(149 days)
No
The document mentions "rhythm analysis software" and an "internal algorithm" for identifying rhythms and determining energy levels, but it does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training/test sets, specific performance metrics like AUC for complex models). The description aligns with traditional algorithmic approaches for analyzing ECG signals.
Yes
The device is intended for the treatment of cardiac arrest and delivers high-energy electrical shocks, which is a therapeutic intervention.
Yes
The device features "rhythm analysis software" and an "ECG display option" which are used to analyze the patient's cardiac rhythm to determine if defibrillation is required, indicating a diagnostic function.
No
The device description explicitly lists multiple hardware components such as LED indicators, buttons, LCD display, defibrillation pads, and a battery system, indicating it is a physical device with integrated 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 medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AccessAED and AccessALS are external defibrillators. Their function is to deliver an electrical shock to the heart to treat cardiac arrest caused by ventricular tachyarrhythmias. This is a direct intervention on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states treatment of cardiac arrest by applying the device to the victim.
- Device Description: The description focuses on the hardware and software for delivering electrical therapy, rhythm analysis, and user interface for operation. There is no mention of analyzing biological samples.
Therefore, the AccessAED and AccessALS fall under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse.
The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semiautomatic mode, AccessALS functions identically to the AccessAED.
The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.
Product codes
MKJ, LDD
Device Description
The AccessAED™ Automatic External Defibrillator has been designed specifically for the treatment of ventricular tachyarrhythmias in cardiac arrest. The AccessAED delivers a high-energy 200 or 360J biphasic waveform to patients in cardiac arrest resulting from ventricular fibrillation or high rate ventricular tachycardia.
The AccessAEDTM features include:
- LED ready indicator .
- power button .
- shock delivery button .
- LCD display with text messaging and ECG display option .
- defibrillation pads housed in a tray for rapid application to patient .
- . disposable Lithium battery system
- rhythm analysis software .
- energy selection button (manual mode only) ●
- synchronization button (manual mode only) .
- . analysis button (manual mode only)
- charge button (manual mode only) .
When the AccessAED™ algorithm software identifies a rhythm that requires defibrillation, the device charges to the required energy level algorithm (200 J or 360 J) as dictated by the internal algorithm. When the device indicates a full charge and instructs the operator to push the shock button, the operator delivers the shock by pressing the shock delivery button.
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 children less than 8 years old (less than approximately 25 kgs. or 55 lbs.)
Intended User / Care Setting
The Access AED is intended for use by emergency responders specifically trained in the operation of the Access AED. Users should have, at the minimum, BCLS/AED training equivalent to that recommended by the American Heart Association or American Red Cross or training in other physician-authorized emergency medical response.
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)
Performance test data is submitted with the 510 (k) documents. These data demonstrate that the device complies with the applicable sections of AAMI DF2-1989 (Cardiac Defibrillator Devices) and AAMI DF39-1993 (Automatic External Defibrillators). The device was developed under design control, and the hardware was tested in accordance with established industry standards.
The efficacy of the biphasic truncated exponential waveform in this device was demonstrated in a study of swine. The results of this study demonstrate the substantial equivalence of the AccessAED biphasic truncated exponential waveform. Though there are minor differences in the characteristics of the AccessAED biphasic waveform and its predicate device waveforms, these differences do not raise new questions of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Heartstream FR2 AED (K003565), Physio-Control Biphasic LifePak 500 (K983393), Zoll M Series Biphasic Defibrillator (K990762)
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
Access CardioSystems 510(k) K020984
AUG 1 4 2002
AccessAED Automatic External Defibrillator
510(k) Summary
| Submitter's Name and Address: | Access CardioSystems
150 Baker Avenue Extension
Concord, MA 01842 |
|-------------------------------|-------------------------------------------------------------------------|
| Contact Person: | David Barash, M.D.
978-371-4985 |
| Device Name: | AccessAED™ Automatic External Defibrillator |
Classification: Automatic External Defibrillator Class III 21 CFR 870.1025
Predicate Devices:
Heartstream FR2 AED (K003565) Physio-Control Biphasic LifePak 500 (K983393) Zoll M Series Biphasic Defibrillator (K990762)
Indications for Use:
The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse.
The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semiautomatic mode, AccessALS functions identically to the AccessAED.
The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.
1
Access CardioSystems 510(k) K020984
AccessAED Automatic External Defibrillator Contraindications for Use
The AccessAED™ semi-automatic external defibrillator is contraindicated for patients who:
- . are conscious
- are breathing ●
- have a detectable pulse ●
Training Requirements
The Access AED is intended for use by emergency responders specifically trained in the operation of the Access AED. Users should have, at the minimum, BCLS/AED training equivalent to that recommended by the American Heart Association or American Red Cross or training in other physician-authorized emergency medical response.
Device Description:
The AccessAED™ Automatic External Defibrillator has been designed specifically for the treatment of ventricular tachyarrhythmias in cardiac arrest. The AccessAED delivers a high-energy 200 or 360J biphasic waveform to patients in cardiac arrest resulting from ventricular fibrillation or high rate ventricular tachycardia.
The AccessAEDTM features include:
- LED ready indicator .
- power button .
- shock delivery button .
- LCD display with text messaging and ECG display option .
- defibrillation pads housed in a tray for rapid application to patient .
- . disposable Lithium battery system
- rhythm analysis software .
- energy selection button (manual mode only) ●
- synchronization button (manual mode only) .
- . analysis button (manual mode only)
- charge button (manual mode only) .
When the AccessAED™ algorithm software identifies a rhythm that requires defibrillation, the device charges to the required energy level algorithm (200 J or 360 J) as dictated by the internal algorithm. When the device indicates a full charge and instructs the operator to push the shock button, the operator delivers the shock by pressing the shock delivery button.
2
Access CardioSystems 510(k) K020984
AccessAED Automatic External Defibrillator Substantial Equivalence:
The AccessAED™ Automatic External Defibrillator is substantially equivalent to other marketed devices delivering a biphasic waveform, specifically the Zoll M Series Biphasic Defibrillator and the Physio-Control Biphasic Lifepak 500, and the HeartStream FR2. The biphasic waveform in the AccessAED™ delivers a biphasic waveform with characteristics and results similar to both the predicate devices. The operation of this device and any other subtle or minor differences between this device and its predicate devices do not raise any new questions regarding safety and efficacy.
Performance Data:
Performance test data is submitted with the 510 (k) documents. These data demonstrate that the device complies with the applicable sections of AAMI DF2-1989 (Cardiac Defibrillator Devices) and AAMI DF39-1993 (Automatic External Defibrillators). The device was developed under design control, and the hardware was tested in accordance with established industry standards.
The efficacy of the biphasic truncated exponential waveform in this device was demonstrated in a study of swine. The results of this study demonstrate the substantial equivalence of the AccessAED biphasic truncated exponential waveform. Though there are minor differences in the characteristics of the AccessAED biphasic waveform and its predicate device waveforms, these differences do not raise new questions of safety and efficacy.
3
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
David Barash, M.D. Executive Vice President and Medical Director Access CardioSystems, Inc. 150 Baker Avenue Extension, Suite 108 Concord, MA 01742
Re: K020984
Trade Name: AccessAED™ Semi-Automatic External Defibrillators (Models Access AED™ and Access ALSTM) Regulation Number: 21 CFR 870.1025, 21 CFR 870.5300 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ, LDD Dated: July 2, 2002 Received: July 30, 2002
Dear Dr. Barash:
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.
4
Page 2 - David Barash, M.D
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 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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Alise Doty M.D.
Bram D. Zuckerman, M.D) Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): __K020984
Device Name:
Indications For Use:
Indications for Use
The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse.
The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semiautomatic mode, AccessALS functions identically to the AccessAED.
The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.
Contraindications for Use
The AccessAED™ semi-automatic external defibrillator is contraindicated for patients who:
- are conscious ●
- are breathing ●
- have a detectable pulse .
Training Requirements
The Access AED is intended for use by emergency responders specifically trained in the operation of the Access AED. Users should have, at the minimum, BCLS/AED training equivalent to that recommended by the American Heart Association or American Red Cross or training in other physician-authorized emergency medical response.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular and Respiratory Devices | |
| 510(k) Number | K020984 |