Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on data acquisition, transmission, processing, storage, and display of physiological signals. There is no mention of AI, ML, or related concepts like training sets, test sets, or complex algorithms beyond standard data processing.

Therapeutic

No
The device is indicated to provide clinicians with information during therapies, not to directly provide therapy itself. It measures physiological signals, which are then displayed for the clinician's use in muscle relaxation training and re-education, implying it is a diagnostic or monitoring tool rather than a therapeutic one.

Diagnostic

No
The device is described as providing "information during therapies that include muscle relaxation training and re-education" and measuring and presenting "physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body." It's indicated to "provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies." This suggests it's a monitoring or assessment tool for therapeutic guidance, rather than for diagnosing a disease or condition. The text also states "Clinical data was not necessary to support that the MyoVision 3G WireFree™ System is substantially equivalent to the currently marketed predicate device," which would typically be required for a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of handheld scanner devices, a system hub, and proprietary application software. The scanners and hub are hardware components that are integral to the device's function of collecting physiological data.

IVD (In Vitro Diagnostic)

Based on the provided information, the PBI MyoVision 3G WireFree™ System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
MyoVision's Function: The MyoVision system measures physiological signals directly from the patient's body (surface EMG, skin temperature, range of motion). It does not analyze samples taken from the body.
Intended Use: The intended use describes providing clinicians with real-time physiological data during therapy, not analyzing biological samples for diagnostic purposes.

Therefore, the MyoVision 3G WireFree™ System falls under the category of a medical device that measures physiological parameters in vivo (within the living body), rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IKN, HCC, KQX, HCS

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™), 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).

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

Clinician, clinical setting

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

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.

Key Metrics

Not Found

Predicate Device(s)

Fasstech, Insight Millennium III (K023209)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

| Submitter: | Precision Biometrics Inc.
PBI/MyoVision
4259 23rd Ave. W, Ste. 400, Seattle, WA 98199
Phone: (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

1

K123399, p. 2/3

| Intended and
Indications for Use: | 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. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Character
Differences: | There are some differences between the predicate device and the
MyoVision 3G WireFree System™ due to the elimination of the
wired connection to the system hub as well as some product
refinements based on AAMI Guidelines. |
| | The most significant difference between the predicate and PBI's
system is the communication technology between the handheld
scanners and the system hub. The Fasstech devices require the use of
proprietary cables whereas the MyoVision 3G WireFree™ System
does not require cables. The MyoVision 3G WireFree™ System's
communication technology uses 3G wireless low-power transmission
similar to Bluetooth (Class III) technology, which has been tested to
ensure safety and effectiveness in a clinical setting. |
| | The other differences have to do with refinements to the
measurement methodology based on AAMI Guidelines for these
types of devices. For instance, the plethsmograph, algometer, and
single inclinometer of the Fasstech are not included in the MyoVision
3G WireFree™ System because PBI's research into these device |

types shows their use is optional, not needed, or ineffective.

·

:

.

:

2

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:

3

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

4

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

5

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

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