(90 days)
There are no predicate devices listed in the input. The section "Predicate Device(s)" explicitly states "Not Found".
Not Found
No
The summary describes electrode adapters and pads for defibrillation, monitoring, and pacing, focusing on electrical and mechanical compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for defibrillation, monitoring, and pacing, which are therapeutic interventions.
No
The device is used for defibrillation, monitoring, and pacing, which are therapeutic and monitoring functions, not primarily diagnostic ones. While "monitoring" can involve observing physiological signs, the primary purpose of this device is delivering therapy (defibrillation and pacing).
No
The device description explicitly states it is made of rigid thermoplastic material and serves as a physical interface (adapter) to connect electrodes to defibrillators. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Defibrillation, Monitoring and Pacing" in conjunction with defibrillators. These are all procedures performed directly on the patient's body (in vivo).
- Device Description: The description focuses on the physical connection and electrical properties for delivering energy and monitoring signals from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The device is an accessory for a medical device (defibrillator) used for therapeutic and monitoring purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
74 MKJ
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 with |
| Preattached Electrode Adapter | |
| Heartstream Electrode Adapter | |
| FDA Panel and Classification | Cardiovascular, 74 DRO, Class III |
| MKJ | |
| Contact Person | Cindy Pestka |
| Regulatory Affairs Manager | |
| Address | Heartstream, Inc. |
| 2401 4th Ave. | |
| Suite 300 | |
| Seattle, 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
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.
1
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.
2
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.
3
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
4
. 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
OR
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)