PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304

K050004 · Philips Medical Systems · MKJ · Feb 25, 2005 · Cardiovascular

Device Facts

• Record ID: K050004
• Device Name: PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
• Applicant: Philips Medical Systems
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is: - Unresponsive when shaken . - Not breathing normally . If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key. Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

Device Story

Automated External Defibrillator (AED) for treatment of sudden cardiac arrest (SCA). Device inputs: patient ECG via pre-connected electrodes. Operation: device analyzes ECG for shockable rhythms using impedance-compensating biphasic waveform; provides voice instructions synchronized with user actions; pauses for CPR. Output: 150J nominal shock (50J for pediatric mode). Used in out-of-hospital settings by lay responders or clinicians. Device features self-calibration and self-testing. Healthcare providers use output to guide resuscitation efforts; device benefits patient by providing automated, impedance-adjusted defibrillation therapy.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Automated External Defibrillator; lithium manganese dioxide battery; biphasic, impedance-compensating waveform; pre-connected electrodes; voice-prompted interface; Infant/Child Key for pediatric energy attenuation. Software-based ECG analysis.

Indications for Use

Indicated for persons suspected of sudden cardiac arrest (unresponsive, not breathing normally). Applicable to adults, infants, and children (using optional Infant/Child Key for those <8 years or <55 lbs/25 kg).

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

• Philips HeartStart OnSite M5066A Defibrillator (K020715)

Submission Summary (Full Text)

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FEB 2 5 2005

#### 13 510(k) Summary

510(k) Number (if known): K050004

# 510(k) Summary for the Philips HeartStart FRx Defibrillator

- Date Summary Prepared 1. February 24, 2005
- Submitter's Name and Address 2. Philips Medical Systems Heartstream 2301 5th Avenue, Suite 200 Seattle, WA 98121
- 3. Contact Person Tish Treherne Requiatory Specialist Philips Medical Systems Heartstream Telephone: [phone] Facsimile: [phone]

### Device Name and Classification Information 4.

Philips HeartStart FRx Defibrillator Proprietary Name: Defibrillator Common Name: Classification Names: Automated External Defibrillator Device Classification: Class III Automated External Defibrillator Regulation: 21 CFR § 870.5310 MK1 Product Code :

#### Predicate Devices 5.

Fredicate Devices device to which Philips Medical Systems, The Tegally marketed device to the Philips HeartStart FRx Heartstream is the Philips HeartStart OnSite M5066A Defibrillator (K020715).

The design and intended use of the FRx is substantially equivalent in THC acong r afformance to the HeartStart OnSite M5066A.

#### Device Description 6.

Device Description
The Philips HeartStart FRx Defibrillator is an automated external The Philips HeartStart TTXx Donomiator fibrillation, the most common cause of sudden cardiac arrest (SCA). Features of the Philips common cause of sudden cardido arroot (Self-Calibration, and self-calibration, and HeartStart TRX Dellibrillato: Include estimated exponential therapy impedance-compensating - biphable - transmiss System (PAS) for

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determining if a shock is required and integrated human factors designs actormining in & of lay responders and pre-connected electrodes.

A non-rechargeable lithium manganese dioxide battery powers the Philips A hon-rechargedblo killiator with a minimum capacity of 200 shocks or 4 hours of operating time.

The HeartStart FRx Defibrillator issues voice instructions appropriate_to The Fleartolan FTA Bollband keeps pace with the user's actions. The the stage of the rocates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR and otherwise predention "intorvals" to "cally analyzes the patient's ECG to determine if continuously and actomatically afibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode assess the £50 valiany as were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.

The HeartStart FRx Defibrillator utilizes the same biphasic, impedance-The Heartourt FFX Delia waveform used in previous-generation Philips Compensating Oxponsibilition delivers 150J shocks (nominal) ALDs. The ficur(Start r... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . shock button as instructed by the defibrillator (50J nominal with Shock button as instructed by HeartStart FRx Defibrillator offers no manual-shock capability.

#### Intended Use 7.

The HeartStart FRx Defibrillator is indicated for use on a person suspected to be in sudden cardiac arrest who is:

- Unresponsive when shaken .
- . Not breathing normally

#### Indications for Use 8.

The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:

- . Unresponsive when shaken
- Not breathing normally .

If in doubt, apply the pads. A training class in CPR/AED use is II in Goubt, apply the page:

If the person is an infant or child younger than eight years old or weighs if the person is an thant of child Johnsylange. If the child appears less than 55 lbs (20 kg), aco (and/Child Key. Do not delay treatment to oldemarger, do not as act age or weight. If in doubt, do not use the Infant/Child Key.

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#### Comparison of Technology Characteristics 9.

The HeartStart FRx Defibrillator employs the same fundamental scientific technology as the commercially available Philips HeartStart OnSite M5066A Defibrillator.

## Data Used in Determination of Substantial Equivalence 10.

The HeartStart FRx Defibrillator employs the similar technologies to provide similar performance characteristics as the predicate device.

Testing demonstrates that the FRx performs in a manner substantially equivalent to the M5066A predicate and demonstrates that the introduction of the FRx does not raise and new issues of safety or efficacy.

#### 11. Conclusion

The introduction of the HeartStart FRx Defibrillator does not present new issues of safety or effectiveness.

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Image /page/3/Picture/2 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 an abstract symbol resembling an eagle or bird with three horizontal lines forming its wings.

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical System c/o Ms. Tish Treherne Regulatory Affairs Specialist 2301 Fifth Avenue, Suite 200 Seattle, WA 98121-1825

Re: K050004

Trade Name: Philips HeartStart FRx Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: January 27, 2005 Received: January 28, 2005

Dear Ms. Treherne:

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). and Coometer fore, 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 he 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. Tish Treherne

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 that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any 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 CI R Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) I mis lotter will and in your to one finding of substantial equivalence of your device to a legally prematics notification "The 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 its you dome effice 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/industry/support/index.html.

Sincerely yours,

Blimmo for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use 14

510(k) Number (if known):

Philips HeartStart FRx Defibrillator, model 861304 Device Name:

Indications for Use:

The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:

- Unresponsive when shaken .
- Not breathing normally .

If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator.

If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.

Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Kamiyama

Division Sign-Off) Division of Cardiovascular Devices 510/k) Number

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