NEONATAL ECG ELECTRODE, M203KEN

K092744 · R & D Medical Products, Inc. · DRX · Dec 10, 2009 · Cardiovascular

Device Facts

• Record ID: K092744
• Device Name: NEONATAL ECG ELECTRODE, M203KEN
• Applicant: R & D Medical Products, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Dec 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Neonatal ECG Electrodes are intended for use in pediatric or neonatal electrocardiographic procedures where resting ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis recording. The Neonatal ECG Electrodes are applied to the surface of the body, single use only, and disposable. Neonatal ECG electrodes should be changed every 24 hours.

Device Story

Device consists of three prewired ECG electrodes on a single release card. Construction includes a surface layer (tricot/polyester fabric, polyethylene foam, or polypropylene), a metallic Ag/AgCl coated layer for leadwire connection, and a biocompatible conductive hydrogel layer. Electrodes are applied to the neonate's chest for resting ECG monitoring and diagnostic recording. Used in hospital neonatal/pediatric units; operated by clinical staff. Output is an electrical signal transmitted via leadwires to an ECG monitor for clinical surveillance and diagnosis. Benefits include non-invasive, disposable monitoring of infant cardiac activity.

Clinical Evidence

Bench testing only. No clinical data. Performance testing verified compliance with ANSI/AAMI EC12:2000 (R) 2005 and ANSI/AAMI EC53:1995 (R) 2008 standards, including AC impedance, DC offset voltage, defibrillation overload recovery, combined offset instability, internal noise, and bias current tolerance. Biocompatibility testing (cytotoxicity, sensitization, primary skin irritation) confirmed safety for skin contact.

Technological Characteristics

Multi-layer construction: surface layer (tricot/polyester, PE foam, or polypropylene), Ag/AgCl coated metallic layer, and conductive hydrogel. Complies with ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008. Passive sensing device; no energy source or software.

Indications for Use

Indicated for resting ECG monitoring of newborn and premature infants in neonatal or pediatric hospital units. Single-use, disposable, applied to body surface, changed every 24 hours.

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

• Ameritus Accu-Lead (K050443)
• Neolead (K011564)

Submission Summary (Full Text)

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KD912744

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# 510(k) Summary

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| Submitter's Information: | R&D Medical Products, Inc.<br>20492 Crescent Bay Drive, Building 106<br>Lake Forest, CA 92630 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Perrault<br>Phone: [phone] x202<br>Fax: [phone] |
| Date Prepared: | September 3, 2009, revised November 19, 2009 |
| | DEC 10 2009 |
| Proprietary Name: | Neonatal ECG Electrodes |
| Common Name: | Electrocardiograph (ECG) Electrodes |
| Classification Name: | Electrodes, Electrocardiograph |
| Regulation: | Electrocardiographic electrode, 21 C.F.R. § 870.2360 |
| Regulatory Class: | Class II |
| Product Code: | DRX |
| Predicate Devices: | K050443 - Ameritus Accu-Lead of Kentec Medical, Inc.<br>K011564 - Neolead of Neotech Products, Inc. |
| Description of Device: | The Neonatal ECG Electrodes are three prewired ECG electrodes<br>supplied on the same release card in a single package. The<br>electrodes are a multi-layer construction containing a first layer<br>surface (made of tricot/polyester fabric, polyethylene foam, or<br>polypropylene substrate), a second layer ( metallic with Ag/AgCl<br>coating ) prewired for connection to patient leadwires, and a third<br>layer (made of biocompatible conductive hydrogel coupling media)<br>The electrodes are placed on the neonate patient's chests. |
| Intended Use: | Neonatal ECG Electrodes are intended for use in pediatric or<br>neonatal electrocardiographic procedures where resting ECG<br>monitoring is deemed necessary and is ordered by a physician.<br>Such procedures include, in particular, patient ECG surveillance<br>and ECG diagnosis recording. The Neonatal ECG Electrodes are |

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applied to the surface of the body, single use only, and disposable. Neonatal ECG electrodes should be changed every 24 hours.

Technological Comparison:

The Neonatal ECG Electrodes have technological characteristics that are substantially equivalent to those of the predicate devices as determined by testing, common materials, and common manufacturer. The following testing was conducted: AC impedance: DC offset voltage: defibrillation overload recovery; combined offset instability and internal noise; and bias current tolerance. The Neonatal ECG Electrodes and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008.

R&D Medical Products, Inc. contract manufactures the predicate Basis for Equivalence: devices and now seeks to make the same product under private label for distribution.

-Performance testing: Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria. According to the performance data, the Neonatal ECG Electrodes met specifications as established in ANSI/AAMI EC12:2000 (R) 2005 for skin contact. The tests included cytotoxicity, sensitization and primary skin irritation tests. The predicate devices use the same materials and meet the same biocompatibility specifications.

> Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices.

-Labeling:

Conclusions from Testing:

The labeling of the Neonatal ECG Electrodes is substantially equivalent to that of the predicate devices.

In all material respects, the Neonatal ECG Electrodes are substantially equivalent to the predicate devices. Testing was performed according to FDA recognized standards. Test results support the conclusion that the electrical output is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three figures representing health, services, and humanity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 0 2009

R&D Medical Products, Inc. c/o Mr. James Perrault 20492 Crescent Bay Drive Building 106 Lake Forest, CA 92630

Re: K092744

Trade Name: Neonatal ECG Electrode, M203KEN Regulation Number: 21 CFR § 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: 74 DRX Dated: November 23, 2009 Received: November 24, 2009

#### Dear Mr. Perrault:

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 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. James Perrault

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W.M.P.

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

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### 510(k) Number: K092744

Device Name: Neonatal ECG Electrodes

Indications for Use:

These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
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| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K092744 |
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