(103 days)
For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.
Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/algorithm-based device. Therefore, many of the requested points, especially those related to AI system validation (e.g., sample size for test datasets, expert ground truth, MRMC studies), are not applicable to this type of submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for an electrotherapy system, mainly through bench testing and technical comparisons, rather than clinical performance studies against a "ground truth" derived from expert consensus or pathology, as would be common for AI-driven diagnostic tools.
Acceptance Criteria and Device Performance (for an Electrotherapy System)
Since this is an electrotherapy system and not an AI/algorithm, the "acceptance criteria" are related to safety, electrical performance, and electromagnetic compatibility. The "reported device performance" demonstrates compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance
| Category / Characteristic | Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 for basic safety and essential performance | Complied. The device was tested and found to comply with IEC 60601-1. |
| EM Compatibility | IEC 60601-1-2 for electromagnetic compatibility | Complied. The device was tested and found to comply with IEC 60601-1-2. |
| Usability | IEC 60601-1-6 for usability | Complied. The device was tested and found to comply with IEC 60601-1-6. |
| Home Healthcare | IEC 60601-1-11 for home healthcare | Complied. The device was tested and found to comply with IEC 60601-1-11. |
| Nerve/Muscle Stim. | IEC 60601-2-10 for performance of nerve and muscle stimulators | Complied. The device was tested and found to comply with IEC 60601-2-10. |
| FCC Requirements | FCC Part 15 Subpart B:2008 Class B | Complied. The device was tested to FCC requirements and found to comply with FCC Part 15 Subpart B:2008 Class B. |
| FCC CFR Title 47 Part 15 Subpart C | Complied. The device was tested to FCC requirements and found to comply with FCC CFR Title 47 Part 15 Subpart C. | |
| Software Validation | FDA's guidance document: General Principles of Software Validation, Jan 2002 | Verified. The device's software was verified in accordance with the requirements, and "software testing demonstrated that the software meets its design requirements." |
| Wireless Coexistence | Performance in environment with other 2.4 GHz wireless devices (Bluetooth, Wi-Fi) | Met all specified requirements. "The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements." |
| Patient Leakage Current | <100μA per channel | Channel 1-4: <100μA. (This is a technical specification for electrical safety, not a performance outcome from a clinical study.) |
| Output Current | Specific mA at various Ω for VitalStim™ and VMS™ waveforms (e.g., 25mA at 500Ω) | Matches predicate device for most listed impedances. (Minor difference noted for 10000Ω where the new device is 7mA vs predicate's 12mA, but considered acceptable for substantial equivalence). |
Regarding the points typically associated with AI/algorithm-based medical devices (which are largely N/A for this submission):
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. This document describes a traditional electrotherapy device. The "test set" here refers to the units of the device itself undergoing electrical, software, and wireless performance testing, not a dataset of patient images or clinical data for an algorithm. There is no patient data or "test set" in the sense of clinical validation for AI.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. Ground truth for AI systems (like disease presence in images) is not applicable here. The "ground truth" for this device's performance is adherence to electrical and safety standards, which is verified by engineering and testing professionals, not clinical experts for data labeling.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are used to establish ground truth in the context of human interpretation of medical data (e.g., for AI training/testing). This is not relevant for the testing of an electrotherapy device's electrical and safety performance.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is not an AI-assisted diagnostic or therapeutic device. It is an electrotherapy device. No MRMC study was conducted or is relevant for this type of device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" for this device's performance relates to its conformance to established engineering, electrical, and safety standards (e.g., IEC, FCC) and its design specifications, not clinical outcomes or diagnoses.
-
The sample size for the training set:
- N/A. This device does not use a "training set" in the context of machine learning or AI.
-
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no AI training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2016
Djo, LLC Natalia Shirina Regulatory Affairs Specialist 3 1430 Decision Street Vista, California 92081
Re: K153224
Trade/Device Name: VitalStim® Plus Electrotherapy System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, HCC Dated: January 14, 2016 Received: January 19, 2016
Dear Natalia Shirina:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153224
Device Name VitalStim® Plus Electrotherapy System
Indications for Use (Describe)
For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
| 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 807.92.
The assigned 510(k) number is K153224.
| Submitted by: | DJO, LLC1430 Decision StreetVista, CA 92081FDA Establishment Registration: 2020737 |
|---|---|
| Contact Person: | Natalia ShirinaRegulatory Affairs Specialist 3760-734-5534 |
| Date Summary Prepared: | February 8, 2016 |
| Trade Name: | VitalStim® Plus Electrotherapy System |
| Classification Name: | Stimulator, muscle, powered (21 CFR 890.5850)Device, Biofeedback (21 CFR 882.5050) |
| Product Code: | IPF, Stimulator, muscle, poweredHCC, Device, Biofeedback |
| Regulatory Class: | Class II |
| Predicate Device: | VitalStim Experia (K070425)Class II |
Device Description:
The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.
Indications for Use:
For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
- . Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
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Intended Uses- VMS™M Waveform
VMS waveform is a square symmetrical biphasic waveform with the application for use on the musculature of the face.
The intended uses are:
Optional application of sEMG biofeedback with Muscle Stimulation VMS TM waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function.
Intended Uses- VitalStim Waveform
VitalStim waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are:
The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Nonmechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional.
Intended Uses- Surface EMG
sEMG is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are:
The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.
Technological Comparison to Predicate Devices:
Based on the critical functional characteristics and indications for use, the VitalStim® Plus Electrotherapy System is substantially equivalent to the VitalStim Experia device (K070425). Both are Class II devices, powered muscle stimulator, biofeedback devices, subject to 21 CFR 890.5850 and 21 CFR 882.5050. Both devices are for prescription use only and the indications for use are the same.
The differences between the VitalStim® Plus Electrotherapy System and the predicate devices are considered to be minor by nature. Any differences in technological characteristics are explained in this submission to demonstrate that these differences do not raise new issues of safety and effectiveness.
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| Characteristic | New Device | Predicate Device | Similar/Different |
|---|---|---|---|
| 510(k) Number | K153224 | K070425 | Similar |
| Device Name, Model | VitalStim® Plus ElectrotherapySystem, Model 5923-3 | VitalStim Experia, Model5950 | Similar |
| Manufacturer | DJO, LLC | DJO, LLC 510(k)sponsor:Chattanooga Group | Similar |
| Type of device | A non-implantable, batterypowered, hand held, electricalmuscle conditioning device usedfor the treatment of medicalpurposes to apply an electricalcurrent to stimulate and re-educate the swallowingmusculature (pharyngealcontractions) in the treatment ofdysphagia from any etiologyexcept mechanical causes thatwould need surgical intervention(e.g., obstructing tumors) | A non-implantable,mains powered, desktop,electrical muscleconditioning device usedfor the treatment ofmedical purposes toapply an electricalcurrent to stimulate andre-educate theswallowing musculature(pharyngeal contractions)in the treatment ofdysphagia from anyetiology exceptmechanical causes thatwould need surgicalintervention (e.g.,obstructing tumors) | Similar |
| Connection of device to electrodes | Lead wires | Lead wires | Similar |
| Indications for Use | For VMS™ and VitalStimWaveforms and sEMGTriggered Stimulation.- Muscle re-education byapplication of externalstimulation to the musclesnecessary for pharyngealcontraction. | For VMS™ andVitalStim Waveforms,High Voltage PulsedCurrent (HVPC) andsEMG TriggeredStimulation.- Muscle re-education byapplication of externalstimulation to themuscles necessary forpharyngeal contraction. | Similar |
| Power Source(s) | 6V (4x1.5V AA battery cells) | 100-240V - 1.3 A MainP. Supply | Different |
| Characteristic | New Device | Predicate Device | Similar/Different |
| VMS™-Square Symmetrical Biphasic | Yes | Yes | Similar |
| HVPC™-Monophasic Pulsed | No | Yes | Different |
| VitalStim™ - Square Symmetrical Biphasic | Yes | Yes | Similar |
| Patient Leakage Current: Normal Condition & Single Fault Condition | |||
| Channel 1 | <100μA | <100μA | Similar |
| Channel 2 | <100μA | <100μA | Similar |
| Channel 3 | <100μA | <100μA | Similar |
| Channel 4 | <100μA | <100μA | Similar |
| Number of Output Channels | Four | Four | Similar |
| Synchronous or Alternating? | Synchronous and Alternating | Synchronous andAlternating | Similar |
| Regulated Current or Regulated Voltage? | Regulated current (all channels) | Regulated current (allchannels) | Similar |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Similar |
| Automatic Shut Off? | Yes (timer) | Yes (timer) | Similar |
| Patient Override Control? | Yes | Yes | Similar |
| Biofeedback Feature | Yes | Yes | Similar |
| Indicator Display- On/Off Status? | Yes | Yes | Similar |
| Compliance with 21 CFR 898? | Yes, leads with conductiveconnection to a patient areconstructed such that noconductive connection remotefrom the patient can contact earthor hazardous voltages. | Yes, leads withconductive connection toa patient are constructedsuch that no conductiveconnection remote fromthe patient can contactearth or hazardousvoltages. | Similar |
| Weight | 0.35lb | 6lbs | Different |
| Dimensions in inches [W x H x D] | 3.5"Wx5.9"Hx1.37"D | 9.75"W x8.75"H x12.75"D | Different |
Basic Device Characteristics – Comparison with Predicate Device
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Output Specifications – Comparison with Predicate Device
VitalStim™ Square Symmetrical Biphasic Waveform Specification Matrix
| Characteristic | New Device | Predicate Device | Similar/Different |
|---|---|---|---|
| Waveform | Symmetrical Biphasic (DC Zero) | Symmetrical Biphasic(DC Zero) | Similar |
| Shape | Square | Square | Similar |
| Maximum Output Current (± 30%) | |||
| 500Ω | 25mA | 25mA | Similar |
| 1000Ω | 25mA | 25mA | Similar |
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| 2000Ω | 25mA | 25mA | Similar |
|---|---|---|---|
| 2500Ω | 25mA | 25mA | Similar |
| 10000Ω | 7mA | 12mA | Different |
| Pulse Width | Fixed 300 µsec | Fixed 300µsec | Similar |
| Frequency Hz | Fixed 80 Hz | Fixed 80Hz | Similar |
| Ramp Time | 2sec | 2sec | Similar |
| For multiphasic waveforms only: | Yes | Yes | Similar |
| Symmetrical phases? | Yes | Yes | Similar |
| Phase Duration (include units) (state range,if applicable) (both phases, ifasymmetrical) | Fixed 300µsec | Fixed 300µsec | Similar |
| Net Charge [µC/pulse] | 0 µC | 0 µC | Similar |
| Stim + EMG Biofeedback | Yes | Yes | Similar |
Output Specifications – Comparison with Predicate Device VMS™ Square Symmetrical Biphasic Waveform Specification Matrix
| Characteristic | New Device | Predicate Device | Similar/Different |
|---|---|---|---|
| Waveform | Symmetrical Biphasic (DC Zero) | Symmetrical Biphasic(DC Zero) | Similar |
| Shape | Square | Square | Similar |
| Maximum Output Current (± 30%) | |||
| 500Ω | 25mA | 25mA | Similar |
| 1000ΩΩ | 25mA | 25mA | Similar |
| 2000ΩΩ | 25mA | 25mA | Similar |
| 2500Ω | 25mA | 25mA | Similar |
| 10000ΩΩ | 7mA | 12mA | Different |
| Pulse Width | 60-300 usec | 100 - 300psec | Different |
| Frequency Hz | 1 to 80 Hz | 5 to 80 Hz | Different |
| Ramp Time | 0-3 sec | 2 sec | Different |
| For multiphasic waveforms only: | Yes | Yes | Similar |
| Symmetrical phases? | Yes | Yes | Similar |
| Phase Duration (include units) (state range,if applicable) (both phases, ifasymmetrical) | 60-300usec | 100 - 300usec | Different |
| Stim + EMG Biofeedback | Yes | Yes | Similar |
Although there are minor differences in the maximum output current, the physical dimensions, and the batteries used as a power source, the most significant difference between the two devices is the absence of HVPC™-Monophasic Pulsed waveform.
The intended use of the HVPC™-Monophasic Pulsed waveform of the VitalStim Experia device is the same as the VMS waveform offered in both the VitalStim Plus and the VitalStim
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Experia devices. HVPC™-Monophasic Pulsed waveform is only an optional application of the same intended use. The same intended use can be achieved by the VMS waveform. Therefore, absence of HVPC™-Monophasic Pulsed waveform does not raise any question in regards to safety and effectiveness and is substantially equivalent.
Performance Testing:
Electrical Safety and Electromagnetic Compatibility: The VitalStim® Plus Electrotherapv System was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.
- . IEC 60601-1 for basic safety and essential performance
- IEC 60601-1-2 for electromagnetic compatibility ●
- IEC 60601-1-6 for usability ●
- IEC 60601-1-11 for home healthcare ●
- IEC 60601-2-10 for performance of nerve and muscle stimulators ●
FCC Testing: The VitalStim® Plus Electrotherapy System was tested to FCC requirements and found to comply with the requirements of the following regulation:
- FCC Part 15 Subpart B:2008 Class B .
- FCC CFR Title 47 Part 15 Subpart C .
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.
Wireless Coexistence Testing: The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.
Conclusion:
Based on the performance testing and the supporting documentation, it can be concluded that the VitalStim® Plus Electrotherapy System is as safe and effective as, and substantially equivalent to, the predicate device.
§ 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).