(24 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
The name of this device is the IntelliVue MX40 Patient Monitor.
This document outlines information found in the provided 510(k) summary for the Philips IntelliVue MX40 Patient Monitor. Please note that the available text primarily focuses on regulatory compliance and substantial equivalence to a predicate device, rather than a detailed comparative clinical study. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, and details of clinical studies, may not be explicitly present.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | The modified device is substantially equivalent to the previously cleared MX40 IntelliVue Patient Monitor (K103646), having the same Indications for Use, Intended Use, and technological characteristics as the legally marketed predicate device. Pass/Fail criteria were based on the specifications cleared for the predicate device. | "Test results showed substantial equivalence." "The results demonstrate that MX40 patient monitor meets all defined reliability requirements and performance claims." The device was cleared, indicating it met the acceptance criteria for substantial equivalence to its predicate. |
| System Level Tests | Not explicitly detailed in the provided summary, but implied to be part of the predicate device's cleared specifications. | "Testing involved system level tests..." |
| Performance Tests | Not explicitly detailed in the provided summary, but implied to be part of the predicate device's cleared specifications. These are likely to cover the physiological parameters it monitors (arrhythmia detection, ST segment monitoring, oximetry, etc.). Specific numerical performance metrics (e.g., accuracy, sensitivity, specificity for arrhythmia detection) are not provided in this summary. | "...performance tests, and safety testing from hazard analysis." This general statement indicates that performance was evaluated against established specifications, likely derived from the predicate device and relevant standards. Given the clearance, it implies satisfactory performance. |
| Safety Testing (Hazard Analysis) | Not explicitly detailed in the provided summary, but implied to be part of the predicate device's cleared specifications. | "...and safety testing from hazard analysis." The device met the safety requirements. |
| Reliability Requirements | Defined reliability requirements, likely stemming from internal Philips standards and relevant voluntary standards (e.g., IEC 60601-1, ANSI/AAMI EC 13). | "The results demonstrate that MX40 patient monitor meets all defined reliability requirements..." |
| Voluntary Standards Compliance | Compliance with applicable voluntary standards: IEC 60601-1:1998 + A1:1991 + A2:1995 (General Electrical Safety), IEC 60601-1-2:2001 + A1:2004 (EMC), ANSI/AAMI EC 13:2002 (Cardiac monitors, heart rate monitors and alarms), ISO EN 9919: 2005, IEC 60601-2-25:1993 + A1:1999, EC 53:1998 + A1:2008 (ECG Cables and leadwires), ISO 10993-1:2010 (Biocompatibility - for accessory lead wires). | The document states, "The following voluntary standards were used where applicable for this product modification..." and implies compliance as part of the overall testing and clearance. |
Study Information
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a separate "test set" sample size in terms of patient data or clinical cases. The testing described is at a system, performance, and safety level, likely using engineering tests, simulations, and possibly limited human factor evaluations (though not explicitly stated as such). It is not a clinical study with a patient cohort. The evaluation is primarily based on demonstrating substantial equivalence to a predicate device and compliance with technical standards.
- Data Provenance: Not applicable in the context of a clinical test set from patients. The testing involved internal verification and validation activities, which would use simulated data, test equipment, and engineering specifications.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes a technical verification and validation process against predefined specifications and standards, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here would be the technical specifications and performance characteristics of the predicate device, as well as the requirements of the cited voluntary standards.
-
Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) summary. The "adjudication" in this context would be the pass/fail assessment against the established technical specifications and standards by the engineering and regulatory teams at Philips, and ultimately, by the FDA.
-
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. The document makes no mention of AI assistance or human readers. This is a 510(k) submission for a patient monitor, which is a standalone device providing physiological parameter monitoring. It is not an AI-powered diagnostic or assistive technology for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "performance" being evaluated is that of the device itself (the monitor), which operates in a standalone capacity to measure and display physiological parameters and generate alarms. The verification and validation activities described (system level tests, performance tests, safety testing) assess the device's inherent function, without explicitly involving human-in-the-loop performance measurement or comparison in the context of a clinical study. The device is intended for use by healthcare professionals, but the performance testing described here is about the device's technical capabilities, not its impact on human action or diagnostic accuracy in a study context.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission against the acceptance criteria is primarily based on:
- Predicate Device Specifications: The established performance and reliability specifications of the previously cleared MX40 IntelliVue Patient Monitor (K103646).
- Voluntary National and International Standards: Such as IEC 60601-1, ANSI/AAMI EC 13, ISO EN 9919, etc., which define acceptable performance limits and safety requirements for medical devices of this type.
- Internal Engineering Specifications: Philips's own internal design and performance specifications for the updated device.
- The "ground truth" for this submission against the acceptance criteria is primarily based on:
-
The sample size for the training set:
- Not applicable. There is no mention or indication of a "training set" in the context of this 510(k) summary. The device is an updated version of an existing patient monitor, implying its core algorithms and functions are established and validated-it is not a machine learning model that undergoes a training phase as described in AI/ML development.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned.
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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 CFR §807.92.
The submitter of this premarket notification is:
Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099 Tel: 978 659 7621 Fax: 978 685 5624 Email: claire.arakaki@philips.com
This summary was prepared on 10 November 2011.
The name of this device is the IntelliVue MX40 Patient Monitor. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| none | 74 MHX | Physiological Monitor, Patient Monitor |
| §870.1025, II | DSI | Detector and alarm, arrhythmia |
| §870.1025, II | MLD | Monitor, ST Segment with Alarm |
| §870.1025, II | MHX | Monitor, Physiological, Patient (with arrhythmiadetection or alarms) |
| §870.2350, II | DRW | Electrocardiograph, Lead Switching Adapter |
| §870.2700, II | DQA | Oximeter |
| §870.2900, I | DSA | Cable, Transducer and Electrode, incl. PatientConnector |
| §870.2300, II | MSX | System, Network and Communication, PhysiologicalMonitors |
| §870.2910, II | DRG | Transmitters and Receivers, Physiological Signal,Radiofrequency |
The modified device is substantially equivalent to the previously cleared MX40 Intelli Vue Patient Monitor (K103646). Updated compatibility to lead sets and other devices.
Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.
The modified device has the same Indications for Use and Intended Use as the legally marketed predicate device.
The modified 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
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level tests, performance 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 MX40 patient monitor meets all defined reliability requirements and performance claims.
The following voluntary standards were used where applicable for this product modification per FDA Guidance of March 12, 2000 entitled "Use of Standards in Substantial Equivalence Determinations":
General Electrical Safety IEC 60601-1:1998 + A1:1991 + A2:1995
EMC IEC 60601-1-2:2001 + A1:2004
Safety and Performance ANSI/AAMI EC 13:2002 Cardiac monitors, heart rate monitors and alarms ISO EN 9919: 2005 IEC 60601-2-25:1993 + A1:1999 EC 53:1998 + A1:2008 ECG Cables and leadwires ISO 10993-1:2010 Biocompatability (only applicable to accessory lead wires) ISO 9919:2005
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems. c/o Ms. Theresa Poole Regulatory Affairs Engineer Patient Monitoring Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099
NOV 1 7 2011
Re: K113125
Trade/Device Name: Philips MX40 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Codes: DSI, MHX, MLD, DRW, DQA, DSA, MSX, and DRG Dated: October 19, 2011 Received: October 24, 2011
Dear Ms. Poole:
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 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.
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
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Page 2 - Ms. Theresa Poole
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 (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.
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/CDRH0ffices/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/ReportalProblem/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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K113125
Intelli Vue MX40 Patient Monitor Device Name:
Indications for Use:
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (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 |
| 30(k) Number | K/13125 |
|---|---|
| -------------- | --------- |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.