REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351

K052465 · Heartsine Technologies, Inc. · MKJ · Dec 12, 2006 · Cardiovascular

Device Facts

• Record ID: K052465
• Device Name: REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
• Applicant: Heartsine Technologies, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Samaritan Pediatric-Pak (Model SPP 351) is a disposable electrode/battery cartridge for the samaritan PAD (Model SAM 300P) AED. It enables delivery of reduced-energy (50 Joules) defibrillation therapy to pediatric patients. The device contains a magnet that, upon insertion into the host PAD, triggers the device to switch to a pediatric-specific energy look-up table in the host's embedded software. Energy reduction is achieved via a purely resistive attenuator circuit board housed within the cartridge. The device prompts the user 'child patient' upon detection. It is used by trained personnel in emergency settings to treat cardiopulmonary arrest. The output is a therapeutic electrical shock. The device benefits patients by providing age-appropriate defibrillation energy, reducing the risk of over-delivery of energy to smaller patients.

Clinical Evidence

Bench testing and validation against a pediatric heart rhythm database were performed. No clinical trials were conducted. The device demonstrated safety and effectiveness equivalent to the predicate.

Technological Characteristics

Disposable electrode/battery cartridge containing a resistive attenuator circuit board. Uses a magnet for automatic detection by the host AED. Energy reduction is achieved through resistive attenuation and a software-based energy look-up table. Electrodes are sealed in poly/foil pouches. Form factor is a molded housing, color-coded pink for pediatric identification.

Indications for Use

Indicated for pediatric patients 1 to 8 years of age or up to 55 lbs (25 kg) in cardiopulmonary arrest (unconscious, pulseless, apneic). For use by trained personnel only.

Regulatory Classification

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.

Predicate Devices

• Medtronic LIFEPAK 500 (K052057)

Submission Summary (Full Text)

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# EXHIBIT 2 510(k) Summary 510(k) Number K052465 Heartsine Technologies, Inc. 105 Terry Drive Newtown, PA 18940 Phone: [phone] Fax: [phone] 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:

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.

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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 | Medtronic<br>LIFEPAK® 500 | Heartsone<br>Technologies |
|---------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Model No. | Medtronic Physio-Control<br>Infant/Child Reduced Energy<br>Electrodes | Reduced Energy Pediatric Electrode<br>Pads For the samaritan® PAD |
| 510(k) No. | K052057 | K052465 |
| Indications | For automated defibrillation of<br>infants and children up to<br>approx. 8 years of age or 25 kg<br>weight. | For automated defibrillation of children<br>from 1 year to 8 years of age or 55 lbs (25<br>kg) weight. |
| Energy<br>Reduction | 4:1 | Fixed at 50 Joules |
| Technology | Encapsulated resistive divider<br>part of disposable electrode<br>assembly | Encapsulated resistive divider part of<br>disposable electrode/battery pack<br>assembly 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 [phone] or [phone] 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:

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.

# (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)

or

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

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