(419 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard electrical muscle stimulation technology and software validation.
Yes
The device is intended to stimulate healthy muscles to improve or facilitate muscle performance, which is a physiological effect. Although it explicitly states it's not for "therapy or treatment of medical diseases or medical conditions," improving or facilitating muscle performance falls under the broader definition of a therapeutic effect, especially given its use of neuromuscular electrical stimulation (NMES) to create muscle contractions.
No.
The device is intended to stimulate healthy muscles to improve muscle performance and for training, not for diagnosis of any medical condition or disease.
No
The device description explicitly states that the Pepper EMS Training System is a "battery powered muscle stimulator" and consists of hardware components like the "Pepper Suit" and "Pepper Battery Box." While it uses a software application for control, it is not solely software.
Based on the provided information, the Pepper EMS Training System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for stimulating healthy muscles to improve or facilitate muscle performance. It is explicitly not intended for use in conjunction with therapy or treatment of medical diseases or conditions.
- Device Description: The description focuses on electrical muscle stimulation (EMS) and neuromuscular electrical stimulation (NMES) to cause muscle contractions. This is a physical interaction with the body, not an in vitro test.
- Lack of In Vitro Activities: There is no mention of analyzing samples (like blood, urine, tissue) or performing tests outside of the body, which are the hallmarks of IVD devices.
- Regulatory Testing: The non-clinical testing listed (biocompatibility, software validation, battery testing, engineering bench testing, electrical safety, wireless coexistence) are typical for medical devices that interact with the body, but not specifically for IVD devices.
In summary, the Pepper EMS Training System is a device that applies electrical stimulation to the body for muscle training purposes, which falls under the category of a physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults only.
Intended User / Care Setting
Over-The-Counter device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Pepper EMS Training System
Indications for Use (Describe)
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.
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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4
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 |
5
| Regulatory Class: | Class II |
|---|---|
| Product Code: | NGX |
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.
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.
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.
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 EMS | ||
| Training System | Katalyst Training | ||
| System Model 1 | N/A | ||
| Classification | |||
| name | Powered muscle | ||
| stimulator | Powered muscle | ||
| stimulator | Same | ||
| Product code | NGX | NGX | Same |
| Regualtion | |||
| number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical | ||
| Medicine | Physical | ||
| Medicine | Same | ||
| Class | Class II | Class II | Same |
| 510(k) number | K233770 | K190966 | N/A |
| Prescription/OTC | OTC | OTC | Same |
| 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. | |||
| The Pepper EMS | |||
| Training System's | |||
| electrical | |||
| impulses allow | |||
| the triggering of | |||
| action potentials | The Katalyst | ||
| 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 | |||
| Katalyst 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. | |||
| The Katalyst | |||
| Training System's | |||
| electrical | |||
| impulses allow | |||
| the triggering of | |||
| action potentials | Same | ||
| 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. | 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. | |||
| Target population | It is to be used by | ||
| adults only. | It is to be used by | ||
| adults only. | Same | ||
| Connection of | |||
| device to | |||
| electrode | The Pepper EMS | ||
| Battery Box | |||
| connects | |||
| to the Suit | |||
| through output | |||
| cables that | |||
| terminate with | |||
| pogo pin | |||
| connectors. | |||
| The Suit contains | |||
| embedded cables | |||
| which make | |||
| connection | |||
| with the built-in | |||
| electrodes. | The Impulse Pack | ||
| connects | |||
| to the Suit | |||
| through output | |||
| cables that | |||
| terminate with | |||
| pogo pin | |||
| connectors. | |||
| The Suit contains | |||
| an | |||
| embedded cable | |||
| harness | |||
| which makes | |||
| connection | |||
| with the built-in | |||
| electrodes. | Different | ||
| The Pepper EMS Training | |||
| System contains a one-piece | |||
| suit and does not need extra | |||
| connectors like the predicate | |||
| device. Both devices connect | |||
| their accessories, suit and | |||
| battery box, via pogo pins. This | |||
| does not affect safety and | |||
| effectiveness of the subject | |||
| device. | |||
| Neither the cables | |||
| nor the electrodes | |||
| are removable. | Neither the cable | ||
| harness or the | |||
| electrodes are | |||
| removable. | |||
| The Suit also | |||
| features leads | |||
| with snap | |||
| connectors for | |||
| connecting to the | |||
| arm electrodes. | |||
| Power source(s) | Lithium Polymer | ||
| (Li-Po) | |||
| rechargeable | |||
| battery | |||
| 3,8 V, 2,650 mAh | Lithium Polymer | ||
| (Li-Po) | |||
| rechargeable | |||
| battery | |||
| 7.4V, 2,050 mAh | Different | ||
| The Pepper battery has a lower | |||
| voltage and higher capacity to | |||
| improve efficiency and | |||
| longevity. | |||
| Method of line | |||
| current isolation | N/A (battery | ||
| operated | |||
| device) | N/A (battery | ||
| operated | |||
| device) | Same | ||
| Patient leakage | |||
| current | N/A (battery | ||
| operated | |||
| device) | N/A (battery | ||
| operated | |||
| device) | Same | ||
| Normal condition | N/A (battery | ||
| operated | |||
| device) | N/A (battery | ||
| operated | |||
| device) | Same | ||
| Single fault | |||
| condition | N/A (battery | ||
| operated | |||
| device) | N/A (battery | ||
| operated | |||
| device) | Same | ||
| Number of output | |||
| modes | One (NMES) | One (NMES) | Same |
| Number of output | |||
| channels | 16 | 13 | Different |
| Three extra channels, all | |||
| channels are identical and | |||
| conforming to regulations. | |||
| -Synchronous or | |||
| alternating? | Synchronous, but | ||
| never 2 | |||
| channels activated | |||
| at the same time | Synchronous, but | ||
| never 2 | |||
| channels activated | |||
| at the same time | Same | ||
| -Method of | |||
| channel isolation | Multi-Channel | ||
| High Voltage | |||
| Analog Switches. | |||
| Except | |||
| during channel | |||
| activation, | |||
| each channel is | |||
| always in | |||
| high Z state. | Multi-Channel | ||
| High Voltage | |||
| Analog Switches. | |||
| Except | |||
| during channel | |||
| activation, | |||
| each channel is | |||
| always in | |||
| high 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 EMS | ||
| Training System | Katalyst Trainings | ||
| System | N/A | ||
| Waveform | Cardio: | ||
| Symmetrical | |||
| Biphasic | |||
| Strength: | |||
| Symmetrical | |||
| Biphasic | |||
| Relax: | |||
| Symmetrical | |||
| Biphasic | Endurance: | ||
| Symmetrical | |||
| Biphasic | |||
| Resistance: | |||
| Symmetrical | |||
| Biphasic | |||
| Strength: | |||
| Symmetrical | |||
| Biphasic | |||
| Explosive | |||
| Strength: | |||
| Symmetrical | |||
| Biphasic | |||
| Potentiation: | |||
| Symmetrical | |||
| Biphasic | |||
| Training | |||
| Recovery : | |||
| Symmetrical | |||
| Biphasic | |||
| Competition | |||
| Recovery: | |||
| Symmetrical | |||
| Biphasic | |||
| Warmup: | |||
| Symmetrical | |||
| Biphasic | |||
| Muscle | |||
| Relaxation: | |||
| Symmetrical | |||
| Biphasic | Same |
The 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:
Rectangular
Strength:
Rectangular
Relax:
Rectangular | Endurance:
Rectangular
Resistance:
Rectangular
Strength:
Rectangular
Explosive
Strength:
Rectangular
Potentiation:
Rectangular
Training | Same |
| | | | |
| | | Rectangular
Competition
Recovery:
Rectangular
Warmup:
Rectangular
Muscle
Relaxation:
Rectangular | |
| Maximum output
voltage (+/-10%) | Cardio:
50 V @ 500 Ω
50 V @ 2 kΩ
50 V @ 10 kΩ
Strength:
54 V @ 500 Ω
53 V @ 2 kΩ
51 V @ 10 kΩ
Relax:
51 V @ 500 Ω
52 V @ 2 kΩ
51 V @ 10 kΩ | Endurance:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Resistance:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Strength:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Explosive
Strength:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Potentiation:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Training
Recovery :
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Competition
Recovery:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Warmup:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ
Muscle
Relaxation:
60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ | Different
The Pepper EMS Training
System's maximum voltage is
less than that of the predicate
device. |
| Maximum output
current (+/-10%) | Cardio:
100 mA @ 500Ω | Endurance:
120 mA @ 500 Ω | Different |
| | 25mA @ 2 kΩ
5mA @ 10 kΩ
Strength:
108 mA @ 500Ω
27mA @ 2 kΩ
5mA @ 10 kΩ
Relax:
102 mA @ 500Ω
26mA @ 2 kΩ
5mA @ 10 kΩ | 50 mA @ 2 kΩ
10 mA @ 10 kΩ
Resistance:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Strength:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Explosive
Strength:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Potentiation:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Training
Recovery :
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Competition
Recovery:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Warmup:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ
Muscle
Relaxation:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ | The Pepper EMS
Training System's maximum
current is less than that of the
predicate devices. |
| Pulse width | Cardio:
160 to 490 μs
Strength:
160 to 490 μs
Relax:
160 to 490 μs | Potentiation:
250 to 375 μs
Endurance:
250 to 375 μs
Resistance:
250 to 375 μs
Strength:
250 to 375 μs
Explosive
Strength:
250 to 375 μs
Training
Recovery: | Different
The subject device provides
customization through a wider
spectrum of pulse width. 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. |
| | | | |
| | | 250 to 375 µs
Competition
Recovery:
250 to 375 µs
Warmup:
250 to 375 µs
Muscle
Relaxation:
250 to 375 µs | |
| Frequency | Cardio:
15 Hz
Strength:
85 Hz
Relax:
100 Hz | Endurance:
10 Hz
Resistance:
50 Hz
Strength:
75 Hz
Explosive
Strength:
105 Hz
Potentiation:
1 to 75 Hz
Training
Recovery :
1 to 9 Hz
Competition
Recovery:
1 to 6 Hz
Warmup:
5 Hz
Muscle
Relaxation:
1 Hz | Different
The Pepper EMS Training
System's frequency range (15-
100Hz) is a subset of that of
the predicate device: 1-105Hz. |
| Phase duration | 160 to 490 µs | 250 to 375 µs | Different
The phase duration of Pepper
EMS Training System is wider
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. |
| Net charge | Cardio:
0 µC @ 500 Ω
Strength:
0 µC @ 500 Ω
Relax:
0 µC @ 500 Ω | Endurance:
0 µC @ 500 Ω
Resistance:
0 µC @ 500 Ω
Strength:
0 µC @ 500 Ω
Explosive
Strength: | Same |
| | 0 $\mu$ C @ 500 Ω
Potentiation:
0 $\mu$ C @ 500s Ω
Training
Recovery :
0 $\mu$ C @ 500 Ω
Competition
Recovery:
0 $\mu$ C @ 500 Ω
Warmup:
0 $\mu$ C @ 500 Ω
Muscle
Relaxation:
0 $\mu$ C @ 500 Ω | | |
| Maximum phase charge | 53 $\mu$ C @ 500 Ω | 45 $\mu$ C @ 500 Ω | Different
Maximum 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 | Different
Subject 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 | Different
Subject 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 | Different
The 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 |
6
7
8
9
10
Output Specification - Comparison with Predicate Devices
11
12
13
14
15
| 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
16
• 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
17
• 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.
18
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.