(57 days)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature measurement is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP5 and MP5SC, that consist of display units including built-in and central processing units (CPU) and physiological measurements. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive etc., generate alarms, record physiological pressure, signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification introduces the optional The Philips Tympanic Temperature Module (866149) for the IntelliVue Patient Monitors MP5 and MP5SC. This Tympanic Temperature extends the capability of the IntelliVue Patient Module Monitors MP5 and MP5SC to interface the Genius™ 2 Tympanic Temperature Probe (cleared by Covidien, K060649). Additionally the software revision J.21 is made available for the IntelliVue Patient Monitors MP5 and MP5SC.
The provided text is a 510(k) summary for a patient monitor and mainly focuses on showing substantial equivalence to previously cleared devices. It does not contain the kind of detailed study information (like sample sizes for test and training sets, data provenance, expert qualifications, ground truth establishment, or specific performance metrics with acceptance criteria) that would typically be associated with performance studies for AI/ML devices.
The document discusses "Verification & Validation Activities" but these primarily reference compliance with general safety and EMC standards (IEC 60601-1-2 and IEC 60601-1), environmental testing, and software functionality testing. These tests confirm the device works safely and to specifications, but they don't involve the kind of performance metrics against ground truth that your questions imply for AI/ML models.
The "acceptance criteria" discussed are largely implicit: that the device works safely, effectively, and correctly in accordance with specifications and labeling claims, and that all applicable requirements of the standards are met. "Reported device performance" is also general, stating it "worked safely and according to their specifications" and "met all reliability requirements and performance claims."
Therefore, based on the provided text, I cannot complete the requested tables and information for most of your points. This document is a regulatory submission for a patient monitor with an added temperature module and software update, not a clinical performance study for an AI/ML diagnostic or prognostic device.
If this were a document for an AI/ML device, the detailed information you requested would be crucial. Since it's not, I can only address what is present in the text.
Here's an attempt to answer the questions based only on the provided text, with many fields explicitly stated as "Not Applicable" or "Not Provided" due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implicit from Text) | Reported Device Performance (from Text) |
|---|---|
| Compliance with IEC 60601-1-2:2001 +A1:2004 (EMC) | "All applicable requirements have been met." |
| Compliance with IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) | "All applicable requirements have been met." |
| Withstand Environmental Testing (temperature, humidity, shock, vibration, free fall) | "All specified test requirements have been met. The tests confirmed that the IntelliVue Patient Monitors MP5 and MP5SC worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage." |
| Software Functionality and Hazard Analysis requirements met | "All specified criteria have been met. The tests demonstrated that the IntelliVue Patient Monitors MP5 and MP5SC worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use." |
| Performance and reliability characteristics align with predicate devices | "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate... test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitors MP5 and MP5SC meet all reliability requirements and performance claims." |
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 provided. The document describes engineering and system-level verification and validation, not a clinical trial with a "test set" in the context of AI/ML performance evaluation.
- Data Provenance (country of origin, retrospective/prospective): Not provided.
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. The "ground truth" for this monitoring device is its adherence to technical specifications, safety standards, and functional claims, not expert-labeled clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described.
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
- Not applicable. This is not an AI/ML diagnostic or prognostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a patient monitor, not an algorithm being evaluated for standalone performance in the context of AI/ML. Its performance is inherent in its operation (e.g., accuracy of parameter measurement, alarm functionality).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device appears to be defined by its engineering specifications, adherence to recognized consensus standards (like IEC 60601), and functional requirements for safety and effectiveness.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document does not describe an AI/ML model or a training set.
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K131829 Page 1 of 5
AUG 1 6 2013
510 (k) Summary
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. §807.92.
- The submitter of this premarket notification is:
Herbert van Dyk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1734 Fax: ++49 7031 463-2442 e-mail: herbert.van dyk@philips.com
This summary was prepared on June 14, 2013.
- Names and classification of the devices
| Trade name: | IntelliVue Patient Monitors MP5 and MP5SCRevision J.21. |
|---|---|
| Common name: | Multiparameter Patient Monitor |
Classification names are as follows:
| Device Panel | Classification | ProCode | Device Description |
|---|---|---|---|
| CardiovascularDevices | §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 arrhythmia detection oralarms) | |
| §870.1100, II | DSJ | Alarm, Blood Pressure | |
| §870.1110, II | DSK | Computer, Blood Pressure | |
| §870.1130, II | DXN | System, Measurement, Blood-Pressure, Non-Invasive | |
| §870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | |
| §870.1915, II | KRB | Probe, Thermodilution | |
| §870.2060, II | DRQ | Amplifier and SignalConditioner, Transducer Signal | |
| §870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm) | |
| §870.2340, II | DPS | Electrocardiograph | |
| §870.2340, II | MLC | Monitor, ST Segment | |
| §870.2350, II | DRW | Electrocardiograph, LeadSwitching Adapter | |
| §870.2370, II | KRC | Tester, Electrode, Surface,Electrocardiograph | |
| §870.2600, I | DRJ | System, Signal Isolation | |
| §870.2700, II | DQA | Oximeter | |
| §870.2770, II | DSB | Plethysmograph, Impedance | |
| §870.2800, II | DSH | Recorder, Magnetic tape,Medical | |
| §870.2810, I | DSF | Recorder, Paper Chart | |
| Device Panel | Classification | ProCode | Device Description |
| §870.2850, II | DRS | Extravascular Blood PressureTransducer | |
| §870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector | |
| - | MSX | System, Network andCommunication, PhysiologicalMonitors | |
| §870.2910, II | DRG | Transmitters and Receivers,Physiological Signal,Radiofrequency | |
| AnesthesiologyDevices | §868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,Gaseous-Phase |
| §868.1500, II | CBQ | Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration) | |
| §868.1500, II | NHO | Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | |
| §868.1500, II | NHP | Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration) | |
| §868.1500, II | NHQ | Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | |
| §868.1620, II | CBS | Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration) | |
| §868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration) | |
| §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | |
| §868.1880, II | BZC | Data calculator Pulmonary-function | |
| §868.2375, II | BZQ | Monitor, Breathing Frequency | |
| §868.2480, II | LKD | Monitor, Carbon Dioxide,Cutaneous | |
| §868.2500, II | KLK | Monitor, Oxygen, Cutaneous, forInfant not under Gas Anesthesia | |
| §868.2775, II | KOI | Electrical peripheral nerveStimulator | |
| General Hospitaland Personal UseDevices | §880.2910, II | FLL | Thermometer, Electronic,Clinical |
| NeurologicalDevices | §882.1400, II | GWR | Electroencephalograph |
| §882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
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K131829
Page 2 of 5
-
- The subject devices Philips IntelliVue Patient Monitors MP5 and MP5SC, both with software revision J.21 are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors MP5 and MP5SC marketed pursuant to K122439, K120366, K113657, K113441, K110474, K110622, K102562, K101449, K100939,
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Page 3 of 5
K093268, K091927, K091395, K083517, K083228, K082633, K082583,
K081793, K072070, K071426, K063725, K063315, K062392
- Description of the Devices
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP5 and MP5SC, that consist of display units including built-in and central processing units (CPU) and physiological measurements. All monitors share the same system architecture and exactly the same software is executed on each monitor.
The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive etc., generate alarms, record physiological pressure, -------------------------------------------------------------------------------------------------------------------------------------------------------------------signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network.
subject modification introduces the optional The Philips Tympanic Temperature Module (866149) for the IntelliVue Patient Monitors MP5 and MP5SC. This Tympanic Temperature extends the capability of the IntelliVue Patient Module Monitors MP5 and MP5SC to interface the Genius™ 2 Tympanic Temperature Probe (cleared by Covidien, K060649).
Additionally the software revision J.21 is made available for the IntelliVue Patient Monitors MP5 and MP5SC.
- Intended Use
The subject devices IntelliVue Patient Monitors MP5 and MP5SC have the same Intended Use as the legally marketed predicate IntelliVue Patient Monitors MP5 and MP5SC. The Indications for Use of the subject Philips IntelliVue Patient Monitors MP5 and MP5SC have not changed as a result of the device modification.
The subject and predicate devices IntelliVue Patient Monitors MP5 and MP5SC have the following detailed Indications for Use Statements in their Instructions for Use:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alams for, multiple
physiological parameters of adults, pediatrics, and neonates. monitors are intended for use by trained healthcare The professionals in a hospital environment.
The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.
{3}------------------------------------------------
K131829
Page 4 of 5
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST seqment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
-
- Technological Characteristics
The subject devices IntelliVue Patient Monitors MP5 and MP5SC have the same technological characteristics such as design, energy sources, portability, user interface, performance, and robustness as the legally marketed predicate IntelliVue Patient Monitors MP5 and MP5SC devices. The physical specifications of all devices and performed V&V testing have demonstrated the equivalence of the devices with respect to the intended use. Biocompatibility aspects of the Philips IntelliVue Patient Monitors MP5 and MP5SC are not affected and have not changed, the Covidien Genius™ 2 Tympanic Temperature Probe was cleared by Covidien under K060649.
- Technological Characteristics
-
- Summary of Verification & Validation Activities
Testing according to the recognized consensus standards:
- Summary of Verification & Validation Activities
-
. IEC 60601-1-2:2001 +A1:2004 (EMC)
-
. IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) All applicable requirements have been met.
Environmental testing (temperature, humidity), mechanical testing (shock, vibration, and free fall).
All specified test requirements have been met. The tests confirmed that the IntelliVue Patient Monitors MP5 and MP5SC worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage.
Software Functionality and as required by the Hazard Analysis testing on the IntelliVue Patient Monitors MP5 and MP5SC.
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All specified criteria have been met. The tests demonstrated that the IntelliVue Patient Monitors MP5 and MP5SC worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use.
-
- Conclusion
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitors MP5 and MP5SC meet all reliability requirements and performance claims.
- Conclusion
{5}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2013
Philips Medizinsysteme Boeblingen Gmbh c/o Mr. Herbert Van Dyk Quality and Regulation Function Manager Hewlett-packard Str. 2 Boeblingen, GM D 71034
Re: K131829
Trade/Device Name: Intellivue Patient Monitor (MP5 and MPSSC) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX, DRT, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRQ, DPS, MLC, DRW, KRC, DRJ, DQA, DSP, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWR, GWS, FLL Dated: July 15, 2013 Received: July 17, 2013
Dear Mr. Herbert Van Dyk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
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
{6}------------------------------------------------
Page 2 - Mr. Herbert Van Dyk
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 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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillemann
for
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
3.1 -Indications Statement
Indications for Use MP5 and MP5SC
510 (k) Number (if known) : __
Device Name: Philips IntelliVue patient monitors MP5 and MP5SC, software revision J.21.
MP5 and MP5SC IntelliVue Patient Monitors:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is use during patient transport outside of the hospital for environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording rhythm and detailed morphology of complex cardiac complexes of (according to AAMI EC 11) .
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The Predictive Temperature measurement is intended for use with adult and pediatric patients in a hospital environment.
The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
Over-The-Counter Use No Prescription Use Ycs_ AND/OR (21 CFR 807 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)
M. A. Lillemann
Page 15
§ 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.