performance test protocols and results demonstrate that, in consideration of its intended use, the design, labeling, and packaging of the MyoVision 3G WireFree™ System is compliant with all applicable standards."
- No numerical performance data (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the device's functions (EMG activity, skin temperature, range of motion).
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable or not reported. The document describes "bench data" and "non-clinical performance test protocols," implying testing was conducted on the device hardware and software against standards, not on a clinical test set of patient data.
- Data Provenance: Not applicable, as there's no mention of a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of a human-adjudicated test set or ground truth established by experts.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an electromyography, range of motion, and thermography system that measures physiological signals directly. It's not an AI/ML-enabled device designed to assist human readers in interpreting complex images or data in a comparative effectiveness study scenario.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated for an "algorithm only" performance because the device's function is to collect and display physiological signals. Its performance is measured by the accuracy and reliability of these measurements against established standards, not by an algorithm's classification accuracy. The "proprietary application software" was "developed and validated by Precision Biometrics, Inc.," but details of this validation are not provided in terms of standalone performance metrics.
7. The type of ground truth used
- For the non-clinical performance, the "ground truth" would be established by the specifications and measurement ranges defined by the standards (e.g., ANSI/AAMI EC12:2006 for ECG electrodes, IEC 60601-1 for safety and essential performance, IEC 60601-2-40 for electromyographs). The device's measurements would be compared against these standard requirements, rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set of data with established ground truth.
Summary of the Study:
The study described is a set of non-clinical performance tests conducted per standardized methods and PBI test protocols for bench data. These tests aimed to demonstrate that the MyoVision 3G WireFree™ System (hardware and software combined for signal acquisition and display) is compliant with applicable standards (e.g., ANSI/AAMI, IEC, ISO) and is substantially equivalent to the predicate device (Fasstech, Insight Millennium III). The document explicitly states, "Clinical data was not necessary to support that the MyoVision 3G WireFree™ System is substantially equivalent to the currently marketed predicate device."
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| Submitter: | Precision Biometrics Inc.PBI/MyoVision4259 23rd Ave. W, Ste. 400, Seattle, WA 98199Phone: (206) 357-6508, Fax: (206) 357-6455 |
|---|---|
| Contact: | Eric Chen |
| Date Summary Prepared: | July 29, 2013 |
| Trade Name: | MyoVision 3G WireFree System |
| Common Name: | Diagnostic Electromyography, Range of Motion, and Thermography |
| Classification Name: | Diagnostic electromyography (21 CFR 890.1375) |
| Classification Panel: | 89, Physical Medicine |
| Product Code: | IKN (Secondary procodes HCC, KQX, HCS) |
| Regulatory Class: | II |
| Predicate: | Fasstech, Insight Millennium III (K023209) |
| Device Description: | The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer.The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education.The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the static surface EMG scanners (ScanVision™),dynamic surface EMG scanner (DynaVision™),range of motion inclinometers (FlexVision™), andthermograph (ThermoVision™). Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI). |
AUG 1 2013
MyoVision 3G WireFree™ System – 510(k) Summary
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K123399, p. 2/3
| Intended andIndications for Use: | The PBI MyoVision 3G WireFree™ Systems are indicated to providethe clinician with EMG activity, skin temperature, angles of thepatient's motion information during therapies that include musclerelaxation training and re-education. |
|---|---|
| TechnologicalCharacterDifferences: | There are some differences between the predicate device and theMyoVision 3G WireFree System™ due to the elimination of thewired connection to the system hub as well as some productrefinements based on AAMI Guidelines. |
| The most significant difference between the predicate and PBI'ssystem is the communication technology between the handheldscanners and the system hub. The Fasstech devices require the use ofproprietary cables whereas the MyoVision 3G WireFree™ Systemdoes not require cables. The MyoVision 3G WireFree™ System'scommunication technology uses 3G wireless low-power transmissionsimilar to Bluetooth (Class III) technology, which has been tested toensure safety and effectiveness in a clinical setting. | |
| The other differences have to do with refinements to themeasurement methodology based on AAMI Guidelines for thesetypes of devices. For instance, the plethsmograph, algometer, andsingle inclinometer of the Fasstech are not included in the MyoVision3G WireFree™ System because PBI's research into these device |
types shows their use is optional, not needed, or ineffective.
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Non-Clinical Performance Data:
Performance testing per standardized methods and PBI test protocols for bench data was conducted and provides support that the MyoVision 3G WireFree™ System is substantially equivalent to currently marketed predicate devices. Non-clinical performance test protocols and results demonstrate that, in consideration of its intended use, the design, labeling, and packaging of the MyoVision 3G WireFree™ System is compliant with all applicable standards, including the following:
- ANSI/AAMI EC12:2006, Disposable ECG electrodes, . 2000
- IEC 60601-1:1988 Medical Electrical Equipment Part . 1 : General Requirements For Safety and Essential Performance.
- . IEC 62304:2006 Medical device software -- Software Lifecycle processes: 2006
- . ISO 14971:2007-2nd Edition: Medical devices --Application of risk management to medical devices
- ISO 15223:2000 Medical Devices Symbols to be Used. . with Medical Devices Labels, Labeling and Information to be Supplied
- IEC 60601-2-40:1998 Medical Electrical equipment -. Part 2-40: Particular Requirements for Safety of Electromyographs and Evoked Response Equipment
- ISO 13485:2003: Medical Devices Ouality . Management Systems - Requirements for Regulatory Purposes
- . IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))
- Draft Guidance for Industry and FDA Staff: Radio-. Frequency Wireless Technology in Medical Devices
Clinical data was not necessary to support that the MyoVision 3G WireFree™ System is substantially equivalent to the currently marketed predicate device.
Clinical Performance Data:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 1, 2013
Precision Biometrics, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
K123399 Re:
Trade/Device Name: Myovision 3G WireFree System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: Class II Product Code: IKN, HCC, KOX, HCS Dated: July 16, 2013 Received: July 17, 2013
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Mark Job
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: ____ Myo/ision 3G WireFree™ System
Indications For Use:
The PBI MyoVision 3G WireFree™ System is indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
K123399 510(k) Number
Page 1 of 1
§ 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).