(118 days)
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.
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.
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.
The provided text describes a 510(k) premarket notification for the Vitalstim Experia device. This review is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving device performance in the typical sense (e.g., accuracy, sensitivity, specificity) is not explicitly present.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The submission does not define explicit performance-based acceptance criteria in terms of metrics like accuracy, sensitivity, or specificity, nor does it report such performance. The primary "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices.
The acceptance criteria implicitly relate to:
- Safety and Effectiveness: Demonstrated through compliance with recognized consensus standards (UL 60601-1: 2003, IEC 60601-1-2: 2001) for electrical and electromagnetic safety.
- Intended Use and Technology: The device's waveforms and intended uses (VitalStim, VMS, HVPC, sEMG) are compared to the predicate devices.
- Accessories: The use of special patient electrodes and lead wires.
- Certification Program: Recommendation for healthcare provider certification.
There is no quantitative performance data reported in the document that would typically be presented in a table for device performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical test set or data provenance is mentioned as this is a 510(k) submission focused on substantial equivalence to existing devices rather than a new clinical performance study. The "test set" in this context refers to the comparison against predicate devices.
3. 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)
Not applicable. The ground truth for this submission is based on regulatory compliance and the established safety and effectiveness of the identified predicate devices, as approved by the FDA. There is no mention of experts establishing a ground truth for a test set of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring an adjudication method. The review process involved the FDA evaluating the submission against regulatory requirements and comparison to predicate devices.
5. 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
Not applicable. This device is an electrotherapy device (powered muscle stimulator and biofeedback device), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device. It is a physical medical device delivering electrotherapy and biofeedback.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in the context of this 510(k) submission is the established regulatory compliance and presumed safety and effectiveness of the predicate devices. The submission asserts that the Vitalstim Experia is substantially equivalent to these already-approved devices, implying that their established 'truth' (i.e., that they are safe and effective for their intended use) extends to the new device.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Since there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.
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510(k) Summarv per 21 CFR 807.92(c)
| 510(k) # | K070425 |
|---|---|
| ---------- | --------- |
| SUBMITTER: | Chattanooga Group,A Division of Encore Medical, L.P.4717 Adams RoadHixson, TN 37343 |
|---|---|
| ESTABLISHMENTREGISTRATION: | 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 NUMBERSAND COMMON NAMES: | 21 CFR 890.5850- Stimulator, Muscle, Powered21 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, IPFBiofeedback Device, 882.5050, Class II, HCC |
| K972997 | AM800 Automovewith EMG | Stimulator Muscle Powered, 890.5850, Class II, IPFBiofeedback 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.
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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
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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.
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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
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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
§ 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).