ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

Device Description

ViMove is comprised of five key components:

4 Wireless Sensors (2 for movement and 2 for muscle activity)
Disposable Application Pads for holding the wireless sensors. movement (DAP-M) and muscle (DAP-E) sensors
Recording and Feedback Device (RFD) is worn in the patient's pocket or within one meter of the sensors
Recharging Cradle
ViMove software package

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the ViMove device as "substantially equivalent" to predicate devices, particularly the Insight Discovery and Vicon. The performance testing focused on proving this substantial equivalence rather than fulfilling specific numeric acceptance criteria for novel claims.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
Technological Equivalence to Predicate Devices	ViMove is substantially equivalent to Insight Discovery and Vicon in: - Non-invasive medical device - Surface Electromyography (compared to Insight Discovery) - Provides Real-time biofeedback - Energy detected from muscle activity only (not delivered) - Wireless Inclinometer - Rechargeable batteries in wireless sensors (compared to Insight Discovery, Vicon N/A) - ISM band - 2.4GHz (compared to Insight Discovery, Vicon N/A) - Real-time objective measurement of Range of Motion - Dedicated Software - Report generated for health care professional - ABS used for Case (compared to Insight Discovery, Vicon No) - Device used on Spine - Isolated USB/Ethernet to connect to PC
Measurement Capabilities	Assessed against Insight Discovery. Specifics on range or precision are not provided, but the conclusion is "substantially equivalent."
Accuracy (Range of Motion)	"The accuracy of the ViMove was tested and compared to the accuracy of the Vicon and found to be substantially equivalent for measuring range of motion in the sagittal and coronal anatomical planes."
Compliance to International Standards	Complied with: - ISO 14971 (Risk Management) - ISO 13485 (Quality Management) - ISO 14155 (Clinical investigation, Good clinical practice - though no clinical data was submitted) - IEC 60601-1 (Electrical Safety) - IEC 60601-1-2 (EMC) - ISO 15223 (Medical device symbols) - ISO 10993-5 (In vitro cytotoxicity) - ISO 10993-10 (Irritation and skin sensitization) - 16 CFR 1500 (FHSA Regulations for Cytotoxicity, Sensitization and Primary Skin Irritation tests) - IEC 62304 (Software life cycle processes)
Mechanical Durability	Bench tested to withstand: - Crush and shock (drop) tests for components (IEC 60601-1) - DAP-M/E assembled with MD sensors: drop test from 1.5 meters onto hardwood floor with concrete base & crush force of 25kg. - RFD: drop from 2m onto hardwood floor with concrete base without functional damage & crush force of 25kg.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" sample size for proving substantial equivalence in terms of performance metrics like accuracy. The evaluation was primarily comparision of the ViMove's features and its performance to existing predicate devices (Insight Discovery and Vicon).

Clinical Data: "Not applicable." This indicates there was no clinical study conducted with human subjects specifically for this 510(k) submission to generate new performance data from a "test set."
Data Provenance: The performance assessment was based on bench testing and comparison to existing predicate devices' known performance. There's no mention of country of origin for any human subject data, as none was used. The study is not prospective or retrospective in the clinical sense, as it's a device comparison and bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As no clinical data or "test set" involving human subjects was used to establish novel performance claims or ground truth in this submission, no experts were utilized for this purpose. The device's "accuracy" was compared to a predicate device (Vicon), implying the Vicon's output served as a reference or "ground truth" for that specific comparison, but the document doesn't detail how Vicon's "ground truth" itself was established in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or referenced. The device is a measurement tool, not an interpretive AI tool that would assist human readers in diagnosing cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The accuracy comparison described ("The accuracy of the ViMove was tested and compared to the accuracy of the Vicon...") suggests a standalone performance evaluation of the ViMove's ability to measure range of motion. It was compared directly to another device (Vicon) without human intervention in the measurement process itself, thus evaluating its "algorithm only" performance for that specific function.

7. Type of Ground Truth Used

For the accuracy of range of motion, the ground truth was effectively the measurement provided by the Vicon device, which itself is a commercially available and presumably validated goniometer. The document states, "The accuracy of the ViMove was tested and compared to the accuracy of the Vicon..."
For other performance characteristics, the "ground truth" was established by compliance with voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and bench testing criteria (e.g., drop test parameters, crush force).

8. Sample Size for the Training Set

Not applicable. The ViMove is a measurement device that employs sensors and software. The submission does not indicate the use of AI/machine learning requiring a "training set" in the context of its 510(k) summary. The "software life cycle processes" standard IEC 62304 is mentioned, but this refers to general software development practices, not necessarily machine learning model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/machine learning algorithm was referenced in this submission.

Summary

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dorsaVi Pty Ltd Level 1, 120 Jolimont Road Melbourne East, Victoria, 3002 Phone: +61-(0)3-9652-2191 Fax: +61-(0)3-8610-1024 Email: info@dorsavi.com Web: www.dorsavi.com ABN: 15 129 742 409

JUL 1 1 2014

510(K) SUMMARY [as required by section 807.92(c)] ViMove

510(k) Number K131094

Applicant Name:

dorsaVi Ltd Level 1, 120 Jolimont Road East Melbourne 3002, Victoria, Australia

Company Contact:

Dan Ronchi, CTO. +61-(0)3-9652-2191 Phone: Fax: +61 - (0) 3-8610-1024 Email: dr@dorsavi.com

Date 510K Summary Prepared: 09 July 2014

Contact Person:

Shoshana (Shosh) Friedman, RAC Name: Address: 1914 J N Pease Pl., Charlotte, NC 28262 Phone: (704) 430-8695 or (704) 899-0092 Fax: (704) 899-0098 E-mail: shosh@pushmed.com

Trade Name:

ViMove

Classification:

The ViMove is classified as a Diagnostic Electromyograph (product code IKN) according to 21 CFR 890.1375, with subsequent product codes HCC (Biofeedback Device) and KQX (Goniometer).

Predicate Devices:

Insight Discovery manufactured by Fasstech (K063447).
Vicon manufactured by Oxford Medilog, Inc. (K811172).

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Device Description:

ViMove is comprised of five key components:

4 Wireless Sensors (2 for movement and 2 for muscle activity) .
Disposable Application Pads for holding the wireless sensors. movement . (DAP-M) and muscle (DAP-E) sensors
Recording and Feedback Device (RFD) is worn in the patient's pocket or . within one meter of the sensors
Recharging Cradle ●
ViMove software package .

Intended Use/Indications for Use:

Technological Characteristics:

ViMove is substantially equivalent to the Insight Discovery as both devices are non invasive, multi-modality physiological monitoring devices. Both devices incorporate surface EMGs to measure muscle activity, and inclinometers to measure range of motion.

Both devices use dedicated software to acquire data to provide real time biofeedback and generate a report for the healthcare practitioner, and use Acrylonitrile Butadiene Styrene (ABS) for the physical material. The technological similarities between ViMove and the predicates Insight Discovery and Vicon are summarized in the Table below.

	ViMove	InsightDiscovery	Vicon
510(k) Number	K131094	K063447	K811172
Manufacturer	dorsaVi	Fasstech	OxfordMetrics Inc.
Product Code	IKNHCCKQX	IKNHCC	IKN
Non-invasive medical device	Yes	Yes	Yes

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Image /page/2/Picture/0 description: The image shows the dorsaVi logo. The logo consists of the word "dorsaVi" in a bold, sans-serif font, with the "V" slightly larger than the other letters. Below the word "dorsaVi" is the tagline "Inspiring the world to move". To the right of the word "dorsaVi" is a graphic of two arrows that are intertwined.

dorsaVi Pty Ltd Level 1, 120 Jolimont Road Melbourne East, Victoria, 3002 Phone: +61-(0)3-9652-2191 Fax: +61-(0)3-8610-1024 Email: info@dorsavi.com Web: www.dorsavi.com ABN: 15 129 742 409

Surface Electromyography	Yes	Yes	No
Provides Real time biofeedback to the user	Yes	Yes	Yes
Energy is not delivered to the muscles, energy is detected from muscle activity only	Yes	Yes	Yes
Wireless Inclinometer	Yes	Yes	Yes
Rechargeable batteries in the wireless sensors	Yes	Yes	N/A
ISM band - 2.4GHz	Yes	Yes	N/A
Real-time objective measurement of Range of Motion	Yes	Yes	Yes
Dedicated Software	Yes	Yes	Yes
Report generated for health Care Professional	Yes	Yes	Yes
ABS used for Case	Yes	Yes	No
Device used on Spine	Yes	Yes	Yes
Isolated USB/Ethernet to connect to PC	Yes	Yes	Yes

Performance Data:

ViMove's performance characteristics were assessed against the Insight Discovery by comparing intended use, technological characteristics, and performance characteristics. Performance data assessed included measurement capabilities, accuracy, and compliance to international electrical safety and electromagnetic compatibility standards.

The accuracy of the ViMove was tested and compared to the accuracy of the Vicon and found to be substantially equivalent for measuring range of motion in the sagittal and coronal anatomical planes.

ViMove has been tested and complies with the following voluntary standards:

ISO 14971	Medical Devices – Application of Risk Management toMedical Devices
ISO 13485	Medical devices – Quality management systems –Requirements for regulatory purposes
ISO 14155	Clinical investigation of medical devices for human subjects –Good clinical practice
IEC 60601-1	Medical electrical equipment, Part 1: General requirements

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	for basic safety and essential performance
IEC 60601-1-2	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests
ISO 15223	Medical devices - Symbols to be used with medical devicelabels, labeling, and information to be supplied - Part 1:General requirements
ISO 10993-5	Biological evaluation of medical devices -- Part 5: Tests for invitro cytotoxicity
ISO 10993-10	Biological evaluation of medical devices -- Part 10: Tests forirritation and skin sensitization
16 CFR 1500	Guidelines of the Federal Hazardous Substances Act (FHSA)Regulations for Cytotoxicity, Sensitization and Primary SkinIrritation tests.
IEC 62304	Medical device software - Software life cycle processes

Additionally, bench testing has been performed to ensure that the components of the ViMove can withstand crush and shock (drop) tests with no noticeable change or degradation of surfaces, color or structure in accordance to IEC 60601-1.

The DAPs when assembled with the MD sensors of the ViMove have been tested to ensure that they are able to withstand a drop test performed from 1.5 meters on to hardwood floor with a concrete base and a crush force of 25kg

The RFD is required to withstand a drop from 2m on to a hardwood floor with a concrete base without functional damage and a crush force of 25kg.

Clinical Data:

Not applicable.

Conclusion:

Based on the information provided in this submission, ViMove is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

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Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MI) 20993-0002

July 11, 2014

dorsaVi Ltd. c/o Ms. Shoshana Friedman Push-Med. LLC. 1914 J N Pease Pl. Charlotte, NC 28262

Re: K131094 Trade/Device Name: ViMove

Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: Class II Product Code: IKN, HCC, KOX Dated: June 12, 2014 Received: June 13, 2014

Dear Ms. Friedman:

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.

ff 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 of medical

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Page 2 - Ms. Shoshana Friedman

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 Industry and Consumer Education 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131094

Device Name ViMove

Indications for Use (Describe)

ViMove is a wireless medical device that measures, records, and reports and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

・・

Carlos L. Pena -S

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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).