The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,

Device Description

NEONATAL PEDIATRIC ECG ELECTRODE

AI/ML Overview

The provided document, K050443, is a 510(k) summary for a Neonatal Pediatric ECG Electrode manufactured by Kentec Medical, Inc. This submission is for a medical device cleared via the regulatory pathway of substantial equivalence to a previously cleared predicate device, rather than an AI/ML-driven diagnostic or therapeutic device. As such, many of the requested fields related to AI/ML device performance studies (e.g., ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "Common Technological Characteristics" and passing "NON-CLINICAL TEST" standards, primarily related to device safety and performance as an ECG electrode. The submission claims substantial equivalence to the predicate device K011564, "Neolead" by Neotech Products.

Acceptance Criteria (Standard / Characteristic)	Reported Device Performance (Compliance / Characteristic)
Common Technological Characteristics:
Silver Silverchloride Sensing Eyelet	Present
DIN Standard Socket Safety Lead Wire	Present
Hydrogel	Present
Nonwoven Backing	Present
Non-Clinical Performance Data:
ANSI/AAMI EC12-1991 (ECG electrodes)	Met (implicitly, by claiming substantial equivalence to a device that met this standard)
ANSI/AAMI EC53:1995/(R)2001 (General safety of medical electrical equipment)	Met (implicitly, by claiming substantial equivalence to a device that met this standard)

2. Sample size used for the test set and the data provenance

Not applicable in the context of an AI/ML performance study. This submission refers to non-clinical testing against standards. Test sets for patient data or clinical performance are not described in this 510(k) summary. The "test set" in this context refers to the physical electrode devices tested against the ANSI/AAMI standards. The document does not specify the number of electrodes tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in the context of expert consensus is not relevant for this type of device. The "ground truth" for an ECG electrode is its ability to maintain electrical contact and provide a clear signal according to established standards. This is assessed through physical and electrical testing, not expert interpretation of outputs in the same way an AI diagnostic would be.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data/images in AI/ML performance studies. Testing against ANSI/AAMI standards for an ECG electrode primarily involves objective measurements conducted in a laboratory setting.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, so an MRMC comparative effectiveness study is not applicable. The device is a physical electrode, not a tool to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware medical device (an ECG electrode), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is compliance with recognized industry standards for ECG electrodes (ANSI/AAMI EC12-1991) and general safety of medical electrical equipment (ANSI/AAMI EC53:1995/(R)2001). This is established through laboratory and bench testing, not expert consensus, pathology, or outcomes data in the sense of a diagnostic claim.

8. The sample size for the training set

Not applicable. This is a hardware medical device; there is no "training set" for an algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no corresponding ground truth to be established.

Summary

{0}------------------------------------------------

K050443

Page 1 of 1

510K SUMMARY

KENTEC MEDICAL, INC. Submitter's Name: SEP 0 2 2005 17871 FITCH, IRVINE, CA 92614, USA Address: 949 863-0810 Telephone No.: DAVID SHERATON Contact Person: APRIL 25, 2005 Date: NEONATAL PEDIATRIC ECG ELECTRODE Common or Usual Name: ELECTRODE, ELECTROCARDIOGRAPH Classification Name: Proprietary Name: Accu-Lead

INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

510(k) Number	Proprietary Name	Manufacturer
K011564	Neolead	Neotech Products

COMMON TECHNOLOGICAL CHARACTERISTICS

1. Silver Silverchloride Sensing Eyelet
1. DIN Standard Socket Safety Lead Wire
1. Hydrogel
Nonwoven Backing 4.

PERFORMANCE DATA COMPARISON NONCLINICAL TEST

510(k) Number	Proprietary Name	Manufacturer	NON-CLINICAL TEST
K011564	Neolead	Neotech Products	ANSI/AAMI EC12-1991
K011564	Neolead	Neotech Products	ANSI/AAMIEC53:1995/(R)2001

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Kentec Medical, Inc. c/o Mr. David Sheraton Sr. President & CEO R & D Medical, Inc. 20492 Crescent Bay Drive, Building 106 Lake Forest, CA 92630

Re: K050443

Trade Name: Neonatal Pediatric ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: August 9, 2005 Received: August 9, 2005

Dear Mr. Sheraton:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications referenced and nave determined the arrest of creative devices marketed in interstate for use stated in the encrosule) to regally manatiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Tru commerce prof to May 20, 1970, the chaemience with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance who are archarted approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses as provisions of and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the genirements for annual registration, listing of
general controls provisions of the Act include requirements michvending general controls provisions of the Fee Mercials requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional Controlist Extronic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Peachar Reg...
publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 – Mr. David Sheraton Sr.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advisou has I Dravination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I vath 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 (21 CFR Part 801), adoming (21 CFR Part 820); and if applicable, the electronic form in the quality by seems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro revice as described in your device as described in your Section 510(k) I mis letter will anon your of substantial equivalence of your device of your device to a legally prematics notification. "The stassification 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 if you desire specific arrentiance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference on your responsibilities under the Act may be obtained from the Oiner general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimmatmar for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

M203/510K/0415A05

Indications for Use

510(k) Number (if known): K050443

NEONATAL PEDIATRIC ECG ELECTRODE Device Name:

Indications For Use:

Single Use Only - Disposable

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma

intrision Sign-Off) Division of Cardiovascular Devices 510(k) Number_K000443

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.