(248 days)
Not Found
Not Found
No
The description focuses on standard AED functionality, including ECG analysis and impedance compensation, without mentioning AI or ML algorithms. The "multi-parameter Patient Analysis System (PAS)" is a common term for the algorithms used in AEDs to detect shockable rhythms, which typically rely on established signal processing techniques rather than AI/ML.
Yes
The device, an automated external defibrillator (AED), is indicated to treat victims of sudden cardiac arrest (SCA) by delivering a therapeutic electrical shock to the heart to restore a normal rhythm.
Yes
The device (M5066A/M5068A) includes a "multi-parameter Patient Analysis System (PAS) for determining if a shock is required" and "continuously and automatically analyzes the patient's ECG and alerts the responder when the ECG changes to a possible shockable rhythm," which are diagnostic functions.
No
The device description clearly details hardware components such as a battery, therapy waveform delivery, patient analysis system, shock button, and infrared communication port. It is an automated external defibrillator (AED), which is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro means "in glass" or "outside the body"). This device is applied to the body to deliver electrical therapy.
- The intended use and device description clearly state it's an automated external defibrillator (AED) used to treat sudden cardiac arrest. This involves analyzing the patient's ECG (electrical activity of the heart) and delivering a shock if necessary. This is a direct intervention on the patient's body, not an analysis of a sample.
- The device analyzes the patient's ECG in real-time. While it performs analysis, it's analyzing a physiological signal from the living patient, not a biological sample.
Therefore, the M5066A/M5068A is a therapeutic medical device, specifically an AED, and not an IVD.
N/A
Intended Use / Indications for Use
The M5066A is designed to be used on a person in sudden cardiac arrest, who is:
- unresponsive when shaken, and
- not breathing normally. .
If in doubt, apply the pads.
If the victim is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), you should use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child's exact age or weight.
The M5066A is intended for use by people who have been specifically trained in its operation. A M5066A user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements.
The M5068A is designed to be used on a person who is in sudden cardiac arrest and who is:
- unresponsive when shaken, and
- not breathing normally. .
The defibrillator should not be used on a person who is: - responsive when shaken, or ●
- breathing normally.
If you are not certain if the person is in sudden cardiac arrest, apply the defibrillator and follow its instructions.
For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads that come with it. For younger children to those who weigh less than 55 pounds, the special infant/child pads should be used. When used with these pads, the M5068A delivers a lower energy appropriate for infants and small children.
The M5068A is intended for use by people who have been specifically trained in its operation. The user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency response program in accordance with local and state requirements.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The M5066A/M5068A is an automated external defibrillator indicated to treat victims of sudden cardiac arrest (SCA). Features of the M5066A/M5068A includes self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multi-parameter Patient Analysis System (PAS) for determining if a shock is required and integrated human factors designs to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the M5066A/M5068A with a minimum capacity of 40 shocks and 30 minutes of operating time.
Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the M5066A/M5068A continuously and automatically analyzes the patient's ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the M5066A/M5068A advises a shock and arms - if the ECG spontaneously converts to a non-shockable rhythm prior to a responder pressing the shock button, the M5066A/M5068A disarms.
If significant artifact is detected in the ECG, the PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the M5066A/M5068A directs the responder to press the shock button to deliver a biphasic shock to the patient.
The M5066A/M5068A has an infrared communication port to facilitate data management. Event and incident data is recorded during use that can be retrieved later for viewing, printing, annotating and forwarding. Factory settings of the M5066A/M5068A can be customized. In addition, the M5066A/M5068A converts into a training device with selectable training "scripts" that simulate different SCA 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
M5066A:
Infant or child younger than eight years old or weighs less than 55 lbs (25 kg)
If the child appears older/larger, use the adult pads.
M5068A:
For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads.
For younger children to those who weigh less than 55 pounds, the special infant/child pads should be used.
Intended User / Care Setting
People who have been specifically trained in its operation. A user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements.
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 demonstrated that the performance of the M5066A/M5068A meets its specifications. Furthermore, additional bench testing will demonstrate that the M5066A/M5068A will meet its predefined criteria.
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.
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letters 'ic', followed by the numbers '020715'. The handwriting is somewhat rough, with the characters appearing slightly uneven and the ink distribution varying in thickness.
NOV 8 2002
510(k) Summary
510(k) Number (if known): K020715
510(k) Summary for the Philips M5066A/M5068A
1. Date Summary Prepared
November 6, 2002
2. Submitter's Name and Address
Philips Medical Systems Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121
3. Contact Person
Tamara Yount Philips Medical Systems Heartstream Telephone: (206) 664-5000 Facsimile: (206) 664-5001
4. Device Name
Proprietary Name: M5066A/M5068A Automated external defibrillator Common Name: Classification Names: Low-Energy Defibrillator
5. Predicate Devices
The legally marketed device to which Philips Medical Systems. Heartstream claims equivalence for the M5066A/M5068A is the Heartstream FR2 AED. The modified device is also substantially equivalent to the Cardiac Science/SurVivaLink FirstSave AED and the Katecho Adult/Defibrillator/Pacing Electrodes.
The design and intended use of the M5066A/M5068A is substantially equivalent in safety and performance to the devices named above.
6. Device Description
The M5066A/M5068A is an automated external defibrillator indicated to treat victims of sudden cardiac arrest (SCA). Features of the M5066A/M5068A
1
includes self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multi-parameter Patient Analysis System (PAS) for determining if a shock is required and integrated human factors designs to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the M5066A/M5068A with a minimum capacity of 40 shocks and 30 minutes of operating time.
Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the M5066A/M5068A continuously and automatically analyzes the patient's ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the M5066A/M5068A advises a shock and arms - if the ECG spontaneously converts to a non-shockable rhythm prior to a responder pressing the shock button, the M5066A/M5068A disarms.
If significant artifact is detected in the ECG, the PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the M5066A/M5068A directs the responder to press the shock button to deliver a biphasic shock to the patient.
The M5066A/M5068A has an infrared communication port to facilitate data management. Event and incident data is recorded during use that can be retrieved later for viewing, printing, annotating and forwarding. Factory settings of the M5066A/M5068A can be customized. In addition, the M5066A/M5068A converts into a training device with selectable training "scripts" that simulate different SCA scenarios.
7. Intended Use
The M5066A is designed to be used on a person in sudden cardiac arrest, who is:
- unresponsive when shaken, and .
- not breathing normally. .
If in doubt, apply the pads.
If the victim is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), you should use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child's exact age or weight.
The M5066A is intended for use by people who have been specifically trained in its operation. A M5066A user should also have training in cardiopulmonary
2
resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements.
The M5068A is designed to be used on a person who is in sudden cardiac arrest and who is:
- unresponsive when shaken, and .
- not breathing normally. .
The defibrillator should not be used on a person who is:
- responsive when shaken, or ●
- breathing normally. .
If you are not certain if the person is in sudden cardiac arrest, apply the defibrillator and follow its instructions.
For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads that come with it. For younger children to those who weigh less than 55 pounds, the special infant/child pads should be used. When used with these pads, the M5068A delivers a lower energy appropriate for infants and small children.
The M5068A is intended for use by people who have been specifically trained in its operation. The user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency response program in accordance with local and state requirements.
8. Comparison of Technology Characteristics
The M5066A/M5068A employs the same fundamental scientific technologies as the commercially available FR2 AED. The device is also similar to the Cardiac Science/SurVivaLink FirstSave AED and Katecho Adult Electrodes.
9. Data Used in Determination of Substantial Equivalence
The M5066A/M5068A employs the similar technologies to provide similar performance characteristics as the predicate devices.
Testing demonstrated that the performance of the M5066A/M5068A meets its specifications. Furthermore, additional bench testing will demonstrate that the M5066A/M5068A will meet its predefined criteria.
10. Conclusion
The introduction of the M5066A/M5068A does not present new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Ms. Tamara Yount 2401 Fourth Avenue, Suite 500 Seattle. WA 98121-1436
8 2002 NOV
Re: K020715
Philips M5066A/M5068A Regulation Number: 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ Dated: September 3, 2002 Received: September 5, 2002
Dear Ms. Yount:
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 - Ms. Tamara Yount
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 compliv 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 (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 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,
signature
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
12.Indications for Use
November 1, 2002 -
510(k) Number (if known): #K020715
Device Name: Philips M5066A/M5068A
Indications for Use: The M5066A is designed to be used on a person in sudden cardiac arrest, who is:
- unresponsive when shaken, and
- not breathing normally. .
If in doubt, apply the pads.
If the victim is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), you should use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child's exact age or weight.
The M5066A is intended for use by people who have been specifically trained in its operation. A M5066A user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements.
Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020715
Prescription Use __ or Over-The-Counter Use
6
Indications for Use (continued)
November 1, 2002
510(k) Number (if known): #K020715
Device Name: Philips M5066A/M5068A
Indications for Use:. The M5068A is designed to be used on a person who is in sudden cardiac arrest and who is:
- unresponsive when shaken, and
- not breathing normally. .
The defibrillator should not be used on a person who is:
- responsive when shaken, or ●
- breathing normally.
If you are not certain if the person is in sudden cardiac arrest, apply the defibrillator and follow its instructions.
For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads that come with it. For younger children to those who weigh less than 55 pounds, the special infant/child pads should be used. When used with these pads, the M5068A delivers a lower energy appropriate for infants and small children.
The M5068A is intended for use by people who have been specifically trained in its operation. The user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency response program in accordance with local and state requirements.
Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number IC926 7/5
Prescription Use