(24 days)
Indicated for use by health care professionals monitoring the physiological parameters whenever there is a need for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environment and during transport within hospital environments. Models 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 / tcpCO₂) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors underwent verification, validation, and testing activities to establish their performance, functionality, and reliability characteristics. The study that proves the device meets the acceptance criteria is described as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance | Meets all reliability requirements and performance claims. |
| Functionality | Meets specifications cleared for the predicate device. |
| Reliability | Meets all reliability requirements and performance claims. |
| Safety | Meets safety requirements based on hazard analysis. |
| System-level | Test results showed substantial equivalence to the predicate device. |
Note: The 510(k) summary explicitly states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." However, the exact quantitative metrics for these specifications are not provided in the summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generally refers to "system level tests, performance tests, and safety testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not provided in the 510(k) summary. The testing appears to be based on engineering and predefined specifications rather than expert adjudicated ground truth on clinical data.
4. Adjudication Method for the Test Set:
This information is not provided. The testing described appears to be based on objective pass/fail criteria derived from predicate device specifications, rather than a clinical adjudication process.
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 explicitly mentioned or performed. The submission focuses on substantial equivalence to predicate devices through technical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The testing described appears to be standalone performance testing of the device's hardware and software against predefined specifications. The summary does not describe any human-in-the-loop performance evaluation in the context of this submission.
7. The type of Ground Truth Used:
The "ground truth" for the device's performance was based on the "specifications cleared for the predicate device." This implies a comparison to established technical and performance requirements of previously approved devices, rather than clinical outcomes data or pathology.
8. The Sample Size for the Training Set:
This information is not applicable or provided. The submission describes a medical device update (software release and new models) and does not suggest the use of machine learning algorithms that would require a distinct "training set" for model development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided, as the submission does not detail the use of a training set for machine learning. The device's performance validation is based on adherence to the specifications of predicate devices.
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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: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: markus.stacha@philips.com
This summary was prepared on May 07, 2004.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, 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) | |
| $870.2340, 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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| 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 modified devices are substantially equivalent to 3. previously cleared Philips devices marketed pursuant to K014159, K021778, K032858, K040304, K040183 and K040357.
-
- The modification is the introduction of Release B.1 software for the IntelliVue patient monitor devices MP40, MP50, MP60, MP70 and MP90, and the introduction of the models MP20 and MP30.
-
- 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.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
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-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the endrate. 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/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers. The image is in black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2004
Mr. Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany
Re: K041235
Trade/Device Name: Philips IntelliVue Patient Monitors (Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90) Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and alarm Regulatory Class: II Product Code: MHX, DQA Dated: May 7, 2004 Received: May 11, 2004
Dear Mr. Stacha:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & na re re re read have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in 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, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, incresery maxis 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 if your de vice is onashined (600 as controls. Existing major regulations affecting your device can may be subject to saterial 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. Markus Stacha
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issuated on a basevice complies with other requirements of the Act that FDA has made a decorminancis as administered by other Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, with and manufacturing practice requirements as set CFR Part 807), labeling (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This product factation confecting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: The PDF Imaling of cation 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 If you desire specific advice 101 Jour ac 1100 1100 - 4646. Also, please note the regulation entitled, comact the Office of Compunance as (S = ) = = = = = = = = = = = = = = = = = = = = = = = = other general information on your responsibilities under the Act from the Division of Small other general 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,
Ken Mulvey
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko41235-
The Philips MP20, MP30, MP40, MP50, MP60, MP70 and Device Name: Deviorname.
MP90 IntelliVue Patient Monitors, Release B.1.
Indications for Use: Indicated for use by health care professionals multanons for Ose. Indreason monitoring the physiological parameters whenever there is a neou br monitoring, recording and alarming of of of patients. Inconded frameters of adults, pediatrics and neonates murtiple physiological paramotes MP20, MP30, MP40 and MP50 are intended for use in transport situations within additionally hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp0₂ / tcpCO₂) is restricted to neonatal patients only.
Over-The-Counter Use _ No Use Prescription yes AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auyi Takom
510(k) Number.
§ 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.