(87 days)
Not Found
No
The document describes a "proprietary ECG analysis algorithm" but does not mention AI, ML, or any related terms. The description focuses on standard AED functionality and signal processing.
Yes
The device is described as an "Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest" and delivers "therapeutic energy to the patient" through a "low energy, escalating truncated exponential biphasic waveform pulse."
Yes
The device is an automated external defibrillator (AED) that incorporates a "proprietary ECG analysis algorithm [to] automatically renders a shock or no-shock decision," which is a diagnostic function to determine the need for a defibrillation shock.
No
The device description clearly details hardware components such as a battery, electrodes, LCD display, and physical controls, indicating it is a physical medical device with embedded software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The HeartSine Samaritan® AED is a device that analyzes the electrical activity of the heart (ECG) and delivers an electrical shock to treat cardiac arrest. It interacts directly with the patient's body, not with a sample taken from the body.
- Intended Use: The intended use clearly states it's for use on victims of cardiac arrest exhibiting specific signs, and it's used by trained personnel to deliver therapy. This is a therapeutic and diagnostic device used in vivo (within the living body), not in vitro (in glass/outside the body).
The device description and intended use focus on analyzing the patient's ECG rhythm and delivering a therapeutic electrical pulse, which are not functions of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs: - . Unconscious - Not breathing . - Without circulation . The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.
Product codes
MKJ
Device Description
The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.
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 currently indicated for use on children less than 8 years old.
Intended User / Care Setting
personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program.
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 and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® AED complies with the applicable sections of ANSI / AAMI DF2- 1996 (Cardiac Defibrillator Devices) and ANSI / AAMI DF39 - 1993 Automatic External Defibrillators & Remote Controlled Defibrillators. The efficacy of the biphasic waveform in this device has been demonstrated in animal and human clinical trials. The information in this 510(k) submission demonstrates that the HeartSine Samaritan® AED is substantially equivalent to the predicate device with respect to safety. effectiveness and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(k) Summary
Date Summary Prepared:
November 15, 2002
Submitter's Name and Address:
HeartSine Technologies, Inc. 25892 Jamon Lane Mission Viejo, CA 92691
Contact Person:
William J. Smirles, EMT-P Telephone: 1.847.317.0926 Facsimile: 1.517.809.6748
Device Name:
Proprietary Name: HeartSine Samaritan® AED Common Name: Automated External Defibrillator Classification Names: DC-Defibrillator, Low Energy
Predicate Device:
The features and functions of the HeartSine Samaritan® AED are substantially equivalent to those of the Phillips Heartstream FR2 (K003565).
Device Description:
The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.
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The Samaritan® AED incorporates the following features:
- . Backlight LCD display providing text prompts and ECG display
- Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
- Automated self tests with a separate status indicator display .
- . Controls for Power On/Off, Shock, Backlight, Contrast & manual override
- Integral event data recording incorporated in the removable battery .
A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.
Indications for Use:
The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- . Unconscious
- Not breathing .
- Without circulation .
The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.
Summary of Performance Information:
Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® AED complies with the applicable sections of ANSI / AAMI DF2- 1996 (Cardiac Defibrillator Devices) and ANSI / AAMI DF39 - 1993 Automatic External Defibrillators & Remote Controlled Defibrillators. The efficacy of the biphasic waveform in this device has been demonstrated in animal and human clinical trials.
The information in this 510(k) submission demonstrates that the HeartSine Samaritan® AED is substantially equivalent to the predicate device with respect to safety. effectiveness and performance.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Heartsine Technologies, Inc. Mr. William J. Smirles Senior Vice President 25892 Jamon Lane Mission Viego, CA 92691
Re: K023854
Trade/Device Name: Samaritan® AED Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III Product Code: MKJ Dated: November 15, 2002 Received: November 19, 2002
Dear Mr. Smirles:
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.
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
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Page 2 - Mr. William J. Smirles
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), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section
Indications for Use
510(k) Number (if known):
KO23854
Device Name: HeartSine Technologies, Inc. Samaritan® AED
Indications for Use: The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- Unconscious .
- Not breathing .
- Without circulation .
The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Num
Prescription Use:
Over-the-Counter Use: or