The Heartstream XL Defibrillator/Monitor is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless. Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials. Synchronized defibrillation is indicated for termination of atrial fibrillation. The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications. 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.

Device Description

The Heartstream XL Defibrillator/Monitor is a full-featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS) procedures. Manual operation allows users to select biphasic waveform energy levels for external defibrillation, intra-thoracic defibrillation, delivery of synchronized shocks, and noninvasive external pacing.

AI/ML Overview

The provided text describes the Heartstream XL Defibrillator/Monitor and its comparison to predicate devices, but it does not include details about acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of clinical study parameters as requested.

The document states:

Nonclinical Tests Used in Determination of Substantial Equivalence:
- Waveform analysis, comparing the performance of the Heartstream XL BTE waveform to the LifePak 12 BTE waveform at various energy and impedance levels typical of intra-thoracic applications.
- Animal test data, comparing the performance of the Heartstream XL BTE to the LifePak 12 BTE in domestic swine.
Conclusion from Testing: Based on the results of the testing (waveform analysis and animal data), it is concluded that the Heartstream XL BTE waveform for intra-thoracic defibrillation applications does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.
Clinical Testing for SMART Biphasic waveform (mentioned briefly in "Indications for Use"): "The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J." and "The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation."

However, none of these descriptions provide the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence through non-clinical and animal testing for the new BTE waveform, and references prior clinical testing for the SMART Biphasic waveform without providing its details.

Therefore, based only on the provided text, I cannot complete most of the requested fields.

Here's a summary of what can be extracted and what is missing:

Information Requested	Details from the Provided Text
1. Table of acceptance criteria and reported device performance	No explicit acceptance criteria or a dedicated table are provided. The text states that "waveform analysis" and "animal test data" were used to compare the Heartstream XL's BTE waveform to the LifePak 12's BTE waveform, concluding "substantial equivalence" and that it "does not raise any different questions regarding the safety or effectiveness."
2. Sample size and provenance for test set	Not provided for the clinical trials. For non-clinical tests: waveform analysis (no sample size applicable), "domestic swine" for animal test data (specific number not given). Provenance is "nonclinical" and "animal test data".
3. Number/qualifications of experts for ground truth	Not provided.
4. Adjudication method	Not provided.
5. MRMC comparative effectiveness study? Effect size?	No MRMC study is described. The device is a defibrillator, so the concept of human readers improving with AI assistance is not directly applicable in this context.
6. Standalone (algorithm only) performance?	Not explicitly described as a standalone study for the clinical trials. The "waveform analysis" and "animal test data" are standalone comparative tests of the device's waveform.
7. Type of ground truth used	For the clinical trials: Effectiveness for defibrillation of ventricular tachyarrhythmias and cardioversion of atrial fibrillation. The exact method of establishing ground truth (e.g., patient outcomes, expert consensus on rhythm) is not specified.
8. Sample size for training set	Not applicable/Not provided. The text describes clinical testing but does not mention specific training sets in the context of AI/machine learning.
9. How training set ground truth was established	Not applicable/Not provided.

Summary

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510(k) Summary for Heartstream XL. Defibrillator/Monitor

K021 453

Date Summary Prepared

May 3, 2002

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Submitter's Name and Address

Philips Medical Systems Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099

Contact Person

Richard J. Petersen Philips Medical Systems Cardiac Resuscitation Solutions Division Telephone: (978) 659-2213 Facsimile: (978) 659-7360

Device Name

Proprietary Name:	Heartstream XL Defibrillator/Monitor
Common Name:	Defibrillator/Monitor
Classification Names:	Low-Energy Defibrillator

Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for the Heartstream XL Defibrillator/Monitor are as follows:

LIFEPAK 12 Defibrillator/Monitor, Medtronic Physio-Control Corp. .
Heartstream XL Defibrillator/Monitor, Philips Medical Systems .

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

Device Description

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Intended Use

, l

The Heartstream XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Comparison of Technology Characteristics

The Heartstream XL's Biphasic Truncated Exponential waveform utilized for intrathoracic defibrillation shocks, is similar to the BTE waveform used in the LIFEPAK 12.

Nonclinical Tests Used in Determination of Substantial Equivalence

The testing performed to show substantial equivalence to the Lifepak 12 included:

Waveform analysis, comparing the performance of the Heartstream XL BTE . waveform to the LifePak 12 BTE waveform at various energy and impedance levels typical of intra-thoracic applications.
. Animal test data, comparing the performance of the Heartstream XL BTE to the Likepak 12 BTE in domestic swine.

Conclusion from Testing

Based on the results of the testing described above, it is concluded that the Heartstream XL BTE waveform for intra-thoracic defibrillation applications does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 an abstract symbol resembling three human profiles facing right, arranged in a stacked, flowing manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2002 . JUL

Philips Medical Systems c/o Mr. Richard J. Peterson 3000 Minuteman Road Andover, MA 01810

Re: K021453

Heartstream XL M4735A Defibrillator/Monitor Regulation Number: 870.1025, 870.5300 Regulation Name: Automated External Defibrillator, DC-Defibrillator Low Energy (Including Paddles) Regulatory Class: III (three)

Product Code: MKJ, LDD Dated: May 3, 2002 Received: May 6, 2002

Dear Mr. Petersen:

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.

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 - Mr. Richard J. Peterson

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 (OS) 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duta Tell

Donna-Bea Tillman, Ph.D. Acting 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): To be assigned

Device Name: Philips Medical Systems, Heartstream XL Defibrillator/Monitor

Indications For Use: The Heartstream XL Defibrillator/Monitor is for use for the termination of ventricular tachycardia and ventricular fibrillation.

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

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

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.

Synchronized defibrillation is indicated for termination of atrial fibrillation. The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation.

There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.

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 Off)	Division of Cardiovascular and Respiratory Devices
510(k) Number	K021453
Prescription Use	✓
	or Over-The-Counter Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.