(248 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and electrical conductivity of the garment electrodes, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
No.
The device itself does not provide therapy; it acts as an interface between an electrical stimulator (which delivers the therapy) and the patient's skin. Its function is to deliver electrical stimulation from an external stimulator, not to generate or apply therapeutic effects independently.
No
The device is described as an electrode for delivering electrical stimulation from various stimulators (e.g., inferential devices, galvanic devices, TENS) to a patient's skin. Its function is to facilitate the delivery of therapy, not to diagnose a condition.
No
The device description clearly states it is a "cloth type device" made of fabric (Nylon and Silver) with physical components like a snap connector and lead wire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "interface between electrical stimulators... and a patient's skin for the delivery of electrical stimulation." This describes a device used on the patient's body for therapeutic purposes, not for testing samples from the body in a laboratory setting.
- Device Description: The description details a conductive garment/fabric electrode designed for external application to the skin. This aligns with a device used for electrical stimulation therapy, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
Product codes
GXY
Device Description
The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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)
Biocompatibility confirms the EMSI Garment Electrode performs safely for its intended use. Bench testing demonstrated very low impedance to the treatment signals compared to the patient and the other electrode impedances in the circuit. Testing verified the garments to maintain performance specifications up to 30 wash cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
2090889 510 k :
Section-5: 510(k) Summary
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the EMSI Garment Electrodes is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
| Applicant: | EMSI
3504 Cragmont Dr. Suite#100
Tampa, Florida 33619
Ph: 813-471-0129
Fax: 813-471-0130
Registration Number: 3003573572 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Asiatic Fiber Corporation
11F, No. 166, Sec. 2,
Fu Hsing S. Rd.,Taipei(106),Taiwan
Phone : 886-2-27082136
Fax : 886-2-27082139 |
| Contact: | Cherita James
M Squared Associates, Inc
901 King Street, Suite 200
Alexandria, Virginia 22314
Phone: 703-562-9800 Ext. 257
Facsimile: 703-562-9797 |
| Date of submission: | March 30, 2009 |
| Proprietary Name: | EMSI Garment Electrodes |
| Common Name: | Cutaneous Electrodes Garment (CEG) |
| Classification Status: | Class II |
| Product Code: | GXY Cutaneous Electrodes |
| Panel: | Neurological Devices |
| Predicate Device: | EMSI Garment Electrodes are substantially equivalent, |
| | for the purpose of this 510(k), to other devices that have received |
| | 510(k) clearance for similar indications for use. |
| Intended Use: | Garment Electrodes that are applied directly to a patient's skin to |
. Electrostim Medical Services, Inc.
8
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510 k :
apply electrical stimulation.
Indications for Use: Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
Device Description: The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.
Discussion of performance testing: Biocompatibility confirms the EMSI Garment Electrode performs safely for its intended use. Bench testing demonstrated very low impedance to the treatment signals compared to the patient and the other electrode impedances in the circuit. Testing verified the garments to maintain performance specifications up to 30 wash cycles.
Technological Characteristics and Substantial Equivalence
The subject device is made up of similar fabrics and in similar configurations. The intended use and indications are identical to the predicate device. Comparison of surface and connector resistance of the subject and predicate device demonstrated the EMSI Garment Electrodes to be substantially equivalent to the predicate device.
$\varnothing$
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in uppercase letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
M Squared Associates, Inc. c/o Ms. Cherita James Regulatory Consultant 901 King Street Suite 200 Alexandria, VA 22314
DEC - 4 2009
Re: K090889
Trade/Device Name: EMSI Garment Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: October 30, 2009 Received: November 2, 2009
Dear Ms. James:
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 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 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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
E.A.Kahn, mo f
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
K090889 510(k) Number: To be assigned Device Name: EMSI GARMENT ELECTRODE Indications for Use: Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
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)
R
(Division Sign-BA) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K090897
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