(32 days)
Not Found
No
The document describes a "proprietary analysis algorithm" for shock decisions, but there is no mention of AI, ML, or related technologies like neural networks or deep learning. The algorithm is stated to be identical to a previously cleared device, suggesting a more traditional, rule-based approach rather than a learning-based one.
Yes
The device is an automated external defibrillator (AED) designed to deliver an electrical shock to treat victims of cardiac arrest, which is a therapeutic intervention.
Yes
Explanation: The device uses a proprietary analysis algorithm to automatically render a shock or no-shock decision based on the patient's heart rhythm obtained through defibrillation/monitoring electrodes. It records continuous ECG data, which are then used to inform the therapeutic decision. This process of analyzing physiological data to make a medical decision aligns with the definition of a diagnostic device.
No
The device description clearly outlines hardware components such as a portable, battery-operated automated external defibrillator (AED), LED graphic display, battery, electrodes, and a USB communication port. While it includes software for analysis and data recording, it is an integral part of a physical medical device.
Based on the provided text, the HeartSine Samaritan® PAD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Samaritan® PAD Function: The Samaritan® PAD is an Automated External Defibrillator (AED). Its function is to analyze the electrical activity of the heart in vivo (within the body) and deliver an electrical shock if necessary to treat a cardiac arrest. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for use on victims of cardiac arrest exhibiting specific signs (unconscious, not breathing, without circulation). This is a direct intervention on the patient, not an analysis of a specimen.
- Device Description: The description details how it analyzes the patient's heart rhythm using electrodes placed on the skin and delivers a therapeutic electrical pulse. This is an in vivo process.
Therefore, the HeartSine Samaritan® PAD falls under the category of a therapeutic medical device, specifically a defibrillator, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- Unconscious .
- Not breathing
- Without circulation .
The Samaritan® PAD 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 Samantan® PAD is not currently indicated for use on children less than 8 years old.
Product codes
MKJ
Device Description
The HeartSine Samaritan® PAD is a small, lightweight portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® PAD incorporates a simple user interface of voice prompts and visual graphic prompts to guide the user. A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model Samaritan® AED. If a shock is required, the Samaritan® PAD will automatically charge to the appropriate energy level and prompt 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® PAD will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® PAD uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's heart rhythm and, if required, deliver the defibrillation pulse to the patient.
The Samaritan® PAD incorporates the following features:
- An LED graphic display providing visual graphic prompting to the . user
- Automated self tests with an LED flashing status indicator .
- Integral event data recording
The Samaritan® PAD uses a disposable, non-rechargeable lithium manganese dioxide battery to operate the Samaritan® PAD for a minimum of 3 hours of continuous operation or provide a minimum of 30 - 200 Joule shocks. The disposable battery is housed in a plastic tray with the disposable defibrillation pads. By housing the battery in the same rigid plastic tray as the electrodes, this will greatly assist the end user in keeping the device in a state of readiness. This will also help eliminate the chance that the end user would respond to an incident with a good battery but expired electrodes, as could happen with many other AEDs currently.
Event details are recorded internally in the Samaritan® PAD for later retrieval on a computer. 1.5 hours of continuous ECG as well as incident events time stamped are recorded. Event and incident data can be viewed, printed, annotated and forwarded using the HeartSine SAVER software program. The Samaritan® PAD incorporates a USB communication port that allows for downloading event details to the SAVER software program. This USB port also allows for changing language settings for the Samaritan® PAD voice prompts and allows for customizing the factory settings.
Samaritan® PAD also incorporates a training module which converts the Samaritan® PAD into a training device. The training module will automatically disable the Samaritan® PAD energy delivery capability. This training module will allow the user to select training scripts, which simulate different rescue and demonstration scenarios.
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
The Samaritan® PAD is 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® PAD complies with the applicable FDA guidelines and industry standards. The Samaritan® PAD was developed under extensive design controls. The hardware and software were tested in accordance with established industry standards and found to perform as intended. The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials.
The results of the testing have shown the Samaritan® PAD does not raise any new questions of safety or effectiveness.
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.
0
MAY 2 5 2004
510(k) Summary
Date Summary Prepared:
April 21, 2004
Submitter's Name and Address:
HeartSine Technologies, Inc. 940 Calle Amanecer, Suite E San Clemente, CA 92673
Contact Person:
William J. Smirles, EMT-P Telephone: 1.847.317.0926 Facsimile: 1.517.809.6748
Device Name:
Proprietary Name: HeartSine Samaritan® PAD Common Name: Automated External Defibrillator Classification Names: DC-Defibrillator, Low Energy
Device Description:
The HeartSine Samaritan® PAD is a small, lightweight portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® PAD incorporates a simple user interface of voice prompts and visual graphic prompts to guide the user. A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model Samaritan® AED. If a shock is required, the Samaritan® PAD will automatically charge to the appropriate energy level and prompt 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® PAD will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® PAD uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's heart rhythm and, if required, deliver the defibrillation pulse to the patient.
1
The Samaritan® PAD incorporates the following features:
- An LED graphic display providing visual graphic prompting to the . user
- Automated self tests with an LED flashing status indicator .
- Integral event data recording �
The Samaritan® PAD uses a disposable, non-rechargeable lithium manganese dioxide battery to operate the Samaritan® PAD for a minimum of 3 hours of continuous operation or provide a minimum of 30 - 200 Joule shocks. The disposable battery is housed in a plastic tray with the disposable defibrillation pads. By housing the battery in the same rigid plastic tray as the electrodes, this will greatly assist the end user in keeping the device in a state of readiness. This will also help eliminate the chance that the end user would respond to an incident with a good battery but expired electrodes, as could happen with many other AEDs currently.
Event details are recorded internally in the Samaritan® PAD for later retrieval on a computer. 1.5 hours of continuous ECG as well as incident events time stamped are recorded. Event and incident data can be viewed, printed, annotated and forwarded using the HeartSine SAVER software program. The Samaritan® PAD incorporates a USB communication port that allows for downloading event details to the SAVER software program. This USB port also allows for changing language settings for the Samaritan® PAD voice prompts and allows for customizing the factory settings.
Samaritan® PAD also incorporates a training module which converts the Samaritan® PAD into a training device. The training module will automatically disable the Samaritan® PAD energy delivery capability. This training module will allow the user to select training scripts, which simulate different rescue and demonstration scenarios.
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.
2
Predicate Device:
HeartSine Technologies, Inc. Phillips Medical
Samaritan® AED Onsite M5066A
Substantial Equivalence:
The HeartSine Samaritan® PAD is substantially equivalent to those of the previously cleared HeartSine Samaritan® AED (K023854) and the Phillips Onsite M5066A (K020715). The Samaritan® PAD does not raise any new issues of safety and effectiveness.
Summary of Performance Testing:
Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® PAD complies with the applicable FDA guidelines and industry standards. The Samaritan® PAD was developed under extensive design controls. The hardware and software were tested in accordance with established industry standards and found to perform as intended. The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials.
The results of the testing have shown the Samaritan® PAD does not raise any new questions of safety or effectiveness.
Conclusion:
The information in this 510(k) submission demonstrates that the HeartSine Samaritan® PAD is substantially equivalent to the predicate device with respect to safety, effectiveness and performance and does not present any new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. William J. Smirles NI. William J. Similes
Senior Vice President, Marketing & Business Development HeartSine Technologies, Inc. 940 Calle Amanecer, Suite E San Clemente, CA 92673
K041067 Re:
Samaritan® PAD Regulation Number: 21 CFR 870.1025 Regulation Name: 27 Crice of Crice of Alarm Defibrillator, AED Regulatory Class: Class III Product Code: MKJ Dated: April 21, 2004 Received: April 30, 2004
Dear Mr. Smirles:
We have reviewed your Section 510(k) premarket notification of intent to market the ievices We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications referenced above and have determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regary mances prought the Medical Device Amendments, or to commerce provide way 20, 1970, the encordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment ACT (ACC) that do not require appen of the general controls provisions of the Act. The You may, therefore, mance the device, seeject of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (see above) als. Existing major regulations affecting your device can may be subject to sueri additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Cours of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advisod that I Dr 3 tassance or our device complies with other requirements of the Act that I DA has mude a determissions administered by other Federal agencies. You must of any I cuttlar statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 -- Mr. William J. Smirles
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seting your device as described in your Section 510(k) This ictir will anow you w to begin maing of substantial equivalence of your device to a legally prematication. The PDF Printation 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 If you desire specific advice 101 your as (301) 594-4646. 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 from the Division of Small other general mionmational 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,
Neif Rr Ogden
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section
Indications for Use
510(k) Number (if known): KU41067
Device Name: HeartSine Technologies, Inc. Samaritan® PAD
Indications for Use: The HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- Unconscious .
- Not breathing �
- Without circulation .
The Samaritan® PAD 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 Samantan® PAD 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)
Neil R.P. Oslen for SDZ
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K041067
Prescription Use:
Over-the-Counter Use: or
HeartSine Technologies, Inc
Section 3, Page 2 of 3