(28 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Seqment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02/tcpCO2) is restricted to neonatal patients only.
The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. The modification is the introduction of Release B.1.1 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50 interfacing the Gas Analyzer model M1013A EGM (K041956). The modified devices have the same technological characteristics as the legally marketed predicate devices.
Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., "accuracy must be >95%") or detailed reported device performance in a numerical format for individual parameters. Instead, it makes a general statement about meeting specifications and reliability.
| Acceptance Criteria (Implied) | Reported (General) Device Performance |
|---|---|
| Conformance to specifications cleared for the predicate devices | Meets all reliability requirements |
| Performance of the modified device with respect to the predicate | Meets all performance claims |
| Functionality of the modified device with respect to the predicate | Established |
| Reliability of the modified device with respect to the predicate | Established |
| Safety testing pass/fail based on hazard analysis | Pass/Fail criteria met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but doesn't quantify the number of test cases, patient data, or specific scenarios used.
- Data Provenance: Not explicitly stated. It's unclear if the testing involved real patient data, simulated data, or a combination, nor the country of origin. The regulatory submission is from Germany, suggesting testing might have occurred there or within Phillips' global network. It is implied to be prospective testing, as it's for a new software release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not mentioned in the document. The type of device (patient monitor) suggests that ground truth would likely be based on established physiological measurement standards and potentially clinical expert review, but this is not detailed.
4. Adjudication Method for the Test Set
Not mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study is not applicable and was not performed. This device is a physiological patient monitor, not an AI-assisted diagnostic tool for human readers. Its primary function is to measure and display physiological parameters, and alarm if they fall outside set limits. There's no AI component for improving human interpretation in the way one would see in an imaging AI application.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be a standalone evaluation of the device's performance, functionality, and reliability, without explicitly involving human-in-the-loop performance for its core functions. The software Release B.1.1 itself is the "algorithm only" component that was tested.
7. The Type of Ground Truth Used
The document does not specify the exact "type of ground truth" in the way one might for an imaging algorithm (e.g., pathology, outcomes data). For a patient monitor, ground truth would be established through a combination of:
- Known physical inputs/simulations: Using calibration equipment or simulators to generate precise physiological signals (e.g., a known ECG rhythm, a specific blood pressure waveform) and verifying the device's output against these known inputs.
- Comparison to reference devices: Comparing the monitor's readings to those of other validated and highly accurate reference monitoring devices.
- Technical specifications: Verifying that the device's measurements fall within the specified accuracy and precision limits for each parameter.
8. The Sample Size for the Training Set
Not applicable. This device is a patient monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would involve the development and engineering process of the software itself, not a data-driven training pipeline for a predictive model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.
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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 C.F.R. §807.92.
KO42845
- The submitter of this premarket notification is: Egon Pfeil Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1926 Fax: ++49 7031 463-2442 e-mail: egon.pfeil@philips.com
This summary was prepared on October 13, 2004.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices(12625) | $870.1025, III | DSI | Detector and alarm, arrhythmia |
| $870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, III | 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 | |
| $870.2450, 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 | |
| $870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector |
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p.2/3
| MSX | System, Network andCommunication, PhysiologicalMonitors | ||
|---|---|---|---|
| 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 | |
| $868.2375, 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 modification is the introduction of Release B.1.1 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50 interfacing the Gas Analyzer model M1013A EGM (K041956).
-
- The modified devices have the same intended use as the leqally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital 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
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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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized graphic of what appears to be an abstract bird or wing-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 12 2004
Philips Medizin Systeme Böblingen GmbH c/o Mr. Egon Pfeil Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 71034 Böblingen GERMANY
Re: K042845
K042643
Trade Name: Philips Medical System MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors, Release B.1.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitors Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: October 13, 2004 Received: October 15, 2004
Dear Mr. Pfeil:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave rowled your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfale in the encreated 776, the enactment date of the Medical Device Amendments, or 10 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 r ou may a works 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. Egon Pfeil
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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Bhummar for
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): Koy28GS
The Philips IntelliVue MP20, MP30, MP40, MP50, MP60, Device Name: MP70 and MP90 Patient Monitors, Release B.1.1
Indicated for use by health care professionals Indications for Use: whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Seqment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02/tcpCO2) is restricted to neonatal patients only.
Prescription Use yes (Part 21 CFR 801 Subpart D)
AND/OR
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)
Blumensa
Page _ of _
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).