(54 days)
Not Found
No
The document describes standard AED functionality including ECG analysis and impedance compensation, but does not mention AI or ML technologies. The analysis of the ECG is described as "continuously and automatically analyzes" and "assess the ECG validity using both common mode and differential mode," which are typical signal processing techniques, not necessarily AI/ML.
Yes
The device is a defibrillator, which delivers electrical shocks to treat sudden cardiac arrest, making it a therapeutic device.
Yes
The device analyzes the patient's ECG to determine if a shock is required and whether the heart rhythm is shockable, which constitutes a diagnostic function.
No
The device description clearly describes a physical hardware device (defibrillator) with a battery, electrodes, and the capability to deliver electrical shocks. While it contains software for analysis and voice instructions, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat a person suspected to be in sudden cardiac arrest by delivering an electrical shock. This is a therapeutic intervention, not a diagnostic test performed on a sample from the body.
- Device Description: The device is described as an automated external defibrillator (AED) that analyzes the patient's ECG to determine if a shock is required and delivers a shock. This is a treatment device.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
The device is clearly designed for direct application to a patient to treat a medical condition, which is the definition of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HeartStart FRx Defibrillator is indicated for use on a person suspected to be in sudden cardiac arrest who is:
- Unresponsive when shaken .
- . Not breathing normally
The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:
- . Unresponsive when shaken
- Not breathing normally .
If in doubt, apply the pads. A training class in CPR/AED use is II in Goubt, apply the page:
If the person is an infant or child younger than eight years old or weighs if the person is an thant of child Johnsylange. If the child appears less than 55 lbs (20 kg), aco (and/Child Key. Do not delay treatment to oldemarger, do not as act age or weight. If in doubt, do not use the Infant/Child Key.
The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:
- Unresponsive when shaken .
- Not breathing normally .
If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator.
If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.
Product codes
MK1, MKJ
Device Description
The Philips HeartStart FRx Defibrillator is an automated external The Philips HeartStart TTXx Donomiator fibrillation, the most common cause of sudden cardiac arrest (SCA). Features of the Philips common cause of sudden cardido arroot (Self-Calibration, and self-calibration, and HeartStart TRX Dellibrillato: Include estimated exponential therapy impedance-compensating - biphable - transmiss System (PAS) for determining if a shock is required and integrated human factors designs actormining in & of lay responders and pre-connected electrodes.
A non-rechargeable lithium manganese dioxide battery powers the Philips A hon-rechargedblo killiator with a minimum capacity of 200 shocks or 4 hours of operating time.
The HeartStart FRx Defibrillator issues voice instructions appropriate_to The Fleartolan FTA Bollband keeps pace with the user's actions. The the stage of the rocates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR and otherwise predention "intorvals" to "cally analyzes the patient's ECG to determine if continuously and actomatically afibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode assess the £50 valiany as were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.
The HeartStart FRx Defibrillator utilizes the same biphasic, impedance-The Heartourt FFX Delia waveform used in previous-generation Philips Compensating Oxponsibilition delivers 150J shocks (nominal) ALDs. The ficur(Start r... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . shock button as instructed by the defibrillator (50J nominal with Shock button as instructed by HeartStart FRx Defibrillator offers no manual-shock capability.
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
If the person is an infant or child younger than eight years old or weighs less than 55 lbs (20 kg), If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg).
Intended User / Care Setting
Not Found
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 demonstrates that the FRx performs in a manner substantially equivalent to the M5066A predicate and demonstrates that the introduction of the FRx does not raise and new issues of safety or efficacy.
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
FEB 2 5 2005
13 510(k) Summary
510(k) Number (if known): K050004
510(k) Summary for the Philips HeartStart FRx Defibrillator
- Date Summary Prepared 1. February 24, 2005
- Submitter's Name and Address 2. Philips Medical Systems Heartstream 2301 5th Avenue, Suite 200 Seattle, WA 98121
-
- Contact Person Tish Treherne Requiatory Specialist Philips Medical Systems Heartstream Telephone: (206) 664-5283 Facsimile: (206) 664-2070
Device Name and Classification Information 4.
Philips HeartStart FRx Defibrillator Proprietary Name: Defibrillator Common Name: Classification Names: Automated External Defibrillator Device Classification: Class III Automated External Defibrillator Regulation: 21 CFR § 870.5310 MK1 Product Code :
Predicate Devices 5.
Fredicate Devices device to which Philips Medical Systems, The Tegally marketed device to the Philips HeartStart FRx Heartstream is the Philips HeartStart OnSite M5066A Defibrillator (K020715).
The design and intended use of the FRx is substantially equivalent in THC acong r afformance to the HeartStart OnSite M5066A.
Device Description 6.
Device Description
The Philips HeartStart FRx Defibrillator is an automated external The Philips HeartStart TTXx Donomiator fibrillation, the most common cause of sudden cardiac arrest (SCA). Features of the Philips common cause of sudden cardido arroot (Self-Calibration, and self-calibration, and HeartStart TRX Dellibrillato: Include estimated exponential therapy impedance-compensating - biphable - transmiss System (PAS) for
1
determining if a shock is required and integrated human factors designs actormining in & of lay responders and pre-connected electrodes.
A non-rechargeable lithium manganese dioxide battery powers the Philips A hon-rechargedblo killiator with a minimum capacity of 200 shocks or 4 hours of operating time.
The HeartStart FRx Defibrillator issues voice instructions appropriate_to The Fleartolan FTA Bollband keeps pace with the user's actions. The the stage of the rocates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR and otherwise predention "intorvals" to "cally analyzes the patient's ECG to determine if continuously and actomatically afibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode assess the £50 valiany as were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.
The HeartStart FRx Defibrillator utilizes the same biphasic, impedance-The Heartourt FFX Delia waveform used in previous-generation Philips Compensating Oxponsibilition delivers 150J shocks (nominal) ALDs. The ficur(Start r... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . shock button as instructed by the defibrillator (50J nominal with Shock button as instructed by HeartStart FRx Defibrillator offers no manual-shock capability.
Intended Use 7.
The HeartStart FRx Defibrillator is indicated for use on a person suspected to be in sudden cardiac arrest who is:
- Unresponsive when shaken .
- . Not breathing normally
Indications for Use 8.
The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:
- . Unresponsive when shaken
- Not breathing normally .
If in doubt, apply the pads. A training class in CPR/AED use is II in Goubt, apply the page:
If the person is an infant or child younger than eight years old or weighs if the person is an thant of child Johnsylange. If the child appears less than 55 lbs (20 kg), aco (and/Child Key. Do not delay treatment to oldemarger, do not as act age or weight. If in doubt, do not use the Infant/Child Key.
2
Comparison of Technology Characteristics 9.
The HeartStart FRx Defibrillator employs the same fundamental scientific technology as the commercially available Philips HeartStart OnSite M5066A Defibrillator.
Data Used in Determination of Substantial Equivalence 10.
The HeartStart FRx Defibrillator employs the similar technologies to provide similar performance characteristics as the predicate device.
Testing demonstrates that the FRx performs in a manner substantially equivalent to the M5066A predicate and demonstrates that the introduction of the FRx does not raise and new issues of safety or efficacy.
11. Conclusion
The introduction of the HeartStart FRx Defibrillator does not present new issues of safety or effectiveness.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines forming its wings.
FEB 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical System c/o Ms. Tish Treherne Regulatory Affairs Specialist 2301 Fifth Avenue, Suite 200 Seattle, WA 98121-1825
Re: K050004
Trade Name: Philips HeartStart FRx Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: January 27, 2005 Received: January 28, 2005
Dear Ms. Treherne:
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). and Coometer fore, 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 he 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. Tish Treherne
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 that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I 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 CI R Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) I mis lotter will and in your to one finding of substantial equivalence of your device to a legally prematics notification "The 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 its you dome effice of Compliance at (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Blimmo for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 14
510(k) Number (if known):
Philips HeartStart FRx Defibrillator, model 861304 Device Name:
Indications for Use:
The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:
- Unresponsive when shaken .
- Not breathing normally .
If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator.
If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.
Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Kamiyama
Division Sign-Off) Division of Cardiovascular Devices 510/k) Number
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SECTION 14 PAGE 1