(206 days)
No
The document describes a "proprietary ECG analysis algorithm" but does not mention AI or ML. The validation uses standard databases, not training/test sets typical of ML development.
Yes
The device is an Automated External Defibrillator (AED) that delivers therapeutic electrical energy to victims of cardiac arrest to treat a life-threatening condition. Its intended use is to restore normal heart rhythm, which is a therapeutic action.
Yes
The device explicitly states it uses a "proprietary ECG analysis algorithm [to] automatically determine whether a victim has a shockable or non-shockable rhythm," and records "the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram)," which are features of a diagnostic device.
No
The device description clearly states it is a "small, lightweight portable battery operated Automated External Defibrillator (AED)" and describes hardware components like electrodes, controls, and a battery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The HeartSine samaritan® PAD 350P is an Automated External Defibrillator (AED). Its function is to analyze the electrical activity of the heart (ECG) and deliver an electrical shock to a patient experiencing cardiac arrest. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is for use on victims of cardiac arrest who are unconscious, not breathing, and without circulation. This is a direct intervention on the patient, not an analysis of a sample.
- Device Description: The description focuses on the device's ability to analyze the ECG, deliver a shock, and provide guidance for CPR. It does not mention any analysis of bodily fluids or tissues.
Therefore, based on the provided information, the HeartSine samaritan® PAD 350P is a therapeutic device used for emergency medical intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HeartSine samaritan® PAD 350P is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- . Unconscious
- Not breathing .
- Without circulation .
The samaritan® PAD 350P 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® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The HeartSine samaritan® PAD (Public Access Defibrillator) 350P (also called the SAM 350P) is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The samaritan® PAD 350P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. The samaritan® PAD 350P also incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation guidelines.
A proprietary ECG analysis algorithm automatically determines whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. If a shock is required, the samaritan will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.
An escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines.
After initial analysis and shock delivery (if appropriate), the PAD 350P will advise that CPR (cardiopulmonary resuscitation) may be commenced via a number of voice prompts such as "It is safe to touch the patient" and "Begin CPR" in addition to emitting an audible metronome.
The defibrillator records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.
The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the samaritan® PAD 350P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a pediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft.
The samaritan® PAD 350P incorporates the following features:
- . Controls for Power ON/OFF and Shock
- Automated charging at escalating energies of 150J, 150J, 200J .
- Automated self-tests and LED status indicator .
- Combined, disposable battery and electrodes (Pad-Pak™) .
- Electrode placement guidance voice prompts and LED/icon indicators .
- CPR voice prompts and metronome .
- Pediatric function for victims between the ages of 1 and 8 years at non-. escalating energy of 50 J
- . Integral event data recording
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
patients greater than 8 years old or over 55 lbs (25 kg)
children between 1 and 8 years of age or up to 55 lbs (25 kg)
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)
Extensive biocompatibility, Usability, EMC and Environmental testing was conducted in accordance with ISO 10993, IEC 62366, IEC60601 (Edition 3) and MIL-STD 810F.
Software validation testing was carried out as appropriate for a major level of concern device. Validation also included testing on key device subassemblies and performance testing of the device as a whole in accordance with device specifications. Standardised AHA, MIT and CU databases were used to extensively validate the HeartSine samaritari® PAD 350P algorithm.
GLP Animal data and Post Marketing Surveillance data were submitted in addition to the referencing of clinical data used to support the 510(k) clearance of the predicate device for the Samaritan AED (K023854). No adverse events or complications were reported. This data demonstrate the safety and efficacy of the HeartSine samaritan® PAD 350P SCOPE® waveform and its substantial equivalence to other automated external defibrillators.
The performance testing demonstrates that the PAD 350P is as safe, as effective, and performs as well as the predicate devices (HeartSine samaritan® PAD 300 (K041067) and PAD300P (K052465)).
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.
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.
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
K123881 pg 1 of 6
Image /page/0/Picture/3 description: The image shows the title of a section. The section is titled "510(k) Summary". The section number is 5.
JUL 1 1 2013
Date Summary Prepared:
November 26, 2012
Submitter's Name and Address:
HeartSine Technologies Ltd. 203 Airport Road West Belfast, Northern Ireland, United Kingdom BT3 9ED
Contact Person:
James McGuinness, Quality Manager
Telephone: +44 28 9093 9419 Fax Number: +44 28 9093 9401
Device Name:
Proprietary Name: HeartSine samaritan® PAD 350P (also known as SAM 350P) Common Name: Automated External Defibrillator Classification Name: DC-Defibrillator, Low Energy Product Code: MKJ
5-2 | P a g e
1
K123881 pg 2 of 6
Predicate Device:
The features and functions of the HeartSine samaritan® PAD 350P are substantially equivalent to those of the HeartSine samaritan® PAD 300 (K041067) also known as SAM 300 and PAD300P (K052465) also known as SAM 300P.
Device Description:
The HeartSine samaritan® PAD (Public Access Defibrillator) 350P (also called the SAM 350P) is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The samaritan® PAD 350P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. The samaritan® PAD 350P also incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation guidelines.
A proprietary ECG analysis algorithm automatically determines whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. If a shock is required, the samaritan will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.
An escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines.
After initial analysis and shock delivery (if appropriate), the PAD 350P will advise that CPR (cardiopulmonary resuscitation) may be commenced via a number of voice prompts such as "It is safe to touch the patient" and "Begin CPR" in addition to emitting an audible metronome.
5-3 | P a g e
2
K123881 pg 3 of 6
The defibrillator records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.
The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the samaritan® PAD 350P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a pediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft.
The samaritan® PAD 350P incorporates the following features:
- . Controls for Power ON/OFF and Shock
- Automated charging at escalating energies of 150J, 150J, 200J .
- Automated self-tests and LED status indicator .
- Combined, disposable battery and electrodes (Pad-Pak™) .
- Electrode placement guidance voice prompts and LED/icon indicators .
- CPR voice prompts and metronome .
- Pediatric function for victims between the ages of 1 and 8 years at non-. escalating energy of 50 J
- . Integral event data recording
Indications for Use:
The HeartSine samaritan® PAD 350P is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- . Unconscious
- Not breathing .
- Without circulation .
3
K123881 pg 4 of 6
The samaritan® PAD 350P 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® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).
Substantial Equivalence:
The PAD 350P is substantially equivalent to the HeartSine PAD Models 300 (K041067) and 300P (K052465) in intended use, technological characteristics and performance:
Indications: The indications for use of the PAD 350P are the same as the indications for the PAD 300P. The PAD 350P indications are also very similar to the PAD 300 indications, except that the PAD 300 was not indicated for pediatric use.
Technological Characteristics: The PAD 350P has very similar technological characteristics to the predicate devices. All three devices are prescription use automated external defibrillators designed to treat victims of a cardiac arrest that incorporate a simple user interface of voice and textlicon prompts to guide the user in the use of the device. The key differences between the PAD 350P and the predicate devices are that the PAD 350P has the following additional features:
-
- Addition of CPR coaching prompts
-
- Complies with 2010 AHA guidelines, including a CPR metronome that signals rate of chest compressions during the 2-minute CPR period(s) at 110 compressions-per-minute
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4
K123881 pg 5 of 6
-
- Larger capacity battery which allows longer standby and operating times and the delivery of a greater number of shocks
-
- More intuitive LED status indicator
-
- A refined arrhythmia analysis algorithm
-
- Longer event recording
-
- Logging of additional types of event information
-
- Addition of a new version of the Pad-Pak (electrode/battery pack) meeting US FAA requirements for use in commercial aircraft
-
- Meets current IEC 60601 standards
The above do not raise any concerns of safety and effectiveness for PAD 350P when compared to its predicate devices, HeartSine PAD Models 300 (K041067) and 300P (K052465).
Performance: As summarized in the section below, the 510(k) includes performance testing demonstrating that the PAD 350P and its accessories have successfully completed comprehensive bench, animal and clinical studies as well as biocompatibility evaluation for the patient contacting materials and software validation appropriate for a major level of concern device. This testing demonstrates the safety and effectiveness of the PAD 350P and that its performance is substantially equivalent to the predicate devices and other legally marketed AEDs.
Summary of Performance Information:
Non-Clinical Testing:
Extensive biocompatibility, Usability, EMC and Environmental testing was conducted in accordance with ISO 10993, IEC 62366, IEC60601 (Edition 3) and MIL-STD 810F.
Software validation testing was carried out as appropriate for a major level of concern device. Validation also included testing on key device subassemblies and performance testing of the device as a whole in accordance with device
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
5
specifications. Standardised AHA, MIT and CU databases were used to extensively validate the HeartSine samaritari® PAD 350P algorithm.
Clinical and Usability Testing:
GLP Animal data and Post Marketing Surveillance data were submitted in addition to the referencing of clinical data used to support the 510(k) clearance of the predicate device for the Samaritan AED (K023854). No adverse events or complications were reported. This data demonstrate the safety and efficacy of the HeartSine samaritan® PAD 350P SCOPE® waveform and its substantial equivalence to other automated external defibrillators.
The performance testing demonstrates that the PAD 350P is as safe, as effective, and performs as well as the predicate devices (HeartSine samaritan® PAD 300 (K041067) and PAD300P (K052465)).
Conclusion:
The information in this 510(k) submission demonstrates the HeartSine samaritan® PAD 350P is substantially equivalent to the predicate devices (HeartSine samaritan® PAD 300 (K041067) and PAD300P (K052465)) with respect to intended use, technological characteristics and performance.
510(k) Summary
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
July 11, 2013
Heartsine Technologies Inc. c/o Mr. James McGuinness Quality Manager Canberra House 203 Airport Road West Belfast. BT3 9ED Northern Ireland
Re: K123881
Trade/Device Name: Samaritan PAD 350P AED Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: June 18. 2013 Received: June 19, 2013
Dear Mr. McGuinness:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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
7
Page 2 - Mr. James McGuinness
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Image /page/8/Picture/3 description: The image shows a title card for Section 4, which is titled "Indications for Use". The text is white and bolded, and the background is black. The text is centered on the card.
510(k) Number (if known):
Device Name: HeartSine Technologies, Ltd. samaritan® PAD 350P
The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
- . Unconscious
- . Not breathing
- Without circulation
The samaritan® PAD 350P 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® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.07.11 12:51:12
-04'00'
Prescription Use: ✓ or Over-the-Counter Use: __
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Section 04
Indications for Use Statement
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