(257 days)
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- increasing local blood circulation
- immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle re-education
As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.
The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.
| Characteristic / Specification | Acceptance Criteria (implied by predicate comparison) | Reported Device Performance (TrainFES Advanced) |
|---|---|---|
| Basic Device Characteristics | ||
| Classification | Class II | Class II |
| Prescription/OTC Use | Prescription and Home Use | Prescription and Home Use |
| Environment of Use | Clinics, hospitals, and home | Clinics, hospitals, and home |
| Indications for Use | Similar to predicate (specific conditions) | Similar to predicate, with specific conditions listed, and the functions of powered muscle stimulator and external functional neuromuscular stimulator are exactly the same |
| Power Source | Battery-powered, compliant with IEC 62133 | Battery: Li-Ion 3.7V (4000mAh), compliant with IEC 62133 |
| Method of Line Current Isolation | N/A (Battery) | N/A (Battery) |
| Patient leakage current (Normal) | <100μA | <100μA |
| Patient leakage current (Single fault) | <100μA | <100μA |
| Number of Output Modes | Compliant with IEC 60601-1 and IEC 60601-2-10 | 2, compliant with IEC 60601-1 and IEC 60601-2-10 |
| Software/Microprocessor control | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut Off | Yes | Yes |
| Patient Override Control | Yes | Yes (Button) |
| Indicator Display On/Off Status | Yes (Led) | Yes (Led) |
| Indicator Display Low Battery | Yes | Yes |
| Indicator Display Voltage/Current Level | Yes | Yes |
| Standards | Compliance with relevant IEC standards | ISO 13485:2016, Bluetooth: FCC 15.2473, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133, IEC 62304:2015, IEC 62366 |
| Compliance with 21 CFR 898 | Yes | Yes |
| Weight | Considered acceptable if within safety/effectiveness | 218 g (considered similar enough to 112g of predicate not to raise safety issues) |
| Dimension | Considered acceptable if within safety/effectiveness | 130 x 79 x 33mm (considered similar enough to 91.5 x 68.4 x 24mm of predicate not to raise safety issues) |
| Housing material & Construction | Plastic (ABS) | ABS Plastic |
| Apply Part | BF | BF |
| Powered Muscle Stimulator (PMS) | ||
| Number of channels | Compliant with IEC 60601-1 and IEC 60601-2-10 | 6 Channels, compliant with IEC 60601-1 and IEC 60601-2-10 |
| Synchronous or alternating | Alternating or Synchronous (if safety/effectiveness not impacted) | Alternating (difference from predicate not impacting essential performance or safety) |
| Method of channel isolation | Multiplexer | Multiplexer |
| Regulated Current or voltage | Regulated Current | Regulated Current |
| Time Range | 1 - 60 min | 1 - 60 min |
| Waveform | Biphasic | Biphasic |
| Shape | Rectangular, also other shapes for predicate | Rectangular (tested and compliant with IEC 60601-2-10) |
| Symmetrical or asymmetrical | Symmetrical | Symmetrical |
| Maximum voltage output | Tested and compliant with IEC 60601-2-10 | 50V @500Ω, 164V @2kΩ, 170V @10kΩ (tested and compliant) |
| Maximum output Current | Tested and compliant with IEC 60601-2-10 | 100mA @500Ω, 82 mA @2kΩ, 17 mA @10kΩ (tested and compliant) |
| Current output channel | 0 - 100 mA | 0 - 100 mA (steps 1mA) |
| Pulse Width | 50 µs - 400 µs | 50 µs - 400 µs |
| Frequency | 1 - 140 Hz | 1 - 140 Hz |
| Net charge (µC per pulse) | 0µC (Balanced pulses) | 0µC (Balanced pulses) |
| Max phase charge @500Ω | 40 µC | 40 µC |
| Maximum current density (mA/cm²) @500Ω | Complies with FDA guidance for PMS 510(k)s | 0.224 mA/cm² (25 cm² electrode area) (complies with FDA guidance) |
| max. power density (W/cm²) | Complies with FDA guidance for PMS 510(k)s | 0.00062 W/cm² (25 cm² electrode area) (complies with FDA guidance) |
| Functional Electrical Stimulation (FES) | ||
| All FES parameters | Same as PMS parameters, with differences justified as not impacting essential performance or safety. | Same as PMS parameters, with differences justified as not impacting essential performance or safety. |
2. Sample Size for the Test Set and Data Provenance:
The document explicitly states: "No clinical testing was performed in support of this submission."
Therefore, there is no test set in the sense of clinical data from human subjects described in this document. The evaluation relies on non-clinical (bench) testing, comparison to a predicate device, and compliance with recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that no clinical testing was performed, there were no "experts" involved in establishing ground truth for a clinical test set from human subjects. The assessment relies on the expertise of the engineers and regulatory professionals who performed the non-clinical testing and drafted the 510(k) submission, confirming compliance with engineering standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission relies entirely on non-clinical testing and comparison to a predicate device, without involving human readers or a comparative effectiveness study with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this question doesn't directly apply here. The "TrainFES Advanced" is a physical medical device (a neuromuscular electrical stimulator) that includes software control, not an AI algorithm intended for diagnostic or prognostic purposes on its own. The "device performance" is assessed through its electrical and mechanical characteristics and compliance with safety standards, not through an algorithm's standalone interpretative accuracy.
7. The Type of Ground Truth Used:
For this device, the "ground truth" for the non-clinical testing is based on:
- Engineering specifications and regulatory standards: The device is tested against established limits and requirements defined in standards like IEC 60601 series, IEC 62133, IEC 62304, IEC 62366, and ISO 14971.
- Predicate device characteristics: The predicate device (Stella BIO, K210002) serves as a benchmark for comparison, implying that its established safety and effectiveness characteristics represent a "ground truth" for what is acceptable in this device class.
8. The Sample Size for the Training Set:
Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced or implied in the context of this 510(k) submission for this type of medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced.
In summary: The submission for TrainFES Advanced demonstrates substantial equivalence primarily through comprehensive non-clinical (bench) testing against recognized industry standards (IEC series, ISO 14971) and a detailed comparison of its technical specifications to a previously cleared predicate device (K210002). The core argument is that any differences in characteristics do not raise new questions of safety or effectiveness. No clinical studies, human reader studies, or AI algorithm performance evaluations against clinical ground truth were conducted or presented in this document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2025
Biomedical Devices Spa % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445
Re: K241488
Trade/Device Name: TrainFES Advanced Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. GZI Dated: May 24, 2024 Received: May 24, 2024
Dear Juan Tezak:
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"
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(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).
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 Rue"). 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-devices/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,
Heather L. Dean -S
for Amber Ballard, PhD Assistant Director 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)
K241488
Device Name
TrainFES Advanced
Indications for Use (Describe)
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- increasing local blood circulation
- immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle re-education
As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
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) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K241488 Prepared July 03, 2024
| I) | ApplicantSubmitterAddress | Biomedical Devices SpaCamino El Alba 8760, of 903 LasCondes RM Chile |
|---|---|---|
| ContactTelephoneE-mail | Mr. Matias Hosiasson+56 998 954326matias@trainfes.com | |
| II) | DeviceTrade Name | TrainFES Advanced |
| Common Name | External functional neuromuscular stimulator | |
| Classification Name | Stimulator, Neuromuscular, External Functional | |
| Regulation Number | 890.5850 IPF / 882.5810 GZI | |
| Product Code | IPF, GZI | |
| III) | Predicate Device510(k) Number | K210002 |
| Applicant | EGZOTech Sp. Z.o.o | |
| Trade Name | Stella BIO |
Power Muscle Stimulator
876.5320 882.5810
NYN
890.5850 / 882.5890 / 882.5050 /
IPF, GZJ, HCC, GZI, KPI, NGX, NUH,
Classification Name
Regulation Number
Product Code
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IV) Indication For Use
For Prescription and Home Use by prescription from a medical professional: The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
Muscle re-education
As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions: Helps to relearn voluntary motor functions of the extremities. TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
V) Device Description
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
VI) Comparison of Technological Characteristics
| Basic Device Characteristics | |||
|---|---|---|---|
| Characteristics /Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| FDA product code | IPF, GZI | IPF, GZJ, HCC, GZI, KPI,NGX, NUH, NYN | N/A |
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |
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| Classification | Class II | Class II | Same |
|---|---|---|---|
| Prescription or OTC | Prescription and Home Use | Prescription and Home Use | Same |
| Environment of Use | Clinics, hospitals and home environments | Clinics, hospitals and home environments | Same |
| Indications for use | For Prescription and Home Use by prescription from a medical professional:The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Maintaining or increasing range of motion• Muscle re-educationAs an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:• Helps to relearn voluntary motor functions of the extremities. | The Stella BIO is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.As a powered muscle stimulator, Stella BIO is indicated for the following conditions:• Relaxation of muscle spasms,• Prevention or retardation of disuse atrophy,• Increasing local blood circulation,• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,• Maintaining or increasing range of motion,• Muscle re-education.As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions:• Symptomatic relief and management of chronic (long-term), intractable pain,• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.As a biofeedback device, Stella BIO is indicated for:• Biofeedback, relaxation, and muscle re- education. | Similar Note 1 |
| TrainFES' Advancedintended population isanybody aged 22 or over.Environments of use:TrainFES Advanceddevices can be used byboth therapists andpatients, in the clinic,hospitals or at home.Platform: TrainFES is abattery-powered, wirelessdevice, accessible throughsoftware. | As an external functionalneuromuscular stimulator,Stella BIO is indicated forthe followingconditions:• Helps to relearn voluntarymotor functions of theextremities.As a non-implantedelectrical continencedevice, Stella BIO isindicated for the followingconditions:• Acute and ongoingtreatment of stress, urge ormixed urinary incontinenceand where the followingresults may improveurinary control: inhibition ofthe detrusor musclesthrough reflexivemechanismsand strengthening of pelvicfloor muscles.• Incontinence treatmentfor assessing EMG activityof the pelvic floor andaccessory muscles such asabdominal and the gluteusmuscles.Patient population: StellaBIO Prescription and HomeUse by prescription from amedical professionalcan be used on adultsaged 22 yrs and older.Environments of Use:Clinics, hospital and homeenvironments.Platform: Stella BIO is abattery-powered, wirelessdevice, accessible throughsoftware. | ||
| Power Source | Battery: Li-Ion 3,7V(4000mAh) | Battery pack Li-Ion 7,4V | DifferentNote 2 |
| Method of LineCurrent Isolation | N/A (Battery) | N/A (Battery) | Same |
| Patient leakagecurrent (Normalcondition, μA) | N/ABattery Operated Device(<100μA patient leakage) | N/ABattery Operated Device(<100μA patient leakage) | Same |
| Patient leakagecurrent (Single faultcondition, μA) | N/ABattery Operated Device(<100μA patient leakage) | N/ABattery Operated Device(<100μA patient leakage) | Same |
| Number of OutputModes | 2 | 4 | DifferentNote 3 |
| Software/Microprocessorcontrol | Yes | Yes | Same |
| Automatic OverloadTrip | Yes | Yes | Same |
| Automatic No-LoadTrip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient OverrideControl | Yes (Button) | Yes | Same |
| Indicator DisplayOn/Off Status | Yes (Led) | Yes | Same |
| Indicator DisplayLow Battery | Yes | Yes | Same |
| Indicator DisplayVoltage/CurrentLevel | Yes | Yes | Same |
| Standards | ISO 13485:2016Bluetooth: Complies withFCC 15.2473 (for U.S.)regulationsIEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11IEC 62133ComplianceIEC 62304:2015IEC 62366 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11IEC 62304IEC 62366IEC 62133ANSI/AAMI NS4 | DifferentNote 4 |
| Compliance with 21CFR 898 | Yes | Yes | Same |
| Weight | 218 g | 112 g | SimilarNote 5 |
| Dimension | 130 x 79 x 33mm | 91.5 x 68.4 x 24 mm | SimilarNote 5 |
| Housing materialand Construction | ABS Plastic | Plastic (Injection MoldedABS) | Same |
| Apply Part | BF | ||
| Powered Muscle Stimulator | |||
| Characteristics /Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |
| Number of channels | 6 Channels | 8 Channels | DifferentNote 1 PMS |
| Synchronous oralternating | Alternating | Synchronous | DifferentNote 2 PMS |
| Method of channelisolation | Multiplexer | Multiplexer | Same |
| Requlated Current orregulated voltage | Regulated Current | Regulated Current | Same |
| Time Range | 1 — 60 min | 1 – 60 min | Same |
| Output Specifications | |||
| Waveform(Monophasic orbiphasic) | Biphasic | Biphasic | Same |
| Shape | Rectangular | Rectangular, triangular,trapezoidal, sinusoidal | DifferentNote 3 PMS |
| Symmetrical orasymmetrical | Symmetrical | Symmetrical | Same |
| Maximum voltageoutput | 50V @500Ω164V @2kΩ170V @10kΩ | 50V @500Ω60V @2kΩN/A @10kΩ | DifferentNote 4 PMS |
| Maximum outputCurrent | 100mA @500Ω82 mA @2kΩ17 mA @10kΩ | 100mA @500Ω30mA @2kΩN/A @10kΩ | DifferentNote 4 PMS |
| Current outputchannel | 0 - 100 mA (steps 1mA) | 0 - 100 mA | Same |
| Pulse Width | 50 µs - 400 µs | 50 µs - 400 µs | Same |
| Frequency | 1 - 140 Hz | 1 - 140 Hz | Same |
| Beat Frequency | N/A | N/A | N/A |
| Net charge (µC perpulse) | 0µC (Balanced pulses) | 0µC Same positive andnegative impulse | Same |
| Max phase charge@500Ω | 40 µC | 40 µC | Same |
| Maximum currentdensity (mA/cm)@500Ω | 0.224 mA/cm2 (25cm2 electrode area) | 0.22 mA/cm2 | DifferentNote 5 PMS |
| max. power density(W/cm2) | 0.00062 W/cm2 (25cm2 electrode area) | 0.63 mW/cm2 | DifferentNote 5 PMS |
| Temperature in Use | 0°C to 40 °C32°F to 104 °F | Unknown | N/A |
| Temperaturetransporting/storing | -20°C - 60 °C-4°F to 140 °F | Unknown | N/A |
| Relative humidity | In use: 10 % to 75%.In Transportation/Storage:10% to 85%. | Unknown | N/A |
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Substantial Equivalence discussion and Differences analysis for Basic Device Characteristics:
Note 1: Indication for Use
Although the predicates are not exactly the same, the difference is that the predicate device has more functions than the subject device, but the functions of powered muscle stimulator and the external functional neuromuscular stimulator are exactly the same.
Note 2: Power Source
The predicate device as well as the subject device are battery powered. Although the battery provided by the new device is different from the battery of the predicate device, it is compliant with IEC 62133 standard. Moreover, the new device is IEC 60601-1 compliant and has been tested for electrical safety with a positive result. Therefore, differences in power source doesn't influence essential performance or basic safety, as well as doesn't impact substantial equivalence to the predicate device.
Note 3: Number of Output Modes
Although the "Number of Output Channels" are different from the predicate device they all comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.
Note 4: Voluntary Standards
The new device complies with the same voluntary standards as the predicate device except standard ANSI/AAMI NS4. All voluntary standards are recognized FDA standards and this change difference doesn't impact essential performance, basic safety or substantial equivalence.
Note 5: Weight and Dimensions
Although Weight and Dimensions of subject device are different from the predicate device, they all comply with IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 requirements, thus the differences of the function specifications do not raise any safety or effectiveness issue.
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Powered muscle stimulator designation comparison of proposed new device and predicate device
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Substantial Equivalence discussion and Differences Analysis. Comparison with Predicate Device - Output Specifications for Powered Muscle Stimulator
Note 1 PMS: Number of Output Channels
Although the "Number of Output Channels" are different from the predicate device they all comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.
Note 2 PMS: Alternating or Synchronous
The predicate device has a Synchronous EMG acquisition triggering. The different is that the EMG samples can be acquired and compared sample-to-sample, which in Alternating sampling is not possible. This difference doesn't impact essential performance, basic safety or substantial equivalence.
There are other devices on the market that have this same feature such as the K080950 without impacting the essential performance and basic security of the device.
Note 3 PMS: Shape of the waveforms
Predicate device provides waveforms shapes (triangular, trapezoidal and sinusoidal) in addition to rectangular waveforms. Electrical stimulation for triangular, trapezoidal and sinusoidal waveforms are considerate safer than rectangular waveforms due to lower maximal phase charge, current density and power density, but it does not mean that the rectangular waveforms is not safe, besides the predicate also uses it. Electrical stimulation for rectangular waveforms were tested and are compliant with the requirements in IEC 60601-2-10.
The difference in waveforms doesn't impact essential performance, basic safety or substantial equivalence.
Note 4 PMS: Maximum Output Voltage
Although the Maximum Output Voltage of the new device are different than in the predicate device, they were all tested and are compliant with IEC 60601-2-10. Therefore, the difference doesn't impact essential performance, basic safety or substantial equivalence.
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Note 5 PMS: Maximum Current Density and Maximum Power Density
Although the Maximum Current Density and Maximum Power Density of subject device are different from the predicate device, which is related to the electrode surface that is different for both devices, they all comply with the FDA guidance requirement for Powered Muscle Stimulator 510 (k)s, so the differences of function specification will not raise any safety or effectiveness issue.
Functional electrical stimulation designation comparison of proposed new device and predicate device
| Functional Electrical Stimulation (FES) | |||
|---|---|---|---|
| Characteristics /Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |
| Number of channels | 6 Channels | 8 Channels | DifferentNote 1 FES |
| Synchronous oralternating | Alternating | Synchronous | DifferentNote 2 FES |
| Method of channelisolation | Multiplexer | Multiplexer | Same |
| Regulated Current orregulated voltage | Regulated Current | Regulated Current | Same |
| Time Range | 15 - 60 min | 15 – 60 min | Same |
| Output Specifications | |||
| Waveform(Monophasic orbiphasic) | Biphasic | Biphasic | Same |
| Shape | Rectangular | Rectangular, triangular,trapezoidal, sinusoidal | DifferentNote 3 FES |
| Symmetrical orasymmetrical | Symmetrical | Symmetrical | Same |
| Maximum voltageoutput | 50V @500Ω164V @2kΩ170V @10kΩ | 50V @500Ω60V @2kΩN/A @10kΩ | DifferentNote 4 FES |
| Maximum outputCurrent | 100mA @500Ω82 mA @2kΩ17 mA @10kΩ | 100mA @500Ω30mA @2kΩN/A @10KΩ | DifferentNote 4 FES |
| Current outputchannel | 0 - 100 mA (steps 1mA) | 0 - 100 mA | Same |
| Pulse Width | 50 µs - 400 µs | 50 µs - 400 µs | Same |
| Frequency | 1 - 140 Hz | 1 - 140 Hz | Same |
| Beat Frequency | N/A | N/A | N/A |
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| Net charge (µC perpulse) | 0µC (Balanced pulses) | 0µC Same positive andnegative impulse | Same |
|---|---|---|---|
| Max phase charge@500Ω | 40 µC | 40 µC | Same |
| Maximum currentdensity (mA/cm)@500Ω | 0.224 mA/cm2 (25cm2 electrode area) | 0.22 mA/cm2 | DifferentNote 5 FES |
| max. power density(W/cm2) | 0.00062 W/cm2 (25cm2 electrode area) | 0.63 mW/cm2 | DifferentNote 5 FES |
| Temperature in Use | 0°C to 40 °C32°F to 104 °F | Unknown | N/A |
| Temperaturetransporting/storing | -20°C - 60 °C-4°F to 140 °F | Unknown | N/A |
| Relative humidity | In use: 10 % to 75%.In Transportation/Storage:10% to 85%. | Unknown | N/A |
Substantial Equivalence discussion and Differences Analysis. Comparison with Predicate Device - Output Specifications for Functional Electrical Stimulation
Note 1 FES: Number of Output Channels
Although the "Number of Output Channels" are different from the predicate device they all comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.
Note 2 FES: Alternating or Synchronous
The predicate device has a Synchronous EMG acquisition triggering. The different is that the EMG samples can be acquired and compared sample-to-sample, which in Alternating sampling is not possible. This difference doesn't impact essential performance, basic safety or substantial equivalence.
There are other devices on the market that have this same feature such as the K080950 without impacting the essential performance and basic security of the device.
Note 3 FES: Shape of the waveforms
Predicate device provides waveforms shapes (triangular, trapezoidal and sinusoidal) in addition to rectangular waveforms. Electrical stimulation for triangular, trapezoidal and sinusoidal waveforms are considerate safer than rectangular waveforms due to lower maximal phase charge, current density and power density, but it does not mean that the rectanqular waveforms is not safe, besides the predicate also uses it. Electrical stimulation for rectangular waveforms were tested and are compliant with the requirements in IEC 60601-2-10.
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The difference in waveforms doesn't impact essential performance, basic safety or substantial equivalence.
Note 4 FES: Maximum Output Voltage
Although the Maximum Output Voltage of the new device are different than in the predicate device, they were all tested and are compliant with IEC 60601-2-10. Therefore, the difference doesn't impact essential performance, basic safety or substantial equivalence.
Note 5 FES: Maximum Current Density and Maximum Power Density
Although the Maximum Current Density and Maximum Power Density of subject device are different from the predicate device, which is related to the electrode surface that is different for both devices, they all comply with the FDA quidance requirement for Powered Muscle Stimulator 510 (k)s, so the differences of function specification will not raise any safety or effectiveness issue.
VII) Summary of Non-Clinical Testing
The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate device:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance.
- IEC 60601-1-2 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 Medical electrical equipment Part 2: Particular requirements ● for the basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-1-11 Medical electrical equipment-Part 1-11: General ● requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 62133-2 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.
- IEC 62304 Medical device software Software life cycle processes. ●
- IEC 62366 Applying Human Factors and Usability Engineering to Medical ● Device.
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- ISO 14971 Medical devices Application of risk management to medical . devices.
- VIII) Summary of Clinical Testing No clinical testing was performed in support of this submission.
- IX) Conclusion
The intended use of the TrainFES Advanced device is equivalent to that of the predicate device K210002. The basic technological features are virtually the same for the subject and predicate devices, with minor differences that do not raise safety or efficacy issues. Comparing the hardware and software of the subject device it is equivalent to the predicate device mentioned above. The TrainFES Advanced device meets the requirements of IEC 60601-1, IEC 60601-2-10, IEC60601-1-2 and IEC 60601-1-11. The bench test and safety report documentation provided in this presentation demonstrates that possible differences in their technological characteristics do not raise new safety or effectiveness issues. Thus, the TrainFES Advanced device is substantially equivalent to the predicate device K210002.
§ 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).