TELECTRODE WET GEL ECG ELECTRODE

K083148 · Bio Protech, Inc. · DRX · Nov 7, 2008 · Cardiovascular

Device Facts

• Record ID: K083148
• Device Name: TELECTRODE WET GEL ECG ELECTRODE
• Applicant: Bio Protech, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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).

Device Story

Single-use, self-adhesive, non-sterile, disposable ECG electrode; transmits electrical signals from body surface to external processor for ECG/vectorcardiogram generation. Sensor composed of ABS plastic with Silver/Silver Chloride coating. Applied to patient skin in hospital, clinic, ambulance, or home settings. Device does not include lead wires, cables, or processors. Healthcare providers use the resulting ECG output to monitor cardiac electrical activity; aids in diagnosis and management of cardiac conditions.

Clinical Evidence

Bench testing only. Device performance validated against ANSI/AAMI EC-12 standards for electrical characteristics and ISO 10993-1 for biocompatibility. No clinical study data provided.

Technological Characteristics

Materials: ABS plastic, Silver/Silver Chloride coating. Form factor: Disposable, self-adhesive electrode. Connectivity: Passive interface (no internal electronics). Standards: ANSI/AAMI EC-12 (electrical performance), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for adult and pediatric patients requiring resting ECG, exercise ECG, or ambulatory (Holter) monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Skintact ECG Electrodes (K982521)

Submission Summary (Full Text)

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K083148 #/3

# 510(k) Summary

NOV - 7 2008

| Company Name: | BIO PROTECH, INC.<br>1720-26, Taejang 2 – Dong, Wonju<br>Woonju-Si, Gangwon-Do<br>Republic of South Korea |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Company Address | 1720-26, Taejang 2 – Dong, Wonju<br>Woonju-Si, Gangwon-Do<br>Republic of South Korea |
| Contact Person: | Mr. Kevin Han<br>17962 Sky Park Circle<br>Suite G<br>Irvine, CA 92614<br>Phone: [phone] |

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 | | BIOPROTECH<br>Wet-gel ECG electrodes | Predicate Device<br>(Skintact ECG electrodes<br>/ S&W electrodes) |
|---------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | Pending | K982521 |
| Indications for Use | | TELECTRODE Wet gel ECG<br>Electrodes are used to record the<br>following ECGs from a patient: Resting<br>ECG, Exercise ECG and/or ambulatory<br>(Holter) monitoring.<br>The intended patient population can be<br>adult and pediatric, while the<br>environment of use can be hospital (or<br>clinic), ambulance, or daily use<br>environment (for Holter monitoring). | Skintact ECG electrodes are intended<br>for use in general electrocardiographic<br>procedures where ECG monitoring is<br>deemed necessary and is ordered by a<br>physician. |
| Target patient population | | General [Adult, Pediatric] | General |
| Intended Use | | General<br>[Hospital, Clinic, ambulance,<br>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 ----- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>. |

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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 [phone]. 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 [phone] or [phone] 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

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