The FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.

Device Description

The FirstSave STAR Biphasic AED is a portable battery operated semi-automatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic AED feature includes:

. Biphasic defibrillation waveform
. Lithium battery and battery fuel gauge
Single user button .
LED diagnostic panel ●
Non-volatile status indicator ●
Voice prompts .
The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.

AI/ML Overview

The provided text describes a 510(k) summary for the SurVivaLink FirstSave™ STAR Biphasic™ AED. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device's diagnostic algorithm.

Here's an breakdown based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Rhythm Detection Accuracy	The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm.
Efficacy of Biphasic Waveform	Found to be equivalent to the monophasic truncated exponential waveform in the FirstSave (a predicate device).
Compliance with AAMI DF39-1993 and AAMI DF2-1996	Demonstrated that the device complies with the applicable sections.
EMC (Electromagnetic Compatibility)	Test results included.
Charge Time	Test results included.
Pulse Shape	Test results included.
Battery Capacity	Test results included.
Defibrillation Recovery	Test results included.
Hardware and Software Testing	Developed under design control and tested in accordance with established industry standards; design verification and validation data are included.
Environmental Tests	Performed on the finished device.
Safety and Effectiveness Equivalence	Demonstrated to be substantially equivalent to HeartStream's Forerunner and SurVivaLink's FirstSave AEDs.

Missing Information:

Specific quantifiable acceptance criteria for rhythm detection (e.g., sensitivity, specificity, accuracy thresholds for shockable vs. non-shockable rhythms).
Quantifiable performance results for rhythm detection from a specific study. The text only states that the algorithm "analyzes" the rhythm and that the biphasic waveform was "found to be equivalent" in a clinical study for efficacy, not diagnostic accuracy of the rhythm analysis itself.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "Clinical studies was performed to test the efficacy of the biphasic waveform." However, it does not provide any details regarding:

The sample size (number of patients) used in this clinical study.
The data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The text does not mention the number of experts used or their qualifications for establishing ground truth, particularly for the rhythm detection algorithm. The clinical study mentioned was for the efficacy of the biphasic waveform, not explicitly for validating the diagnostic algorithm's accuracy with expert-established ground truth.

4. Adjudication Method for the Test Set

The text does not provide any information about the adjudication method used for any test set or clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The text does not report on an MRMC comparative effectiveness study or any effect size indicating how much human readers improve with AI vs. without AI assistance. The device is described as a "semi-automatic" AED, meaning the device makes a recommendation, and the operator presses a button to deliver the shock. The focus here is on the device's diagnostic algorithm itself, not on assisting human readers in interpreting data.

6. Standalone (Algorithm Only) Performance

The device is described as having a "diagnostic algorithm that analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm." This implies a standalone algorithm's performance is central to the device's function. However, the document does not present a standalone performance study with specific metrics (like sensitivity, specificity, or accuracy) for this algorithm against a defined ground truth. Instead, it relies on demonstrating compliance with standards and equivalence to predicate devices. The clinical study mentioned focuses on the efficacy of the biphasic waveform, which is about the treatment's outcome, not necessarily the diagnostic accuracy of the rhythm analysis.

7. Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for validating the rhythm detection algorithm. For the "efficacy of the biphasic waveform" study, the ground truth would likely be patient outcomes in response to defibrillation. For the diagnostic algorithm, ideal ground truth would be expert consensus on ECG rhythms, but this is not mentioned.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for training the device's diagnostic algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how ground truth was established for the training set.

Summary of Device Performance Claim:

The SurVivaLink FirstSave™ STAR Biphasic™ AED is positioned as substantially equivalent to its predicate devices (SurVivaLink's FirstSave and HeartStream Forerunner AEDs). The primary performance claims regarding the device's diagnostic algorithm are that it "analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm" and that the "biphasic waveform...was found to be equivalent to the monophasic truncated exponential waveform in the FirstSave." The submission emphasizes compliance with AAMI standards and various technical tests (EMC, charge time, etc.) rather than specific, quantified performance metrics for the diagnostic algorithm itself.

Summary

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K982264

JAN 25 1999

510(k) Summary

ADMINSTRATIVE INFORMATION L-1.

L-1.1 Name and address

SurVivaLink Corporation Submitted by: 5430 Feltl Road Minneapolis, MN 55343

Contact Person:	Sew-Wah Tay, Ph.D.
Telephone No.:	612-939-2942
Facsimile No.:	612-939-4191

June 24, 1998 Date Prepared:

L-1.2 Device Name

Common or Usual Name: Semi-Automatic External Defibrillator (AED) Device Name: FirstSave™ STAR Biphasic™ AED

L-1.3 Classification

Classification Name: a) DC defibrillator

21CFR&870.5300; Class II

b) Cardiac Monitor (Cardiotachometer and Rate Alarm) 21CFR§870.2300; Class II

Note: FDA has determined that Semi-Automatic External Defibrillators are currently classified as class III devices

L-1.4 Applicant

Applicant's Name: SurVivaLink, Corporation 5430 Feltl Road Minneapoils, MN 55343

L-2. PREDICATE DEVICE

FirstSave™ AED manufactured by SurVivaLink Corporation models 9100/9110 (K970481) and Forerunner AED manufactured by HeartStream models S, E and EM (K955628).

L-3. INDICATION FOR USE

The SurVivaLink's FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.

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DEVICE DESCRIPTION L-4

. Biphasic defibrillation waveform
. Lithium battery and battery fuel gauge
Single user button .
LED diagnostic panel ●
Non-volatile status indicator ●
Voice prompts .

The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.

PERFORMANCE DATA L-5.

The performance test data is provided in the 510(k) submission. The performance data demonstrate that the device complies with the applicable sections of AAMI DF39-1993 and AAMI DF2-1996. The device was developed under design control and the hardware and software tested in accordance with established industry standards.

Tests results include rhythm detection, EMC, charge time, pulse shape, battery capacity, defibrillation recovery, design verification and validation data for hardware and software incorporated into the FirstSave STAR Biphasic AED. Environmental tests were performed on the finished device.

Clinical studies was performed to test the efficacy of the biphasic waveform in the FirstSave STAR Biphasic AED device and was found to be equivalent to the monophasic truncated exponential waveform in the FirstSave.

Test data demonstrate that the safety and effectiveness of the FirstSave STAR Biphasic AED are substantially equivalent to the HeartStream's Forerunner and the SurVivaLink's FirstSave AEDs.

L-6 SUBSTANTIAL EQUIVALENCE

The FirstSave STAR Biphasic AED is a portable, battery powered, semi-automatic, low energy DC external defibrillator. The materials, accessories and user interfaces are identical to the FirstSave AED (K970481).

The Company's FirstSave STAR Biphasic AED covered by this submission is substantially equivalent to other legally marketed semi-automatic low power DC

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defibrillators. Specifically, the FirstSave STAR Biphasic AED is substantially equivalent to the SurVivaLink's FirstSave and the HeartStream Forerunner AED. The FirstSave STAR Biphasic AED has the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared Forerunner and FirstSave devices. Although there are minor differences in the characteristics of the FirstSave STAR Biphasic AED and its predicate devices, those differences do not raise new questions of safety or efficacy.

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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 symbol that resembles a caduceus, featuring a staff with three intertwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Sew-Wah Tay, Ph.D. SurVivaLink Corporation 5420 Feltl Road Minneapolis, MN 55343

K982264 Re: FirstSave STAR Biphasic Regulatory Class: III (three) Product Code: 74 MKJ November 13, 1998 Dated: November 16, 1998 Received:

Dear Dr. Tay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Sew-Wah Tay, Ph.D.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices throuqh the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

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 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 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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers 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,

Arle A. Cich.

Yo Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Number : K982264

Device Name: FirstSave STAR Biphasic AED

Indication For Use

The FirstSave STAR Biphasic AED is intended for use by or on the order of a Physician or persons licensed by State law. It is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The FirstSave STAR Biphasic AED is intended to be used on patients older than eight years'.

Marle Kramer

PRESCRIPTION USE

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

1 American Heart Association (1994): "Advanced Cardiac Life Support" Ed by R.O. Cummins. pp 4-11.

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.