(22 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, 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, Release D.00:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it offers a general statement about meeting "specifications cleared for the predicate device." Therefore, the table below reflects this general statement.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Performance, Functionality, and Reliability | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." | This statement indicates that all the specified performance, functionality, and reliability requirements for the predicate device were met. Specific numerical criteria (e.g., accuracy ranges for physiological parameters, alarm response times) are not explicitly detailed in this summary but were likely part of the underlying documentation. |
| Safety Testing | "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 underwent safety testing based on a hazard analysis, and it met the safety specifications of the predicate device. |
| System Level Tests | "Testing involved system level tests... Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." | The device's overall system functionality was tested and found to be substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the testing. The testing described appears to be internal validation by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used, nor their qualifications, for establishing ground truth. Given the nature of a patient monitor (measuring physiological parameters rather than diagnostic interpretation of images), the "ground truth" would likely be derived from established reference measurement devices rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context. There is no mention of AI assistance in the context of human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone patient monitor, designed to measure and display physiological parameters directly. The testing described (system level tests, performance tests, safety testing) directly relates to the standalone performance of the monitor. The document describes a standalone performance evaluation of the device's functionality.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for a patient monitor measuring physiological parameters, the ground truth would most typically be established through:
- Reference Measurement Devices: Using highly accurate and calibrated reference instruments (e.g., dedicated ECG machines for cardiac signals, precise pressure transducers for blood pressure, gas analyzers for gas measurements) to establish the true physiological values against which the monitor's readings are compared.
- Physical Simulators/Phantoms: Using controlled simulators that generate known physiological signals or conditions to test the monitor's accuracy and response.
It is highly unlikely that "expert consensus," "pathology," or "outcomes data" would be the primary ground truth for validating the fundamental performance of a patient monitor in the way it is for diagnostic imaging or clinical decision support AI.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set." The device is a patient monitor with software (Release D.00) that likely incorporates established signal processing algorithms and control logic, rather than a machine learning model that requires a distinct training set in the modern sense. The text refers to "specifications cleared for the predicate device" as the basis for evaluation, implying a comparison to known benchmarks rather than an iterative learning process from a large data set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning context, this question is not applicable based on the provided document. The "ground truth" for the device's development and validation would be the physical and physiological accuracy standards it must meet, as defined by its intended use and regulatory requirements.
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8.0 510 (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 December 16, 2005.
-
- The names of the devices are the Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices(12625) | $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) | |
| $870.2300, II | MSX | System, Network andCommunication, PhysiologicalMonitors | |
| $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 | |
| $870.2450, II | DXJ | Display, Cathode-Ray Tube,Medical | |
| $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 |
COMPANY CONFIDENTIAL
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| $870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector | |
|---|---|---|---|
| $870.2910, II | DRG | Transmitters and Receivers,Physiological Signal,Radiofrequency | |
| Anesthesiologyand RespiratoryTherapy (12624) | $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 Use(12520) | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| Neurological(12513) | $882.1400, II | GWR | Electroencephalograph |
| $882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
-
- The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300″ (K960831, K963380, K982499, and K030886)
-
- The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital
COMPANY CONFIDENTIAL
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environment and during transport within hospital environments.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system 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 the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims.
COMPANY CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle or bird-like figure with three stylized lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the central emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2006
Mr. Herbert Van Dyk Senior Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Street 2 D-71034 Boeblingen, Baden-Wttbg GERMANY
Re: K053522
Trade/Device Name: The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.00 Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Mesasurement and Alarm) Regulatory Class: II Product Code: MHX Dated: December 16, 2005 Received: December 19, 2005
Dear Mr. 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.
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. Dyk
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suita Y. Michael Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 Device Name: IntelliVue Patient Monitors, Release D.00
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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
| Prescription(Part 21 CFR 801 Subpart D) | Use ___ yes_______________________________________________________________________________________________________________________________________________________________________ AND/OR |
|---|---|
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Over-The-
(21 CFR
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smöhiue
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053522
§ 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.