ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

K020003 · Bio Protech, Inc. · DRX · Nov 7, 2002 · Cardiovascular

Device Facts

• Record ID: K020003
• Device Name: ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
• Applicant: Bio Protech, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Self-adhesive, non-sterile, single-use disposable ECG electrodes; Ag/AgCl sensing element; solid adhesive hydrogel with low impedance. Adhesive gel secures electrode to patient skin and sensing element to minimize movement artifact. Foam backing provides adhesion for stress testing and Holter monitoring. Applied to patient body surface by healthcare professionals; transmits electrical signals to ECG processor for electrocardiogram or vectorcardiogram production. Facilitates cardiac monitoring in clinical and ambulatory settings.

Clinical Evidence

Bench testing only. Electrical performance verified against ANSI/AAMI EC12-2000 and EU Council Directive 93/42/EEC. Biocompatibility assessed per ISO 10993-1. Shelf life validated via real-time studies confirming 24-month stability.

Technological Characteristics

Ag/AgCl sensing element; solid adhesive hydrogel; foam backing. Dimensions/form factor not specified. Connectivity: passive electrical conductor. Sterilization: non-sterile. Standards: ANSI/AAMI EC12-2000, ISO 10993-1.

Indications for Use

Indicated for recording resting ECG, exercise ECG, and ambulatory (Holter) monitoring in adult, pediatric, and neonatal patient populations in hospital, clinic, ambulance, or daily use environments.

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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K020003 网上

# 510(k) SUMMARY

| Submitted For: | BIO PROTECH INC.<br>303 Boryung B/D 37-10<br>Kangnam Ku,<br>Seoul, Korea 135-090 | NOV 7 2002 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Submitted by: | TUCKER & ASSOCIATES<br>Official Correspondent and United States Agent for<br>Bio Protech Inc.<br>JANNA P. TUCKER, President -- CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434<br>Phone: [phone] Fax: [phone]<br>E-mail: [e-mail] | |
| Date of Submission: | | |
| Classification Name: | ELECTRODE, ELECTROCARDIOGRAPH<br>Product Code: DRX<br>Class II Device | |
| Proprietary Name: | (Multiple Labels) Telectrode ECG Electrode | |
| Common Name: | ECG Electrode | |
| Regulatory Reference: | CFR 870.2360 | |
| Predicate Device: | Skintact™ ECG Electrodes (K982521) | |
| Labels/Labeling: | This device will be marketed to medical device suppliers,<br>Dentist and Doctor Offices, Clinics, Emergency Response<br>Professionals, Hospitals and other healthcare professionals<br>for the Intended Use purposes below, and will be<br>appropriately labeled in accordance with Title 21 CFR<br>Part 801. | |
| Intended Use: | An electrocardiograph electrode is the electrical conductor<br>which is applied to the surface of the body to transmit the<br>electrical signal at the body surface to a processor that<br>produces an electrocardiogram or vectorcardiogram. | |

EXHIBIT K
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| Description: | Bio Protech electrodes are self-adhesive, non-sterile, single<br>use disposable ECG electrodes. All include an Ag/Agc 1<br>sensing element and the solid adhesive hydro gel has very<br>low impedance level. Most importantly, the adhesive gel<br>sticks on both skin of patient and the sensing element so<br>that the movement artifact can be significantly lowered.<br>The adhesive qualities of the foam is strong enough to use<br>for stress test and holter. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | This device is equivalent to those in commercial<br>distribution for use in general electrocardiographic<br>procedures where ECG monitoring is deemed necessary<br>and is ordered by a physician. |
| | Both in its intended use and/or physical characteristics, this<br>device is equivalent to devices currently marketed by U.S.<br>companies. It is substantially equivalent to the device<br>manufactured by Leonhard Lang GmbH under K982521. |
| Performance Summary: | The electrical performance of BIO PROTECH ECG<br>electrodes meets the requirements of the Medical Devices<br>Directive: EU Council Directive 93/42/EEC, ANSI/AAMI<br>ec12-2000, and has been issued a Certificate of Conformity<br>(01-KOR-MDD-0003) |
| Biocompatibility Testing: | The biological safety of the PRO TECH ECG electrodes<br>has been assured through the selection of materials which<br>demonstrate appropriate levels of biocompatibility. The<br>tests were selected on the basis of ISO 10993-1, Biological<br>Evaluation of Medical Devices - Part 1 - Guidance on<br>selection of tests. |
| Shelf Life: | Data obtained in real time shelf life studies was reviewed<br>and found to substantiate the 24 month shelf life claim. |
| Conclusion: | This device is substantially equivalent to the device<br>approved as K982521. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio ProTech, Inc. c/o Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparks, NV 89434-9550

Re: K020003

Trade Name: Electrocardiograph (ECG) Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: August 6, 2002 Received: August 9, 2002

Dear Ms. Tucker:

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.

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Page 2 – Ms. Janna P. Tucker

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,
Elis Molles

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

#### BIO PROTECH, INC. APPLICANT:

### 510(k) NUMBER:

长020003

### ELECTROCARDIOGRAPH (ECG) DEVICE NAME: ELECTRODE

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, pediatric and neonatal, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K020003 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | __________ |
|--------------------------|------------|
| (Optional Format 1-2-96) | |

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