(51 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, pediatrics and neonates in hospital environments
The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments The MP5 is also intended for use during patient transport outside of a hospital environment The monitors are not intended for home use They are intended for use by health care professionals
The Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. The modification is a change of the labelling with regard to M1021A and the introduction of software revision G.06 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue Patient Monitors, structured according to your request:
Based on the provided 510(k) summary, the device in question is the Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, with a modification involving a software revision G.06. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than a de novo submission with specific acceptance criteria for a novel algorithm.
Therefore, the requested information elements related to algorithmic performance and ground truth establishment are largely not applicable or not explicitly detailed in this type of 510(k) submission which focuses on a software update for an existing, cleared device family.
1. A table of acceptance criteria and the reported device performance
Given that this 510(k) pertains to a software update for an existing patient monitor, the "acceptance criteria" are intrinsically tied to the performance specifications of the predicate devices. The document states:
"Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."
This implies that the acceptance criteria are to meet or exceed the performance of the previously cleared versions of the IntelliVue Patient Monitors. Specific quantitative metrics for individual physiological parameters (e.g., accuracy of heart rate, blood pressure, etc.) are not provided in this summary. Instead, a general statement of meeting prior specifications is used.
| Acceptance Criteria (Derived from Predicate Specifications) | Reported Device Performance |
|---|---|
| Meet all reliability requirements of predicate devices | Met |
| Meet all performance claims of predicate devices | Met |
| Exhibit equivalent functionality to predicate devices | Met |
| Ensure safety as per predicate devices | Ensured |
| Demonstrate substantial equivalence | Demonstrated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "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 regression tests, safety and performance tests, EMC and environmental tests, such as testing from the hazard analysis."
- Sample Size for Test Set: Not explicitly stated. The document refers to "system level and regression tests, safety and performance tests, EMC and environmental tests," but does not provide details on the number of test cases, durations, or subjects.
- Data Provenance: Not explicitly stated. Given the nature of patient monitors, testing would typically involve a combination of simulated data, bench testing, and potentially clinical data, but the specifics (country, retrospective/prospective) are not provided in this summary.
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 stated. As this is for a patient monitor and a software update, the "ground truth" would generally refer to the accuracy of physiological measurements against established standards or reference devices (e.g., a calibrated ECG simulator for arrhythmia detection, a reference blood pressure cuff for NIBP, etc.). It does not involve expert adjudication in the way AI imaging algorithms do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not stated. This type of adjudication method is relevant for expert review of complex data, such as medical images. For patient monitors, performance is typically assessed against quantifiable metrics using reference equipment, not through expert consensus on interpretation.
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 specific 510(k) relates to a software update for a patient monitor, not an AI-powered diagnostic application that would involve human readers interpreting images or data with and without AI assistance. The device's primary function is to monitor and display physiological parameters and generate alarms, not to provide diagnostic insights in the same manner as an AI imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes "system level and regression tests, safety and performance tests," which implies standalone testing of the device's functionality. The patient monitor itself operates largely as a "standalone" system in terms of its parameter acquisition and display, though human healthcare professionals interpret the output. The performance tests would have evaluated the device's ability to accurately measure, process, and display physiological parameters independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated in detail. For patient monitors measuring physiological parameters, the "ground truth" would typically involve:
- Reference Standards/Calibrated Equipment: For accuracy of measurements (e.g., using a known voltage input for ECG, a pressure generator for NIBP, a known gas mixture for gas analysis).
- Simulated Data: For testing specific physiological conditions or arrhythmias.
- Clinical Data (potentially): Comparison of device measurements against invasively acquired or laboratory-confirmed values, if applicable for certain parameters, or against a predicate device in a clinical setting.
The summary refers generally to "specifications cleared for the predicate devices," implying that the ground truth for performance metrics aligns with those previously established and validated for the predicate monitors.
8. The sample size for the training set
Not applicable/Not stated. This 510(k) is for an update to an existing patient monitor system, not the clearance of a novel algorithm that would typically undergo a separate training phase with a specific training set size. While the initial development of signal processing algorithms within the monitor might have involved training, this information is not part of this specific software update filing.
9. How the ground truth for the training set was established
Not applicable/Not stated. (As per point 8).
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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: Andreas Suchi JAN 1 6 2009 Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Fax: ++49 7031 463-2442 Tel: ++49 7031 463-1291 e-mail: andreas.suchi@philips.com
This summary was prepared on November 21, 2008.
-
- The names of the devices are the Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | 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 | |
| $870.2850, II | DRS | Extravascular Blood PressureTransducer | |
| $870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector | |
| - | MSX | System, Network andCommunication, PhysiologicalMonitors |
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| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| $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 | |
| General Hospitaland Personal UseDevices | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| Neurological | $882.1400, II | GWR | Electroencephalograph |
| Devices | $882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
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- The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, mazzoos, K040304, K040357, K041235, K042845, K050762, K051106, R053513, K040564, K016337, K061541, K061052, K061610, K062283, R052601, R062392, K063725, K071426, K082633.
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- The modification is a change of the labelling with regard to M1021A and the introduction of software revision G.06 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.
-
- The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments.
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The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally ıntended for use in transport sıtuatıons withın hospital environments The MP5 is also intended for use during patient transport outside of a hospital environment The monitors are not intended for home use They are intended for use by health care professionals
- The modified devices have the same technological റ characteristics as the legally marketed predicate device
- 7 Verification, valıdatıon, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate Testing involved system level and regression tests, safety and performance tests, EMC and environmental tests, such 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 meet all reliability requirements and performance claims
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Phılıps Medızın Systeme Boblıngen GmbH c/o Mr Andreas Suchi Senior Regulatory Affairs Engineer. Hewlett-Packard-Str 2 Boeblingen, 71034 GERMANY
Re K083517 Philips MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intelli Vue Patient Monitors, Software Revision G 06 Regulation Number 21 CFR 870 1025 Regulation Name Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class Class II (two) Product Code DSI Dated January 7, 2009 Received January 9, 2009
Dear Mr Suchi
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 adulteratıon
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
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Page 2- Mr Andreas Suchı
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 requrements, 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
And Station Come of the Cameral Comment of the Comment
Sincerely Yours,
[signature]
Bram D Zuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K083517
Device Name Philips MP2, X2, MP5, MP20, M30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision ତ ତି
Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patıents Intended for monıtorıng and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments
| Prescription Use | yes |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Barrell links & Sell (and on Garters Hi
AND/OR
SHERE MILLE BOOK JUL 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 199
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-Off)
1/16/09
Division of Cardiovascular Devices
510(k) Number K083577
§ 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.