HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE

K992543 · Hewlett-Packard Co. · MKJ · May 18, 2000 · Cardiovascular

Device Facts

• Record ID: K992543
• Device Name: HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
• Applicant: Hewlett-Packard Co.
• Product Code: MKJ · Cardiovascular
• Decision Date: May 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Heartstream XLT Defibrillator/Monitor is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.

Device Story

Heartstream XLT Defibrillator/Monitor provides defibrillation, ECG monitoring, non-invasive pacing, and SpO2 monitoring. Operates in AED or manual modes. Inputs include ECG signals and SpO2 data. Uses Heartstream SMART biphasic waveform for defibrillation. Features shock advisory criteria to guide user via voice prompts. Used by trained emergency personnel in clinical or emergency settings. Data stored on Data Cards for management via CodeRunner system. Output informs clinical decision-making for cardiac arrest and arrhythmia management. Benefits include rapid, physician-authorized emergency cardiac intervention.

Clinical Evidence

Bench and animal testing performed. Animal testing evaluated safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J. Bench testing included hardware, algorithm, and software verification. Clinical trials in adults supported the effectiveness of the SMART biphasic waveform for defibrillation of ventricular tachyarrhythmias at 150J.

Technological Characteristics

Defibrillator/monitor with ECG, pacing, and SpO2 capabilities. Uses Heartstream SMART biphasic waveform. Battery chemistry identical to HP CodeMaster XL. Includes Data Card storage. Software-based algorithm for shock advisory and ECG analysis.

Indications for Use

Indicated for termination of ventricular tachycardia and ventricular fibrillation. AED mode for unresponsive, pulseless, non-breathing patients (not for children <8 years). Pacing for symptomatic bradycardia and asystole. SpO2 monitoring for oxygen saturation assessment. Prescription use 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

• HP CodeMaster 100 Defibrillator/Monitor
• HP Heartstream ForeRunner AED
• HP CodeMaster XL
• HP Viridia Telemetry System

Submission Summary (Full Text)

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MAY 1 8 2000

K992543

# 510(k) Summary for Heartstream XLT Defibrillator/Monitor

# Date Summary Prepared

May 17, 2000

# Submitter's Name and Address

Agilent Technologies, Inc. Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099

### Contact Person

Teresa Skarr Agilent Technologies, Inc. Heartstream Operation Telephone: [phone] Facsimile: [phone]

### Device Name

| Proprietary Name: | Heartstream XLT Defibrillator/Monitor |
|-----------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name: | Defibrillator/Monitor |
| Classification Names: | Low-Energy Defibrillator, Electrocardiograph, External<br>Transcutaneous Pacemaker (noninvasive), and Oximeter |

### Predicate Devices

The legally marketed devices to which Hewlett-Packard claims equivalence for the Heartstream XLT Defibrillator/Monitor are as follows:

- The HP CodeMaster 100 Defibrillator/Monitor, .
- The HP Heartstream ForeRunner AED for the defibrillation waveform and voice . prompts.
- The HP CodeMaster XL for the battery, and .
- The HP Viridia Telemetry System for \$pO2 functionality. ●

The design of the Heartstream XLT Defibrillator/Monitor is substantially equivalent in safety and performance to the devices listed above.

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### Device Description

The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available.

The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED.

ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.

# Intended Use

The Heartstream XLT Defibrillator/Monitor is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response.

# Comparison of Technology Characteristics

The Heartstream XLT Defibrillator/Monitor employs the same technologies as the predicate devices used for comparison. The XLT acquires and analyzes ECG signals like the predicates, utilizes the same shock advisory criteria utilized in the CodeMaster 100, and advises the user to deliver a shock when required utilizing voice prompts as in the Heartstream ForeRunner AED. The Heartstream SMART Biphasic waveform is utilized for defibrillation shocks, as in the Heartstream ForeRunner AED. Heart rate alarms, noninvasive pacing and pulse oximetry functions are provided, as in the HP CodeMaster. The XLT's SpOz technology is identical to the HP Viridia Telemetry System. The battery type and chemistry are the same as the HP CodeMaster XL batterv.

# Nonclinical Tests Used in Determination of Substantial Equivalence

The objective of the testing performed on the Heartstream XLT Defibrillator/Monitor was to determine whether any of the device's new or revised functions raise any questions regarding the safety or effectiveness of the device. The philosophy of this approach is that if the Heartstream XLT passes equivalent tests done with the previous devices, then it can be concluded that there are no questions with respect to safety or effectiveness of the new Heartstream XLT.

For each function on the Heartstream XLT that is leveraged from previous HP products, such as the CodeMaster 100 or the Heartstream ForeRunner, the testing done for the previous product was repeated in order to demonstrate equivalence, although in some cases, more stringent procedures and/or acceptance criteria were required for the XLT. In other cases, the features of the predicate devices are identical to those on the Heartstream XLT and did not require repetition.

The nonclinical tests used in determination of substantial equivalence include both bench and animal testing. Bench testing includes hardware, algorithm and software

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testing. Animal testing was also performed in order to evaluate the safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J.

# Conclusion from Testing

Based on the results of the testing described above, it is concluded that the Heartstream XLT does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three wing-like shapes.

MAY 1 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Teresa Skarr Regulatory and Medical Affairs Manager Agilent Technologies Heartstream Operation 2401 Fourth Ave., Suite 500 98121-1436 Seattle, WA

K992543 Re: K992343
Heartstream XLT Defibrillator/Monitor Model M3500B Regulatory Class: III Product Code: 74 MKJ, DRO, LDD, MWI April 5, 2000 Dated: Received: April 6, 2000

Dear Ms. Skarr:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosing the have determined the device is the device ferenced above and no indications for use stated in the substantially equivalence (see ) (see a seement devices marketed in enclosure) to regarly marketed productions been reclassified interstate commerce prior to hap cost that have been reclassified Medical Device Amendales, of the Federal Food, Drug, and in accordance with the provisions of the market the device, subject to Cosmeric Act (Act). Tour may) canf the Act. The general controls the general Controls provisions of the enter for annual registration, provisions of the not of manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is crassifica (boo aboroval), it may be subject to such Controls) of Class III (Fremains of regulations affecting your device additionar concrerer. Encof Federal Regulations, Title 21, Parts 800 und in the code of realermination assumes compliance to 895. co over in Jubbeancearly officturing Practice requirements, as set with the Current Cood namem Regulation (QS) for Medical Devices: forch in the gaarry by CFR Part 820) and that, through periodic QS General Tegulation (2) orit rare due), and Drug Administration (FDA) will verify such inspections, Ene rood and Brig with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. regulatory accron. In the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premained inder sections 531 through 542 of the Act obligation you might have andoi Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Teresa Skarr

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device equilts 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. (100) advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). firebranding by formation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Brim E. Atwerm

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): K992543

Device Name: Heartstream XLT Defibrillator/Monitor

Indications For Use: The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation.

This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.

The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.

In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.

#### AED Therapy:

To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.

The AED mode is not intended for use on children less than 8 years of age. For children older than 8 years, the American Heart Association recommends that standard operating procedures for AEDs be followed. American Heart Association. Textbook of Advanced Cardiac Life Support. Dallas, Tex: AHA; 1997.

#### Pacing:

Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

#### SpO2 Monitoring:

SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Brim E. Haro
5/18/02

**Prescription Use** √
(Per 21 CFR 801.109)

Over-The-Counter Use _