(103 days)
Not Found
No
The summary describes a standard electrotherapy system with sEMG and Bluetooth connectivity, focusing on electrical safety, EMC, and software validation. There are no mentions of AI, ML, image processing, or descriptions of training/test sets, which are typical indicators of AI/ML components.
Yes
The device is described as "electrotherapy system" for "treating patients," which clearly indicates a therapeutic purpose.
No.
The device description indicates it is an "Electrotherapy System" used for muscle re-education and stimulation, which aligns with therapeutic rather than diagnostic purposes. While it includes "EMG Triggere d Stimulation", EMG is used in this context to trigger stimulation, rather than to diagnose.
No
The device description explicitly states it is a "2 Channel EMG and 4 Channel electrotherapy system," indicating it includes hardware components for electrotherapy and EMG, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states the device is an "Electrotherapy System" used for "Muscle re-education by application of external stimulation" and treating "Oropharyngeal Dysphagia and disorders of the head and neck." It applies electrical stimulation to muscles.
- Lack of Specimen Examination: There is no mention of the device examining any biological specimens (blood, tissue, urine, etc.) from the human body.
- Therapeutic Purpose: The primary purpose described is therapeutic (muscle re-education and treatment of dysphagia), not diagnostic based on in vitro analysis of specimens.
The device is an electrotherapy system used for treatment, not an IVD used for analyzing biological samples.
N/A
Intended Use / 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.
Product codes
IPF, HCC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles necessary for pharyngeal contraction, face, anterior portion of the neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription device intended for use by or on the order of a physician or other licensed health professional.
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)
Electrical Safety and Electromagnetic Compatibility: The VitalStim® Plus Electrotherapy 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, LLC
1430 Decision Street
Vista, CA 92081
FDA Establishment Registration: 2020737 |
|------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Natalia Shirina
Regulatory Affairs Specialist 3
760-734-5534 |
| 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, powered
HCC, 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.
4
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.
5
| Characteristic | New Device | Predicate Device | Similar/
Different |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k) Number | K153224 | K070425 | Similar |
| Device Name, Model | VitalStim® Plus Electrotherapy
System, Model 5923-3 | VitalStim Experia, Model
5950 | Similar |
| Manufacturer | DJO, LLC | DJO, LLC 510(k)
sponsor:
Chattanooga Group | Similar |
| Type of device | A non-implantable, battery
powered, hand held, electrical
muscle conditioning device used
for the treatment of medical
purposes to apply an electrical
current to stimulate and re-
educate the swallowing
musculature (pharyngeal
contractions) in the treatment of
dysphagia from any etiology
except mechanical causes that
would need surgical intervention
(e.g., obstructing tumors) | A non-implantable,
mains powered, desktop,
electrical muscle
conditioning device used
for the treatment of
medical purposes to
apply an electrical
current to stimulate and
re-educate the
swallowing musculature
(pharyngeal contractions)
in the treatment of
dysphagia from any
etiology except
mechanical causes that
would need surgical
intervention (e.g.,
obstructing tumors) | Similar |
| Connection of device to electrodes | Lead wires | Lead wires | Similar |
| Indications for Use | For VMS™ and VitalStim
Waveforms and sEMG
Triggered Stimulation.
- Muscle re-education by
application of external
stimulation to the muscles
necessary for pharyngeal
contraction. | For VMS™ and
VitalStim Waveforms,
High Voltage Pulsed
Current (HVPC) and
sEMG Triggered
Stimulation. - Muscle re-education by
application of external
stimulation to the
muscles necessary for
pharyngeal contraction. | Similar |
| Power Source(s) | 6V (4x1.5V AA battery cells) | 100-240V - 1.3 A Main
P. 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 |