(64 days)
Not Found
No
The document describes a monitor/defibrillator with various physiological monitoring options and a wireless data transfer feature. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device's intended uses include therapies such as AED therapy, manual defibrillation, and non-invasive external pacing therapy, all of which are direct treatments for medical conditions.
Yes
Explanation: The device has multiple options listed under "Intended Use / Indications for Use" that are diagnostic, such as "Pulse Oximetry," "Non-invasive Blood Pressure Monitoring," "End-tidal CO2," "12-Lead ECG," "Invasive Pressure," and "Temperature," all of which are for assessing a patient's physiological state.
No
The device description explicitly states it is a modification to the HeartStart MRx, which is a monitor/defibrillator. The modification adds a Bluetooth option for data transfer, but the core device is hardware.
Based on the provided information, the HeartStart MRx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HeartStart MRx Function: The HeartStart MRx is a medical device that directly interacts with the patient's body for therapeutic and monitoring purposes. Its functions include:
- Defibrillation and Pacing: Delivering electrical therapy to the heart.
- Monitoring: Measuring physiological parameters like ECG, SpO2, NBP, EtCO2, Invasive Pressure, and Temperature.
- CPR Feedback: Providing guidance for chest compressions and ventilation.
- Lack of Specimen Analysis: The description does not mention the analysis of any specimens taken from the patient. All measurements and therapies are applied directly to or monitored from the patient's body.
Therefore, the HeartStart MRx falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy
To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.
Non-invasive External Pacing Therapy
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
Pulse Oximetry
The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring
The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.
End-tidal CO2
The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG
The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR
The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
The Q-CPR option is contraindicated as follows:
- The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
- The Q-CPR option is not for use when CPR is contraindicated. -
Invasive Pressure
The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.
Temperature
The Temperature option is indicated for measuring temperature in patients.
Product codes
74 DPS, 74 DXN, 74 DQA, 74 MWI, 74 MSX, 74 CCK, 74 DRO, 74 LDD, 74 MKJ, 74 LIX, 74 DSK, 80 FLL
Device Description
The modification is a change that provides an optional Bluetooth™ wireless technology option to transfer data from the MRx to a Bluetooth enabled device. This wireless connection is an alternative to the current RS232 cable connection 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
patients of at least 8 years of age
The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
Intended User / Care Setting
qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
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)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the device meets all performance claims.
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
8.0 510(k) Summary
JAN 1 1 2007
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 8807.92.
-
- The submitter of this premarket notification is Philips Medical Systems
This summary was prepared on 24 October 2006
- The submitter of this premarket notification is Philips Medical Systems
-
- The name of this device is the HeartStart MRx Monitor/Defibrillator Software Release 7.01. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.2340, II | 74 DPS | Electrocardiograph device |
| 870.1130, II | 74 DXN | Non-invasive blood pressure |
| 870.2700, II | 74 DQA | Pulse oximeter |
| 870.2300, II | 74 MWI | Monitor, Physiological, Patient |
| 870.2300, II | 74 MSX | System, Network and Communication, Physiological |
| Monitors | ||
| 868.1400, II | 74 CCK | End-tidal Carbon Dioxide |
| 870.5550, II | 74 DRO | External Trascutaneous Pacemaker (Non-invasive) |
| 870.5300, II | 74 LDD | Low-energy defibrillator |
| 870.1025, III | 74 MKJ | Defibrillators, Automatic, External |
| 870.5200, III | 74 LIX | Cardiopulmonary Resuscitation Aid |
| 870.1110, II | 74 DSK | Blood Pressure Computer |
| 880.2910, II | 80 FLL | Clinical Electronic Thermometer |
-
- The modification is a change that provides an optional Bluetooth™ wireless technology option to transfer data from the MRx to a Bluetooth enabled device. This wireless connection is an alternative to the current RS232 cable connection capability.
-
- The new device has the same Indications for Use as the legally marketed predicate device.
-
- The new device has the same technological characteristics as the legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the device meets all performance claims.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2007
Philips Medical Systems Ms. Denise Halev Sr. Quality and Regulatory Engineer 3000 Minuteman Road Andover, MA 01810
Re: K063375
Trade Name: HeartStart MRx Models M3535A/M3536A Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: December 12, 2006 Received: December 12, 2006
Dear Ms. Haley:
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.
2
Page 2 - Ms. Denise Haley
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), please contact the Office 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
. A. Hillelenne
for
E
Γ
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use
K063375 510(k) Number (if known):
Device Name: HeartStart MRx Monitor/Defibrillator
Indications for Use:
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy
To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.
Non-invasive External Pacing Therapy
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
Pulse Oximetry
The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring
The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.
End-tidal CO2
The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG
The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
[continued....]
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | Page 1 of 2 |
| 510(k) Number | K063375 |
PHILIPS MEDICAL SYSTEMS
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HeartStart MRx Monitor/Defibrillator Device Name:
Indications for Use: [continued ... ]
Q-CPR
The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
The Q-CPR option is contraindicated as follows:
- The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
- The Q-CPR option is not for use when CPR is contraindicated. -
Invasive Pressure
The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.
Temperature
The Temperature option is indicated for measuring temperature in patients.
Prescription Use Yes Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
MeleMay
(Division Sign-Off)
510(k) Number K063375