(172 days)
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
Body System (available in models: SX101 and OS2911). Both models utilize the same internal electrical components. The models differ only in the control/display features and exterior casing/dimensions. The Body System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.
The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.
The provided document is a 510(k) Premarket Notification for the "Body System" device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical or diagnostic performance through a typical study with acceptance criteria.
Therefore, the information required to answer the prompt (acceptance criteria, study details, expert involvement, ground truth, etc.) is not present in this document. This submission primarily relies on non-clinical performance data (electrical safety, biocompatibility, electromagnetic compatibility) and a comparison of technological characteristics to already cleared devices.
Specifically:
- There are no acceptance criteria listed for clinical or diagnostic performance, as the device is not claiming to diagnose or treat medical conditions, but rather for "muscle conditioning to stimulate healthy muscles."
- There is no study described to prove the device meets performance criteria in the way a diagnostic AI/ML device would, as this is a physical muscle stimulator. The "non-clinical performance data" mentioned refers to engineering and safety tests, not a clinical trial.
- No sample size for test sets or training sets are provided because there isn't a machine learning algorithm being trained or tested for diagnostic performance.
- No experts were used to establish ground truth for any diagnostic test set, as such a test set does not exist for this device's intended use.
- No adjudication method, MRMC comparative effectiveness study, or standalone algorithm performance are discussed.
- No ground truth type is specified, again, because there is no diagnostic or classification task being performed by an algorithm.
The document states:
- "The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass, Biocompatibility – irritation (ISO-10993-10) – result: Pass, Biocompatibility - Sensitization (ISO-10993-10) - result: Pass. Performance – including Output Waveforms of the Body System as compared to a predicate. Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016. Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)." (Page 5)
- The "Comparison of the Subject and Predicate Devices" table (Pages 6-7) details technical specifications (e.g., maximum output voltage, frequency range, waveform) to demonstrate similarity to commercially available devices. The acceptance criteria for these would be meeting the specified electrical and physical parameters, and passing the relevant safety standards (ISO and IEC). For instance, for "Biocompatibility," the reported performance is "Pass" against the ISO standards. For electrical parameters like "Maximum Output Voltage," the reported performance is "58V @ 500 Ω, 88V @ 2k Ω" for the subject device, which is compared to the predicate devices' outputs to argue for substantial equivalence.
In summary, this document proves the device's safety and electrical performance through non-clinical testing and comparison to predicates, not through a clinical performance study with the types of acceptance criteria and methodologies typically used for AI/ML or diagnostic devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2019
A-1 Engineering % Peter Knauer Principal Consultant Sage BioPartners 1741 Little Kate Rd Park City, Utah 84060
Re: K182440
Trade/Device Name: Body System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 26, 2018 Received: November 27, 2018
Dear Peter Knauer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS 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) K182440
Device Name Body System
Indications for Use (Describe)
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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}------------------------------------------------
Section 5. 510(k) Summary / Statement - 21 CFR 807.92(a)
This 510(k) Summary for the Body System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant Name: | A-1 Engineering |
|---|---|
| Applicant Address: | 30 Mauchly, Suite AIrvine, CA 92618 |
| Official Contact: | Tony Picciano, Owner |
| Telephone: | (949) 748-7488 |
| Email: | tony6213@yahoo.com |
| Submission Date: | November 26, 2018 |
| Subject Device: | Trade Name: Body SystemCommon Name: Muscle stimulator for conditioning. |
| Regulation Description: | Powdered Muscle Stimulator |
| Classification: | Regulatory Class II, 21 CFR 890.5850 |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product Code: | NGX |
| Device Description | Body System (available in models: SX101 and OS2911). Both modelsutilize the same internal electrical components. The models differ only inthe control/display features and exterior casing/dimensions. The Body |
{4}------------------------------------------------
System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.
The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.
The Intended Use of the Body System has the same key elements as the predicates: for muscle conditioning to stimulate healthy muscle. There are no differences in Intended Use amongst the predicates.
-
The Body System is intended for muscle conditioning to stimulate healthy Indications for use: muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body Sy is intended to be operated by a trained professional who is present to monit treatment. -
Predicate Device: The Body System is substantially equivalent to the predicate devices listed below:
- . K123158, Ion Magnum Genius, under 21 CFR 890.5850 and Product Code NGX
Predicate Trade Name: Ion Magnum Genius
{5}------------------------------------------------
Conditioning Premarket Notification: K123158 Manufacturer: Ion Genius, Inc. . K143551, Compex Wireless USA, under 21 CFR 890.5850 and Product Code NGX Predicate Trade Name: Compex Wireless USA Classification Name: Stimulator, Muscle, Powered for Muscle Conditioning Premarket Notification: K143551 Manufacturer: DJO, LLC Based on the intended use/Indications for use, design, materials, principle of operation, energy used and materials, the Body System is substantially equivalent to the legally marketed predicate devices. The non-clinical performance data demonstrates substantial equivalence and includes an analysis of output waveforms. Non-Clinical Tests The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Device: ● Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass . Biocompatibility – irritation (ISO-10993-10) – result: Pass ● Biocompatibility - Sensitization (ISO-10993-10) - result: Pass . Performance – including Output Waveforms of the Body System as compared to a predicate . Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016 . Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Summary: There are no differences in the technological characteristics between the subject device and the predicate devices, which raise issues concerning safety, performance or efficacy. The Body System is substantially equivalent to the predicate device(s) in terms of safety and effectiveness.
Classification Name: Stimulator, Muscle, Powered for Muscle
{6}------------------------------------------------
| Comparison of the Subject and Predicate Devices | |||||
|---|---|---|---|---|---|
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| Device Name andModel | Body System | Ion MagnumGenius | Compex WirelessUSA | N/A | |
| 510 (K) Number | Subject of thissubmission | K123158 | K143551 | N/A | |
| Product Code | NGX | NGX | NGX | Similar | |
| RegulationNumber | 890.5850 | 890.5850 | 890.5850 | Similar | |
| Indications forUse | The Body Systemis intended formuscleconditioning tostimulate healthymuscles.The Body Systemis not intended tobe used inconjunction withtherapy ortreatment ofmedical diseasesor medicalconditions of anykind. The BodySystem isintended to beoperated by atrainedprofessional whois present tomonitortreatment. | Ion MagnumGenius isintended formuscleconditioning tostimulate healthymuscles. The IonMagnum Geniusis not intended tobe used inconjunction withtherapy ortreatment ofmedical diseasesor medicalconditions of anykind. None of theIon MagnumGenius programsis designed forinjured or ailingmuscles and itsuse on suchmuscles iscontraindicated.The Ion Magnum | The CompexWireless USA is anOver-The-Counterdevice intendedto stimulatehealthy muscles inorder to improveor facilitatemuscleperformance. It isto be used byadults only.The CompexWireless USA isnot intended foradjunctivetherapy in thetreatment ofmedical diseasesand conditions ofany kind. None ofthe CompexWireless USAstimulationprograms aredesigned forinjured or diseaseafflicted muscles.Its use on such | Similar - althoughthere are somedifferences in theexact language ofeach IntendedUse, each isindicated for theStimulation ofHealthy Muscles | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| offered underprescription givenby a physicianlicensed in thestate in which heor she practices. | contraindicated.The work imposedon the muscles bythe CompexWireless USAprograms isdefinitely notsuitable forrehabilitation andphysiotherapy.The CompexWireless USAelectrical impulsesallow thetriggering ofaction potentialson motoneuronesof motor nerves(excitations).These excitationsof motoneuronesare transmitted tothe muscle fibersvia the motorendplate wherethey generatemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending on theparameters of theelectrical impulses(pulse frequency,duration ofcontraction,duration of rest,total sessionduration),different types of | ||||
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| be imposed onthe stimulatedmuscles.The CompexWireless USA maytherefore beconsidered atechnique ofmuscle training. | |||||
| Body ApplicationAreas | Body | Body | Body | Similar | |
| Power Sources | 110vac — 240 vac(AC wall plug-In) | 110vac — 240 vac(AC wall plug-In) | Lithium Polymer(LiPo)rechargeablebatteries | Different -differences do notpresent differentquestions of/oreffect safety andeffectiveness; thesimilar currentsgenerated byeach channel andapplied to thepatient is isolatedfrom the powersource. | |
| Patient LeakageCurrent | 0.05 µA and | 0.07 μΑ | N/A | Similar | |
| Number ofOutput Modes forMicro currentStimulation | 5 | 3 | 1 | Different -differences do notpresent differentquestions of/oreffect safety and | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| effectiveness; alloutputs meet therequirements ofthe FDA Guidanceon PoweredMuscleStimulators. | |||||
| Number ofChannels forMicro currentStimulation | 16 | 6 | 4 | Different -differences do notpresent differentquestions of/oreffect safety andeffectiveness;; allchannels areisolated andgenerate theidentical signal,which are similarto the predicates. | |
| Channel Output:Synchronous orAlternating | Synchronous | Synchronous | Synchronous | Similar | |
| Channel Output:Method of LineCurrent Isolation | Power Supplyisolation | Power Supplyisolation | Power Supplyisolation | Similar | |
| RegulatedCurrent orRegulatedVoltage | Both | Voltage | Both | Similar (voltageregulated devices) | |
| Software/Firmware/Microprocessor control | No | No | Yes | Different -differences do notpresent differentquestions of/or | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| effect safety andeffectiveness; thesimilar currentsgenerated byeach unit is notrelated tosoftware/firmware. | |||||
| AutomaticOverload Trip | Yes | Yes | Yes | Similar | |
| Automatic Noload Trip | Yes | Yes | Yes | Similar | |
| Indicator Display:On / Off Status | Yes | Yes | Yes | Similar | |
| Indicator Display:Voltage CurrentLevel | Yes | Yes | Yes | Similar | |
| Timer Range | None | Yes | Yes | Similar | |
| Compliance withStandards | Electrical Safety:Comply with IEC60601-1 and IEC60601-2-10EMC: Comply withIEC 60601-1-2Biocompatibility:ISO10993-5 andISO10993-10 | Electrical Safety:Comply with IEC60601-1 and IEC60601-2-10EMC: Comply withIEC 60601-1-2Biocompatibility:ISO10993-5 andISO10993-10 | Electrical Safety:Comply with IEC60601-1 and IEC60601-2-10EMC: Comply withIEC 60601-1-2Biocompatibility:Unknown | Similar | |
| Compliance with21 CFR 898 | Yes | Yes | Yes | Similar | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| Weight | See Section 11 forweight ofindividual models | 12.35 oz | Remote: 3.9 ozConsole:2x 2.1 ozDocking Station28.2 oz | Different -differences do notpresent differentquestions of/oreffect safety andeffectiveness; thesimilar currentsgenerated byeach unit is notrelated to weightof the unit. | |
| Dimensions | See Section 11 fordimensions ofindividual models | 5.6" x 3.9" x 1.4"(L x W x H) | Remote3.5"x1.8"x0.28"Console:2.6"x0.8"Docking Station:9.8"x9.8"x0.8" | Different -differences do notpresent differentquestions of/oreffect safety andeffectiveness; thesimilar currentgenerated byeach unit is notrelated to size ofthe unit. | |
| HousingMaterials andConstruction | Aluminum | Metal | Plastic | Different -differences do notpresent differentquestions of/oreffect safety andeffectiveness; thesimilar current | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| Additional Information | |||||
| Waveform (seeSection 18 fordetails) | Biphasic | Biphasic | Biphasic | Similar | |
| Shape | Rectangular | Rectangular | Rectangular | Similar | |
| Maximum OutputVoltage | 58V @ 500 Ω88V @ 2k Ω | 50 V @ 500 Ω200 V @ 10K Ω | 60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ | Similar | |
| Maximum OutputCurrent | 108 ma at 500 Ω | 100 am at 500 Ω | 120 mA @ 500 Ω | Similar | |
| Frequency range | 200 to 1200 Hz | 90 to 120 Hz | 1 to 120 Hz | Similar | |
| Pulse width range | 500 to 2500 µsec | 416 to 500 µsec | 300 to 400 µsec | Similar | |
| Net Charge | 0 @ 500 ΩZero net charge isachieved by usingsymmetricalbiphasicwaveforms | 10000 µColumns@ 500 Ω4000 µColumns @2K Ω2500 µColumns @10K Ω | 0 @ 500 Ω | Similar | |
| Maximum PhaseCharge | 45 µC @ 500 Ω @200 Hz | 50 µC @ 500 Ω @90 and 100 Hz40 µC @ 500 Ω @120 Hz | 48 µC @ 500Ω | Similar | |
| Comparison of the Subject and Predicate Devices | |||||
| Elements ofComparison | Subject device | PrimaryPredicate Device | SecondaryPredicate Device | Similar/Different | |
| MaximumCurrentDensity | 5 mA / cm2 | 4 mA / cm2 | 1.49 mA/cm2 | Similar | |
| Maximum PowerDensity | 0.011 W/cm^2 | 0.0012 W/cm^2 | 0.00276 W/cm^2 | Similar | |
| Environment foroperating | Temperature:Approximately 15to 40° C | Temperature:Approximately 15to 40° C | Unknown | Similar | |
| Environmentfor storage | Temperature:Approximately 20to 60° CHumidity:Approximately 0to88% RH | Temperature:Approximately 20to 60° CHumidity:Approximately 0to88% RH | Unknown | Similar |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
§ 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).