(23 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 healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.
The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.03 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.
The Philips IntelliVue Patient Monitor, Release D.03, is a patient monitoring device that received 510(k) clearance (K060541) in 2006. The device is intended for monitoring, recording, and alarming multiple physiological parameters of adult, pediatric, and neonatal patients in healthcare facilities, with some models also suitable for in-hospital transport.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance, Functionality, and Reliability Characteristics | "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate." |
| System Level Tests Passed | "Testing involved system level tests..." |
| Performance Tests Passed | "...performance tests..." |
| Safety Testing Passed (based on Hazard Analysis) | "...and safety testing from hazard analysis." |
| Compliance with Predicate Device Specifications (Pass/Fail) | "Pass/Fail criteria were based on the specifications cleared for the predicate device..." |
| Demonstrated Substantial Equivalence to Predicate Device | "...and test results showed substantial equivalence." "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Same Intended Use as Legally Marketed Predicate 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 hospital environment and during transport within hospital environments." (Specific restrictions for ST Segment and transcutaneous gas measurement for certain patient populations are also noted). |
| Same Technological Characteristics as Legally Marketed Predicate Devices | "The modified devices have the same technological characteristics as the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided summary does not specify the sample size used for the test set or the data provenance. It generally refers to "system level tests, performance tests, and safety testing," but does not detail the specific number of patients, data records, or cases used in these tests. The nature of this device (patient monitor) suggests testing would likely involve simulated physiological data, bench testing, and potentially clinical data, but specifics are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided summary does not mention the involvement of experts for establishing ground truth for a test set. Given that this is a patient monitoring device and the evaluation primarily focuses on substantial equivalence to predicate devices and meeting their specifications, the "ground truth" would likely be defined by the known physiological parameters and expected device responses based on engineering and medical standards, rather than expert interpretation of complex medical imagery or conditions.
4. Adjudication Method for the Test Set
The provided summary does not describe any adjudication method. As mentioned above, the evaluation seems to rely on established specifications and objective measures of device performance rather than subjective expert interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided summary. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on human performance is being assessed. For a patient monitor, the primary evaluation is about the accuracy and reliability of its physiological measurements and alarms.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The evaluation of the Philips IntelliVue Patient Monitor is fundamentally about its standalone performance in measuring and alarming physiological parameters. While it's a device that assists human caregivers, the "testing activities" described (system level, performance, safety) intrinsically refer to the device's inherent functional capabilities without necessarily evaluating a human-in-the-loop scenario impacting the device's measurements. The device itself acts in a standalone capacity by continuously monitoring and providing data and alarms.
7. The Type of Ground Truth Used
The ground truth for evaluating this device appears to be based on:
- Established Specifications: "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies adherence to predetermined acceptable ranges and accuracy for physiological measurements (e.g., heart rate, blood pressure, oxygen saturation, gas concentrations).
- Engineering and Medical Standards: The "performance, functionality, and reliability characteristics" are assessed against what are considered acceptable and safe parameters for patient monitoring in a clinical setting.
- Predicate Device Performance: The core of the 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices, meaning its performance matches or is equivalent to established, already-cleared devices.
8. The Sample Size for the Training Set
The provided summary does not mention a training set or its sample size. Patient monitoring devices like the IntelliVue are typically developed and validated against known physiological signals and simulated data, rather than "training" in the machine learning sense from a specific dataset of patient cases. While the internal algorithms (e.g., for arrhythmia detection) might have been developed using data, the document does not elaborate on this.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not described. For a traditional patient monitor, the underlying algorithms for parameter calculation and alarm generation are based on established physiological principles and signal processing, validated through rigorous engineering and clinical testing rather than a separate "training set" with explicit ground truth labels as seen in AI/ML applications.
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K06054/
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 February 24, 2006.
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- 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 PressureTransducer |
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| $870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient Connector | |
|---|---|---|---|
| $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 (Anesthetic Concentration) | |
| $868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | |
| $868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | |
| $868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | |
| $868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Concentration) | |
| $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration) | |
| $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, for Infant 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 |
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- 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 , K053522, K060221, and K053204 to Dräger Medical M1019A IntelliVue G5 Anesthesia Gas Monitor
- The modification is the introduction of Release D.03 software 4 . for the IntelliVue patient monitor devices, MP20, MP30, 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
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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.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2006
Philips Medizin Systeme Boeblingen GmbH c/o Herbert van Dyk Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 D-71034 Boeblingen GERMANY
Re: K060541
Trade Name: Philips MP20, MP30, MP40, MP50, MP60, MP70. MP80, and MP90 IntelliVue Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Paticnt Monitor w/ Arrhythmia Detection or Alarms Regulatory Class: Class II (two) Product Code: MHX, CCK, CCL, CBQ, NHO, NHP, NHQ, CBS, CBR, BZQ Dated: February 24, 2006 Received: March 1, 2006
Dear Mr. van 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. Herbert van 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 vours,
Bram D. Zuckerman, M.D.
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): Ko 60 5 Yi
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.03
Indications for Use: 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 healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.
Prescription Use yes AND/OR (Part 21 CFR 801 Subpart D)
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)
ivision Sign-Off 510(k) Nur
11
§ 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.