(436 days)
No
The device description explicitly states that the electrodes and lead wire do not contain active electronics, software, or firmware, and there are no mentions of AI, DNN, or ML in the summary.
Yes.
The device is intended for "muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction," which is a therapeutic purpose.
No
Explanation: The device is described as cutaneous electrodes for the application of electrical stimulation for muscle reeducation, which is a therapeutic function, not a diagnostic one. It does not mention activities like "diagnosis", "screening", "detection", or "monitoring" in a diagnostic context.
No
The device description explicitly states that the cutaneous electrodes and lead wire do not contain active electronics, software or firmware. The device is a hardware component (electrodes and lead wire) intended to be used with a separate transcutaneous external muscle stimulator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction." This describes a therapeutic application of electrical stimulation to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "single patient, multiple-use cutaneous electrodes for the application of electrical stimulation." This further reinforces its role in delivering electrical stimulation externally.
- Anatomical Site: The anatomical site is "External, anterior pharyngeal region." This is an external application site, not an internal sample collection or analysis site.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly intended for therapeutic electrical stimulation for muscle reeducation, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The devices are single patient, multiple-use [up to three times] cutaneous electrodes for the application of electrical stimulation. The lead wire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator. The cutaneous electrodes are available in two sizes; one for adult patients and one for youth patients. Both sizes are composed of identical materials.
The cutaneous electrodes and lead wire do not contain active electronics, software or firmware. The lead wire connects to the cutaneous electrotherapy device.
The cutaneous electrodes are composed of materials commonly used in this application: polyethylene, medical grade adhesives, 'spunlace' non-woven, carbon film, silver, polyester, and hydrogel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External, anterior pharyngeal region
Indicated Patient Age Range
Adult: 0.85 inch round electrode; pediatric: 0.688 inch round electrode; adhesive butterfly shape; round lead wires with snap connectors
Intended User / Care Setting
Healthcare personnel; office setting and home use
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)
Bench Testing
Biocompatibility of the patient-contacting materials was demonstrated by the source manufacturer per ISO-10993 for cytotoxicity, primary skin irritation, and delayed contact hypersensitivity, per FDA G-95 requirements for skin-contact devices of limited duration use.
Testing of the electrodes and lead wires was done by the contract manufacturer per ANSI/AAMI EC12:2000/[R] 2010, Disposable ECG Electrodes, for impedance and dispersion testing.
Clinical Testing
No clinical studies were required for electrodes and lead wires. The electrotherapy device with which these electrodes and lead wires are used was previously cleared under K092202.
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.
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.
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the word "eSWALLOW" in a stylized font. The "e" is in lowercase, while the rest of the word is in uppercase. There is a registered trademark symbol after the word "SWALLOW", and the word "USA" is written after the trademark symbol.
JAN 2 5 2013
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510(k) Summary
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This summary of information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
510|k] Owner's Name eSWALLOW USA, LLC
Address:
106 Hidden Drive Scottsboro, Alabama 35769
William R. Ingram, Managing Principal
Phone: Toll Free: Fax: Contact:
Summary Date:
January 18, 2013
256-571-0443
866-964-3102
256-571-7539
eSWALLOW USA, LLC
1
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eSWALLOW USA Electrodes and Leadwire Common Name: Cutaneous electrode; leadwire for connection of cutaneous electrode Classification Name: 21 CFR 882.1320, Cutaneous Electrodes
Classification: Class II .
Legally marketed device to which equivalence is claimed [Predicate Device]: K083756, SpectraMed, Inc. Guardian 150 electrode
Description of Electrodes / Leadwire
The devices are single patient, multiple-use [up to three times] cutaneous electrodes for the application of electrical stimulation. The lead wire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator. The cutaneous electrodes are available in two sizes; one for adult patients and one for youth patients. Both sizes are composed of identical materials.
The cutaneous electrodes and lead wire do not contain active electronics, software or firmware. The lead wire connects to the cutaneous electrotherapy device.
The cutaneous electrodes are composed of materials commonly used in this application: polyethylene, medical grade adhesives, 'spunlace' non-woven, carbon film, silver, polyester, and hydrogel.
Indications for Use
The electrodes and lead wires are intended for muscle reeducation by application of external stimulation to the muscles necessary for pharvngeal contraction.
Comparison to Predicate Device
Many devices for external, transcutaneous electrotherapy have been cleared by FDA for multiple intended uses. In this submission only the electrodes and lead wires to be used with a previously cleared NMES device are described.
| Parameter | Device | Predicate Device |
|---|---|---|
| Device Name | eSWALLOW USA Electrodes and | |
| Leadwire | Guardian 150 Electrode | |
| Manufacturer | Pepin Manufacturing, Inc. | SpectraMed [originally cleared by |
| SelectiveMed Components, Inc.] | ||
| 510[k] # | K113375 | K083756 |
| Class | II | Same |
| 21 CFR number | 882.1320 | Same |
| Code | GXY | Same |
| Product Type | Cutaneous electrodes / lead wires | Same |
Summary Comparison Table of New Device to Predicate Device
2
| Parameter | Device | Predicate Device |
|---|---|---|
| Description | Single-patient, multiple-use, self-adhering, disposable electrodes and lead wires | Same |
| To be used with | NMES Device | Same |
| Intended Use | For application of electrical current to patient skin | Same |
| Indications for Use | For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction | Same |
| End User; setting | Healthcare personnel; office setting and home use | Same |
| Body Site | External, anterior pharyngeal region | Same |
| Mode of Action | Electrotherapy | Same |
| Standards met | ANSI/AAMI EC12:2000/[R] 2010 | Same |
| Pt-contacting Materials | Biocompatible per ISO 10993 | Same |
| Component materials | Polyethylene, medical grade adhesives, spunlace, carbon film, silver, polyester, and hydrogel | Silver / silver chloride carbon conductor; proprietary blue hydrogel, medical grade adhesives |
| Sterility | Non-sterile | Same |
| Electrode size, shape | Adult: 0.85 inch round electrode; pediatric: 0.688 inch round electrode; adhesive butterfly shape; round lead wires with snap connectors | Adult: 0.875 inch round electrode; pediatric: 0.6875 inch round electrode; adhesive butterfly shape; round lead wires with snap connectors |
| Packaging | Sealed pouch | Same |
Bench Testing
Biocompatibility of the patient-contacting materials was demonstrated by the source manufacturer per ISO-10993 for cytotoxicity, primary skin irritation, and delayed contact hypersensitivity, per FDA G-95 requirements for skin-contact devices of limited duration use.
Testing of the electrodes and lead wires was done by the contract manufacturer per ANSI/AAMI EC12:2000/[R] 2010, Disposable ECG Electrodes, for impedance and dispersion testing.
Clinical Testing
3
No clinical studies were required for electrodes and lead wires. The electrotherapy device with which these electrodes and lead wires are used was previously cleared under K092202.
Device Comparison Statement
The eSWALLOW electrodes and lead wire have the same intended use and indications for use as the predicate device. The electrodes and lead wires are made of the same biocompatible materials and have similar technological characteristics as previously cleared devices and therefore raise no new issues of safety. Based on the assessment of performance data and the characteristic comparison, the eSWALLOW electrodes and lead wire are substantially equivalent to the legally marketed predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
Public Health Service
January 25.2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
eSwallow™ USA, LLC c/o Mr. William R. Ingram Managing Principal 106 Hidden Drive Scottsboro, Alabama 35769
Re: K113375
Trade/Device Name: eSwallow USA Electrodes and Lead Wires Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 1, 2012 Received: December 3, 2012
Dear Mr. Ingram:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. William R, Ingram
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.
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/ucm115809.htm 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 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.
Joyce M. Whang
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K113375
Device Name: _ eSWALLOW USA Electrode and Lead Wires
Indications For Use:
For muscle reeducation 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jovce M. W
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K113375
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