(14 days)
TELECTRODE Wet gel ECG Electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult and pediatric, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
TELECTRODE Wet gel ECG Electrodes are a single use, self-adhesive, non-sterile, disposable ECG electrode that is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The sensor is made of ABS plastic that has a Silver / Silver Chloride coating. The lead wire, cable and processor are not included with this device so the type of leadwire, cable and connector are not applicable.
The provided text describes the "Telectrode Wet-gel ECG Electrodes" device and its substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the way described in your prompt (e.g., performance metrics, sample sizes for test/training sets, expert involvement, etc., which are typical for AI/ML-based device evaluations).
This document is a 510(k) summary for a Class II medical device (ECG electrodes), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel performance study against acceptance criteria in the context of an AI/ML system.
The "acceptance criteria" discussed are primarily regulatory standards for this type of device, not performance benchmarks of an AI algorithm.
Here's a breakdown of what is available from the text, framed to best answer your request, along with clear indications of what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC-12 2000 (Electrical Performance) | "Pass" |
| ISO 10993-1 (Biocompatibility) | Met (materials selected and tested to demonstrate appropriate levels of biocompatibility) |
| Shelf Life | Ensures 24-month shelf life |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing is for a physical medical device (electrodes), and the testing described (ANSI/AAMI EC-12 and ISO 10993) refers to product testing, not performance evaluation on a "test set" of data in the AI/ML sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for the regulatory submission of an ECG electrode. The "ground truth" for the performance claims here would be the physical measurements and observations made during the standard compliance testing.
4. Adjudication Method
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among experts during the establishment of ground truth in diagnostic studies, which is not what is being described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is specifically relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device's submission.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done or at least not described in this document. This device is a physical electrode, not an algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" used for this device's evaluation is based on objective measurements from standardized physical and biological tests (e.g., electrical measurements conforming to ANSI/AAMI EC-12 and biological responses conforming to ISO 10993-1). It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this device.
Summary regarding the "Study that Proves the Device Meets the Acceptance Criteria":
The document indicates that the device's electrical performance was proven to meet the acceptance criteria by passing the ANSI/AAMI EC-12 2000 standard. Biocompatibility was proven to meet acceptance criteria by selecting materials and conducting tests in accordance with ISO 10993-1. The shelf life was proven to ensure 24 months. These "studies" are standard product testing protocols rather than clinical trials or AI performance evaluations. The document does not provide details on the specific methodology, sample sizes of test articles, or results of these tests beyond stating that the device "passed" or "met" the requirements.
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K083148 #/3
510(k) Summary
NOV - 7 2008
| Company Name: | BIO PROTECH, INC.1720-26, Taejang 2 – Dong, WonjuWoonju-Si, Gangwon-DoRepublic of South Korea |
|---|---|
| Company Address | 1720-26, Taejang 2 – Dong, WonjuWoonju-Si, Gangwon-DoRepublic of South Korea |
| Contact Person: | Mr. Kevin Han17962 Sky Park CircleSuite GIrvine, CA 92614Phone: 310-515-1799 |
Summary Preparation Date: June 30, 2008
Trade Name: Telectrode Wet-gel ECG Electrodes
Common Name: Disposable ECG monitoring electrode
Classification Name: Electrocardiograph electrode
Predicate Device Identification: 21 CFR 870.2360 Product Code: DRX Device Class: Class II
807.92(a)(3) Legally Marketed Equivalent Device: Product Company Skintact ECG Electrodes Leonhard Lang Co.
510(k) # K982521
807.92(a)(4)
DESCRIPTION:
TELECTRODE Wet gel ECG Electrodes are a single use, self-adhesive, non-sterile, disposable ECG electrode that is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The sensor is made of ABS plastic that has a Silver / Silver Chloride coating. The lead wire, cable and processor are not included with this device so the type of leadwire, cable and connector are not applicable.
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807.92(a)(5)
INTENDED USE:
TELECTRODE Wet gel ECG Electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult and pediatric, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
807.92(a)(6)
Predicate Product Comparison Table:
| Parameters | BIOPROTECHWet-gel ECG electrodes | Predicate Device(Skintact ECG electrodes/ S&W electrodes) | |
|---|---|---|---|
| 510(k) number | Pending | K982521 | |
| Indications for Use | TELECTRODE Wet gel ECGElectrodes are used to record thefollowing ECGs from a patient: RestingECG, Exercise ECG and/or ambulatory(Holter) monitoring.The intended patient population can beadult and pediatric, while theenvironment of use can be hospital (orclinic), ambulance, or daily useenvironment (for Holter monitoring). | Skintact ECG electrodes are intendedfor use in general electrocardiographicprocedures where ECG monitoring isdeemed necessary and is ordered by aphysician. | |
| Target patient population | General [Adult, Pediatric] | General | |
| Intended Use | General[Hospital, Clinic, ambulance,daily use for monitoring] | General | |
| Material Used | Stud | Yes | Yes |
| Sticker | Yes | Yes | |
| Pad | Yes | Yes | |
| Sensor | Yes | Yes | |
| Gel | Yes | Yes | |
| Liner | Yes | Yes | |
| Sterile/Non-sterile | Non-sterile | Non-sterile | |
| ANSI/AAMI EC-12 | Pass | Pass | |
| Biocompatibility Tests | ISO 10993-1 | ISO 10993-1 |
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| Shelf life | Ensures 24 month shelf life | Ensures 24 month shelf life |
|---|---|---|
| W START THE FILL ALL AND A ----- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. |
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Substantial Equivalence Discussion
Based on the above predicate product comparison Bio Protech has concluded that no new issues concerning safety and effectiveness are raised in this 510(k) submission. Both products passed the ANSI/AAMI EC-12 tests and both have met the ISO 10993 criteria for biocompatibility.
807.92(b)
SAFETY and EFFECTIVENESS
The electrical performance of Telectrode Wet-gel ECG Electrodes meets the requirements of the voluntary standard ANSI/AAMI EC12 2000.
BIOCOMPATIBILITY
The biological safety of Telectrode Wet-gel ECG Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The tests were selected on the basis of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Guidance on selection of test".
K083148 $3/3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Bio Protech, Inc. c/o Underwriters Laboratories, Inc. Mr. Jeff D. Rongero Senior Project Engineer 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K083148
Trade/Device Name: Telectrode Wet-gel ECG Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: October 22, 2008 Received: October 24, 2008
Dear Mr. Rongero:
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 such 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
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Page 2 - Mr. Jeff D. Rongero
807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
M. A. Hillenner
Car Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko83148
Device Name: Telectrode Wet-gel ECG Electrodes
Indications for Use:
TELECTRODE Wet gel ECG Electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult and pediatric, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. Y. Killorenne
n Sianision of Cardiovascular Devices
Page of
K083142 0(k) Number
17
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.