CARDIOMED by CARDIO MEDICAL PRODUCTS, INC.

The Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (30 joule maximum).

Device Description

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Cardio Med Pediatric Radiotranslucent Multifunction Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device through nonclinical bench testing. It does not contain information typically found in studies for AI/machine learning medical devices, such as those related to reader performance, clinical outcomes, or large-scale data analysis for algorithm development.

Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) cannot be addressed from the given text.

Here's a summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with ANSI/AAMI DF80:2003 for DC offset, offset instability, AC small signal impedance, AC large signal impedance, defibrillator overload	All units passed these tests both initially and after 42-month accelerated aging.
Compliance with FDA performance standard for touch-proof ECG connectors	Verified by inspection of the connectors.
Biocompatibility of patient contact material (hydrogel)	Material passed biocompatibility testing.
Post-pacing characteristics	All units passed these tests.
Shelf Life (Accelerated Aging)	All units passed tests after 42-month accelerated age shelf life.

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

Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. The exact number of samples or lots is not specified.
Data Provenance: Not applicable in the context of this device. The testing was nonclinical bench testing, not involving human data.

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

Not applicable. This was bench testing against engineering standards, not diagnostic device validation requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This was bench testing against engineering standards. Results would be pass/fail based on direct measurement and comparison to thresholds rather than expert adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a passive electrode, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench testing was defined by the quantitative limits specified in the AAMI Standard ANSI/AAMI DF80:2003 and the FDA performance standard for touch-proof ECG connectors. Biocompatibility was assessed against standard biological safety test protocols.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable. There is no training set for an algorithm.

Summary

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

510(k) Summary K103651

OCT - 4 2011

(1) Submitter: Cardio Medical Products, Inc. 385 Franklin Avenue - Suite L Rockaway, NJ. 07866 Phone: 973-586-9500 Toll Free: 800-227-3633 Fax: 973-586-9624 Contact: Nick Mendise, V.P. Sales Date prepared: 21 June 2011

(2) The name of the device: Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models (Various Models) Common or usual name: Defibrillator Pad Classification name: 870.5300 DC-defibrillator (including paddles).

(3) Predicate devices: Identical in function and construction to the PadPro 2603 Pediatric Multifunction Electrodes.

(4) Description of the device: These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

(5) Statement of the intended use of the device: Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, (Various Models) are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac paccmaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (30 joule maximum).

Compatible with:

a. PZ300 = Zoll
b. PO301 = Medtronic-Physio Control
C. PA302 = Cardiac Science (Anderson)
d. PP303 = Phillips Heartstream
PH304 = Philips Barrel (HP) e.

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

(6) This device has the same technological characteristics (i.c., design, material, chemical composition, energy source) as the predicate device. The defibrillator pads meet the AAMI and FDA performance standards for this type of device.

(7) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

Bench testing summary: Various different lots containing multiple samples each were subjected to the AAMI tests for DC offset, offset instability, AC small signal impedance, AC large signal impedance, defibrillator overload. The same testing was performed for post-pacing characteristics. All units passed these tests. The same testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests. Biocompatibility testing was performed on the patient contact material Hydrogel. The material passed biocompatibility testing.

Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof.")

(8) Conclusion: Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device) we conclude that these defibrillator pads are as safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are identical to the predicate.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardio Medical Products, Inc. c/o Mr. Nick Mendise Vice President Sales 385 Franklin Avenue - Suite L Rockaway, NJ 07866

ORT - A. COM

Re: K103651

Trade Name: Cardio Med Radiotranslucent Multifunction Electrodes Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles) Regulatory Class: Class II Product Code: LDD Dated: September 12, 2011 Received: September 20, 2011

Dear Mr. Mendise:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Page 2 - Mr. Nick Mendise

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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/MedicalDcvices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

[signature]

Bran D. Zuckerman M.D. 10-Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number(if known): K103651

Device Name: Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models

Indications for Use:

Compatible with:

PZ300 = Zoll a.
b. PO301 = Medtronic-Physio Control
PA302 = Cardiac Science (Anderson) C.
PP303 = Phillips Heartstream ರ.
PH304 = Philips Barrel (HP) e.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

�

510(k) Number K103651

Regulation Number and Section

§ 870.5300 DC-defibrillator (including paddles).

(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.