(23 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 MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.
The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors and IntelliVue XDS.
The provided text describes a 510(k) premarket notification for Philips IntelliVue Patient Monitors with software release G.02, which is deemed substantially equivalent to previously cleared predicate devices. The document does not contain specific acceptance criteria, reported device performance metrics in a table, or detailed information about a study proving the device meets acceptance criteria in the way typically found in an AI/ML device submission (e.g., performance against a ground truth dataset).
This submission appears to be for a software update to an existing line of patient monitors, not a novel AI/ML diagnostic or prognostic device that would require performance metrics like sensitivity, specificity, or AUC against a ground truth. The testing described focuses on establishing equivalence to predicate devices and ensuring the software update maintains performance and reliability based on existing specifications.
Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not relevant to this type of device submission or are not detailed in the summary.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance metrics for the software update. Instead, it states: "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." and "The results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims." These are general statements rather than specific quantifiable performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not specify a sample size for any test set or provide details about data provenance (e.g., country of origin, retrospective/prospective). It mentions "system level and regression tests as well as testing from the hazard analysis" but not the dataset characteristics.
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)
This information is not provided. Given this is a software update for physiological monitors, the "ground truth" would likely be established through physical testing and comparison with established measurement techniques, rather than expert consensus on interpretive data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
No MRMC comparative effectiveness study is mentioned. This type of study is typically relevant for interpretative AI devices that assist human readers (e.g., radiologists, pathologists). The devices described are physiological monitors.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The submission describes a software update for patient monitors, which inherently operate in a "standalone" fashion by measuring and displaying physiological parameters and generating alarms. The testing focused on performance, functionality, and reliability against predicate device specifications, which implies evaluating the device's inherent operation rather than its impact on human performance in an interpretive task. No specific "standalone performance study" with detailed metrics like those for an AI algorithm is provided in the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The text doesn't specify the type of "ground truth." For physiological monitors, ground truth would typically refer to the true physiological values measured by highly accurate reference standards or established clinical methods, against which the device's measurements (e.g., heart rate, blood pressure, SpO2) are compared. The phrase "Pass/Fail criteria were based on the specifications cleared for the predicate devices" indicates that the new software was evaluated against the performance standards already established for the previous versions of the monitors.
8. The sample size for the training set
This information is not provided. The document describes a software update for patient monitors and does not mention any machine learning or AI components that would require a "training set" in the typical sense.
9. How the ground truth for the training set was established
This information is not provided, as no training set is mentioned in the context of this software update.
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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.
- 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 Sep 8, 2008.
-
- The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors and IntelliVue XDS. 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. Patient | |
| Device Panel | Classification | ProCode | Description |
| - | 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 |
| NeurologicalDevices | $882.1400, II | GWR | Electroencephalograph |
| $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, K052881, K063315, K062392, K063725, K71426, K72020.
-
- The modification is the introduction of software release G.02 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP60, and MP90 and the introduction of the IntelliVue XDS application.
-
- The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, x2, MP5, MP20,
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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. The MP2, X2, MP5, MP20, 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 modified devices have the same technological characteristics as the legally marketed 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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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle emblem with three overlapping wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2008
Philips Medizin Systeme Böblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer, Hewlett-Packard-Str. 2 Boeblingen, 71034 GERMANY
Re: K082633
Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Software Revision G.02. 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: September 8, 2008 Received: September 10, 2008
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.
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 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 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 ohtain 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,
uma R. bochner
\ 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
K082433 510 (k) Number (if known):
Device Name: Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.02.
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, 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 Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (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)
R. Vochmer
(Division Sign-Off)
Division of Cardiovascular Devices
KOB2635
§ 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.