(419 days)
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 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.
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.
§ 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).