PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20

K053011 · Bio Protech, Inc. · DRX · Dec 14, 2005 · Cardiovascular

Device Facts

• Record ID: K053011
• Device Name: PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
• Applicant: Bio Protech, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or monitoring for noonata. This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin. Caution: Federal law restricts this device to sale by or on the order of physician.

Device Story

PRONEO Neonatal ECG Electrode; disposable surface electrode for cardiac monitoring. Input: bio-potential signals from patient skin. Components: conductive adhesive hydrogel, Ag/AgCl plated sensor, non-woven substrate, vinyl label, 100cm flexible tinned copper or carbon lead wire with 1.5mm/2.0mm DIN connector. Used in clinical settings by trained medical personnel. Output: electrical signal transmission to external ECG monitor. Facilitates continuous heart rate/rhythm observation; aids clinical decision-making regarding patient cardiac status. Non-sterile; 24-month shelf life.

Clinical Evidence

Bench testing only. Device performance validated against ANSI/AAMI EC12:2000 standards for disposable ECG electrodes. Biocompatibility testing conducted per ISO 10993; device confirmed non-irritating, non-cytotoxic, and non-sensitizing. Accelerated aging testing supports 24-month shelf life.

Technological Characteristics

22mm square electrode; conductive adhesive hydrogel; Ag/AgCl sensor; non-woven substrate; vinyl label; 100cm tinned copper/carbon lead wire; 1.5mm/2.0mm DIN connector. Non-sterile. Complies with ANSI/AAMI EC12:2000 electrical requirements. Biocompatible per ISO 10993.

Indications for Use

Indicated for neonatal and pediatric patients requiring cardiac monitoring. For use on intact skin only. Prescription use only.

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

• PALS NEONATAL PEDIATRIC ECG ELECTRODE (K000206)

Submission Summary (Full Text)

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K053011
p.1/2

www.protechsite.co

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# DEC 1 4 2005

## BIO PROTECH INC.

Bio Sensors & Bio Products

## 510(k) Summary

Data : June 30, 2005

Manufacturing Facility : BIO PROTECH, INC. 1720-26, Taejang 2-Dong, Wonju Medical Instrument Ind. Park Wonju-Si, Gangwon-Do, REPUBLIC OF KOREA Tel: [phone] Fax: [phone]

Contract Person : Eunseo Heo Researcher of Regulatory Affairs Tel: [phone] Fax: [phone]

Device Trade Name : PRO-NEO NEONATAL ECG ELECTRODE

Device Common Name : Neonatal ECG Monitoring Electrode

Classification Name : Electrocardiograph Electrode

Regulatory Reference : 74 DRX

Predicate Device :

K000206, PALS NEONATAL PEDIATRIC ECG ELECTRODE, AXELGAARD MFG, CO., LTD.

#### Description:

The PRONEO Neonatal ECG Electrodes (and also to be sold under various private label trade names; i.e. Multiple Labels) are 22mm in square and consist of a conductive adhesive hydrogel, a Ag/AgCl plated sensor element a non-woven substrate and vinyl label, and a 100cm flexible tinned copper or carbon lead wire terminating in a 1.5mm, 2.0mm standard DIN connector. Electrodes are packaged in pouches of 3, 100 pouches per carton and are supplied non-strerile.

#### Intended Use:

The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency This electrode is for use on neonatal and pediatric patients. personnel.

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www.protechsite.com

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### BIO PROTECH INC.

Bio Sensors & Bio Products

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#### Performance Summary:

The device and the predicate were subjected to AAMI electrical tests as described in ANSI/AAMI voluntary standard, EC12:2000, Disposable ECG Electrodes. Test results for both the device and the predicate met the specifications as established in ANSI/AAMI EC12:2000.

#### Biocompatibility Testing:

The device was subjected to biocompatibility testing as recommended FDA memorandum entitled Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device was found to be non-irritating, non-cytotoxic and non-sensitizing.

#### Shelf Life:

Accelerated aging testing was performed to substantiate an expiration of 24 months.

### Conclusion:

This device is substantially equivalent to the devices approved as K000206

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2005

Bio Protech, Inc. c/o Mr. E. J. Smith Smith Associates 1676 Village Green Suite A Crofton, MD 21114

Re: K053011

Trade Name: Neonatal Electrocardiograph (ECG) Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: June 29, 2005 Received: October 26, 2005

Dear Mr. Smith:

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 - Mr. E. J. Smith

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 (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. 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,

Blymmmer for

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): ____________________________________________________________________________________________________________________________________________________

K053011

Device Name: NEONATAL ELECTROCARDIOGRAPH (ECG) ELECTRODE

Indications for Use:

The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or monitoring for noonata. This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Caution: Federal law restricts this device to sale by or on the order of physician.

Prescription Use X (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)

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lvision Sign-Off; vision of Cardiovascular Devices -10(k) Number K0530/ | -------------------------------------------------------------------------------------------------------------------------------------------------------