(18 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 MP20, MP30, 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 / tcpCO2) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release E.03, are patient monitoring devices. The information provided does not contain specific acceptance criteria values or detailed performance metrics. The submission focuses on demonstrating substantial equivalence to previously cleared devices through verification, validation, and testing activities.
Here's an analysis based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lacks a table explicitly stating acceptance criteria and corresponding reported device performance values for specific clinical metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, ST-segment monitoring, or other physiological parameters).
The general statement provided is:
"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."
This indicates that the acceptance criteria were the existing specifications of the predicate devices, and the device's performance met these specifications. However, the specific metrics (e.g., error margins, detection rates) are not quantified in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document
- Does not specify the sample size used for the test set.
- Does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any clinical data that might have been used in performance testing. The testing described appears to be primarily system-level, performance, and safety testing rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document
- Does not mention the use of experts to establish ground truth for a test set. The described testing focuses on engineering verification and validation against pre-defined specifications.
- Does not specify any qualifications for experts as none are mentioned in the context of ground truth establishment.
4. Adjudication Method for the Test Set:
The document
- Does not describe any adjudication method for a test set. This implies that if any human review was involved, it wasn't a formal adjudication process as typically seen in clinical studies for AI/CAD devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
- No MRMC comparative effectiveness study was mentioned or indicated. The submission pertains to a software update (Release E.03) for existing patient monitors and demonstrates equivalence through engineering and performance testing rather than a clinical effectiveness study comparing human readers with and without AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes "system level tests, performance tests, and safety testing." While these tests evaluate the device's functions, it's unclear if a specific "standalone" performance study in the context of an algorithm (i.e., measuring the algorithm's performance on clinical data without user interaction) was conducted and reported in this summary. The device itself is a monitor that presents data to a human, implying a human-in-the-loop for interpretation and action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used. Given the nature of the device (physiological parameter monitoring) and the testing described (system level, performance, safety), the ground truth for "performance tests" would likely be:
- Reference standards: Calibrated instruments or validated simulators for physiological parameters (e.g., heart rate, blood pressure, oxygen saturation, ECG signals).
- Pre-defined specifications: The accepted operating ranges and accuracy limits of the predicate devices.
8. The sample size for the training set:
- Not applicable / Not mentioned. The submission describes a software update for existing patient monitors. It does not refer to a machine learning or AI algorithm development that would typically involve a "training set." The testing performed is to ensure the new software release functions equivalently to the previous versions and meets specifications.
9. How the ground truth for the training set was established:
- Not applicable / Not mentioned. As there's no mention of a training set, the establishment of ground truth for such a set is not discussed.
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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 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 October 31, 2006.
-
- The names of the devices are the Philips MP20, MP30, 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 Pressure |
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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 | |
| $868.2375, 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 software Release E.03 for the IntelliVue patient monitor devices.
-
- 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 healthcare facilities and during transport within healthcare facilities.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
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K04.3315
P 3/3
-
- 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.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 2006
Andreas Suchi Ouality and Regulatory Philips Medizinsysteme Boeblingen GMBH Hewlett-Packard-Str. 2 71034 Boblingen, Germany
Re: K063315
Trade/Device Name: INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm). Regulatory Class: II
Product Code: MHX Dated: October 31, 2006 Received: November 2, 2006
Dear Mr. Suchi:
This letter corrects our substantially equivalent letter of November 20, 2006.
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 the rederal 1 000, 2008). 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 additional controls. Existing major regulations affecting your (1 will ), w that 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. Suchi
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 continue 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/dsma/dsmamain.html
fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Sincerely vours.
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Indications for Use
510(k) Number (if known): ドレビ331S
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release E.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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, 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 / tcpCO2) is restricted to neonatal patients only.
Prescription Use yes___________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Dung R. be dines
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K063315
11
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3.2 Philips Medical Systems Draft Labeling
The following labeling documents are found in Annex A:
- · A draft of the relevant chapters of the Instructions for Use for the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors
- o Chapter 13 Monitoring Cardiac Output
- o Chapter 27 Installation and Specifications
in the state of the time
§ 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.