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.

Device Description

The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Neonatal ECG Electrodes (KD912744), based on the provided document:

This 510(k) summary does not describe an AI/ML device or a comparative effectiveness study involving human readers with and without AI assistance. The device is a traditional medical device (ECG electrodes) and the testing focuses on its physical and electrical performance against recognized standards. Therefore, many of the requested categories (like MRMC study, standalone algorithm performance, training set details, and expert qualifications for ground truth) are not applicable to this submission.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Electrical Performance	ANSI/AAMI EC12:2000/(R) 2005 (for ECG Electrodes)	Meets specifications
- AC impedance	(Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005)	Meets specifications
- DC offset voltage	(Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005)	Meets specifications
- Defibrillation overload recovery	(Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005)	Meets specifications
- Combined offset instability and internal noise	(Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005)	Meets specifications
- Bias current tolerance	(Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005)	Meets specifications
Biocompatibility	ANSI/AAMI EC53:1995/(R) 2008 & "required skin sensitivity testing criteria"	Passed required skin sensitivity testing criteria. Met specifications for skin contact.
- Cytotoxicity	(Implicitly covered by biocompatibility testing standards)	Passed
- Sensitization	(Implicitly covered by biocompatibility testing standards)	Passed
- Primary skin irritation	(Implicitly covered by biocompatibility testing standards)	Passed

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was primarily bench testing to assess electrical characteristics and biocompatibility testing. The submission explicitly states:

"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."
"Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria."
"Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices."

The conclusion is that "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the electrical performance bench tests. For biocompatibility, it states "Biocompatibility testing was performed," but does not detail the number of samples or subjects.
Data Provenance: The data is from bench testing (electrical and physical characteristics) and biocompatibility testing. The country of origin is not explicitly stated, but it would be expected to be from controlled laboratory environments. The nature of these tests is inherently prospective as they are conducted specifically for the device submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is a hardware medical device (ECG electrodes). Ground truth in this context refers to established technical standards (ANSI/AAMI EC12 and EC53) and laboratory measurements, not expert review of images or clinical data.

4. Adjudication Method for the Test Set

Not Applicable. As noted above, this involves technical measurements against standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where human interpretation is involved. This device is an electrode.

6. Standalone Performance Study (Algorithm Only)

No. This is a hardware device; there is no "algorithm" in the sense of AI/ML software for standalone performance evaluation.

7. Type of Ground Truth Used

Technical Standards and Lab Measurements: The ground truth for this device's performance is defined by the requirements outlined in ANSI/AAMI EC12:2000/(R) 2005 (for ECG electrodes) and ANSI/AAMI EC53:1995/(R) 2008 (for biocompatibility and skin contact). The device's performance was measured against these objective standards.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no training set for this type of device.

Summary

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KD912744

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510(k) Summary

Submitter's Information:	R&D Medical Products, Inc.20492 Crescent Bay Drive, Building 106Lake Forest, CA 92630
Contact Person:	James PerraultPhone: (949) 472-9346 x202Fax: (949) 472-9347
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.K011564 - Neolead of Neotech Products, Inc.
Description of Device:	The Neonatal ECG Electrodes are three prewired ECG electrodessupplied on the same release card in a single package. Theelectrodes are a multi-layer construction containing a first layersurface (made of tricot/polyester fabric, polyethylene foam, orpolypropylene substrate), a second layer ( metallic with Ag/AgClcoating ) prewired for connection to patient leadwires, and a thirdlayer (made of biocompatible conductive hydrogel coupling media)The electrodes are placed on the neonate patient's chests.
Intended Use:	Neonatal ECG Electrodes are intended for use in pediatric orneonatal electrocardiographic procedures where resting ECGmonitoring is deemed necessary and is ordered by a physician.Such procedures include, in particular, patient ECG surveillanceand 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 (800) 638-2041 or (301) 796-7100 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

510(k) Number: K092744

Device Name: Neonatal ECG Electrodes

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)	X
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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Regulation Number and Section

§ 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.