VIMOVE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for dorsaVi. 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 curved and 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 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: 1. Insight Discovery manufactured by Fasstech (K063447). 2. Vicon manufactured by Oxford Medilog, Inc. (K811172). {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for dorsaVi. The logo consists of the word "dorsaVi" in a stylized font, with the "i" being replaced by a checkmark. 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 in a circular motion. # 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: 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. ## 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 | Insight<br>Discovery | Vicon | |-----------------------------|-------------------|----------------------|------------------------| | 510(k) Number | K131094 | K063447 | K811172 | | Manufacturer | dorsaVi | Fasstech | Oxford<br>Metrics Inc. | | Product Code | IKN<br>HCC<br>KQX | IKN<br>HCC | IKN | | Non-invasive medical device | Yes | Yes | Yes | {2}------------------------------------------------ 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 to<br>Medical Devices | |-------------|------------------------------------------------------------------------------------------| | ISO 13485 | Medical devices – Quality management systems –<br>Requirements for regulatory purposes | | ISO 14155 | Clinical investigation of medical devices for human subjects –<br>Good clinical practice | | IEC 60601-1 | Medical electrical equipment, Part 1: General requirements | {3}------------------------------------------------ Image /page/3/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 forming a circle. | | for basic safety and essential performance | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility -<br>Requirements and tests | | ISO 15223 | Medical devices - Symbols to be used with medical device<br>labels, labeling, and information to be supplied - Part 1:<br>General requirements | | ISO 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for in<br>vitro cytotoxicity | | ISO 10993-10 | Biological evaluation of medical devices -- Part 10: Tests for<br>irritation and skin sensitization | | 16 CFR 1500 | Guidelines of the Federal Hazardous Substances Act (FHSA)<br>Regulations for Cytotoxicity, Sensitization and Primary Skin<br>Irritation 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. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.