(336 days)
The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
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.
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.
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.
List of accessories:
- 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).
- 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.
- 1 instruction manual
- 1 9V alkaline battery
- 1 lanyard
- 1 carrying case: L22.5W4.5H17cm.
This document describes the Veinoplus® Sport Neuromuscular Stimulator. However, it does not include information about specific acceptance criteria, study details, or performance data that would allow a comprehensive answer to your request. The document primarily focuses on establishing substantial equivalence to predicate devices (Veinoplus® and Compex® Sport Plus) for FDA 510(k) clearance, rather than presenting a performance study with detailed acceptance criteria and results.
Specifically, the document states:
- "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 gel of electrodes was tested according ISO 10993-5 and ISO 10993-10 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."
These statements indicate that the device met certain safety, electrical, EMC, biocompatibility, software verification, and usability standards. However, they do not provide quantitative performance metrics specific to its intended use (stimulating healthy muscles to improve and facilitate muscle performance) with defined acceptance criteria.
Therefore, I cannot provide the requested information in the format you specified. The supplied text does not contain:
- A table of acceptance criteria and reported device performance related to its muscle stimulation effectiveness.
- Sample size, data provenance, number of experts, adjudication method for a performance study.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone algorithm performance.
- Type of ground truth used for performance metrics.
- Sample size for the training set or how its ground truth was established, as this is a physical device, not an AI/ML algorithm requiring training data in the traditional sense.
{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.
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."
{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 SARL162 Rue du Faubourg Saint- Honoré75008 Paris, FranceMs. Noémie Dumérain, Quality and Regulatory Affairs Manager,nd@veinoplus.comTel: + 33 (0)1.42.60.00.22; Fax: + 33 (0)1.42.60.00.63 |
|---|---|
| Establishmentregistration number: | 3005671018 |
| Date of preparation | June 13, 2014 |
| Contact person | Norman F. Estrin, Ph.D.Managing PartnerEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Authorized Agent inthe United States | Norman F. Estrin, Ph.D.Managing PartnerEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Proprietary Name | Veinoplus® Sport Neuromuscular Stimulator |
| Trade name | VEINOPLUS® SPORT |
| Device ClassificationName, Product Code,Reviewing Panel,Regulatory Class,(Regulation) | Device, Stimulator, Muscle, Powered, For Muscle ConditioningNGX Physical Medicine, Class II (21 CFR 890.5850)Electrode, cutaneousGXY Neurology, Class II (21 CFR 882.1320) |
| Indications foruse: | The VEINOPLUS® SPORT is intended to stimulate healthymuscles 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.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.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.List of accessories:- 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).- 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.- 1 instruction manual- 1 9V alkaline battery- 1 lanyard- 1 carrying case: L22.5W4.5H17cm. | |
| Predicate Devices | Veinoplus® (K072252)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:
-
- The mode 1 (powered muscle stimulator, IPF) of the Veinoplus® with 510k K072252 (except for the indications for use).
-
- 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 ofstimulation) | Compex® Sport Plus(Program Active Recovery) |
| OTC/Rx Onlyinformation : | OTC use | Prescription use | OTC use |
| Energydelivered: | Electrical | Electrical | Electrical |
| Technical information: | |||
| Power Source: | One Internal 9 V alkalinebattery.Types: 522, 6LR61,MN1604Shape: rectangularSize: 48x25x16 mm;Volume: 20 cm³ | One Internal 9 V alkalinebatteryTypes: 522, 6LR61,MN1604Shape: rectangularSize: 48x25x16 mm;Volume: 20 cm³ | One NIMH rechargeablebattery ( 4.8V ≥1200 mA/h )(4 cells pack of 1.2V)Type: 4H-AA1500Shape: cylindricalSize: 1 cell = 14 mm x47mm , diameter 14 mm;Volume: 7.3 cm³ |
| Number ofoutput modes | 1 mode/program | 2 modes/programs :Mode 1 : EMSMode 2 : TENS | 9 modes/programs :PotentiationEnduranceStrengthResistanceActive recoveryRecovery plusExplosive strengthPre warm-upMassage |
| Timer range | 30 minutes | Mode 1: 20 minutesMode 2: 20 minutes | Potentiation : 3' 27''Endurance: 50' 23''+ 5'03'' ofoptional warm upStrength: 22'07''23''+ 5'03'' ofoptional warm upResistance: 27'33''23''+ 5'03''of optional warm upActive recovery: 26'40''23''+5'03'' of optional warm upRecovery plus: 24'20''Explosive strength: 25'18''Pre warm up: 25'03''Massage: 20'03'' |
| Number ofoutputchannels: | 1 | 1 | 4 |
| Automaticoverload trip | NO | NO | NO |
| Automatic noload 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 rectangularasymmetrical | Monophasic rectangularasymmetrical | Biphasic rectangularsymmetrical |
|---|---|---|---|
| Max OutputVoltage | 50 V@ 500 Ohm | 50 V@ 500 Ohm | 60 V@ 500 Ohm (eachphase) |
| Max OutputCurrent | 100 mA@ 500 Ohm | 100 mA@ 500 Ohm | 120 mA @ 500 Ohm (eachphase) |
| Max PhaseCharge (µC) | 24μC @500Ω | 24μC @500Ω | 48µC (each phase)@500Ω |
| Maximumcurrent density(mA/cm2, r.m.s.) | <14 μΑ (rms) /cm2@500Ω | <13 μΑ (rms)/cm2 @500Ω | Not available |
| MaximumAverage powerdensity (W/cm2,r.m.s.) (usingsmallest electrodeconductivesurface area) | <500 μW (r.m.s.) /cm2(microwatt) @500 ΩOnly one size ofelectrodes is permittedand supplied by themanufacturer. | <10 μW/cm2 (microwatt)@500 ΩOnly one size of electrodesis permitted and supplied bythe manufacturer. | <12 mW/cm2 (microwatt)@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-off | Yes at 30 mn | Yes at 20 mn | Yes, at the end of thesession |
| User overrideControl | Yes | Yes | Yes |
| Software | Stimulation pre-setprogram encoded in amicrochip | Stimulation pre-set programencoded in a microchip | Stimulation pre-setprogram encoded in amicrochip |
| Controls | 3 controls | 3 controls | Similar, 6 controls |
| Display/interface | LCD Screen and datadisplay | LCD Screen and datadisplay | LCD screen and similardata. |
| Electrodesize/shape | 8x13 cm OVAL | 8x13 cm OVAL | 5x5 cm square and 5x10cm rectangular |
{8}------------------------------------------------
| Compliance with safety and performance Standards: | |||
|---|---|---|---|
| Biocompatibility | Electrodes material incontact with skin user arecompliant with ISO10993-5 and ISO 109993-10 standards requirements | Electrodes material incontact with skin user arecompliant with ISO10993-5 and ISO 109993-10 standards requirements | Data unknown |
| Electrical safety | Comply with IEC 60601-1, IEC 60601-1-2 (EMC),IEC 60601-2-10 | Comply with IEC 60601-1, IEC 60601-1-2 (EMC),IEC 60601-2-10 | Comply with IEC 60601-1,IEC 60601-1-2 (EMC), IEC60601-2-10 |
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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).