The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.

The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

Device Description

The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the samaritan® Pediatric-Pak (Model SPP 351).

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings and conclusions of studies and does not typically contain exhaustive details about the methodologies of those studies. Therefore, some information requested may not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and a detailed performance table for the new device's efficacy. The core acceptance criteria appear to be implicit in the comparison to the predicate device's established safety and effectiveness.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (samaritan® Pediatric-Pak)
Safety: Device is as safe as the predicate device (Medtronic LIFEPAK® 500 Infant/Child Reduced Energy Electrodes).	Bench testing and validation against a pediatric heart rhythm database demonstrated substantial equivalence in safety. (Details of specific safety metrics are not provided in this summary.)
Effectiveness: Device is as effective as the predicate device.	Bench testing and validation against a pediatric heart rhythm database demonstrated substantial equivalence in effectiveness. The device delivers a fixed 50 Joules of energy, similar in principle to the predicate's 4:1 energy reduction for pediatric patients.
Energy Reduction Mechanism: Provides appropriate energy reduction for pediatric patients (1-8 years old or up to 25kg/55lbs).	Fixed at 50 Joules via an encapsulated resistive divider within the disposable electrode/battery pack assembly. This is an analogous technology to the predicate's encapsulated resistive divider.
Compatibility: Designed for specific AED host (samaritan® PAD 300P) and reduces energy appropriately.	Incorporates a magnet sensed by the host PAD, automatically prompting "child patient" mode and using a pediatric look-up table to define voltage and duration for 50 Joules delivered.
Indications for Use: Matches or is substantially equivalent to the predicate's indications for pediatric use.	For automated defibrillation of children from 1 year to 8 years of age or 55 lbs (25 kg) weight, matching the predicate's age/weight range.

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

Sample Size: Not explicitly stated for the "pediatric heart rhythm database" used for validation. The summary only mentions "validation against a pediatric heart rhythm database."
Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as a "pediatric heart rhythm database," implying it contains recorded heart rhythms from pediatric patients.
Retrospective or Prospective: Not explicitly stated, however, the phrase "validation against a pediatric heart rhythm database" strongly suggests a retrospective analysis of existing recorded data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a "heart rhythm database," it's likely that established medical criteria or a consensus of cardiologists previously annotated the rhythms within the database, but this is not detailed in the summary.

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

MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The comparison is between the new device's technology and performance (as evaluated via bench testing and database validation) against a predicate device, not typically involving human readers.
Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study involving human readers and AI assistance was reported.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Standalone Study Done: Yes, a standalone evaluation of the device's performance was conducted. The summary states: "The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices." This implies that the device's ability to appropriately identify and deliver a shock (or withhold if not required, though the focus is on reduced energy delivery) was evaluated without a human-in-the-loop, against pre-recorded rhythms.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the standalone performance was based on a "pediatric heart rhythm database." This implies that the rhythms in the database were classified according to their clinical significance (e.g., shockable vs. non-shockable rhythms for pediatric patients, or specific energy requirements for different rhythm types). This would typically be established by expert medical consensus or established diagnostic criteria.

8. Sample Size for the Training Set

Sample Size: The provided 510(k) summary does not mention a training set or its sample size. This device appears to rely on a fixed resistive attenuation and a "pediatric look-up table" for energy delivery, rather than an adaptive algorithm that would typically require a training set. The "pediatric heart rhythm database" was used for validation, not training.

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

How Ground Truth Established: Not applicable, as no training set is mentioned for an adaptive algorithm. The device's operation is described as a "purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software," indicating a deterministic rather than machine-learning-based approach requiring a training set. The "pediatric look-up table" itself would have been developed based on established medical guidelines for pediatric defibrillation.

Summary

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EXHIBIT 2 510(k) Summary 510(k) Number K052465 Heartsine Technologies, Inc. 105 Terry Drive Newtown, PA 18940 Phone: 1-215-860-8100 Fax: 1-215-860-8192 December 6, 2006 Contact: Alan B. Hershman, RAC

1. Identification of the Device:

Proprietary-Trade Name: samaritan® Pediatric-Pak (Model SPP 351) Classification Names: Defibrillators, automatic, external 74 MKJ Common/Usual Name: Automated external defibrillator and electrodes.

2. Equivalent legally marketed device: Medtronic LIFEPAK 500, K052057

3. Indications for Use:

The samaritan Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously, They should only be used by personnel who have been trained in its operation.

The samaritan Pediatric-Pak is specially designed for use with the samaritan PAD (Model SAM 300P) only. The SAM 300P, in conjunction with the Pediatric Pak, allows the samaritan® PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

4. Description of the Devices:

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5. Safety and Effectiveness, comparison to predicate device:

The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices.

Company	MedtronicLIFEPAK® 500	HeartsoneTechnologies
Model No.	Medtronic Physio-ControlInfant/Child Reduced EnergyElectrodes	Reduced Energy Pediatric ElectrodePads For the samaritan® PAD
510(k) No.	K052057	K052465
Indications	For automated defibrillation ofinfants and children up toapprox. 8 years of age or 25 kgweight.	For automated defibrillation of childrenfrom 1 year to 8 years of age or 55 lbs (25kg) weight.
EnergyReduction	4:1	Fixed at 50 Joules
Technology	Encapsulated resistive dividerpart of disposable electrodeassembly	Encapsulated resistive divider part ofdisposable electrode/battery packassembly for the PAD model.

6. Substantial Equivalence Chart

7. Conclusion

After analyzing testing data and the predicate device, it is the conclusion of HeartSine Technologies, Inc that the samaritan® Pediatric-Pak in conjunction with the samaritan® PAD Model 300P are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HeartSine Technologies, Inc c/o Alan B. Hershman. RAC Quality and Regulatory Affairs 105 Terry Drive Newtown, PA, 18940

DEC 1 2 2006

Re: K052465

Trade/Device Name: Samaritan Pediatric-Pak (Model SPP351) Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: November 2, 2006 Received: November 7, 2006

Dear Mr. Hershman:

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. Hershman

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 240-276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bhimimon 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): K052465

Device Name:

The samaritan® Pediatric-Pak (Model SPP 351)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blymmmon

Division Sign-Off) Division of Cardiovascular Devices KO52465 510(k) Number

Prescription Use X (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.