(210 days)
Not Found
No
The 510(k) summary describes a passive electrode device for signal acquisition and stimulation. There is no mention of any computational processing, analysis, or interpretation of signals using AI/ML techniques. The focus is on the physical and electrical properties of the electrode itself.
No
Explanation: The device is described as being for "recording/stimulation and monitoring" of signals like EMG, EEG, and EP, and for detecting electrophysiological signals or providing electrical stimulation. These are diagnostic and monitoring functions, not therapeutic.
Yes
The device description explicitly states, "The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient." Additionally, the intended use includes recording EMG, EEG, and EP signals, which are used for diagnostic purposes.
No
The device description clearly outlines physical components (woven layer, carbon layer, Ag/AgCl layer, hydrogel layer, lead wire, connector) and its function as an interface medium between equipment and the patient, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording/stimulation and monitoring of electrophysiological signals (EMG, EEG, EP). This involves measuring electrical activity from the body, not analyzing samples from the body (like blood, urine, or tissue) in a lab setting.
- Device Description: The description details a surface electrode that interfaces with the patient's skin to detect electrical signals or provide electrical stimulation. This is a direct interaction with the body, not an in vitro analysis of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a medical device used for physiological monitoring and stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Pre-gelled Ag/AgCl Surface Electrodes are intended for recording/stimulation and monitoring of the Electromygraphy (EMG), Electroencephalograph(EEG) and Evoked Potential(EP) signals.
Product codes
GXY
Device Description
Friendship's Pre-gelled Ag/AgCl Surface Electrodes are disposable (for "single Use Only"). Used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The surface electrodes is comprised of top woven layer, carbon layer, Ag/AgCl layer and hydrogel layer on one end electrically connected to lead wire and a touch-proof connector on the other end. The surface electrodes are placed cutaneously by a licensed physician or technologist under the supervision of a licensed physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician or technologist under the supervision of a licensed physician.
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)
Clinical studies were not deemed necessary regarding the surface electrodes due to their similarity in materials, design and function to those "predicate device". The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.
The contact material Katecho hydrogel is of known biocompatibility. Those materials were already tested for material safety and biocompatibility by the Katecho Inc.:
- Cytotoxicity study ISO 10993-5 .
- Skin irritation study ISO 10993-10 .
- Skin sensitization study ISO 10993-10 .
The electrical performance of the Surface Electrode has been tested and meet the voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 300 2011
3. Attachment 1: 510(K) Summary
Summary Date:
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.
May 6, 2011
| Submitter's information: | Zhai Ying Chuan
General Manager
Xian Friendship Medical Electronics Co., Ltd.
Gao Xin 1st Road,
Hi-Tech Development Zone,
Xi'an, Shaanxi,
China, 710075
Phone: (86) -29-88225200
Fax: (86)- 29-88236285
georgezhai2616@163.com |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Friendship Pre-gelled Ag/AgCl Surface Electrodes |
| Common Name: | Disposable Ag/AgCl Pre-gelled Surface Electrodes |
| Classification Name: | 21 CFR section 882.1320. Cutaneous Electrode. |
| Product Code: | GXY |
| Predicate Devices: | Sunspot Pre-gelled Surface Electrodes (K062198) manufactured
by Axon Systems, Inc.
Rthymlink International Cutaneous Pad Electrodes (K052188)
manufactured by Rhythmlink International, LLC |
10.1 Device Description:
Friendship's Pre-gelled Ag/AgCl Surface Electrodes are disposable (for "single Use Only"). Used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The surface electrodes is comprised of top woven layer, carbon layer, Ag/AgCl layer and hydrogel layer on one end electrically connected to lead wire and a touch-proof connector on the other end. The surface electrodes are placed cutaneously by a licensed physician or technologist under the supervision of a
1
were already verified and validated.
10.6 Brief discussion of the clinical tests submitted:
Clinical studies were not deemed necessary regarding the surface electrodes due to their similarity in materials, design and function to those "predicate device". The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.
10.7 Biocompatibility testing
The contact material Katecho hydrogel is of known biocompatibility. Those materials were already tested for material safety and biocompatibility by the Katecho Inc.:
- Cytotoxicity study ISO 10993-5 .
- Skin irritation study ISO 10993-10 .
- Skin sensitization study ISO 10993-10 .
10.8 Performance testing
The electrical performance of the Surface Electrode has been tested and meet the voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1.
10.9 Conclusions:
Xian Friendship Medical Electronics Co., Ltd.'s Surface Electrodes are substantially equivalent to the predicate devices. Xian Friendship Medical Electronics Co., Ltd. manufactures the Surface Electrodes for Axon Systems, Inc. There are no new questions of safety or effectiveness raised or evident.
2
| area @ Salaha The Partier States of the Parties of Children Come of the Children Comes of the Children
LA B SUNNER AT CREATING
ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ | ----------------
CALL CLAIM CLAIM CLAIM CLAIM CLAIM CLASS COLUMN CALL CALIFORNIA | 100 mm 1 1 m
1 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and the first of the many of the many of the may be any and the may be and the may be any and
THE LEAST LEAST LEAST LEAST LEAST MAIL BE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- LA-A-A-A-BERTIS -LA-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-
Comments of the comments of the
And Status of Acres of Cattle Company of |
| Specification | Equivalent Device | Predicate Device 1 B |
|---|---|---|
| Manufacturer | Xian Friendship Medical | |
| Electronics Co., Ltd. | Axon Systems, Inc | |
| Part number or 510(k) | Part Number: SEAg-Cu-S | FDA 510(K): K062198 |
| Part number | SEAg-Cu-S-1500/2.0x2.7 | DSE2115 |
| Part | Pre-gelled Surface Electrode | Pre-gelled Surface Electrode |
| Classification | II | II |
| Description | Single and twisted pair, Pre- | |
| gelled Surface Electrode | Single and twisted pair, Pre- | |
| gelled Surface Electrode | ||
| Dimensions | 27 mm x 20 mm , various | |
| size | 27 mm x 20 mm , various size | |
| Electrode shapes | Round/oval design , various | Duck-foot design , various |
| Sensor Material | Ag/AgCl | Ag/AgCl |
| Hydrogel type | Solid gel | |
| Katecho KM10E. | Solid gel | |
| Katecho KM 10E | ||
| Connector | DIN 42802 | DIN 42802 |
| Lead Length | Various: 1.5M, 2.0M, 2.5M, | |
| 3.0M (other lengths may be | ||
| added) | Various: 1.5M, 2.0M, 2.5M, | |
| 3.0M (other lengths may be | ||
| added) | ||
| Lead wire color | Multiple colors | Multiple colors |
| Labeled as | Single use, disposable | Single use, disposable |
| Indications for use | Stimulation and recording | Stimulation and recording |
| Pouch | Aluminum polyester | Aluminum polyester |
| Standard Electrode Type | AAMI EC12 2000 | AAMI EC12 2000 |
| Stated potential adverse reactions | Skin irritation | Skin irritation |
.
.
3
| Pouch | Aluminum polyester | Aluminum polyester |
|---|---|---|
| Standard Electrode Type | AAMI EC12 2000 | AAMI EC12 2000 |
| Stated potential adverse reactions | Skin irritation | Skin irritation |
| Packaging | 1 electrode/pouch | 1 electrode/pouch |
| Box | 24 electrodes/box | 24 electrodes/box |
| Specification | Equivalent Device | Predicate Device 1 D |
|---|---|---|
| Manufacturer | Xian Friendship Medical | |
| Electronics Co., Ltd. | Axon Systems, Inc | |
| Part number or 510(k) | Part Number: SEAg-Cu-S | FDA 510(K): K062198 |
| Part number | SEAg-C 3.0 | DSE3003 |
| Part | Pre-gelled Surface Electrode | Pre-gelled Surface Electrode |
| Classification | II | II |
| Description | Single and twisted pair, Pre- | |
| gelled Surface Electrode | Single and twisted pair, Pre- | |
| gelled Surface Electrode | ||
| Dimensions | 30mm in diameter, round | |
| size | 50 mm x50 mm x 60 mm , | |
| triangle | ||
| Electrode shapes | Round/oval design , various | Triangle design , various |
| Sensor Material | Ag/AgCl | Ag/AgCl |
| Hydrogel type | Solid gel | Solid gel |
| Connector | Katecho KM10E. | |
| Metal snap | Katecho KM 10E | |
| Metal snap | ||
| Labeled as | Single use, disposable | Single use, disposable |
| Indications for use | Stimulation and recording | Stimulation and recording |
| Pouch | Aluminum polyester | Aluminum polyester |
| Standard Electrode Type | AAMI EC12 2000 | AAMI EC12 2000 |
4
Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is an emblem featuring an abstract depiction of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Xian Friendship Medical Electronics Co., Ltd. c/o Zhai Ying Chuan General Manager No. 9 Gao Xin 156 Road, Hi-Tech Development Zone Xi'an Shaanxi 710075 China
AUG 30 2011
Re: K110289
Trade/Device Name: Friendship Medical Disposable Pre-gelled Ag/AgCl Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: Undated Received: July 21, 2011
Dear Mr. Zhai:
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.
5
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/5/Picture/7 description: The image shows a stylized cursive letter 'f'. The letter has a large, sweeping loop at the top, extending upwards and slightly to the right. A smaller loop is present at the bottom of the letter. The overall impression is of a handwritten signature or monogram.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K110289
Device Name: Disposable Pre-gelled Ag/AgCl Surface Electrode
Indications For Use:
Disposable Pre-gelled Ag/AgCl Surface Electrodes are intended for recording/stimulation
and monitoring of the Electromygraphy (EMG), Electroencephalograph(EEG)
and Evoked Potential(EP) signals.
Prescription Use X X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) C)
(21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
D. Dolan
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110289
Page 1 of 1_________________________________________________________________________________________________________________________________________________________________