(153 days)
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components:
Katalyst Suit: Worn by the client, the Katalyst Suit is a compression textile with embedded electrodes connected by a cable harness. When connected to the Impulse Pack it provides localized EMS impulses to major muscle groups at controllable intensities.
Impulse Pack: A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers electrical impulses through a battery powered regulated booster. The Impulse Pack is operator controlled wirelessly via the Katalyst Application over Bluetooth.
Katalyst Application: Controlled by the Operator, the Katalyst Application is run on a Microsoft Surface Pro 3 running Windows 10 Professional. It is used to configure and run a Katalyst training, including the setting of independent intensities for each muscle group channel.
Accessories included: cable harnesses and an Impulse Pack charging cable.
The provided document is a 510(k) Summary for the Katalyst Mark 1 Muscle Stimulation System. It details the device, its indications for use, comparison with predicate devices, and non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or effect size for AI assistance.
Instead, the document outlines various non-clinical tests conducted to demonstrate that the device is substantially equivalent to existing predicate devices in terms of safety and effectiveness, based on recognized standards and guidance. The 'acceptance criteria' in this context refer to compliance with these standards and established performance parameters of the predicate devices, rather than a specific performance target for diagnostic or assistive accuracy.
Therefore, many of the requested sections of your prompt, particularly those related to a clinical study demonstrating AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, cannot be extracted from this document as such information is not present. The Katalyst Mark 1 is a physical muscle stimulation system, not an AI-powered diagnostic or assistive tool in the way your prompt defines.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a powered muscle stimulator, the "acceptance criteria" are primarily based on compliance with electrical safety, EMC, and biocompatibility standards, as well as a comparison of its technical specifications (e.g., waveform, output voltage, current, pulse width, frequency) to predicate devices to establish substantial equivalence.
| Acceptance Criteria (Compliance/Comparison) | Reported Device Performance (Katalyst Mark 1) |
|---|---|
| Biocompatibility (ISO 10993-10:2009, ISO 10993-5:2009) | Tested to standards under GLP. |
| Software Verification & Validation (Moderate level of concern) | All software requirement specifications met, all software hazards mitigated to Accepted risk level. |
| Electrical Safety (IEC/EN 60601-1:2005 Ed 3.1) | Complies and tested. |
| Muscle Stimulator Specific Safety (IEC 60601-2-10:2012 Ed 2.0) | Complies and tested. Specifically, concerning current density >2mA/cm², additional warnings and guidance included in Operator's Guide, and tested to standard. |
| Electromagnetic Compatibility (EMC) (IEC/EN 60601-1-2:2014 Ed 4.0) | Complies and tested. |
| Battery Safety (IEC 62133 Ed 2.0, for Li-Po) | Tested by battery manufacturer for compliance. |
| Wireless Risks Mitigation (FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices") | System validation testing scenarios covering mitigation of wireless risks were added to full system testing protocol to ensure safe and effective use. |
| Output Waveform | Symmetrical Biphasic, Rectangular. |
| Maximum Output Voltage | 60 V @ 500 Ω, 96 V @ 2 kΩ, 114.2 V @ 10 kΩ. |
| Maximum Output Current | 120 mA @ 500 Ω, 48 mA @ 2 kΩ, 11 mA @ 10 kΩ. |
| Positive Pulse Width | 75µs or 175µs. |
| Negative Pulse Width | 75µs or 175µs. |
| Frequency | 85Hz or 100Hz. |
| Net Charge [µC/pulse] | 0.5 [µC] @ 500Ω, Excitation pulse fully compensated. |
| Maximum Phase Charge [µC] | 21µC @ 500 Ω. |
| Maximum Current (RMS) Density [mA/cm2] | 2.4mA/cm² @ 500Ω. |
| Maximum Power Density [mW/cm2] | 5.04mW/cm² @ 500 Ω. |
| Adherence to FDA Guidance Document for Powered Muscle Stimulator 510(k)s (1999) | Testing conducted in accordance with recommendations. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is non-clinical (bench testing, software validation, component testing) rather than a study on a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided as this is not a diagnostic device involving expert ground truth for image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is a muscle stimulator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The "system validation testing" for software ensures that the device's software functions as intended to control the electrical stimulation, but it's not an AI algorithm performing a diagnostic or interpretive task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Biocompatibility: Ground truth is established by the pass/fail criteria of the ISO 10993 standards.
- Software Verification and Validation: Ground truth is established by the software requirement specifications and hazard analysis.
- Electrical Safety, EMC, Battery Testing: Ground truth is established by the pass/fail criteria of the respective IEC/EN standards.
- Engineering Bench Testing: Ground truth is established by comparing measured output waveforms, voltages, currents, etc., against the specified design parameters and potentially against predicate device performance characteristics (though not explicitly stated as direct comparison on every parameter, rather overall substantial equivalence).
8. The sample size for the training set
This information is not applicable and not provided. The term "training set" is usually relevant for machine learning models, which is not the primary focus of this submission. The software validation is for deterministic software.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a stream.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
Katalyst Inc. Amish Patel Chief Product Officer 316 Occidental Avenue South B300 Seattle, Washington 98104
Re: K171035
Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 1, 2017 Received: August 3, 2017
Dear Mr. Patel:
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.
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.
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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 devicerelated 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 (DICE) 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" (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 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 (DICE) 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,
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
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Indications for Use
510(k) Number (if known) K171035
Device Name
Katalyst Mark 1 Muscle Stimulation System
Indications for Use (Describe)
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1.1 Submitter
Katalyst Inc. 316 Occidental Avenue S. B300 Seattle, WA 98104
Contact: Amish Patel, Chief Product Officer Tel: 406-616-3671 Email: devices@katalyst-fitness.com
1.2 Date Prepared
September 6, 2017
1.3 Device Name and Classification Information:
Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Common Name: Powered Muscle Stimulator for Muscle Conditioning Classification Name: Powered Muscle Stimulator Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine
1.4 Predicate Devices
Primary Predicate: Compex® Sport Plus (K083140)
Secondary Predicate: E-Fit EF-1280 (K133225)
1.5 Device Description
The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components:
| Katalyst Suit | Worn by the client, the Katalyst Suit is a compression textilewith embedded electrodes connected by a cable harness. Whenconnected to the Impulse Pack it provides localized EMSimpulses to major muscle groups at controllable intensities. |
|---|---|
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Impulse Pack | A powered muscle stimulation device specifically designed tomate with the Katalyst Suit through a single port connector. Itdelivers electrical impulses through a battery powered regulatedbooster. The Impulse Pack is operator controlled wirelessly viathe Katalyst Application over Bluetooth. |
|---|---|
| KatalystApplication | Controlled by the Operator, the Katalyst Application is run on aMicrosoft Surface Pro 3 running Windows 10 Professional. It isused to configure and run a Katalyst training, including thesetting of independent intensities for each muscle group channel. |
Accessories included: cable harnesses and an Impulse Pack charging cable.
1.6 Indications for Use:
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
1.7 Contraindications
The Katalyst Mark 1 should only be operated by a certified Katalyst Operator. Trainings should not be used by anyone under 18 years of age, with a cardiac pacemaker, with known heart conditions, with a history of cardiac arrhythmia, who is pregnant, with an implanted defibrillator, or with other implanted metallic or electronic device. Such use could cause cardiac arrhythmia, electric shock, burns, electrical interference, or death. Other contraindications are provided in the operator guide.
1.8 Basic Device Characteristics - Comparison with Predicate Devices
| Characteristic | New Device(Katalyst Mark 1Muscle StimulationSystem) | Primary PredicateCompex Sport Plus(K083140) | SecondaryPredicate:E-Fit EF-1280(K133225) | Similar/Different |
|---|---|---|---|---|
| Device Name,Model | Katalyst Mark 1 MuscleStimulation System | Compex Sport Plus(currently marketed) | E-Fit EF-1280 | K083140 -Different |
| Manufacturer | as Compex Sport Elite) | K133225 - DifferentK083140 - Different | ||
| Katalyst Inc. | DJO LLC | FIT PRO, LLC | K133225 - DifferentK083140 - SimilarK133225 - Similar | |
| Indications for Use | The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.The Katalyst Mark 1 is Rx only. | The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the | E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance.The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None |
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| motor endplatewhere they generatemechanical musclefiber responses thatcorrespond tomuscle work.Depending on theparameters of theelectrical impulses(pulse frequency,duration ofcontraction,duration of rest,total sessionduration), differenttypes of musclework can beimposed on thestimulated muscles.The various types ofmuscle work thatthe Compex® SportPlus can impose onthe stimulatedmuscles are able toimprove or facilitatemuscleperformance.The Compex®Sport Plus maytherefore beconsidered atechnique of muscletraining | of the E-Fit EF-1280 trainingprograms isdesigned forinjured or ailingmuscles and itsuse on suchmuscles iscontraindicated.The E-Fit EF-1280 electricalimpulses allowthe triggering ofaction potentialsonmotoneurones ofmotor nerves(excitations).Theseexcitations ofmotoneuronesare transmittedto the musclefibers via themotor endplatewhere theygeneratemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending onthe parametersof the electricalimpulses (pulsefrequency,duration ofcontraction,duration of rest,total sessionduration),different typesof muscle work | |
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Connection ofdevice toelectrodes | The Katalyst ImpulsePack unit is connected tothe electrodes via a cableelectrode harness. Theconnection to theImpulse Pack is via aROHS compliantstandard DB-25 Femaleconnector, and snappingonto the electrodes usingstandard 4mm SNAPconnectors integrated inthe electrodesthemselves. The SNAPheaders are combinedand over molded in thelead cables. | With 6-pole cablesincluding femalecustom SNAPplugged on thecustom Compexfemale SNAPassembled in theelectrode. Entireelectronic circuit forfour (4) StimulationChannels and UserInterface iscombined into samecasing, connected tothe electrodes with6-pole cables. | on thestimulatedmuscles.The varioustypes of musclework that the E-Fit EF-1280 canimpose on thestimulatedmuscles are ableto improve orfacilitate muscleperformance.The E-Fit EF-1280 maytherefore beconsidered atechnique ofmuscle training.The EF-1280unit is connectedto the electrodesvia a cableelectrodeharness which isconnected to theEMS devicewith a physicalconnection. Theconnection tothe EMS device1s via a plastic12pinwaterproof ip68Connector andthe connectionto the electrodesis via SNAPconnectorsdirectly onto theouter vest and | K083140 -SimilarK133225 -Similar | LED backlight.The rotaryencoder allowsfor a quick setupand ease of use | DifferentSee section1.10Differencesbelow forjustificationofdifferences | |||
|---|---|---|---|---|---|---|---|---|---|
| PowerSource(s) | Li-Po Battery3.8V, 7.79Wh | Rechargeable Ni-MhBattery 4.6V (4 cells | leg straps.Lead AcidBattery | K083140 -Different | Per ChannelControl | Yes. Using Windows 10control application | Yes, Usingintegrated buttons. | Yes. Usingrotary encoderknobs for eachchannel. | K083140 -SimilarK133225 -Similar |
| (2050mAh) | AA=R6) | K133225 - | ElectrodePlacement | Integrated into wearablebody suit and positionedover correspondingmuscle group positions.Cannot bemodified/altered. | Not defined.Placement ofelectrodes isdictated by theoperator. | Placed into outerlayer,appropriatelypositioned overcorrespondingmuscle grouppositions.Cannot bemodified/altered. | K083140 -DifferentK133225 -Similar | ||
| IEC 62133: 2012 (2ndEdition) | 12V, 3400mAH | Different | ElectrodeLeads | 21 CFR 898 compliant. | 21 CFR 898compliant. | 21 CFR 898compliant. | K083140 -SimilarK133225 -Similar | ||
| ChargingSystem | AC/DC wall plug in,distributed directly to thedevice. 18.0[v], 1.33[A] | AC/DC 9[v] 0.4[A]Distributed directly tothe device | AC/DC wallplug in,distributeddirectly to thedevice. | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectiveness of thedevice | ElectrodeInterface | 4mm Standard SNAPConnector. | 4mm StandardSNAP Connector. | 4mm StandardSNAPConnector. | K083140 -SimilarK133225 -Similar |
| Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 -SimilarK133225 -Similar | Electrodes | Only 2 per channel; Max20. | 2 per channel; Max8. | 2 per channel;Max 24. | K083140 -SimilarK133225 -Similar |
| Channels | 10 | 4 | 12 | K083140 -DifferentK133225 -Similar | Transthoracicstimulation | Yes | No | Yes | K083140 -DifferentK133225 -Similarelectrodeplacementand safetymitigationsas K133225 |
| OperationModes | 3 | 9 | 5+5 | K083140 -SimilarK133225 -Different | |||||
| ChargingIsolation | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar | |||||
| RechargeableIntegratedBattery | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar | |||||
| Display /Control | Yes; (LCD Display onMicrosoft Surface Pro 3 | Yes, Integrated(LCD) | LCD 2x40character LCD | K083140 -Different |
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| Communicationwith ControlInterface | Bluetooth Smart (BT LE4.0). | DifferentK133225 -DifferentSee section1.10Differencesbelow forjustificationofdifferences | ||
|---|---|---|---|---|
| Mobile / FormFactor | Yes (tablet, handhelddevice and wearablesuit). | Yes (pocket devicewith travel case) | Portable withdifficulty, nomobile device,its intended userequires thequalified andtrained operator. | K083140 -SimilarK133225 -Similar |
| ChannelControlInterface | Touch User Interfaceprovided by KatalystApplication on SurfacePro 3 PC | Physical Buttonsand Display on unit. | Using rotaryencoder knobsfor each channeland masterrotary encoderfor all channels. | K083140 -DifferentK133225 -DifferentSee section1.10Differencesbelow forjustificationofdifferences |
| Instant Shutoff | Physical Button | Physical Button | Physical Button | K083140 -SimilarK133225 -Similar |
| MicroprocessorControlled? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| Automaticoverload trip? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| Automatic No-Load Trip? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| AutomaticShutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 -SimilarK133225 -Similar |
| PatientOverrideControl? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| InterfaceIndicators | On/Off - Yes (onImpulse Pack via LEDand in application)Low Battery - Yes (onImpulse Pack)Voltage/Current Level -Yes (in application).Charging - yes onImpulse Pack.Duration of training- yes(in application) | On/Off - yesLow Battery - yesVoltage/CurrentLevel - yesCharging - yesDuration of trainingtraining- yes. | On/Off - yesLow Battery -yesVoltage/CurrentLevel - yesCharging - yesDuration oftrainingtraining- yes. | K083140 -SimilarK133225 -Similar |
| Duration inminutes | 40 (shown on display) | 55 | 30 minutes | K083140 -SimilarK133225 -Similar |
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Table 10: Device Characteristic Comparisons
1.9 Output Specification - Comparison with Predicate Devices
| Characteristic | New Device(Katalyst Mark 1Muscle StimulationSystem) | Primary Predicate:Compex Sport Plus(K083140) | SecondaryPredicate: E-Fit EF-1280(K133225) | Similar/Different |
|---|---|---|---|---|
| Waveform | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | K083140 -SimilarK133225 - |
| Similar | ||||
| Shape | Rectangular | Rectangular | Rectangular | K083140 -SimilarK133225 -Similar |
| Maximum OutputVoltage (+/- 10%) | 60 V @ 500 Ω96 V @ 2 kΩ114.2 V @ 10 kΩ | 60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | 36 V @ 500 Ω | K083140 -SimilarK133225 -Different |
| Maximum OutputCurrent (+/- 10%) | 120 mA @ 500 Ω48 mA @ 2 kΩ11 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 72 mA @ 500 Ω | K083140 -SimilarK133225 -Different |
| Positive Pulse Width | 75µs or175µs | 200 µs to 400 µs | 100µs to500µs | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| Negative Pulse Width | 75µs or175µs | 200 µs to 400 µs | 100µs to500µs | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| Frequency | 85Hz or 100Hz | 1 to 120Hz | 5 to 120Hz | K083140 -SimilarK133225 -Different |
| For interferentialmodes only: | No | No | No | K083140 -SimilarK133225 -Similar |
| For multiphasicwaveforms only: | Yes | Yes | Yes | SimilarK133225 -Similar |
| - Symmetricalphases? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| - Phase Duration(include units)(state range, ifapplicable)(both phases, ifasymmetrical) | 75µs Symmetrical or175uSecSymmetrical | 70-200µsSymmetrical | 100 - 500µsSymmetrical | K083140 -SimilarK133225 -Different |
| Net Charge[µC/pulse] | $0.5 [\mu C] @ 500\Omega$Excitation pulse fullycompensated | $0 [\mu C] @ 500\Omega$Excitation pulsefully compensated | $0 [\mu C] @ 500\Omega$Excitationpulse fullycompensated | K083140 -SimilarK133225 -Similar |
| Maximum PhaseCharge [µC] | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 -SimilarK133225 -Similar |
| Maximum Current(RMS) Density[mA/cm2] | $2.4mA/cm^2 @500\Omega$ | $1.49mA/cm^2 @ 500\Omega$ | $0.85mA/cm^2 @ 500\Omega$ | K083140 -DifferentK133225 -DifferentSee section1.10Differencesbelow forjustificationofdifferences |
| Maximum PowerDensity [mW/cm2] | $5.04mW/cm^2 @ 500 \Omega$ | $27.6mW/cm^2 @500\Omega$ | $6.3mW/cm^2 @ 500 \Omega$ | K083140 -SimilarK133225 -Similar |
| Burst Mode(i.e., pulse trains) | N/A | Unknown | Unknown | K083140 -UnknownK133225 - |
| c. Burst duration(seconds) | ||||
| d. Duty Cycle [Line(b) x Line (c)] | ||||
| ON Time (seconds) | 1 or 4, 1 secondintervals(software adjustablemodes) | Not Adjustable | 0.1 to 60seconds, 0.1secondintervals(adjustablewithin range) | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| OFF Time (seconds) | 1 or 4, 1 secondintervals(software adjustablemodes) | Not Adjustable | 0.1 to 60seconds, 0.1secondintervals(adjustablewithin range) | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| Treatment TrainingTime | 1-40 minutes, 1-minute intervals(software adjustablewithin range) | Not Adjustable | 1-30 minutes,1-minuteintervals(adjustablewithin range) | K083140 -DifferentK133225 -SimilarDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| Ramp up time perimpulse | 0 seconds or 300ms(software adjustablewithin range) | Not Adjustable | 0 ms - 5000ms, 100msintervals(adjustablewithin range) | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectivenessof the device |
| does notadverselyaffect thesafety andeffectivenessof the device |
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Table 11: Output Specification Comparisons
1.10 Differences
Fundamentally, when we compare the core design, output specifications, operating behavior, intended use and general modes of operation we can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulator.
The following table outlines the essential differences with justifications for how the differences do not adversely impact the safety and effectiveness of the subject device.
| Difference | Additional Details | Justification for howthe difference doesnot adversely impactsafety andeffectiveness |
|---|---|---|
| Katalyst Mark 1's use ofwireless communicationbetween the controllerdevice and the impulsegenerator. | In order to better utilizemodern interfaces alongsidewith strong and robustplatforms. Katalyst utilizes aBluetooth Smart connectionbetween its interface controllerand the impulse pack. | System validationtesting scenarioscovering mitigation ofwireless risks inaccordance withFDA's “RadioFrequency WirelessTechnology in MedicalDevices - Guidance forIndustry and Food andDrug AdministrationStaff” were added toour full system testingprotocol to ensure safeand effective useIn addition, this issimilar to thePowerDot Pd-01Muscle Stimulator(with PowerDotMobile Application)(K150078) |
| Using a tablet / touchinterface to controlchannel impulseintensities. | The touch application is usedto control the impulseintensities wirelessly viaBluetooth. | Impulse Packfirmware and KatalystApplication softwaredocumentation,consistent with aModerate level ofconcern, is providedwith this 510(k).System ValidationTesting proves that allsoftware requirementspecifications weremet and all softwarehazards were mitigatedto Accepted risk levelIn addition, this issimilar to thePowerDot Pd-01Muscle Stimulator(with PowerDotMobile Application)(K150078) |
| The Katalyst Mark 1 has acurrent density (RMS)greater than 2mA/cm² | As outlined in IEC 60601-2-10additional warnings andguidance are included in theOperator's Guide to properlyadvice operators on properprocedures to increase tointensities. | The Katalyst Mark 1has been tested andconformed to the IEC60601-2-10:2012"Medical electricalequipment - Part 2-10:Particularrequirements for thebasic safety andessential performanceof nerve and musclestimulators." Edition2.0 standard.Furthermore, thesubject device hascomplied with therecommendations setforth in FDA's"Guidance Documentfor Powered MuscleStimulator 510(k)s" |
| issued on June 9, 1999In addition, CompexSport (K011880) has acurrent density of3.84mA/cm² whichincludes similarwarnings andguidance. |
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1.11 Non-Clinical Tests
The following non-clinical testing was provided in this 510(k):
Biocompatibility Testing
Skin contacting electrodes pads have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP.
Software Verification and Validation
Impulse Pack firmware and Katalyst Application software documentation, consistent with a Moderate level of concern, is provided with this 510(k).
System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.
Electrical Safety and Electromagnetic Compatibility Testing
The Katalyst Suit and the Impulse Pack have been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards:
- . IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety" Edition 3.1
- . IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators." Edition 2.0
- . IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances. Edition 4.0
Battery Testing
Lithium-Polymer battery, used in Impulse Pack was tested by battery manufacturer for compliance with IEC 62133 Edition 2.0.
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Engineering Bench Testing
In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω. 2 kΩ and 10 kΩ. Also, several system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.
Conclusion 1.12
Test results demonstrate the Katalyst Mark 1 Muscle Stimulation System is substantially equivalent to the predicate devices.
§ 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).