(134 days)
Not Found
No
The summary describes a "multi-parameter Patient Analysis System (PAS) algorithm" for determining shockable rhythms, which is a standard algorithmic approach for AEDs, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, or related terms.
Yes
The device is an automated external defibrillator (AED) intended to treat ventricular fibrillation and certain ventricular tachycardias, which are medical conditions, and therefore functions as a therapeutic device.
Yes
The device specification states that it includes a "multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable," indicating its ability to diagnose a patient's heart rhythm.
No
The device description explicitly states that these are "battery powered, automated external defibrillators" and mentions hardware components like pads, a battery, and an optional Bluetooth transceiver module. This indicates it is a physical device with integrated software, not a software-only medical 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is an automated external defibrillator (AED). Its purpose is to deliver an electrical shock to the chest of a person experiencing sudden cardiac arrest to restore a normal heart rhythm.
- Lack of Sample Analysis: The device description focuses on analyzing the patient's heart rhythm (ECG) through pads applied to the skin, not on analyzing biological samples taken from the body.
- Intended Use: The intended use is to treat ventricular fibrillation and certain ventricular tachycardias, which is a direct therapeutic intervention, not a diagnostic test performed on a sample.
Therefore, this device 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 Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- Unresponsiveness .
- . Absence of normal breathing
If in doubt, apply the pads.
The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.
The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.
Product codes
MKJ, LDD
Device Description
These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self tests performed each time the device is turned on, both models perform power on self tests, runtime self tests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.
The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card and various carry cases.
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 Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key.
Intended User / Care Setting
The models 861389 and 861388 are compact, lightweight, battery powered automated external defibrillators designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
#K05004, #K003565, #K003819, #K014157, #K051632, #K072812
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
Section 15 - 510(k) Summary
K 111693
1. Date Summary Prepared
June 8, 201 1
2. Submitter's Name and Address
Philips Medical Systems, Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121-1825
3. Contact Person
Tamara Yount Senior Regulatory Affairs Specialist Telephone: 206.664.5000 Facsimile: 206.664.5001
4. Device Name and Classification Panel Information
| Proprietary Name: | Philips HeartStart Model 861388 (text and graphics only) and Model 861389 (ECG) AEDs |
|---|---|
| Common Name: | Automated External Defibrillator |
| Classification Name: | Automated External Defibrillator |
Device Classification: Class III prc-amendment (primary) Class II (secondary)
Automated External Defibrillator, 21 § 870.5310 (primary) Regulations: Low energy DC Defibrillator, 21 § 870.5300 (secondary)
Product Code: MKJ (primary) LDD (secondary)
5. Predicate Devices
The design technology and intended use of the models 861388 and 861389 arc substantially equivalent in safety and performance to the previously cleared Philips
Philips Medical Systems, Heartstream Traditional 5 10(k) PreMarket Notification 861388 and 861389
Section 15, page 1 of 3
1
HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K003565, #K003819, #K014157 and #K051632) and Philips SMART Pads III (#K072812).
6. Device Description
These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self tests performed each time the device is turned on, both models perform power on self tests, runtime self tests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.
The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card and various carry cases.
7. Intended Use
The models 861389 and 861388 are compact, lightweight, battery powered automated external defibrillators designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The models 861388 and 861388 are used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- Unresponsiveness .
- t Absence of normal breathing
If in doubt, apply the pads.
- The models 861389 and 861388 are intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.
2
8. Comparison of Technology Characteristics
The waveform used in the models 861389 and 861388 are similar to the FRx and FR2+ in terms of specifications, nominal energy and peak current. Like the FRx and PR2+, models 861389 and 861388 use a similar algorithm to determine shock recommendations. Like the FR2+, the models 861389 and 861388 have a SMART CPR algorithm that supports the CPR First function.
9. Data Used in Determination of Substantial Equivalence
The models 861389 and 861388 employ many of the same technologies as those used in the predicate devices. Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness.
10. Conclusion
The introduction of the models 861389 and 861388 does not present any new issues of safety or effectiveness.
Philips Medical Systems, Heartstream Traditional 510(k) PreMarket Notification 861388 and 861389
Section 15, page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 12 2011
Philips Medical Systems c/o Ms. Tamara Yount Senior Regulatory Affairs Specialist 2301 5th Avenue, Suite 200 Seattle, WA 98121
Re: K111693
Trade/Device Name: HeartStart FR3 Automated External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ and LDD Dated: October 18, 2011 Received: October 19, 2011
Dear Ms. Yount:
This letter corrects our substantially equivalent letter of October 28, 2011.
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 (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 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Section 12 - Indications for Use
510(k) Number (if known)
K 11693
Device Name
Philips HeartStart Automated External Defibrillator (AED), Models 861388 and 861389
Indications for Use
The Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- Unresponsiveness .
- . Absence of normal breathing
If in doubt, apply the pads.
The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.
The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
for B Zuckerman
12/12/2011
510(k) Number K111693
Philips Medical Systems, Heartstream
Traditional 510(k) PreMarket Notification 861388 and 861389
Section 12, page 1 of 1