(210 days)
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.
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 provided document describes the "Friendship Pre-gelled Ag/AgCl Surface Electrodes," a disposable device for detecting electrophysiological signals or providing electrical stimulation subcutaneously.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Friendship Pre-gelled Ag/AgCl Surface Electrodes) |
|---|---|---|
| Biocompatibility | Known biocompatibility (Katecho hydrogel) for Cytotoxicity, Skin Irritation, and Skin Sensitization (ISO 10993-5, 10993-10) | Katecho hydrogel is of known biocompatibility, and materials were tested for safety and biocompatibility by Katecho Inc. (Cytotoxicity, Skin Irritation, Skin Sensitization). |
| Electrical Performance | Meet voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1 | Tested and meets voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1. |
| Device Description/Functionality | Similar materials, design, and function to predicate devices. | Similar materials, design, and function to predicate devices. |
| Simulated Use | Found acceptable for intended use by healthcare professionals. | Evaluated by healthcare professionals during a simulated use test and found acceptable for its intended use. |
| Substantial Equivalence | Comparable to predicate devices (Sunspot Pre-gelled Surface Electrodes K062198, Rhythmlink International Cutaneous Pad Electrodes K052188) | Determined to be substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions a "simulated use test" but does not quantify the number of electrodes or participants involved.
- Data Provenance: The document does not specify the country of origin for the "simulated use test." It is implied to be related to the manufacturer's location in Xi'an, Shaanxi, China, but this is not explicitly stated as the origin of the test data. The biocompatibility data is from Katecho Inc. and refers to international ISO standards.
- Retrospective or Prospective: The "simulated use test" sounds like a prospective test, but without more details, it's difficult to confirm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document states the device "was evaluated by health care professionals during a simulated use test."
- Number of Experts: Not specified.
- Qualifications of Experts: It collectively refers to "health care professionals," but no specific qualifications (e.g., years of experience, specialty) are provided.
4. Adjudication Method for the Test Set
- No specific adjudication method is mentioned for the "simulated use test." The evaluation by healthcare professionals seems to have led to a conclusion of "acceptable for its intended use" without detailing a multi-reader review process or conflict resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a pre-gelled surface electrode, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical electrode, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance relies primarily on adherence to established voluntary standards (ANSI/AAMI EC12/2000 and IEC60601-1 for electrical performance) and biocompatibility testing against ISO standards, along with subjective evaluation by healthcare professionals during a simulated use test for overall acceptability.
- There is no mention of pathology, outcomes data, or expert consensus in the typical sense for a diagnostic device. The "ground truth" for substantial equivalence is based on direct comparison to already cleared predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device (electrode), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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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 ChuanGeneral ManagerXian Friendship Medical Electronics Co., Ltd.Gao Xin 1st Road,Hi-Tech Development Zone,Xi'an, Shaanxi,China, 710075Phone: (86) -29-88225200Fax: (86)- 29-88236285georgezhai2616@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) manufacturedby 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
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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.
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| Specification | Equivalent Device | Predicate Device 1 B |
|---|---|---|
| Manufacturer | Xian Friendship MedicalElectronics 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 , varioussize | 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 gelKatecho KM10E. | Solid gelKatecho KM 10E |
| Connector | DIN 42802 | DIN 42802 |
| Lead Length | Various: 1.5M, 2.0M, 2.5M,3.0M (other lengths may beadded) | Various: 1.5M, 2.0M, 2.5M,3.0M (other lengths may beadded) |
| 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 |
.
.
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| 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 MedicalElectronics 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, roundsize | 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 10EMetal 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 |
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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.
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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
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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_________________________________________________________________________________________________________________________________________________________________
§ 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).