(136 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 Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components: Katalyst Suit, Impulse Pack, and Katalyst Training Station. The Katalyst Suit is worn by the client and contains electrodes for major muscle groups. The Impulse Pack is a powered muscle stimulation device that connects to the suit and delivers EMS impulses. The Katalyst Training Station is a computer-based system with a touch screen and rotary encoders used to configure and run training sessions and adjust intensity levels.
This document is a 510(k) Summary for the Katalyst Mark 1 Muscle Stimulation System Model 2. It assesses the substantial equivalence of the new device to existing legally marketed predicate devices. The document does not describe an acceptance criteria table with reported device performance or a study proving that the device meets acceptance criteria in the way a clinical trial or performance study for a new AI/software device would.
Instead, this 510(k) submission focuses on demonstrating substantial equivalence through non-clinical testing, comparing device characteristics and output specifications to predicate devices, and explaining differences.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device (a powered muscle stimulator, not an AI/software as a medical device that makes diagnostic or treatment recommendations).
However, I can extract information relevant to the non-clinical testing performed and how the device's equivalence was established.
Here's a breakdown of what is available and what is N/A based on the provided text:
1. A table of acceptance criteria and the reported device performance
This specific format is not present. The document instead provides tables comparing the characteristics and output specifications of the new device to its predicate devices, aiming to show substantial equivalence. The "acceptance criteria" for a 510(k) submission like this are implicit in meeting regulatory standards and demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing.
Comparison of Device Characteristics (Table 014-2 & 014-3):
| Characteristic | New Device (Katalyst Mark 1) | Primary Predicate (Compex Sport Plus K083140) | Secondary Predicate (E-Fit EF-1280 K133225) | Similar/Different |
|---|---|---|---|---|
| Indications for Use | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. Rx Only. | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. | K083140 - SimilarK133225 - Similar |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | K083140 - SimilarK133225 - Similar |
| Shape | Rectangular | Rectangular | Rectangular | K083140 - Similar |
| Max Output Voltage | 60 V @ 500 Ω, 96 V @ 2 kΩ, 114.2 V @ 10 kΩ | 60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ | 36 V @ 500 Ω | K083140 - Similar (at 500 Ω)K133225 - DifferentNote: Differences in output specs are addressed in the "Differences" section to show they don't adversely affect safety/effectiveness. |
| Max Output Current | 120 mA @ 500 Ω, 48 mA @ 2 kΩ, 11 mA @ 10 kΩ | 120 mA @ 500 Ω, 82 mA @ 2 kΩ, 16 mA @ 10 kΩ | 72 mA @ 500 Ω | K083140 - Similar (at 500 Ω)K133225 - Different |
| Positive Pulse Width | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - DifferentK133225 - Similar |
| Frequency | 85Hz | 1 to 120Hz | 5 to 120Hz | K083140 - Similar (within range)K133225 - Different |
| Net Charge | $0.5 [\mu C] @ 500\Omega$ (fully compensated) | $0 [\mu C] @ 500\Omega$ (fully compensated) | $0 [\mu C] @ 500\Omega$ (fully compensated) | K083140 - SimilarK133225 - Similar |
| Max Phase Charge | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - SimilarK133225 - Similar |
| Max Current Density | $0.788mA/cm^2 @500\Omega$ | $1.49mA/cm2 @ 500\Omega$ | $0.85mA/cm2 @ 500\Omega$ | K083140 - DifferentK133225 - Similar |
| Max Power Density | $8.16mW/cm^2 @ 500 \Omega$ | $27.6mW/cm2 @500\Omega$ | $6.3mW/cm2 @ 500 \Omega$ | K083140 - DifferentK133225 - Similar |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This refers to the number of devices tested (bench testing), not a sample size of patients or images as would be the case for AI/SaMD. The document describes several non-clinical tests (Biocompatibility, Software Verification and Validation, Electrical Safety and EMC, Battery Testing, Engineering Bench Testing). For these types of tests, the sample size typically refers to a small number of manufactured units or components. The specific number of units tested is not specified in this summary.
- Data Provenance: Not applicable in the context of patient data. The tests are bench and laboratory tests on the device hardware and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The ground truth for a muscle stimulator is established by engineering specifications, international safety standards (e.g., IEC 60601 series), and direct measurement of electrical output, not by expert medical review of patient data.
4. Adjudication method for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes for establishing ground truth in image interpretation or clinical outcomes, which is not relevant for this device's testing.
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 is not applicable. This device is a muscle stimulator, not an AI for image interpretation or diagnosis. There are no "human readers" or AI assistance involved in its direct function for which an MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This device is a physical product designed for human interaction (an operator applies and controls it), not a standalone algorithm. Its software validation ensures it performs as designed, but not in a "standalone algorithm" performance sense for diagnostic accuracy.
7. The type of ground truth used
- The "ground truth" for this device's safety and performance is established through adherence to recognized electrical safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133), software verification against requirements, and engineering bench testing (oscilloscope tracings, load testing). The goal is to ensure the device outputs signals within safe and intended parameters and performs reliably.
8. The sample size for the training set
- This is not applicable. This device is not an AI/ML model that learns from large training datasets. Its software is programmed based on engineering design, not trained.
9. How the ground truth for the training set was established
- This is not applicable for the same reasons as #8. The "ground truth" for software functionality is the design specification and functional requirements, which are then verified and validated.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 20, 2018
Katalyst Inc. Bjoern Woltermann Chief Executive Officer, Katalyst Inc 316 Occidental Ave. South Suite B300 Seattle, Washington 98104
Re: K181199
Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 22, 2018 Received: June 26, 2018
Dear Bjoern Woltermann:
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.
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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 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
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Indications for Use
510(k) Number (if known) K181199
Device Name
Katalyst Mark 1 Muscle Stimulation System Model 2
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) | |
|---|---|
| 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. Submitter
Katalyst Inc. 316 Occidental Avenue S. Suite B300 Seattle, WA 98104
Contact: Bjoern Woltermann - Chief Executive Officer, Katalyst Inc. Tel: (206) 488-3939 Email: bjoern@katalyst-fitness.com
Previously Cleared Devices: K171035 Katalyst Mark 1 Muscle Stimulation System
2. Date Prepared
September 20, 2018
3. Device Name and Classification Information:
Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Model Number: 2 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
4. Predicate Devices
Primary Predicate: Compex® Sport Plus (K083140) Secondary Predicate: E-Fit EF-1280 (K133225)
5. Device Description
The Katalyst Mark 1 Muscle Stimulation System Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components:
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| Katalyst Suit | Worn by the client, the Katalyst Suit consists of a base layer textile (clientcontacting), a cable harness, and an outer layer for the cable harness tosnap into corresponding electrode pads for major muscle groups. Whenconnected to the Impulse Pack, it provides localized EMS impulses tomajor muscle groups at controlled intensities. |
|---|---|
| Impulse Pack | A powered muscle stimulation device specifically designed to mate withthe Katalyst Suit through a single port connector. It delivers EMSimpulses through a battery powered regulated booster. The Impulse Packreceives commands over Bluetooth from the Katalyst Training Stationwhich is controlled by the operator. |
| Katalyst TrainingStation | The Katalyst Training Station is based on an MSI computer runningWindows 10. It is paired with a touch screen and rotary encoders whichare used to configure and run a training via the Katalyst Application. Theadjustment of independent intensities for each muscle group are doneusing 10 smaller knobs to adjust channel intensities and 1 larger knob tocontrol the overall master intensity. |
Table 014- 1 Katalyst Mark 1 Component Overview
Accessories included: Cable Harnesses for connecting Impulse packs and Katalyst Suits, Impulse Pack Charging Adaptors and Katalyst Training Station Power Cords.
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.
7. 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,Model 2 | Compex Sport Plus(currently marketedas Compex SportElite) | E-Fit EF-1280 | K083140 -DifferentK133225 -Different |
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| Manufacturer | Katalyst Inc. | DJO LLC | FIT-PRO KFT LTD. | K083140 -DifferentK133225 -Different |
|---|---|---|---|---|
| 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 motor endplate where they | 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 | K083140 -SimilarK133225 -Similar |
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| 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 typesof muscle workthat the Compex®Sport Plus canimpose on thestimulated musclesare able to improveor facilitate muscleperformance.The Compex®Sport Plus maytherefore beconsidered atechnique ofmuscle training | diseases ormedicalconditions ofany kind. Noneof the E-FitEF-1280trainingprograms isdesigned forinjured or ailingmuscles and itsuse on suchmuscles iscontraindicated.The E-FitEF-1280electricalimpulses allowthe triggering ofactionpotentials onmotoneuronesof motor nerves(excitations).Theseexcitations ofmotoneuronesare transmittedto the musclefibers via themotor endplatewhere theygeneratemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending onthe parametersof the electricalimpulses (pulsefrequency,duration ofcontraction, | |
|---|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| is via SNAPconnectorsdirectly onto theouter vest andleg straps. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| duration of rest,total sessionduration),different typesof muscle workcan be imposedon thestimulatedmuscles. | PowerSource(s) | Li-Po Battery3.8V, 7.79Wh(2050mAh)IEC 62133: 2012 (2ndEdition) | RechargeableNi-Mh Battery4.6V (4 cellsAA=R6) | Lead AcidBattery12V, 3400mAH | K083140-DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectiveness of thedevice | ||||
| The varioustypes of musclework that theE-Fit EF-1280can impose onthe stimulatedmuscles areable to improveor facilitatemuscleperformance.The E-FitEF-1280 maytherefore beconsidered atechnique ofmuscle training. | ChargingSystem | AC/DC wall plug in,distributed directly tothe device. 18.0[v],1.33[A] | AC/DC 9[v] 0.4[A]Distributed directlyto the device | AC/DC wallplug in,distributeddirectly to thedevice. | K083140 -DifferentK133225 -DifferentDifferencedoes notadverselyaffect thesafety andeffectiveness of thedevice | ||||
| Connection ofdevice toelectrodes | The Katalyst ImpulsePack is connected to theelectrodes via a cableharness. The connectionto the Impulse Pack isvia a standard MDRconnector, and snappingonto the electrodesusing standard SNAPconnectors integrated inthe electrodesthemselves. | With 6-pole cablesincluding femalecustom SNAPplugged on thecustom Compexfemale SNAPassembled in theelectrode. Entireelectronic circuitfor four (4)StimulationChannels and UserInterface iscombined intosame casing,connected to theelectrodes with6-pole cables. | The EF-1280unit isconnected to theelectrodes via acable electrodeharness whichis connected tothe EMS devicewith a physicalconnection. Theconnection tothe EMS deviceis via a plastic12pinwaterproof ip68Connector andthe connectionto the electrodes | K083140 -SimilarK133225 -Similar | Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 -SimilarK133225 -Similar |
| Channels | 10 | 4 | 12 | K083140 -DifferentK133225 -Similar | |||||
| OperationModes | 1 | 9 | 5+5 | K083140 -DifferentK133225 -Different |
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| See section1.10Differencesbelow forjustification ofdifferences | ||||
|---|---|---|---|---|
| ChargingIsolation | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| RechargeableIntegratedBattery | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| Display /ControlInterface | Yes; LCD Display onKatalyst TrainingStation | Yes, Integrated(LCD) | LCD 2x40character LCDdisplay withLED backlight.The rotaryencoder allowsfor a quicksetup and easeof use | K083140 -DifferentK133225 -Similar |
| Per ChannelControl | Yes. Using rotaryencoder knobs for eachchannel. | Yes, Usingintegrated buttons. | Yes. Usingrotary encoderknobs for eachchannel. | K083140 -SimilarK133225 -Similar |
| ElectrodePlacement | Placed into outer layer,appropriately positionedover correspondingmuscle group positions.Cannot bemodified/altered. | Not defined.Placement ofelectrodes isdictated by theoperator. | Placed intoouter layer,appropriatelypositioned overcorrespondingmuscle grouppositions.Cannot bemodified/altered. | K083140 -DifferentK133225 -Similar |
| Electrode Leads | 21 CFR 898 compliant. | 21 CFR 898compliant. | 21 CFR 898compliant. | K083140 -SimilarK133225 -Similar |
| ElectrodeInterface | 4mm Standard SNAPConnector. | 4mm StandardSNAP Connector. | 4mm StandardSNAPConnector. | K083140 -Similar |
| K133225 -SimilarK083140 -SimilarK133225 -Similar | ||||
| Electrodes | 2 per channel; Max 20. | 2 per channel; Max 8. | 2 per channel; Max 24. | |
| Transthoracicstimulation | Yes | No | Yes | K083140 -DifferentK133225 -Similarelectrodeplacementand safetymitigationsasK133225 |
| WirelessCommunicationwith ControlInterface | Yes. UtilizingBluetooth Smart (BTLE 4.0). | No | No | K083140 -DifferentK133225 -DifferentSee section1.10Differencesbelow forjustification ofdifferences |
| Mobile / FormFactor | Portable with difficulty,no mobile device, itsintended use requires aKatalyst certifiedoperator. | Yes (pocket devicewith travel case) | Portable withdifficulty, nomobile device,its intended userequires thequalified andtrainedoperator. | K083140 -DifferentK133225 -Similar |
| ChannelControlInterface | Using rotary encoderknobs for each channeland master rotaryencoder for allchannels. | Physical Buttonsand Display onunit. | Using rotaryencoder knobsfor eachchannel andmaster rotary | K083140 -DifferentK133225 -Similar |
| encoder for allchannels. | ||||
| 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 |
| AutomaticNo-Load Trip? | No | Yes | Yes | K083140 -DifferentK133225 -DifferentSee section1.10Differencesbelow forjustificationofdifferences |
| AutomaticShutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 -SimilarK133225 -Similar |
| PatientOverrideControl? | No | Yes | Yes | K083140 -DifferentK133225 -DifferentSee section1.10Differencesbelow forjustificationofdifferences |
| InterfaceIndicators | On/Off - Yes (onImpulse Pack via LED | On/Off - yes | On/Off - yes | K083140 -Similar |
| and the Katalystapplication).Low Battery - Yes (onImpulse Pack).Voltage/Current Level -Yes (in the Katalystapplication).Charging - yes (onImpulse Pack).Duration of training-yes (in the Katalystapplication) | Voltage/CurrentLevel - yesCharging - yesDuration oftrainingtraining- yes. | Low Battery -yesVoltage/CurrentLevel - yesCharging - yesDuration oftrainingtraining- yes. | K133225 -Similar | |
| Duration inminutes | 20 | 55 | 30 minutes | K083140 -SimilarK133225 -Similar |
| Rx Only orOTC | Rx Only | OTC | Rx Only | K083140 -DifferentK133225 -Similar |
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Table 014- 2 Device Characteristic Comparisons
8. Output Specification - Comparison with Predicate Devices
| Characteristic | New Device (Katalyst Mark 1 Muscle Stimulation System) | Primary Predicate: Compex Sport Plus (K083140) | Secondary Predicate: E-Fit EF-1280 (K133225) | Similar/ Different |
|---|---|---|---|---|
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | K083140 - SimilarK133225 - Similar |
| Shape | Rectangular | Rectangular | Rectangular | K083140 - 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 | K133225 -SimilarK083140 -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 | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 -DifferentK133225 -Similar |
| Negative Pulse Width | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 -DifferentK133225 -Similar |
| Frequency | 85Hz | 1 to 120Hz | 5 to 120Hz | K083140 -SimilarK133225 -Different |
| For interferentialmodes only: | No | No | No | K083140 -SimilarK133225 -Similar |
| -Beat Frequency | No | No | No | K083140 -SimilarK133225 -Similar |
| For multiphasicwaveforms only: | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| - Symmetricalphases? | Yes | Yes | Yes | K083140 -SimilarK133225 -Similar |
| - Phase Duration(include units)(state range, ifapplicable)(both phases, ifasymmetrical) | 175µs Symmetrical | 200-400μsSymmetrical | 100 - 500μsSymmetrical | K083140 -DifferentK133225 -Similar |
| Net Charge | $0.5 [\mu C] @ 500\Omega$Excitation pulsefully compensated | $0 [\mu C] @ 500\Omega$Excitation pulsefully compensated | $0 [\mu C] @ 500\Omega$Excitation pulse fully compensated | K083140 - SimilarK133225 - Similar |
| Maximum Phase Charge | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - SimilarK133225 - Similar |
| Maximum Current (RMS) Density | $0.788mA/cm^2 @500\Omega$ | $1.49mA/cm2 @ 500\Omega$ | $0.85mA/cm2 @ 500\Omega$ | K083140 - DifferentK133225 - Similar |
| Maximum Power Density | $8.16mW/cm^2 @ 500 \Omega$ | $27.6mW/cm2 @500\Omega$ | $6.3mW/cm2 @ 500 \Omega$ | K083140 - DifferentK133225 - Similar |
| Burst Mode (i.e., pulse trains)a. Pulses per burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | N/A | Unknown | Unknown | K083140 -UnknownK133225 - Unknown |
| ON Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - DifferentK133225 - Similar |
| OFF Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - DifferentK133225 - Similar |
| Treatment Training Time | 20 minutes | Not Adjustable | 1-30 minutes, 1-minute intervals (adjustable within range) | K083140 - DifferentK133225 - Similar |
| Ramp up time per impulse | 300 ms | Not Adjustable | 0 ms - 5000 ms, 100ms | K083140 - Different |
| intervals(adjustablewithin range) | K133225 -Similar | |||
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Table 014- 3 Output Specification Comparisons
9. Differences
When comparing the core design, output specifications, operating behavior, intended use and general modes of operation it can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulation System.
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 |
|---|---|
| The Katalyst Mark 1 has only 1operation mode compared to manymodes of the predicate devices | In order to provide a consistent and predictable trainingexperience, the Katalyst Mark 1 only provide a single modeof operation. |
| Katalyst Mark 1's use of wirelesscommunication between thecontroller device and the impulsegenerator. | In order to better utilize modern interfaces alongside withstrong and robust platforms. Katalyst utilizes a BluetoothSmart connection between its interface controller and theImpulse Pack. This is similar to the PowerDot Pd-01Muscle Stimulator (with PowerDot Mobile Application)(K150078) |
| Patient Override Control | The Katalyst Mark 1 is always operated by an Katalystoperator for a patient, and as such the operator canimmediately turn off the device. |
| Automatic No-Load Trip | The Katalyst Mark 1 is always operated by an Katalystoperator for a patient. The Operator's Guide outlines properno load procedures. |
Table 014- 4 Justification of differences with predicate devices
10.Non-Clinical Tests
The following non-clinical testing was provided in this 510(k):
10.1. Biocompatibility Testing
Skin contacting Katalyst Suit Base Layers have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP.
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10.2. 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.
10.3. 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
10.4. Battery Testing
The Lithium-Polymer battery used in the Impulse Pack was tested by the battery manufacturer for compliance with IEC 62133 Edition 2.0.
10.5. 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.
11.Conclusion
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).