(118 days)
Not Found
No
The description focuses on electrotherapy waveforms and biofeedback, with no mention of AI or ML technologies.
Yes
The device is described as a "comprehensive electrotherapy device for treating patients suffering from dysphagia" and its intended uses include "muscle re-education" and treatment of various conditions, indicating a therapeutic purpose.
No
The device description indicates its purpose is muscle re-education and treatment of dysphagia through electrical stimulation and biofeedback, not the diagnosis of a condition. While it mentions sEMG biofeedback, it's for training and re-education, not for making a diagnosis.
No
The device description explicitly states it is a "comprehensive electrotherapy device" and describes various waveforms (VitalStim™, VMS™, HVPC™) and their application for powered muscle stimulation. This indicates the device includes hardware components for delivering electrical stimulation, 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 used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vitalstim Experia therapy device applies external electrical stimulation to muscles and uses biofeedback to help patients with swallowing difficulties. It directly interacts with the patient's body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device works by stimulating muscles and providing biofeedback based on muscle activity.
Therefore, the Vitalstim Experia therapy device falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
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). Non-mechanical 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. VMS™ waveform is a square symnetrical 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™ 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. HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) 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 posttraumatic conditions or after neurological insult with impaired neuromuscular function. 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.
Product codes (comma separated list FDA assigned to the subject device)
IPF, HCC
Device Description
Vitalstim Experia therapy is a comprehensive electrotherapy device for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended use is achieved by the benefit of powered muscle stimulation and muscle activity biofeedback in one comprehensive device. The intended patient outcome is to regain control of muscles to swallow food without aspirating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
swallowing musculature in the anterior portion of the neck, musculature of the face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023347, K002410, K053266, K972997
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summarv per 21 CFR 807.92(c)
| 510(k) # | K070425 |
|---|---|
| ---------- | --------- |
| SUBMITTER: | Chattanooga Group,
A Division of Encore Medical, L.P.
4717 Adams Road
Hixson, TN 37343 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION: | 1022819 |
| CONTACT: | Michael Treas,
Manager of Regulatory Affairs |
| DATE PREPARED: | May 31, 2007 |
| PROPRIETARY NAME: | Vitalstim Experia |
| MODELS: | 5950, 5951 |
| CLASSIFICATION: | Class II |
| PRODUCT CODES: | IPF, HCC |
| REGULATION NUMBERS
AND COMMON NAMES: | 21 CFR 890.5850- Stimulator, Muscle, Powered
21 CFR 882.5050- Biofeedback device |
| PANEL: | Physical Medicine |
| JUN 1 1 2007 | |
|---|---|
| -- | -------------- |
Description:
Vitalstim Experia therapy is a comprehensive electrotherapy device for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended use is achieved by the benefit of powered muscle stimulation and muscle activity biofeedback in one comprehensive device. The intended patient outcome is to regain control of muscles to swallow food without aspirating.
Indications for Use:
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Intended Uses:
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). Non-mechanical 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.
1
510(k) # K070425
Page 2 of 3
VMS™ waveform is a square symnetrical 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™ 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.
HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face.
The intended uses are:
Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) 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 posttraumatic conditions or after neurological insult with impaired neuromuscular function.
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.
| 510(k) # | Proprietary Name | Device Classification Name(s), Regulation Number(s),
Classification(s) and Product Code(s). |
|----------|----------------------------|---------------------------------------------------------------------------------------------------|
| K023347 | Chattanooga Vitalstim | Stimulator Muscle Powered, 890.5850, Class II, IPF |
| K002410 | Freed Bioelectric | Stimulator Muscle Powered, 890.5850, Class II, IPF |
| K053266 | Myotrac Infiniti | Stimulator Muscle Powered, 890.5850, Class II, IPF
Biofeedback Device, 882.5050, Class II, HCC |
| K972997 | AM800 Automove
with EMG | Stimulator Muscle Powered, 890.5850, Class II, IPF
Biofeedback Device, 882.5050, Class II, HCC |
Substantially Equivalent Predicate Devices
Accessories: The Vitalstim Experia utilizes special patient electrodes and lead wires with indexed connectors to ensure proper connection for intended use. The uniqueness of the electrodes is in the convenient patented snap type connection for attaching to the patient lead wires, as well as their unique small size for use in the anterior portion of the neck.
Certification Program: The VitalStim dysphagia therapy certification program is recommended for healthcare providers prior to administering VitalStim dysphagia therapy. The Vitalstim certification program educates the healthcare professional on the indications, contraindications and the importance of electrode placement. It is recommended that only VitalStim electrodes be used with the Vitalstim Experia therapy device. Any supplemental electrodes must be cleared to market by the FDA specifically for use in the anterior portion of the neck, and for use with the Vitalstim Experia therapy device.
2
510(k) # K070425
Page 3 of 3
Declarations of Conformity
The Vitalstim Experia device is in compliance with the following FDA recognized Consensus Standards:
UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, 1ª Edition
IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 – 2: General requirements for Safety -Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information was included in the premarket submission.
Further Information
In the event that additional information is required, please contact:
Michael Treas Manager of Regulatory Affairs Chattanooga Group, A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37343-0489 U.S.A. Telephone: (423) 870-2281 ext. 7207 Fax: (423) 870-7404 E-mail: Michael Treas@ChattGroup.com
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chattanooga Group % Mr. Michael Treas Manager of Regulatory Affairs 4717 Adams Road Hixson, Tennessee 37343
JUN 1 1 2007
Re: K070425
Trade/Device Name: Vitalstim Experia Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, HCC Dated: April 30, 2007 Received: May 2, 2007
Dear Mr. Treas:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Michael Treas
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Pete
Mark N. Melkerson
Director
Drp D. O. Reager
6/1/07
Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K070425
Device Name: VitalStim Experia
Indications for Use:
"Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction."
| Labels | Values |
|---|---|
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | √ |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Resto and Neurological Devices
510(k) Number L070428