Heartstream Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.

Device Description

Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual defibrillators for external cardiovascular pacing as well as monitoring and delivery of defibrillation shocks up to 360J.

Heartstream electrode adapters are made of rigid thermoplastic material (or equivalent), with varying configurations depending upon the manual defibrillator for which they are designed. The adapters will be provided as reusable stand-alone accessories (to be used in conjunction with standard Heartstream electrodes) or preattached to a Heartstream electrode set, for single use.

AI/ML Overview

The provided text describes Heartstream Electrode Adapters and their substantial equivalence to predicate devices, focusing on their intended use and technological characteristics. However, it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving device performance.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, its provenance, or details about the experts involved in establishing ground truth.
Adjudication methods.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
Details about the training set's size or how its ground truth was established.

What is provided is a summary of the device's characteristics and a claim of compliance with relevant medical device standards, which demonstrated certain functionalities. This suggests that some level of testing was performed, but the details of that testing, in the format you requested, are absent.

Here's a breakdown of what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied from standards/description)	Reported Device Performance (Implied from text)
Compliance with IEC 601-1, 601-2-4, 601-2-25, ANSI/AAMI DF39-1993	"demonstrated that the Heartstream electrodes effectively deliver defibrillation energy up to 360J, allow for external transcutaneous cardiac pacing, demonstrate mechanical and electrical compatibility with manual defibrillators, and minimize safety risks to the user and patient."
Interface with manual defibrillators	Allows connection of Heartstream electrodes to "various manual defibrillators"
Facilitate external cardiovascular pacing	Device allows for "external transcutaneous cardiac pacing"
Facilitate monitoring	Device allows for "monitoring"
Facilitate delivery of defibrillation shocks up to 360J	Device allows for "delivery of defibrillation shocks up to 360J"
Minimize safety risks to user and patient	Device designed to "minimize safety risks to the user and patient"
Firm seating of connectors	Connectors "firmly seated when in use"
No exposure to accidental electrical contact	Connectors "do not expose a user to a risk of accidental electrical contact"
No adverse effects on pacing/monitoring/defibrillation	"designed to ensure that all pacing, monitoring and/or defibrillation functions are not adversely affected by their placement"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The text mentions "Testing per these standards demonstrated..." but does not specify sample size, data provenance, or whether the tests were on actual patient data or conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. Ground truth experts or specific adjudication processes are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not provided. This device is an electrode adapter, a hardware interface, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This device is a hardware component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in terms of ground truth. The "testing" mentioned refers to compliance with safety and performance standards (e.g., IEC, ANSI/AAMI). "Ground truth" in this context would likely be defined by the physical/electrical parameters specified in those standards and confirmed through engineering tests, rather than clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

Not applicable / Not provided. This is a hardware device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable / Not provided. This is a hardware device and does not involve a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the word "HEARTSTREAM" in all caps, with a stylized heart shape to the left of the word. The heart shape is formed by two curved lines that come together at the bottom. The text is in a bold, sans-serif font. The image is in black and white.

Image /page/0/Picture/1 description: The image shows the text "K972418 SEP 25". The text appears to be handwritten in a dark ink. The date "SEP 25" is located below and to the left of the number "K972418".

510(k) Summary Heartstream Electrode Adapters

General Information
Trade Name	Heartstream Defibrillation Pads withPreattached Electrode Adapter
	Heartstream Electrode Adapter
FDA Panel and Classification	Cardiovascular, 74 DRO, Class IIIMKJ
Contact Person	Cindy PestkaRegulatory Affairs Manager
Address	Heartstream, Inc.2401 4th Ave.Suite 300Seattle, WA 98121

Substantially Equivalent Devices

Manufacturer	Product
Heartstream, Inc.	Heartstream External Defibrillation Pads
Katecho, Inc.	K-Defib/Pace Multifunction Electrodes
Darox	R2 series of adapters and cables

Description of Device & Intended Use

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Technological Characteristics

All Heartstream electrode adapters are designed to comply with applicable portions of relevant standards. including:

IEC 601-1, Medical electrical equipment, Part 1: General requirements for safety, 1993 .
IEC 601-2-4, Medical electrical equipment, Part 2: Particular Requirements for the Safety of Cardiac . Defibrillators and Cardiac Defibrillator/Monitors, 1993
IEC 601-2-25, Medical electrical equipment, Part 2: Particular requirements for the safety of . electrocardiographs
ANSVAAMI DF39-1993. Automatic external defibrillators and remote-control defibrillators. . September 16, 1993

Testing per these standards demonstrated that the Heartstream electrodes effectively deliver defibrillation energy up to 360J, allow for external transcutaneous cardiac pacing, demonstrate mechanical and electrical compatibility with manual defibrillators, and minimize safety risks to the user and patient.

Summary of Substantial Equivalence

Heartstream electrode adapters were evaluated in terms of indications for use, technological characteristics and materials, and compared to equivalent devices currently on the market.

The Heartstream electrode adapter is very similar in form, fit and function to other comparable devices. Marketed adapters and adapter cables typically gonsist of two connectors (or a double-sided connector) joined by an insulated conductor or cable of varying length. One connector (or one side of the connector) fits into the connector socket of the defibrillator, while the other attaches to the proximal end of the electrode set. The connectors are typically made of a rigid thermoplastic material. Adapters and adapter cables are designed so that both connectors are firmly seated when in use, and so they, do not expose a user to a risk of accidental electrical contact. They are also designed to ensure that all pacing, monitoring and/or defibrillation functions are not adversely affected by their placement. These characteristics apply to both the stand-alone Heartstream electrode adapter and the Heartstream electrodes with a preattached adapter.

Heartstream electrodes with a preattached electrode adapter are substantially equivalent to the standard Heartstream electrodes regarding device design and usage for defibrillation, and Katecho K-Defib/Pace multifunction electrodes regarding device design and usage for defibrillation, monitoring and pacing.

Heartstream stand-alone electrode adapters are substantially equivalent to the Darox R2 series of adapter cables regarding device design and use as an interface between electrodes and defibrillators for defibrillation, monitoring and pacing, for use with numerous defibrillators.

Therefore, due to the similarity of design features, and the similarity of the indicated use to other predicate devices, Heartstream, Inc. believes this product does not raise any new safety or effectiveness issues.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head facing left and its wings represented by abstract lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 1997

Ms. Lori Glastetter Heartstream, Inc. 2401 4" Avenue, Suite 300 Seattle, Washington 98121

Re: K972418 Heartstream Electrode Adapters Regulatory Class: III (three) Product Code: 74 MKJ Dated: June 26, 1997 Received: June 27, 1997

Dear Ms. Pestka:

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 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). 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 reqistration, 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 (Premarket Approval), 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 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 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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Paqe 2 - Ms. Lori Glastetter

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 note the requlation 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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. telephone 206.443.7630 facsimile 206.443.9694

Image /page/4/Picture/1 description: The image shows the logo for Heartstream. The logo consists of a stylized heart shape on the left, with two curved lines forming the upper part of the heart. To the right of the heart shape is the word "HEARTSTREAM" in all capital letters.

2401 Fourth Avenue, Suite 300 · Seattle, Washington 98121.1436 USA

Page 1 of 1 Submitted: July 22, 1997

K972418 510(k) Number:
Heartstream Electrode Adapter, and Device Names:

Preattached Heartstream External Defibrillation Pads with Electrode Adapter

Heartstream Electrode Adapter: For use with Heartstream Indications for Use: Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atl. A. Cidl.

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

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.