LIFEPAK, MODEL 1000

K042404 · Medtronic Emergency Response Systems, Inc. · MKJ · Dec 22, 2005 · Cardiovascular

Device Facts

• Record ID: K042404
• Device Name: LIFEPAK, MODEL 1000
• Applicant: Medtronic Emergency Response Systems, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The LIFEPAK 1000 defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. The manual and ECG modes of the LIFEPAK 1000 defibrillator are intended for use by health care providers trained in ECG rhythm recognition. Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The LIFEPAK 1000 defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Device Story

Semi-automatic defibrillator with optional manual and ECG modes; inputs include ECG signals via defibrillation electrodes or monitoring cables. Device processes signals to identify fatal arrhythmias (ventricular fibrillation/tachycardia); provides automated analysis in AED mode or manual control for skilled clinicians. Outputs include voice prompts, ECG display, and therapeutic electrical shocks. Used in hospital/pre-hospital settings (ambulances, clinics, aircraft) by trained personnel. Healthcare providers use ECG output for rhythm recognition and heart rate monitoring; manual mode allows clinician-directed therapy. Benefits include rapid termination of life-threatening arrhythmias in cardiac arrest.

Clinical Evidence

Bench testing only. Documentation provided regarding conformance to electrical safety, electromagnetic compatibility, and defibrillator standards. No clinical trial data presented.

Technological Characteristics

Semi-automatic defibrillator; manual/ECG modes. Power: non-rechargeable lithium manganese battery. Connectivity: serial infrared link. Sensing: ECG rhythm/heart rate via electrodes or ECG cable. Form factor: portable unit for indoor/outdoor use. Software: automated rhythm analysis.

Indications for Use

Indicated for patients in cardiopulmonary arrest (unresponsive, apneic, pulseless) for defibrillation therapy. AED mode for adults/children >8 years or >25kg; pediatric mode with reduced energy electrodes for children <8 years or <25kg. ECG monitoring indicated for conscious/unconscious patients of all ages for rhythm/heart rate assessment.

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 AED (K983393, K033275)
• Philips HeartStart FR2+ Defibrillator with ECG Assessment Module (K013425, K014157)

Submission Summary (Full Text)

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K042404

DEC 2 2 2005

Medtronic Emergency Response Systems LIFEPAK® 1000 Defibrillator 510(k) Premarket Notification

# SECTION E: 510(k) SUMMARY

Submitter's Name and Address:

Medtronic Emergency Response Systems (formerly known as Medtronic Physio-Control) 11811 Willows Road Northeast Redmond, WA 98052

Mailing address: PO Box 97006 Redmond, WA 98073-9706

Contact Person:

Michelle Ackermann [phone]

Date Summary Prepared:

November 22nd, 2005

Device:

Medtronic LIFEPAK® 1000 Defibrillator

Classification:

Low Energy DC-Defibrillator: Class II Automatic External Defibrillator (AED): Class III

Substantial Equivalence:

The features and functions of the LIFEPAK 1000 defibrillator are substantially equivalent to the:

- Medtronic LIFEPAK 500 AED, 510(k) K983393 (05/05/99) and K033275 . (11/06/03), and
- Philips HeartStart FR2+ Defibrillator with ECG Assessment Module, . 510(k) K013425 (01/14/02) and K014157 (01/17/02).

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### Description:

The LIFEPAK 1000 defibrillator is a semi-automatic defibrillator with manual mode and ECG mode available as options. The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator.

Features and options of the LIFEPAK 1000 defibrillator include: ECG rhythm and heart rate monitoring using defibrillation electrodes or using an ECG cable with monitoring electrodes, data transmission via serial infrared link, power via non-rechargeable lithium manganese battery, and configurable voice prompts.

#### Intended Use:

The LIFEPAK 1000 defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. The manual and ECG modes of the LIFEPAK 1000 defibrillator are intended for use by health care providers trained in ECG rhythm recognition.

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The LIFEPAK 1000 defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

page 2 of 3

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Performance Information

The 510(k) includes documentation related to the conformance of the The STO(K) includes documentalite is a lectrical safety, electromagnetic compatibility, and defibrillator standards.

The information in this 510(k) demonstrates that the LIFEPAK 1000 defibrillator is I he information in this 510(x) demonstrates that the sespect to safety, effectiveness, and performance.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Medtronic Emergency Response Systems c/o Ms. Michelle Ackermann Sr. Regulatory Affairs Specialist 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073

K042404 Re: LIFEPAK® 1000 Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: III Product Code: MKJ Dated: November 22, 2005 Received: November 23, 2005

Dear Ms. Ackermann:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section JTV(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and have decimined the actricale devices marketed in interstate for use stated in the encrosule) to regally manatical provice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prof to May 28, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general magageste You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the frections and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entisting of Parts 800 to 898. In addition, FDA may be found in the Cour of Peaces oncerning your device in the Federal Register.

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Page 2 - Ms. Michelle Ackermann

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substition with other requirements of the Act
that FDA has made a determination that your device of a comples . You must that FDA nas made a decidination administered by other Federal agencies. You must or any Federal statures and regulations administered or registration and listing (21 )
comply with all the Act's requirements, including, worther supportion and listing (21 comply with all the Act s requirements, mo, good namufacturing practice requirements as set CFR Part 807); labeing (21 CFR Part on (21 CFR Patt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path) 2007 1050 forth in the quanty systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Sections of 1 - Section in your Section 5 10(k)
This letter will allow you to begin marketing your device of your device to Jegal I his letter will allow you to ocgin mancemis, your antial equivalence of your device to a legally premarket notification. THE PDA miding of substance of the more and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your don't and on on one one the regulation entitied, comact the Office of Comphalled at (210) = 16 = 16 = 1 = 1 = 1 = 1 = 1 = 1 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = = \$ Small "Misbranding by reference to premance noutlean in the Act from the Division of Small other general information on your responsion.com and its toll-free number [phone] or html Manufacturers, International and Consanter villeww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimimmofor

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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# SECTION D: STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K042404

Device Name: LIFEPAK 1000 Defibrillator

Indications For Use:

## Defibrillation:

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as Denormation is a roos and symptomatic ventricular tachycardia.

The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. I he definitiator is to be used in AED mouse only of the program. And showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who The deformator may oc used what standard than 25 kg (55lbs). The defibrillator may be used on all o years old of more of who weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

## ECG Monitoring:

ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

_____ 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)

Blumuma
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Division of Cardiovascular Devices
510(k) Number K042404