(60 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 hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQz) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release C.01 software for the IntelliVue patient monitor devices.
The provided text describes a 510(k) submission for Philips IntelliVue Patient Monitors (MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90), Release C.01 software. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through verification, validation, and testing activities.
However, the document does not contain specific acceptance criteria, detailed device performance metrics in a quantitative table, or information about a study proving the device meets those criteria in the way typically expected for an AI/CADe device. Instead, it states that "performance criteria were based on the specifications clear for the predicate device and test results showed substantial equivalence."
Based on the provided text, the following information can be extracted/inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific quantitative acceptance criteria or reported device performance metrics in the format requested (e.g., sensitivity, specificity, accuracy with numerical targets). It broadly states:
| Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Meet specifications of predicate devices. | Test results showed substantial equivalence to predicate devices. |
| Fulfill performance claims and reliability requirements. | Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing involved "system level tests, performance tests, and safety testing from hazard analysis," but the nature of the data (patient data, simulated data, etc.) is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided as the validation appears to be against predicate device specifications and internal testing, not explicitly against an expert-established ground truth on a clinical test set.
4. Adjudication Method for the Test Set:
- This information is not provided. The assessment method described is focused on meeting predicate device specifications and internal performance/safety tests, not an expert panel adjudication of results from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The document focuses on the substantial equivalence of the new software release to predicate devices, not on the improvement of human readers with AI assistance. The devices are patient monitors, not specifically AI-driven diagnostic tools in the context of human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes "performance tests" and "system level tests." While these imply evaluation of the device's functionality (algorithm only), it doesn't explicitly refer to "standalone performance" in the way it's often used for AI/CADe devices to differentiate it from human-in-the-loop performance. However, given that these are patient monitors, their primary function is to continuously monitor and alarm, which is inherently an "algorithm only" function in terms of detecting physiological parameters and triggering alarms according to programmed thresholds.
7. The Type of Ground Truth Used:
- The ground truth used for validation is implicitly the established performance specifications and accepted functionality of the predicate devices. The new software (Release C.01) was tested to ensure it met these existing benchmarks. It is not based on expert consensus, pathology, or outcomes data from a new clinical study.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This is a software release for patient monitors, not a machine learning model that undergoes a distinct "training" phase with a large dataset. The "training set" concept is typically associated with AI/ML development, which is not described here.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided. As there is no mention of a training set in the context of an AI/ML model, the establishment of its ground truth 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: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2031 Fax: ++49 7031 463-2442 e-mail: hauke.schik@philips.com
This summary was prepared on April 28, 2005.
-
- 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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K05i106/51
P2/3
| $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 modified devices are substantially equivalent to 3. previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141 and 050762.
- 4 . The modification is the introduction of Release C.01 software for the IntelliVue patient monitor devices
- The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospitgl environment and during transport within hospital environments.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
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K051106/S1
p3/3
-
- 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. Perrorman criteria were based on the specifications clear 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 logo for the Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Boeblingen GmbH c/o Mr. Hauke Schik Senior Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany
Re: K051106
Trade Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Release C.01 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: DXN Dated: June 8, 2005 Received: June 10, 2005
Dear Mr. Schik:
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.
JUL 1 - 2005
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Page 2 - Mr. Hauk Schik
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) 276-0295. 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.
Sincerely yours,
During R. Vechner
( ) 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): との5/1/06
:
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Release C.01
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 hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQz) is restricted to neonatal patients only.
Prescription Use Over-The-Counter Use No ಸಿಕೆಲ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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)
e R. Vichner
Off)
diovascular Devices
510(k) Number K051106
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).