(568 days)
Not Found
No
The description details a standard electrical stimulator with fixed parameters and no mention of adaptive or learning capabilities.
Yes
The device is described as "intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction," which is a therapeutic purpose.
No
The device is described as an electrical stimulator for muscle re-education, not for detecting, diagnosing, or monitoring a disease or condition. Its purpose is therapeutic (stimulation), not diagnostic.
No
The device description explicitly states it is a "dual channel battery operated electrical stimulator for use with skin surface electrodes," indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Intended Use: The intended use of this device is "muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction." This involves applying electrical stimulation externally to the body, not analyzing specimens taken from the body.
- Device Description: The description details an electrical stimulator for use with skin surface electrodes, which aligns with external application, not specimen analysis.
Therefore, based on the provided information, this device falls under the category of an electrical stimulator for therapeutic purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
This device is a dual channel battery operated electrical stimulator for use with skin surface electrodes. The output current in each channel can be adjusted from 0-25 ma in 1 ma increments. The pulse repetition rate is fixed at 80 Hz. The output waveform is bipolar symmetrical constant current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Tests were performed on the device which demonstrated that the device performs comparably to and is substantially equivalent to the predicate device. Tests include: Electrode resistance, output accuracy, Software Validation, and EMC compatibility testing.
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.
Vital Stim, K023347, CHATTANOOGA GROUP
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) SUMMARY
2202
FEB 1 0 2011
K092202 eSWALLOW™ USA Device: eSWALLOW™ Dysphagia Therapy Unit Page 1 of 2, 510(k) Summary
| Date Prepared | February 9, 2011 |
|---|---|
| Summary prepared by: | William H. "Bill" Ingram, President |
| Applicant | eSwallow USA |
| Device Name | Dysphagia Therapy Unit |
| Trade Name | eSWALLOW™ USA |
| 3477 Creek Circle | |
| Guntersville, AL 35976 |
Phone: 256-571-0443
Toll Free: 866-964-3102
Sales: 800-455-3101
FAX: 256-571-7539 |
| Common Name | Electrical Stimulator |
| Classification | Class: II
Product Code: IPF
Regulation: 21 CFR
890.5850 |
| Identification of
Predicate Devices and
Summary of Substantial
Equivalence | The eSWALLOW™ Dysphagia Therapy Unit is substantially
equivalent with respect to intended use, design, risks, device
characteristics and performance aspects to:
Vital Stim, K023347, CHATTANOOGA GROUP |
| Device Description | This device is a dual channel battery operated electrical stimulator
for use with skin surface electrodes. The output current in each
channel can be adjusted from 0-25 ma in 1 ma increments. The
pulse repetition rate is fixed at 80 Hz. The output waveform is
bipolar symmetrical constant current. |
1
eSWALLOW™ Dysphagia Therapy Unit Page 2 of 2, 510(k) Summary
| Intended Use and
Indications | This device is intended for muscle re-education by application of
external stimulation to the muscles necessary for pharyngeal
contraction. |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics and
Substantial Equivalence | The eSWALLOW™ Dysphagia Therapy unit has many similar
technological characteristics and is substantially equivalent to the
predicate.
The method of use for the eSWALLOW™ device is exactly the same
as the predicate.
The materials used in the eSWALLOW™ are also similar to those
used in the predicate. Both devices use an electronic circuit board
mounted inside a plastic box. Both units are powered by alkaline
batteries. Both units use constant current sources and have nearly
identical pulse widths, intensities, and open circuit voltages. The
output circuit design provides a constant current source allowing
for variations in electrode resistances. |
| Performance
Testing/Data | Tests were performed on the device which demonstrated that the
device performs comparably to and is substantially equivalent to
the predicate device. Tests include: Electrode resistance, output
accuracy, Software Validation, and EMC compatibility testing. |
| Conclusion | Because the technological characteristics and intended use are
nearly identical to the predicate device (including pulse type, rate,
and output) we have determined that the eSWALLOW™ device is
substantially equivalent to the predicate device. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
FEB 10 201
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
eSWALLOWTM USA % Kamin & Associates Mr. Daniel Kamm. P.E. 8870 Ravello Court Naples, Florida 34114
Re: K092202
Trade/Device Name: eSWALLOWIM Dysphagia Therapy Kit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: December 8, 2010 Received: December 14, 2010
Dear Mr. Kamm:
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
3
Page 2 -- Mr. Daniel Kamm, P.E. --
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 device-related adverse events) (21 CFR 803); 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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm113809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.
Sincerely vours.
A.j. B. 12 h
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K092202 Device Name: eSWALLOW™ Dysphagia Therapy Kit
This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K092202
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