SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301

K042088 · Heartsine Technologies, Inc. · MKJ · Sep 2, 2004 · Cardiovascular

Device Facts

• Record ID: K042088
• Device Name: SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
• Applicant: Heartsine Technologies, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, non-sterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Device Story

Single-use, non-sterile, self-adhesive hydrogel polymer electrode pads; designed for use with Samaritan® PAD Automated External Defibrillator (AED). Pads function as interface for ECG signal acquisition and delivery of low-energy DC defibrillation shocks. Used in clinical or emergency settings; operated by trained personnel or lay users. Pads are sealed in protective pouches to maintain integrity and prevent drying. Output consists of patient ECG data to AED and electrical energy to patient. Facilitates cardiac rhythm monitoring and life-saving defibrillation therapy.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI DF80, ISO 10993, and FDA Memorandum G95-1 demonstrated through internal performance and biocompatibility testing. No clinical data provided.

Technological Characteristics

Single-use, non-sterile, self-adhesive hydrogel polymer electrode pads. Designed for ECG monitoring and low-energy DC defibrillation. Complies with AAMI/ANSI DF80 and ISO 10993 biocompatibility standards. Form factor is a sealed pouch-contained pad set.

Indications for Use

Indicated for ECG monitoring and external defibrillation in patients 8 years and older using the Samaritan® PAD Automated External Defibrillator.

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

• Meridian Technologies, PRIME ECG System (K012414)
• Philips Medical Systems, Onsite AED M5066A with M5071A pads (K020715)
• Katecho, Inc., KDP-60A Adult Defib/Pace Multifunction Electrode (K002806)

Submission Summary (Full Text)

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# 510(k) Summary SEP = 2 2004

| Submitter: | HeartSine Technologies, Inc. |
|------------|------------------------------|
| | 940 Calle Amanecer, Suite E |
| | San Clemente, CA 92673 |

Contact: William J. Smirles Senior Vice President, Marketing & Business Development Phone: [phone] FAX: [phone]

Proposed Device Identification and Classification:

| Proprietary Name: | Samaritan® PAD PAK Defibrillation Electrodes |
|---------------------------------------|-----------------------------------------------------------------------------------|
| Common Name: | Disposable Polymer (Hydrogel) External Monitoring<br>and Defibrillation Electrode |
| Classification Name<br>and Reference: | Automated External Defibrillator<br>$§$ 870.5310 |
| Classification Panel: | Cardiovascular |
| Product Code: | 74 MKJ |
| Regulatory Class: | III |
| Performance Standards: | No performance standards have been promulgated<br>under Section 514 |

#### Predicate Devices

- Meridian Technologies, PRIME ECG System (K012414) .
- Philips Medical Systems, Onsite AED M5066A with M5071A pads (K020715) .
- Katecho, Inc., KDP-60A Adult Defib/Pace Multifunction Electrode (K002806) .

#### Substantial Equivalence

The HeartSine Samaritan® PAD PAK defibrillation electrodes are substantially equivalent to the Meridian Medical Technologies, PRIME ECG System electrodes for ECG monitoring, previously cleared under 510(k) # K012414. The Samaritan® PAD PAK electrodes are also substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators, such as the Philips Onsite Defibrillation pads (Philips Model Number M5071A) as described in the 510(k) submission for the Philips Onsite M5066A Automated External Defibrillator (K020715) and the Katecho, Inc. KDP 60A Adult Multifunction Electrodes (K002806). The Philips and Katecho electrodes are designed for ECG monitoring and defibrillation and are intended for use with a semiautomatic, low power DC defibrillator.

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## Intended Use

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, non-sterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

## Device Description

The HeartSine Samaritan® PAD PAK pads are single use, non-sterile, hydrogel polymer self-adhesive electrode pads. The Samaritan® PAD PAK pads will be used in conjunction with Samaritan® PAD low energy semi-automatic external defibrillator (AED). The pads are sealed in a pouch to prevent drying out and to maintain their integrity throughout the duration of the shelf life.

## Performance and Biocompatibility Testing

Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® PAD PAK pads comply with applicable FDA quidelines and industry standards. The PAD PAK pads comply with the requirements of AAMI/ANSI DF80. ISO 10993, and FDA Memorandum G95-1, and with HeartSine Technologies, Inc. internal specifications for a single use, ECG monitoring & defibrillation pad. The testing of the PAD PAK pads demonstrate that the PAD PAK Pads function as intended. The results of the testing have also shown the Samaritan® PAD PAK pads do not raise any new questions of safety or effectiveness.

* * * * End of 510(k) Summary * * * * *

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EP = 2 2004

Heartsine Technologies, Inc. c/o William J. Smirles, EMT-P Senior VP, Marketing & Business Development 940 Calle Amanecer, Suite E San Clemente, CA 92673

Re: K042088

Trade name: Samaritan® PAD PAK Defibrillation Electrode, Model Spp-301 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 30, 2004 Received: August 12, 2004

Dear Mr. Smirles:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rovened your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to conninered province 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 r ou may, diorerore, mains 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 - William J. Smirles, EMT-P

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 or cary I 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 promated 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 it you attire of Compliance at [phone]. 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/dsma/dsmamain.html

Sincerely yours,

Nih. ho. Ogle
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):

HeartSine Technologies Samaritan® PAD PAK Defibrillation Pads Device Name:

Indications For Use:

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, nonsterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K042088 |
| Page 1 of | 1 |