(14 days)
Not Found
No
The device is a passive electrode for transmitting electrical signals and the summary does not mention any AI/ML components or processing.
No.
This device is designed to record ECGs for diagnostic purposes, not to treat a condition.
No
This device is an ECG electrode used to record electrical signals, which are then processed by a separate device to produce an electrocardiogram. It does not, on its own, perform diagnosis.
No
The device description clearly states it is a physical electrode made of ABS plastic with a Silver / Silver Chloride coating, designed to be applied to the body surface. It is a hardware component for transmitting electrical signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The TELECTRODE Wet gel ECG Electrodes are applied to the surface of the body to transmit electrical signals. They are used to record ECGs, which are measurements of electrical activity within the body, not from a specimen taken from the body.
- Intended Use: The intended use is to record ECGs, which is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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).
Product codes
DRX
Device 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.
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
Adult and pediatric
Intended User / Care Setting
hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
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
The electrical performance of Telectrode Wet-gel ECG Electrodes meets the requirements of the voluntary standard ANSI/AAMI EC12 2000.
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".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K083148 #/3
510(k) Summary
NOV - 7 2008
| Company Name: | BIO PROTECH, INC.
1720-26, Taejang 2 – Dong, Wonju
Woonju-Si, Gangwon-Do
Republic of South Korea |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Company Address | 1720-26, Taejang 2 – Dong, Wonju
Woonju-Si, Gangwon-Do
Republic of South Korea |
| Contact Person: | Mr. Kevin Han
17962 Sky Park Circle
Suite G
Irvine, CA 92614
Phone: 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.
1
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 | | BIOPROTECH
Wet-gel ECG electrodes | Predicate Device
(Skintact ECG electrodes
/ S&W electrodes) |
|---------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | Pending | K982521 |
| 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). | Skintact ECG electrodes are intended
for use in general electrocardiographic
procedures where ECG monitoring is
deemed necessary and is ordered by a
physician. |
| 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 |
2
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
3
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
4
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
5
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
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