The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Pepper EMS Training System 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.

Device Description

The Pepper EMS Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate healthy muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training.

The Pepper EMS Training System is the main part and consists of two separate accessories, the Pepper Suit and the Pepper Battery Box. The Pepper EMS Training System is designed to be used with the Pepper Application, which is the interface between the user and the Battery Box and runs on a user supplied iOS or Android device. The iOS or Android device communicates wirelessly with the Battery Box using Bluetooth 4.2.

AI/ML Overview

The provided text is a 510(k) Summary for the Pepper EMS Training System, seeking FDA clearance as substantially equivalent to the Katalyst Training System. This document focuses on demonstrating substantial equivalence through comparison to a predicate device and adherence to recognized standards, rather than presenting a traditional clinical study with defined acceptance criteria for device performance.

Therefore, the acceptance criteria and study proving the device meets these criteria are framed within the context of substantial equivalence and compliance with established medical device standards, as opposed to a standalone performance study with clinical outcomes measures.

Here's an interpretation based on the provided document:

Device: Pepper EMS Training System

Indications for Use: The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. 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.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission showing substantial equivalence, the "acceptance criteria" are primarily defined by the characteristics and safety/performance profile of the predicate device and relevant industry standards. The "reported device performance" is demonstrated through comparison to the predicate and compliance with standards.

Acceptance Criteria Category	Specific Acceptance Criteria (Derived from Predicate & Standards)	Reported Device Performance (Pepper EMS Training System)	Conclusion on Meeting Criteria
Indications for Use	Identical to Predicate: Stimulate healthy muscles to improve/facilitate muscle performance, OTC, adult use only, not for therapy/medical conditions, contraindicated for injured/ailing muscles.	Identical.	Met
Technology / Design	Power Source: Safe, effective for intended use.	Lithium Polymer (Li-Po) rechargeable battery, 3.8V, 2,650 mAh. Different from predicate (lower voltage, higher capacity) but deemed safe and effective.	Met - Deemed equivalent with minor differences.
	Number of Output Channels: Medically safe and effective.	16 channels. Different from predicate (13 channels) but all channels are identical and conform to regulations.	Met - Deemed equivalent with minor differences.
	Connection to Electrode: Secure and effective.	One-piece suit with embedded cables via pogo pins. Different from predicate (multiple pieces, snap connectors) but deemed not to affect safety/effectiveness.	Met - Deemed equivalent with minor differences.
	Duty Cycle, ON/OFF Time: Consistent with predicate.	50% duty cycle, 4 seconds ON, 4 seconds OFF. Identical to predicate.	Met
	Software/Firmware: Control functionality consistent with predicate, verified and validated.	Yes, software/firmware control. Verified and Validated per FDA guidance.	Met
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10.	Compliant with stated standards. Additional compliance to IEC 60601-1-11.	Met
	Parameters (Voltage, Current, Pulse Width, Frequency, Phase Duration, Charge, Density, Pulses per burst) within safe and effective limits, comparable to predicate.	Max Output Voltage: Lower than predicate. Max Output Current: Lower than predicate. Pulse Width: Wider range (160-490 μs) than predicate. Frequency: Subset of predicate's range (15-100Hz vs 1-105Hz). Max Phase Charge: Higher than predicate (53 μC vs 45 μC). Max Current Density: Lower than predicate. Max Power Density: Lower than predicate.	Met - All differences discussed and deemed to comply with IEC 60601-2-10 limits and not raise safety/effectiveness concerns.
Biocompatibility	Compliance with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).	Skin contacting materials tested to ISO 10993-5 and ISO 10993-10 under GLP.	Met
Battery Safety	Compliance with IEC 62133.	Cells comply with IEC 62133-2.	Met
Risk Management	Application of risk management process.	Compliance with ISO 14971.	Met
Software Life Cycle	Compliance with medical device software standards.	Compliance with AAMI/ANSI/IEC 62304.	Met
Usability	Compliance with usability standards.	Compliance with IEC 60601-1-6.	Met

2. Sample Size Used for the Test Set and Data Provenance

This submission does not describe a clinical "test set" in the traditional sense of a patient cohort. Instead, the "test set" refers to the device itself undergoing various bench tests and compliance assessments.

Sample Size: Not applicable in the context of human subject data. The testing was performed on the device prototypes/production samples.
Data Provenance: The data comes from non-clinical bench testing and compliance assessments against international standards (e.g., IEC, ISO). The document does not specify the country of origin for these tests but implies they were conducted by qualified testing facilities to meet international standards. The data is implicitly prospective, as it's generated through specific tests performed for the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set & Qualifications

This type of 510(k) submission does not typically involve multiple human experts establishing "ground truth" for a test set of clinical images or outcomes. The "ground truth" for the device's safety and performance is established by:

International Medical Device Standards: These are developed by committees of experts (e.g., engineers, medical professionals, regulatory bodies) and represent consensus on safe and effective performance.
Predicate Device Performance: The legally marketed predicate device's established safety and effectiveness serves as a benchmark.

Therefore:

Number of Experts: Not directly specified for the "test set" as it's not a clinical data review. However, the standards themselves are products of expert consensus.
Qualifications of Experts: The experts involved are those who developed and maintain the international standards (e.g., AAMI, IEC, ISO committees) and the regulatory personnel at the FDA who review these submissions. Their qualifications would typically involve extensive expertise in medical device engineering, electrical safety, biocompatibility, quality systems, and regulatory science.

4. Adjudication Method for the Test Set

Not applicable. There's no adjudication in the sense of reconciling multiple human interpretations of clinical data. The compliance is assessed against predefined technical specifications and standard requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies are submitted to support this premarket notification submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

Not applicable. This device is a hardware-software system for muscle stimulation, not an AI algorithm that generates a diagnostic output. Its performance is inherent in its electrical characteristics and physical design, as evaluated through bench testing.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Compliance with Recognized Consensus Standards: (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, ISO 14971, ISO 10993-5, ISO 10993-10, AAMI/ANSI/IEC 62304, IEC 60601-1-6). These standards define the accepted electrical, mechanical, software, and biological safety and performance parameters.
Substantial Equivalence to a Legally Marketed Predicate Device: The predicate device (Katalyst Training System, K190966) has already been cleared by the FDA, meaning its safety and effectiveness for its indications for use have been established. The ground truth for the Pepper EMS Training System, in part, rests on its ability to perform similar to or better than the predicate without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there's no training set, there's no ground truth established for one.

Summary

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January 16, 2025

Image /page/0/Picture/1 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 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.

Pepper Interactive Inc Emilia Von Keyserlingk Managing Director 251 Little Falls Drive Wilmington, Delaware 19808-1674

Re: K233770

Trade/Device Name: Pepper EMS Training System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 15, 2023 Received: November 24, 2023

Dear Emilia Von Keyserlingk:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233770

Device Name

Pepper EMS Training System

Indications for Use (Describe)

The Pepper EMS Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

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 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.87(h) and 21 CFR 807.92.

Submitter

Pepper Interactive Inc 251 Little Falls Drive Wilmington DE, 19808-1674

Contact Person

Emilia von Keyserlingk - Managing Director, Pepper Interactive Inc. Tel: (+49) 160 970 32942 Emai: emilia.keyserlingk@peppermove.com

Date Summary Prepared

January 13, 2025

Device

Device Trade Name:	Pepper EMS Training System
Device Common Name:	Powered Muscle Stimulator for Muscle Conditioning
Regulation Name:	Powered Muscle Stimulator
Regulation Number:	21 CFR 890.5850
Regulatory Class:	Class II
Product Code:	NGX
Classification Panel:	89, Physical Medicine

Predicate Device

Device Name:	Katalyst Training System
510(k) Number:	K190966
Regulation Name:	Powered Muscle Stimulator
Regulation Number:	21 CFR 890.5850

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Regulatory Class:	Class II
Product Code:	NGX

Device Description

Indications for Use

The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Pepper EMS Training System 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.

Comparison to the Predicate Device

The similarities and differences between the technology and specifications of the subject device and its predicate devices are reflected below:

		Basic Device Characteristics - Comparison with Predicate Devices
--	--	------------------------------------------------------------------	--	--	--	--

Characteristics	New Device	Predicate Device	Comparison
Manufacturer	Pepper Interactive Inc.	Katalyst Inc.	N/A
Device name,model	Pepper EMSTraining System	Katalyst TrainingSystem Model 1	N/A
Classificationname	Powered musclestimulator	Powered musclestimulator	Same
Product code	NGX	NGX	Same
Regualtionnumber	21 CFR 890.5850	21 CFR 890.5850	Same
Panel	PhysicalMedicine	PhysicalMedicine	Same
Class	Class II	Class II	Same
510(k) number	K233770	K190966	N/A
Prescription/OTC	OTC	OTC	Same
Indications foruse	The Pepper EMSTraining Systemis an Over-The-Counter deviceintended tostimulate healthymuscles in orderto improve orfacilitate muscleperformance. It isto be used byadults only.The Pepper EMSTraining Systemis not intended tobe used inconjunction withtherapy ortreatment ofmedical diseasesor medicalconditions of anykind. None of thetraining programsor operationalparameters aredesigned to targetinjured or ailingmuscles and itsuse on suchmuscles iscontraindicated.The Pepper EMSTraining System'selectricalimpulses allowthe triggering ofaction potentials	The KatalystTraining Systemis an Over-The-Counter deviceintended tostimulate healthymuscles in orderto improve orfacilitate muscleperformance. It isto be used byadults only. TheKatalyst TrainingSystem is notintended to beused inconjunction withtherapy ortreatment ofmedical diseasesor medicalconditions of anykind. None of thetraining programsor operationalparameters aredesigned to targetinjured orailing musclesand its use onsuch muscles iscontraindicated.The KatalystTraining System'selectricalimpulses allowthe triggering ofaction potentials	Same
	on motoneuronsof motor nerves(excitations).These excitationsof motoneuronsare transmitted tothe muscle fibersvia the motorendplate wherethey generatemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending on theparameters of theelectricalimpulses (pulsefrequency,duration ofcontraction,duration of rest,total sessionduration),different types ofmuscle work canbe imposed on thestimulatedmuscles.	of motor nerves(excitations).These excitationsof motoneuronsare transmittedto the musclefibers via themotor endplatewhere theygeneratemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending on theparametersof the electricalimpulses (pulsefrequency,duration ofcontraction,duration of rest,total sessionduration),different types ofmuscle work canbe imposed on thestimulatedmuscles.
Target population	It is to be used byadults only.	It is to be used byadults only.	Same
Connection ofdevice toelectrode	The Pepper EMSBattery Boxconnectsto the Suitthrough outputcables thatterminate withpogo pinconnectors.The Suit containsembedded cableswhich makeconnectionwith the built-inelectrodes.	The Impulse Packconnectsto the Suitthrough outputcables thatterminate withpogo pinconnectors.The Suit containsanembedded cableharnesswhich makesconnectionwith the built-inelectrodes.	DifferentThe Pepper EMS TrainingSystem contains a one-piecesuit and does not need extraconnectors like the predicatedevice. Both devices connecttheir accessories, suit andbattery box, via pogo pins. Thisdoes not affect safety andeffectiveness of the subjectdevice.
	Neither the cablesnor the electrodesare removable.	Neither the cableharness or theelectrodes areremovable.The Suit alsofeatures leadswith snapconnectors forconnecting to thearm electrodes.
Power source(s)	Lithium Polymer(Li-Po)rechargeablebattery3,8 V, 2,650 mAh	Lithium Polymer(Li-Po)rechargeablebattery7.4V, 2,050 mAh	DifferentThe Pepper battery has a lowervoltage and higher capacity toimprove efficiency andlongevity.
Method of linecurrent isolation	N/A (batteryoperateddevice)	N/A (batteryoperateddevice)	Same
Patient leakagecurrent	N/A (batteryoperateddevice)	N/A (batteryoperateddevice)	Same
Normal condition	N/A (batteryoperateddevice)	N/A (batteryoperateddevice)	Same
Single faultcondition	N/A (batteryoperateddevice)	N/A (batteryoperateddevice)	Same
Number of outputmodes	One (NMES)	One (NMES)	Same
Number of outputchannels	16	13	DifferentThree extra channels, allchannels are identical andconforming to regulations.
-Synchronous oralternating?	Synchronous, butnever 2channels activatedat the same time	Synchronous, butnever 2channels activatedat the same time	Same
-Method ofchannel isolation	Multi-ChannelHigh VoltageAnalog Switches.Exceptduring channelactivation,each channel isalways inhigh Z state.	Multi-ChannelHigh VoltageAnalog Switches.Exceptduring channelactivation,each channel isalways inhigh Z state.	Same

Regulated current	Regulated current	Regulated current	Same
or regulated	(all	(all
voltage?	channels)	channels)
Software/firmwar	Yes	Yes	Same
e/microprocessor
control?
Automatic	Yes	Yes	Same
overload trip?
Automatic no-	Yes	Yes	Same
load trip?
Automatic shut	"On/Off" switch	"On/Off" switch	Same
off?
Patient override	Yes	Yes	Same
control?
Indicator display -	Yes	Yes	Same
on/off status?
-Low battery?	Yes	Yes	Same
-Voltage/current	Yes	Yes	Same
level?
Timer range	Maximum	Maximum	Different
(minutes)	program: 25	program: 60
	minutes	minutes	The maximum program length
			of the subject device is more
			restricted that that of the
			predicate device.
Compliance with	Yes	Yes	Different
voluntary
standards?	IEC 60601-1	IEC 60601-1	The subject device is
	IEC 60601-1-2	IEC 60601-1-2	additionally compliant to IEC
	IEC 60601-2-10	IEC 60601-2-10	60601-1-11.
	IEC 60601-1-11
Compliance with	Yes	Yes	Same
21 cfr 898?
Weight	Battery Box -	Impulse Pack -	Different
	152 g	248 g
			Pepper's battery box is smaller
			and therefore also lighter than
			the predicate's impulse pack.

Dimensions	Impulse Pack	Impulse Pack	Different
	-102 x 22mm	— 148x78 mm
		Connector 1	Pepper's battery box is smaller
		-65x32mm	than the predicate's impulse
		Connector 2	pack and doesn't have
		- 56x32mm	additional connectors.
Housing material	Plastic injection	Plastic injection	Same
and construction	molding	molding
Characteristic	New Device	Predicate Device	Comparison
Manufacturer	Pepper Interactive Inc	Katalyst Inc	N/A
Device name, model	Pepper EMSTraining System	Katalyst TrainingsSystem	N/A
Waveform	Cardio:SymmetricalBiphasicStrength:SymmetricalBiphasicRelax:SymmetricalBiphasic	Endurance:SymmetricalBiphasicResistance:SymmetricalBiphasicStrength:SymmetricalBiphasicExplosiveStrength:SymmetricalBiphasicPotentiation:SymmetricalBiphasicTrainingRecovery :SymmetricalBiphasicCompetitionRecovery:SymmetricalBiphasicWarmup:SymmetricalBiphasicMuscleRelaxation:SymmetricalBiphasic	SameThe waveforms of the subject and predicate are the same. The subject device offers only three training programs: Cardio, Strength and Relax. The training programs of the subject device are part of the range of training programs of the predicate device.
Shape	Cardio:RectangularStrength:RectangularRelax:Rectangular	Endurance:RectangularResistance:RectangularStrength:RectangularExplosiveStrength:RectangularPotentiation:RectangularTraining	Same

		RectangularCompetitionRecovery:RectangularWarmup:RectangularMuscleRelaxation:Rectangular
Maximum outputvoltage (+/-10%)	Cardio:50 V @ 500 Ω50 V @ 2 kΩ50 V @ 10 kΩStrength:54 V @ 500 Ω53 V @ 2 kΩ51 V @ 10 kΩRelax:51 V @ 500 Ω52 V @ 2 kΩ51 V @ 10 kΩ	Endurance:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩResistance:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩStrength:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩExplosiveStrength:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩPotentiation:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩTrainingRecovery :60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩCompetitionRecovery:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩWarmup:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩMuscleRelaxation:60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ	DifferentThe Pepper EMS TrainingSystem's maximum voltage isless than that of the predicatedevice.
Maximum outputcurrent (+/-10%)	Cardio:100 mA @ 500Ω	Endurance:120 mA @ 500 Ω	Different
	25mA @ 2 kΩ5mA @ 10 kΩStrength:108 mA @ 500Ω27mA @ 2 kΩ5mA @ 10 kΩRelax:102 mA @ 500Ω26mA @ 2 kΩ5mA @ 10 kΩ	50 mA @ 2 kΩ10 mA @ 10 kΩResistance:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩStrength:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩExplosiveStrength:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩPotentiation:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩTrainingRecovery :120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩCompetitionRecovery:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩWarmup:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩMuscleRelaxation:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩ	The Pepper EMSTraining System's maximumcurrent is less than that of thepredicate devices.
Pulse width	Cardio:160 to 490 μsStrength:160 to 490 μsRelax:160 to 490 μs	Potentiation:250 to 375 μsEndurance:250 to 375 μsResistance:250 to 375 μsStrength:250 to 375 μsExplosiveStrength:250 to 375 μsTrainingRecovery:	DifferentThe subject device providescustomization through a widerspectrum of pulse width. Themain output parameters(output current and outputvoltage) and energy density arelower for the subject devicesthan for the predicate device,which complies with IEC60601-2-10 limits.

		250 to 375 µsCompetitionRecovery:250 to 375 µsWarmup:250 to 375 µsMuscleRelaxation:250 to 375 µs
Frequency	Cardio:15 HzStrength:85 HzRelax:100 Hz	Endurance:10 HzResistance:50 HzStrength:75 HzExplosiveStrength:105 HzPotentiation:1 to 75 HzTrainingRecovery :1 to 9 HzCompetitionRecovery:1 to 6 HzWarmup:5 HzMuscleRelaxation:1 Hz	DifferentThe Pepper EMS TrainingSystem's frequency range (15-100Hz) is a subset of that ofthe predicate device: 1-105Hz.
Phase duration	160 to 490 µs	250 to 375 µs	DifferentThe phase duration of PepperEMS Training System is widerthan predicate device. Themain output parameters (outputcurrent and output voltage) andenergy density are lower forthe subject devices than for thepredicate device, whichcomplies with IEC 60601-2-10limits.
Net charge	Cardio:0 µC @ 500 ΩStrength:0 µC @ 500 ΩRelax:0 µC @ 500 Ω	Endurance:0 µC @ 500 ΩResistance:0 µC @ 500 ΩStrength:0 µC @ 500 ΩExplosiveStrength:	Same
	0 $\mu$ C @ 500 ΩPotentiation:0 $\mu$ C @ 500s ΩTrainingRecovery :0 $\mu$ C @ 500 ΩCompetitionRecovery:0 $\mu$ C @ 500 ΩWarmup:0 $\mu$ C @ 500 ΩMuscleRelaxation:0 $\mu$ C @ 500 Ω
Maximum phase charge	53 $\mu$ C @ 500 Ω	45 $\mu$ C @ 500 Ω	DifferentMaximum phase charge of Pepper EMS Training System is higher than predicate device. The main output parameters (output current and output voltage) and energy density are lower for the subject devices than for the predicate device, which complies with IEC 60601-2-10 limits.
Maximum current (rms) density	0.9 mA/cm2 @ 500 Ω	1.15 mA/cm2 @ 500 Ω	DifferentSubject device has a lower maximum current density than the predicate due to the lower maximum current, which complies with the IEC 60601-2-10 limits.
Maximum Power Density (using smallest electrode conductive surface area)	16.95 mW/cm2 @ 500Ω	22.68 mW/cm2 @ 500Ω	DifferentSubject device has a lower maximum current density than the predicate due to the lower maximum current and output voltage.
Pulses per burst	4 – 400	4 – 420	DifferentThe pulses per burst of the subject device are slightly lower than the pulses per burst of the predicate device. This does not raise any concerns.
Bursts per second	0.125	0.125	Same
Burst duration	4	4	Same

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Output Specification - Comparison with Predicate Devices

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Duty Cycle	50%	50%	Same
ON time(seconds)	4	4	Same
OFF time(seconds)	4	4	Same

Discussion

The predicate device Katalyst Training System Model 1 is currently marketed in the US and approved by the FDA with the 510(k) number K190966. The comparison tables above show similarities and differences between the subject and the predicate device according to the Guidance Document for Powered Muscle Stimulator 510(k)s, which will be discussed in the following.

Indications for use and the target population of the Pepper EMS Training System and the Katalyst Training System are identical. In addition to some general characteristics which are identical, output specifications, like waveform, shape, burst duration and duty cycles are identical. These are the differences which could be observed:

· The Pepper EMS Training System contains a one-piece suit with embedded cables which connect the built-in electrodes whereas the Katalyst Training System uses different pieces and snap connectors which have to be connected before use. Both devices connect their suit and battery box via pogo pins. The composition of the Systems affects the amount of pieces and setup steps but has no effects on the treatment. Similar to the predicate device, the subject 's skin contacting materials have been tested to ISO 10993-5 and ISO 10993-10 standard under GLP

· The Pepper Battery Box uses a lower voltage and a higher capacity than the Katalyst Impulse Pack. This affects the efficiency and longevity of the battery box but has no effects on the treatment or battery safety. Cells comply with IEC 62133-2 "Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems".

· The Pepper EMS Training System and the Katalyst Training System both have one output mode. The Pepper EMS Training System has three additional output channels, 16 compared to 13. This allows for the treatment of more muscle groups; all channels have the same technical characteristics and comply with IEC 60601-2-10.

· The Pepper EMS Training System has a shorter and therefore more restricted maximum program length than that of the predicate device which raises no concerns regarding safety and effectiveness.

· The Pepper EMS Training System is additionally compliant to IEC 60601-1-11.

· The Pepper Battery Box is smaller and therefore also lighter than the predicate's Impulse Pack, and doesn't have any additional connectors. The Pepper Battery Box measures 102 x 22mm and weighs 152g, whereas the Katalyst Impulse Pack measures 148 x 78mm plus two connectors and weighs 248g. This does not affect the treatment or battery safety as the cells comply with IEC 62133-2

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• The waveforms and shape of the subject and predicate device are the same. The subject device only offers three training programs: Cardio, Strength and Relax. The training programs of the subject device are a subset of the predicate's training programs which raises no concerns regarding safety and effectiveness.

• The Pepper EMS Training System has a lower maximum output voltage, current and frequency. This does not raise any concerns which raises no concerns regarding safety and effectiveness and complies with IEC 60601-2-10 limits.

· The Pepper EMS Training System has a wider pulse width range, phase duration and maximum phase charge than the predicate device which allows customization. The main output parameters, current, voltage and density, are lower for the subject device than for the predicate device, which complies with IEC 60601-2-10 limits.

• The Pepper EMS Training System has a lower maximum current and maximum power density than the predicate device due to the lower maximum current and output voltage. This does not raise any concerns.

• The subject device's pulses per burst are 4-400 and therefore slightly lower than of the predicate device with 4-420. This does not raise any concerns.

As these minor differences don't affect the basic safety of the device or create any significant deviation in performance from the predicate devices and given that both devices comply to the same main standards, the Pepper EMS Training System can be considered substantially equivalent to the predicate device Katalyst Training System. This is also supported by the tests according to IEC 60601 1:2005+ A1:2012+ A2:2020.

Standards

In order to ensure adequate performance and safety of the Pepper EMS Training System, it has been designed and manufactured in accordance with the following standards:

• AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.)

• IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests

• IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators

· IEC 62133 Edition 2.0 2012-12 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use in Portable Applications [Including: Corrigendum 1 (2013)]

• ISO 14971 Second Edition 2007-03-01 Medical Devices - Application of Risk Management to Medical Devices

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• ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

• ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

• AAMI /ANSI /IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)]

• IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Non-Clinical Testing

The Pepper EMS Training System was subjected to testing in accordance with the appropriate standards and the results are provided in this 510(k). The non-clinical tests performed are as follows:

· Biocompatibility Testing
The Skin contacting materials have been tested to ISO 10993-5 and ISO 10993-10 standard under GLP.
Software Verification and Validation
The Battery Box firmware and Pepper Application were verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation. This testing proves that all software requirement specifications were met.
· Battery Testing
The Lithium-Polymer battery used in the Battery Box was tested by the battery manufacturer for compliance with IEC 62133.
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.
· Electrical Safety and Electromagnetic Compatibility:
The Pepper EMS Training System has been tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10.
· Wireless Coexistence Testing:
The performance of the Pepper EMS Training System was evaluated in an environment with other Pepper EMS Training Systems and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.

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Clinical Testing

No clinical studies are submitted to support this premarket notification submission.

Conclusion

Test results demonstrate the Pepper EMS Training System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).