VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, suggesting care and support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 15, 2015 Ad Rem Technology SARL c/o Norman F. Estrin, PhD Estrin Consulting Group, LLC 9109 Copenhaver Drive Potomac, MD 20854 Re: K141919 Trade/Device Name: Veinoplus® Sport Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, GXY Dated: May 18, 2015 Received: May 19, 2015 Dear Dr. Estrin: 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. Iisting 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 (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. {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. Sincerely yours, # Felipe Aquel -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K141919 Device Name VEINOPLUS® SPORT Neuromuscular Stimulator Indications for Use (Describe) The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo and contact information for Ad Rem Technology. The logo features the company name in a stylized font, with the words "Ad Rem" in a larger font size and a blue color, and the word "TECHNOLOGY" in a smaller font size. Below the logo is the text "ISO 13485:2003 and ISO 9001:2008", followed by the address "162, rue du Faubourg Saint-Honoré, 75008 Paris - France", telephone number "+33 (0)1 42 60 00 22", fax number "+33 (0)1 42 60 00 63", email address "info@adremtechnology.com", and website address "www.adremtechnology.fr". # 510(k) SUMMARY (Clean) Ad Rem Technology Veinoplus Sport Neuromuscular Stimulator | Sponsor identification | Ad Rem Technology SARL<br>162 Rue du Faubourg Saint- Honoré<br>75008 Paris, France<br>Ms. Noémie Dumérain, Quality and Regulatory Affairs Manager,<br>nd@veinoplus.com<br>Tel: + 33 (0)1.42.60.00.22; Fax: + 33 (0)1.42.60.00.63 | |-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment<br>registration number: | 3005671018 | | Date of preparation | June 13, 2014 | | Contact person | Norman F. Estrin, Ph.D.<br>Managing Partner<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: (301) 279-2899<br>Email: estrin@yourFDAconsultant.com | | Authorized Agent in<br>the United States | Norman F. Estrin, Ph.D.<br>Managing Partner<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: (301) 279-2899<br>Email: estrin@yourFDAconsultant.com | | Proprietary Name | Veinoplus® Sport Neuromuscular Stimulator | | Trade name | VEINOPLUS® SPORT | | Device Classification<br>Name, Product Code,<br>Reviewing Panel,<br>Regulatory Class,<br>(Regulation) | Device, Stimulator, Muscle, Powered, For Muscle Conditioning<br>NGX Physical Medicine, Class II (21 CFR 890.5850)<br>Electrode, cutaneous<br>GXY Neurology, Class II (21 CFR 882.1320) | | Indications for<br>use: | The VEINOPLUS® SPORT is intended to stimulate healthy<br>muscles in order to improve and facilitate muscle performance. | {4}------------------------------------------------ | Device Description | Design and features: | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory.<br><br>The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances.<br><br>The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description.<br><br>List of accessories:<br>- 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F).<br>- 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.<br>- 1 instruction manual<br>- 1 9V alkaline battery<br>- 1 lanyard<br>- 1 carrying case: L22.5*W4.5*H17cm. | | Predicate Devices | Veinoplus® (K072252)<br>Compex® Sport Plus (K083140) | ## Comparison of the indications for use with the predicate devices: The proposed device, VEINOPLUS® SPORT, is substantially equivalent to both of its legally marketed Class II predicate devices: - 1. The mode 1 (powered muscle stimulator, IPF) of the Veinoplus® with 510k K072252 (except for the indications for use). - 2. The mode (program) "active recovery" of the Compex® Sport Plus with 510k K083140. {5}------------------------------------------------ ### Summary of technological characteristics of VEINOPLUS® SPORT with its two predicates Veinoplus® and Compex Sport Plus: | Device name: | VEINOPLUS® SPORT | Veinoplus® (mode 1 of stimulation) | Compex® Sport Plus (Program Active Recovery) | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | K141919 | K072252 | K083140 | | Intended use: | Muscle electrical stimulation | Muscle electrical stimulation | Muscle electrical stimulation | | Indications for use: | The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. | Increasing local blood circulation (common claim with predicates). Relaxation of muscle spasm/ Prevention or retardation of muscle disuse atrophy/ Muscle reeducation/ Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis/Maintaining or increasing range of motion. | Stimulate healthy muscles in order to improve or facilitate muscle performance. | | Mode of Action: | The VEINOPLUS® SPORT contracts the muscles by electrical stimulation. | The Veinoplus stimulates the muscles, resulting in rhythmic muscles contraction, which then increases the blood flow. | The Active Recovery program produces muscle twitches at a very low frequency. Those twitches act like a massage and induce an increase of the blood flow and a faster reduction of the lactic acid blood level. It facilitates recovery of the stimulated muscles after active muscle training or competition. | | Purpose: | Non-Medical | Medical | Non-Medical | | Target Population: | Healthy user | Medical patient | Healthy user | | Parts to be stimulated: | Calf muscles and other body parts (arms, buttocks, back (neck/shoulders). | Calf muscles | Legs/feet, arms/hands, buttock, back, shoulder or abdomen) | | Where used: | Home, hospital, gym, etc. | Home, hospital, gym, etc. | Data unknown | | Device name: | VEINOPLUS® SPORT | Veinoplus® (mode 1 of<br>stimulation) | Compex® Sport Plus<br>(Program Active Recovery) | | OTC/Rx Only<br>information : | OTC use | Prescription use | OTC use | | Energy<br>delivered: | Electrical | Electrical | Electrical | | Technical information: | | | | | Power Source: | One Internal 9 V alkaline<br>battery.<br>Types: 522, 6LR61,<br>MN1604<br>Shape: rectangular<br>Size: 48x25x16 mm;<br>Volume: 20 cm³ | One Internal 9 V alkaline<br>battery<br>Types: 522, 6LR61,<br>MN1604<br>Shape: rectangular<br>Size: 48x25x16 mm;<br>Volume: 20 cm³ | One NIMH rechargeable<br>battery ( 4.8V ≥1200 mA/h )<br>(4 cells pack of 1.2V)<br>Type: 4H-AA1500<br>Shape: cylindrical<br>Size: 1 cell = 14 mm x<br>47mm , diameter 14 mm;<br>Volume: 7.3 cm³ | | Number of<br>output modes | 1 mode/program | 2 modes/programs :<br>Mode 1 : EMS<br>Mode 2 : TENS | 9 modes/programs :<br>Potentiation<br>Endurance<br>Strength<br>Resistance<br>Active recovery<br>Recovery plus<br>Explosive strength<br>Pre warm-up<br>Massage | | Timer range | 30 minutes | Mode 1: 20 minutes<br>Mode 2: 20 minutes | Potentiation : 3' 27''<br>Endurance: 50' 23''+ 5'03'' of<br>optional warm up<br>Strength: 22'07''23''+ 5'03'' of<br>optional warm up<br>Resistance: 27'33''23''+ 5'03''<br>of optional warm up<br>Active recovery: 26'40''23''+<br>5'03'' of optional warm up<br>Recovery plus: 24'20''<br>Explosive strength: 25'18''<br>Pre warm up: 25'03''<br>Massage: 20'03'' | | Number of<br>output<br>channels: | 1 | 1 | 4 | | Automatic<br>overload trip | NO | NO | NO | | Automatic no<br>load trip | NO | NO | YES | | Accessories: | Electrodes, cable, battery | Electrodes, cable, battery | Electrodes, cable, Battery | | Device name: | VEINOPLUS® SPORT | Veinoplus® (mode 1 of stimulation) | Compex® Sport Plus (Program Active Recovery) | | | | (same model and manufacture as Veinoplus Sport) | charger. | {6}------------------------------------------------ {7}------------------------------------------------ | Waveform | Monophasic rectangular<br>asymmetrical | Monophasic rectangular<br>asymmetrical | Biphasic rectangular<br>symmetrical | |--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Max Output<br>Voltage | 50 V@ 500 Ohm | 50 V@ 500 Ohm | 60 V@ 500 Ohm (each<br>phase) | | Max Output<br>Current | 100 mA@ 500 Ohm | 100 mA@ 500 Ohm | 120 mA @ 500 Ohm (each<br>phase) | | Max Phase<br>Charge (µC) | 24μC @500Ω | 24μC @500Ω | 48µC (each phase)<br>@500Ω | | Maximum<br>current density<br>(mA/cm2, r.m.s.) | <14 μΑ (rms) /cm2<br>@500Ω | <13 μΑ (rms)/cm2 @500Ω | Not available | | Maximum<br>Average power<br>density (W/cm2,<br>r.m.s.) (using<br>smallest electrode<br>conductive<br>surface area) | <500 μW (r.m.s.) /cm2<br>(microwatt) @500 Ω<br>Only one size of<br>electrodes is permitted<br>and supplied by the<br>manufacturer. | <10 μW/cm2 (microwatt)<br>@500 Ω<br>Only one size of electrodes<br>is permitted and supplied by<br>the manufacturer. | <12 mW/cm2 (microwatt)<br>@500 Ω | | Pulse duration | from 25 to 240 µs | from 25 to 240 µs | 400 µs (each phase) | | Session duration: | 30 mn | 20 mn | 29 mn including warm-up | | Automatic shut-<br>off | Yes at 30 mn | Yes at 20 mn | Yes, at the end of the<br>session | | User override<br>Control | Yes | Yes | Yes | | Software | Stimulation pre-set<br>program encoded in a<br>microchip | Stimulation pre-set program<br>encoded in a microchip | Stimulation pre-set<br>program encoded in a<br>microchip | | Controls | 3 controls | 3 controls | Similar, 6 controls | | Display/interface | LCD Screen and data<br>display | LCD Screen and data<br>display | LCD screen and similar<br>data. | | Electrode<br>size/shape | 8x13 cm OVAL | 8x13 cm OVAL | 5x5 cm square and 5x10<br>cm rectangular | {8}------------------------------------------------ | Compliance with safety and performance Standards: | | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Biocompatibility | Electrodes material in<br>contact with skin user are<br>compliant with ISO<br>10993-5 and ISO 109993-<br>10 standards requirements | Electrodes material in<br>contact with skin user are<br>compliant with ISO<br>10993-5 and ISO 109993-<br>10 standards requirements | Data unknown | | Electrical safety | Comply with IEC 60601-<br>1, IEC 60601-1-2 (EMC),<br>IEC 60601-2-10 | Comply with IEC 60601-<br>1, IEC 60601-1-2 (EMC),<br>IEC 60601-2-10 | Comply with IEC 60601-1,<br>IEC 60601-1-2 (EMC), IEC<br>60601-2-10 | VEINOPLUS® SPORT is substantially equivalent to Veinoplus® in the Substantial Equivalence perspective of technological characteristics and general intended uses. Both summary: devices are intended for electrical stimulation of muscles. VEINOPLUS® SPORT was developed based on Veinoplus® device and both devices are technically very close. The indications for use of VEINOPLUS®, which is intended to be sold under prescription and for medical purpose, are not used for demonstration of substantial equivalence of VEINOPLUS® SPORT. VEINOPLUS® SPORT is substantial equivalent to Compex® Sport Plus in term of intended use, indications for use and technological characteristics. The technical differences between VEINOPLUS® SPORT and Compex® Sport Plus (power supply, waveform shape ...) do not raise additional issues of safety Compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-Summary of Non-1-2, IEC 60601-2-10 and ISO 14971. clinical The gel of electrodes was tested according ISO 10993-5 and ISO 10993-10 performance testing: Biocompatibility standards. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in Medical Devices. A usability study support as well that the user can operate the device in a safe and effective manner with labeling supplied with the device. Conclusion: The safety and performance of the device is supported by testing with safety and performance standards IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 standards. The differences between VEINOPLUS® SPORT® and the predicate devices do not raise new issues of safety and effectiveness.