(44 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, MP5T, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. 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 pressure, etc., generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification is the introduction of software revision H.03 for the entire IntelliVue Patient Monitors family.
The provided text describes a 510(k) summary for Philips IntelliVue Patient Monitors and does not contain detailed information about specific acceptance criteria or an explicit study proving device performance against those criteria in the way typically expected for AI/ML device submissions. This submission predates the widespread use of AI/ML in medical devices and therefore lacks the detailed performance study information relevant to algorithms.
However, based on the general nature of a 510(k) submission for a non-AI/ML device, I can infer some aspects and highlight why other information requested is not present.
Inferred Acceptance Criteria and Reported Device Performance (based on common 510(k) practice for patient monitors):
The acceptance criteria for this type of device (patient monitors with software revisions) would generally revolve around demonstrating that the new software revision maintains the safety, effectiveness, and performance of the predicate devices. The study proving this would typically be a series of verification and validation tests.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (from text) |
|---|---|
| System Level Performance | "demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims." |
| Functionality | "establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate." |
| Reliability | "establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate." |
| Safety (Hazard Analysis) | "Testing involved system level and regression tests as well as testing from the hazard analysis." |
| Substantial Equivalence | "Test results showed substantial equivalence." |
| Alarm Functionality | (Implied by device description: "generate alarms for multiple physiological parameters") |
| Physiological Parameter Accuracy | (Implied by device description: "measure multiple physiological parameters") |
Information Not Available in the Provided Text (and Explanations):
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Explanation: This type of detail is not typically provided in a high-level 510(k) summary for a patient monitor software update. The "test set" here refers to the actual testing environment (e.g., simulators, human subjects, recorded physiological data), but specific numbers, provenance, or retrospective/prospective nature of data for such testing are not disclosed.
-
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):
- Explanation: For a patient monitor, "ground truth" for physiological parameters is often established through calibrated reference devices or established physiological models, rather than expert human interpretation in the way it is for image analysis in AI/ML. Therefore, the concept of "experts" in this context is not directly applicable.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Explanation: Adjudication methods are relevant for subjective interpretations, especially in AI/ML where multiple experts might disagree. For physiological monitoring, accuracy is typically measured against objective numerical standards from reference devices, so adjudication amongst experts wouldn't be part of the testing.
-
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:
- Explanation: No. This is not an AI/ML device. MRMC studies are specific to evaluating how AI assistance impacts human performance, which is not applicable here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Explanation: While the device's algorithms for physiological parameter measurement and alarm generation would have been tested in a standalone manner (e.g., against simulated signals or reference data), the term "standalone performance" is most commonly used in the context of AI/ML for its direct diagnostic or classification output. The submission does not detail specific standalone performance metrics for individual algorithms within the monitor.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Explanation: The "ground truth" for a patient monitor would be established using:
- Reference Devices: Calibrated instruments for measuring ECG, blood pressure, SpO2, etc., against which the monitor's readings are compared.
- Simulators: Devices that generate known physiological waveforms and values.
- Clinical Data (less likely for initial software change, more for initial device clearance): Real patient data where physiological parameters are independently measured by gold-standard methods.
- The document does not explicitly state which methods were used, but these are standard for patient monitor testing.
- Explanation: The "ground truth" for a patient monitor would be established using:
-
The sample size for the training set:
- Explanation: This device is not an AI/ML device, so there is no "training set" in the machine learning sense. The software revision is based on traditional programming and engineering principles, not statistical learning from a dataset.
-
How the ground truth for the training set was established:
- Explanation: As there is no training set for an AI/ML model, this question is not applicable.
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K102562
Page 1 of 3
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.
OCT 2 1 2010
- The submitter of this premarket notification is:
Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com
This summary was prepared on Oct 10, 2010.
-
- The names of the devices are the Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX800 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 | |
| Device Panel | Classification | ProCode | Description |
| $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 | |
| $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 |
| Device Panel | Classification | ProCode | Description |
| 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, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725, K071426, K072020, K081793, K082633, K083517, K091927, K093268, K100939
-
- The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. 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 pressure, etc., generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification is the introduction of software revision
-
- The modified devices have the same intended use as the predicate devices. The Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX800 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. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2, and MP5 are 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.
H.03 for the entire IntelliVue Patient Monitors family.
-
- The modified devices have the same technological characteristics as the predicate device.
-
- 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 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 meet all reliability requirements and performance claims.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Philips Medical Systems c/o Mr. Andreas Suchi Sr. Regulatory Affairs Engineer Philips Medizin Système Boblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boblingen, Germany
OCT 2 1 2010
Re: K102562
Trade/Device Name: Philips Medical Systems MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX8000 IntelliVue Patient Monitors with Software Revisions H.03
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia detection or alarms (including ST-segment measurement and alarm)
Regulatory Class: Class II
Product Code: MHX
Dated: September 3, 2010
Received: September 7, 2010
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 adulteration.
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Page 2 - Mr. Andres Suchi
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.
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,
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
OCT 2 1 2010
510 (k) Number (if known) :
Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, Device Name: MP60, MP70, MP80, MP90 and MX800 IntelliVue Patient Monitors, Software Revision H:-03.
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, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP5T, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.
Prescription Use es (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C) No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102562
§ 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.