(112 days)
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.
The name of this device is the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. The modification is a change that provides network connectivity via the Philips IntelliVue Network.
The provided text describes a 510(k) summary for the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and study particulars.
The document states that "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." This indicates that the device met the acceptance criteria based on its equivalence to a predicate device, but the specific numerical acceptance criteria and performance data are not provided.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific functional, performance, and reliability specifications based on the predicate device (K031187 and K051134). | Met all reliability requirements and performance claims, demonstrating substantial equivalence to the predicate device. |
| (e.g., Sensitivity ≥ X%, Specificity ≥ Y%) | (e.g., Sensitivity = A%, Specificity = B%) |
Explanation: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence," and that "The results demonstrate that web software interface functionality meets all reliability requirements and performance claims." However, the exact numerical acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) and the corresponding reported performance values for these criteria are not provided in the given text. The focus of this 510(k) is on the network connectivity modification and its substantial equivalence to the predicate, rather than detailed performance metrics for the core defibrillator functionalities.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified
- Data Provenance: The document mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." This suggests internal testing by Philips Medical Systems, but no details about the origin of patients data (if any was used for performance validation), country of origin, or whether it was retrospective or prospective are provided. The testing appears to focus on the technical functionality of the network modification and its impact on the device as a whole, rather than clinical performance on a patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Specified. The document describes engineering and system-level verification and validation for a network connectivity update and overall device functionality, not a study evaluating diagnostic accuracy against a ground truth established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Specified. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for diagnostic or interpretative tasks. This document describes technical device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The device described is a monitor/defibrillator with networking software; it is not an AI-assisted diagnostic tool that would typically involve human readers evaluating results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a monitor/defibrillator that interacts directly with patients and is operated by medical personnel. The "performance" described relates to its overall functionality, reliability, and connectivity, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Based on predicate device specifications and engineering requirements. The "ground truth" for the tests described appears to be the established specifications and expected behavior based on the predicate device and design documents for the new network functionality. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used for this 510(k) submission, as the focus is on substantial equivalence of technical features and safety.
8. The sample size for the training set
- Not Applicable. The device described is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense of AI/ML development.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is mentioned or implied for an AI/ML model, the establishment of its ground truth is not relevant to this submission.
{0}------------------------------------------------
8.0 510 (k) Summary
summary of 510(k) safety and effectiveness information is This submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
-
- The submitter of this premarket notification is:
11/4 2 2 2006
- The submitter of this premarket notification is:
Philips Medical Systems
This summary was prepared on 1 August 2006
-
- The name of this device is the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking 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 |
-
- The modification is a change that provides network connectivity via the Philips IntelliVue Network.
-
- 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 web software interface functionality meets all reliability requirements and performance claims.
Page
{1}------------------------------------------------
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical System c/o Michael J. Doyle Regulatory Affairs Specialist Cardiac and Monitoring Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099
Re: K062233
Trade/Device Name: Heartstart MRx Monitor/Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DRO, DPS, DXN, CCK, DQA, MWI, MSX, LIX Dated: October 31, 2006 Received: November 1, 2006
NOV 2 2 2006
Dear Mr Doyle:
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. Iisting 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 - Michael J. Doyle
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 clectronic 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 vours.
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): _ K062233
Device Name: HeartStart MRx Monitor/Defibrillator with IntelliVue Networking
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.
| Prescription Use | Yes |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | No |
| (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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Ui-j Division of Cardiovascular Devices 510(k) Number 166 No
Paqe
§ 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.