(16 days)
Not Found
Not Found
No
The description focuses on the physical and electrical interface function of the adapter, with no mention of AI/ML capabilities or data processing beyond signal transmission.
Yes.
The device facilitates defibrillation, monitoring, and pacing, which are all therapeutic interventions used to treat cardiac conditions.
No
The device is an electrode adapter for defibrillators, facilitating therapeutic interventions like defibrillation and pacing, and also monitoring. While monitoring involves collecting physiological data, the primary function of the adapter itself is not to diagnose conditions but to connect electrodes for treatment delivery.
No
The device description explicitly states the device is made of "rigid thermoplastic and conductive material" and is a "reusable stand-alone accessory," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "Defibrillation, Monitoring and Pacing" using external defibrillators and electrodes. This involves direct interaction with the patient's body for therapeutic and monitoring purposes.
- Device Description: The device description confirms its function as an interface for connecting electrodes to defibrillators for delivering electrical energy and monitoring.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The device described is an accessory for external defibrillation, monitoring, and pacing, which are procedures performed directly on the patient's body, not on in vitro samples.
N/A
Intended Use / Indications for Use
Heartstream Electrode Adapter: For use with Automatic and Manual External Defibrillators and Heartstream Electrodes. For Defibrillation, Monitoring and Pacing.
Product codes (comma separated list FDA assigned to the subject device)
MLN
Device Description
Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual and automatic 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 and conductive material (or equivalent), with varying configurations depending upon the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and automatic defibrillators, and minimize safety risks to the user and patient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 17 1998
984286 510(k) Summary Heartstream Electrode Adapters
General Information
| Trade Name | Heartstream Electrode Adapter |
|---|---|
| FDA Panel and Classification | HLW |
| Cardiovascular, 74 MKJ, Class III | |
| Contact Person | William D. Jordan |
| Regulatory Affairs Specialist | |
| Address | Heartstream, Inc. |
| A wholly-owned subsidiary of | |
| Hewlett Packard Company |
2401 4th Ave.
Suite 500
Seattle, WA 98121 |
Substantially Equivalent Devices
Manufacturer
Product
Heartstream, Inc. A wholly-owned subsidiary of Hewlett Packard Company
Heartstream Electrode Adapter
Description of Device & Intended Use
Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual and automatic 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 and conductive material (or equivalent), with varying configurations depending upon the 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.
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
1
- IEC 601-2-25, Medical electrical equipment, Part 2: Particular requirements for the safety of . electrocardiographs
- ANSI/AAMI 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 and automatic defibrillators, and minimize safety risks to the user and patient.
Summary of Substantial Equivalence
The Heartstream Electrode Adapter is very similar in form, fit and function to the predicate device. All adapter applications are tested using the actual model defibrillators specified on the packaging label. The adapter engineering specifications for the predicate and new device are the same - full compatibility with the specified defibrillator. The technology is the same - thermoplastic (or equivalent) adapter body with gold plated conductors. The applicable voluntary standards and quidances for both the predicate and new device are the same.
As with the predicate, the adapters 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. The adapters are also designed to ensure that all pacing, monitoring and/or defibrillation functions are not adversely affected by their placement.
Heartstream, Inc. concludes that the new adapter does not raise any new safety or effectiveness concerns and that the predicate and new devices are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1998
Mr. William D. Jordan Hewlett-Packard Company Heartstream Operation 2401 Fourth Avenue, Suite 300 Seattle, WA 98121-1436
K984286 Re: Heartstream Electrode Adapter Regulatory Class: III (three) Product Code: MLN November 30, 1998 Dated: Received: December 1, 1998
Dear Mr. Jordan:
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, 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 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 (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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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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Page 2 - Mr. William D. Jordan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial en your 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 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.qov/cdrh/dsma/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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Page 1 of 1 Submitted: November 18, 1998
510(k) Number: Device Names: Heartstream Electrode Adapter Heartstream Electrode Adapter: For use with Automatic and Indications for Use: Manual External Defibrillators and Heartstream Electrodes. 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)
| Mark Kramer | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K984286 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------------- |
(Optional Format 1-2-96)