HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A

K014157 · Philips Medical Systems · MKJ · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K014157
• Device Name: HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
• Applicant: Philips Medical Systems
• Product Code: MKJ · Cardiovascular
• Decision Date: Jan 17, 2002
• Decision: ST
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Heartstream FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response. The Heartstream FR2 is indicated for use on victims of sudden cardiac arrest exhibiting the following signs: Unresponsiveness. Absence of breathing.

Device Story

Heartstream FR2 is an automated external defibrillator (AED) for use by trained personnel (BLS/ALS/emergency responders) in sudden cardiac arrest (SCA) scenarios. Device inputs include patient ECG signals via electrodes. The Patient Analysis System (PAS) continuously monitors ECG; it automatically detects shockable rhythms and suspends analysis if significant artifact is present. If a shockable rhythm is detected, the device prompts the user to deliver a biphasic truncated exponential waveform shock. The device features self-testing, an optional ECG display, and manual shock capability. It is powered by lithium manganese dioxide or rechargeable lithium-ion batteries. Data recording (ECG/events/voice) is available via optional data cards. An infrared port facilitates parameter setup, and an optional Training and Administration Pack allows simulation of SCA scenarios. The device provides visual/auditory guidance to the responder, facilitating clinical decision-making by automating rhythm analysis and shock delivery, potentially improving patient survival outcomes in emergency settings.

Clinical Evidence

Bench testing and simulated use testing only. No clinical trial data presented.

Technological Characteristics

Automated external defibrillator; biphasic truncated exponential waveform; impedance-compensating. Power: non-rechargeable lithium manganese dioxide or optional rechargeable lithium-ion battery. Connectivity: infrared communication port. Features: Patient Analysis System (PAS), self-testing, optional ECG display. Software: automated rhythm analysis.

Indications for Use

Indicated for sudden cardiac arrest victims (unresponsive, not breathing). Pediatric use (under 8 years or <55 lbs/25 kg) requires attenuated pediatric defibrillation pads.

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

• Heartstream FR2 AED (K04157)
• Medtronic/Physio-Control LifePak 500

Submission Summary (Full Text)

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## 16. 510(k) Summary

K04157

# 510(k) Summary for the Heartstream FR2 AED

with the M3848A and M3849A

#### 1. Date Summary Prepared

December 11, 2001

#### 2. Submitter's Name and Address

Philips Medical Systems Heartstream 2401 Fourth Avenue, Suite 500 Seattle. WA 98121

#### 3. Contact Person

Tamara Yount Philips Medical Systems Heartstream Telephone: [phone] Facsimile: [phone]

#### 4. Device Name

Heartstream FR2 AED with M3848A and M3849A Proprietary Name: Common Name: Automated external defibrillator Classification Names: Low-Energy Defibrillator

#### 5. Predicate Devices

The legally marketed device to which Philips Medical Systems, Heartstream claims equivalence for the modified Heartstream FR2 AED with the M3848A and M3849A is the Heartstream FR2 AED. The modified device is also substantially equivalent to the Medtronic/Physio-Control LifePak 500.

The design and intended use of the modified Heartstream FR2 AED is substantially equivalent in safety and performance to the devices named above.

#### Device Description 6.

The Heartstream FR2 is an automated external defibrillator available in two models, including one model with ECG display and manual shock capability. Features include self-testing, impedance-compensating biphasic truncated exponential waveform, multiparameter Patient Analysis System (PAS), and human factors design to facilitate use by lay responders.

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A non-rechargeable lithium manganese dioxide battery powers the FR2 with a typical capacity of 300 shocks or 12 hours of operating time. An optional rechargeable lithiumion battery with a typical capacity of 100 shocks and 4 hours of operating time, and its companion charger, will also be available.

Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2 advises a shock and arms - if the ECG spontaneously converts to a nonshockable rhythm prior to a responder pressing the shock button, the FR2 disarms.

If significant artifact is detected in the ECG, Heartstream's PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2 directs the responder to press the shock button to deliver a biphasic shock to the patient.

Event and incident data can be recorded during FR2 use with an optional data card having a recording capacity of four hours of event and ECG data (or thirty minutes with voice recording).

The FR2 has an optional Training and Administration Pack that is used for device training and for customizing FR2 set-up options. Use of the Training and Administration Pack converts the FR2 to a training device with ten training "scripts" that simulate different SCA scenarios.

The FR2 also has an infrared communication port to facilitate communication of set-up parameters.

#### Intended Use 7.

The Heartstream FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response.

The Heartstream FR2 is indicated for use on victims of sudden cardiac arrest exhibiting the following signs:

- Unresponsiveness .
- Absence of breathing .

#### Comparison of Technology Characteristics 8.

The modified Heartstream FR2 AED with the M3848A employs the same fundamental scientific technologies as the commercially available Heartstream FR2 AED. The modified device is also similar to the Medtronic/Physio-Control LifePak 500.

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#### Data Used in Determination of Substantial Equivalence 9.

The modified Heartstream FR2 with the M3848A and M3849A employs the similar the modified in provide similar performance characteristics as the predicate devices.

Bench testing demonstrated that the performance of the M3848A and M3849A meets specifications. In addition, it was demonstrated by simulated use testing that the M3848A and M3849A are appropriate for the intended users.

#### 10. Conclusion

The modifications proposed to include the M3848A and M3849A to the FR2 accessory product offerings do not present new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN 1 7 2002

Ms. Tamara Yount Senior Regulatory Affairs Associate Philips Medical Systems 2401 Fourth Avenue, Suite 500 Seattle, WA 98121-1436

### Re: K014157

Heartstream FR2 AED with M3848A and M3849A Regulation Number: 21 CFR 870.1025 Regulation Name: Automatic External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: December 17, 2001 Received: December 19, 2001

### Dear Ms. Yount:

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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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 - Ms. Tamara Yount

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dale Hill

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

Enclosure

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### 12.Indications for Use

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems, Heartstream FR2 Automated External Defibrillator (AED)

Indications for Use: The Heartstream FR2 is indicated for use on persons experiencing the symptoms of sudden cardiac arrest:

- Lack of responsiveness .
- . Lack of breathing

When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads. DO NOT DELAY TREATMENT TO DETERMINE THE CHILD'S EXACT AGE/WEIGHT.

The Heartstream FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Denk Tuh
Division of Cardiovascular & Respiratory Devices
510(k) Number K014157

Or

Prescription Use

Over-The-Counter Use _

PHILIPS MEDICAL SYSTEMS, HEARTSTREAM HEARTSTREAM FR2 AED, WITH THE M3848A AND M3849A રૂદ