(29 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/tcpC02) is restricted to neonatal patients only.
The Philips MP20, MP30, MP30, MP50, MP60, MP70 and MP90 Patient Monitors, Release C.00.
The Philips IntelliVue Patient Monitors (MP30, MP30, MP50) with Release C.00 software, along with the M3014A Capnography Extension interfacing the Philips Mainstream CO2 Sensor model M2501A, underwent verification, validation, and testing activities to establish performance, functionality, and reliability, demonstrating substantial equivalence to predicate devices.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets all reliability requirements and performance claims. | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
| Functional equivalence to predicate devices. | "Testing the modified device with respect to its predicate... results showed substantial equivalence." |
| Safety equivalence to predicate devices. | "Testing... performance tests, and safety involved system level tests... Pass/Fail criteria were based on testing from hazard analysis." |
| Performance equivalence to predicate devices. | "Testing... performance tests, and safety involved system level tests... Pass/Fail criteria were based on testing from the predicate and creating and test the specifications cleared for the predicate." |
| Intended use as monitoring, recording, and alarming of multiple physiological parameters for adults, pediatrics, and neonates in hospital environments. | "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 environments." |
| ST Segment monitoring restricted to adult patients. | "ST Segment monitoring is restricted to adult patients only." |
| Transcutaneous gas measurement (tcp02/tcpC02) restricted to neonatal patients. | "The transcutaneous gas measurement (tcp02/tcpC02) is restricted to neonatal patients only." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample size used for the test set (number of patients, records, or data points). It broadly mentions "system level tests, performance costs, and on the based on testing from hazard analysis" and refers to "the predicate" without detailing the specific data used.
The data provenance is not specified beyond implicitly being related to the device development and testing within Philips Medizin Systeme Boeblingen GmbH, Germany. It does not mention country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The document refers to "Pass/Fail criteria were based on testing from hazard analysis" and "specifications cleared for the predicate," implying internal technical specifications and hazard assessments rather than expert-established ground truth for a test set in the traditional clinical or algorithmic sense.
4. Adjudication Method for the Test Set
This information is not provided in the document. The testing described appears to be technical verification and validation against pre-defined specifications and safety criteria, not clinical judgment necessitating an adjudication method.
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
This information is not provided. The devices are patient monitors, and their performance evaluation focuses on the accuracy and reliability of physiological parameter measurement, not on AI-assisted analysis that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The document describes the introduction of "Release C.00 software" into patient monitoring devices. The testing activities ("system level tests, performance tests, and safety") inherently evaluate the performance of the device's software and hardware in a standalone manner as a monitoring system. While the device is intended for use by "health care professionals," the performance evaluation described does not seem to involve human-in-the-loop performance in the context of an "AI effect size" study. It assesses the device's ability to accurately measure and alarm on physiological parameters.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests appears to be based on:
- Technical Specifications and Predicate Device Performance: "Pass/Fail criteria were based on testing from the predicate and creating and test the specifications cleared for the predicate."
- Hazard Analysis: "Pass/Fail criteria were based on testing from hazard analysis."
- Reliability Requirements and Performance Claims: The stated outcome is that the device "meets all reliability requirements and performance claims."
This suggests a technical and engineering-based ground truth, comparing the new device's output to established benchmarks, previous device performance, and safety standards, rather than direct human clinical expert consensus, pathology, or outcomes data in a diagnostic accuracy study.
8. The Sample Size for the Training Set
This information is not provided as the device and its software are described in the context of traditional medical device validation (verification and validation of performance, functionality, and reliability), not as a machine learning model that would typically have a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning sense is not indicated, this information is not applicable/not provided. The software's functionality would have been developed according to engineering principles and validated against specifications and predicate device performance.
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APR 2 2 2005
510 (k) Summary
This summary of 510(k) safety and effectiveness information is
t the summer by the versions versions of the Safe Medical This summary of 510 (K) salety and errecessor entered in and Submitted In accordance and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: Egon Pfeil Egon Freir
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany 9-71034 Boebfingen) Country
Tel: ++49 7031 463-1926 Fax: ++49 7031 463-2442 e-mail: egon.pfeil@philips.com
This summary was prepared on March 22, 2005.
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- The names of the devices are the Philips MP30, MP30, MP50,
Classified of Chilips Totallilles Patient Monitor Classification The names of the devices are the firstips with and the mannel of the mannel of the securities and names are as follows:
- The names of the devices are the Philips MP30, MP30, MP50,
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices(12625) | $870.1025, III | DSI | Detector and alarm, arrhythmia |
| $870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, III | 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 |
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- The modification is the introduction of Release C.00 software The modiffeation is the at monitor devices, MP20, MP30, MP30, MP40, For the Incerrivas packed , and M3014A Capnography Extension interfacing the Philips Mainstream CO2 Sensor model M2501A (K042601) .
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, marketed predicate devices. multiple physiological parameters of recording, and draimend neonates in hospital environment and adures, pearsort 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
ssent of the formationality, and reliability characteristics of verification, validation, and cesting activeres esteristics of performance, function of performance, for the performance, functionality, and reflabsity, and predicate. Testing the modified device with respect co cre preats, and safety involved system level tests, performance costs, and on the based on
testing from hazard analysis. Pass/Fail criteria were based on testing from hazard analysis. Passy and creating and test the specifications cleared for the predicate assults demonstrate
results showed substantial equivalence. The results mete all results showed substantial equivarenoom
that the Philips IntelliVue Patient Monitor meets all that the Philips Incellive racess.
reliability requirements and performance claims.
::
- Verification, validation, and testing activities establish the
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Egon Pfeil Senior Regulatory Affairs Engineer Cardiac and Monitoring Systems Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2, 71034 Böblingen, GERMANY
Re: K050762
Troover Name: The Philips IntelliVue MP20, MP30, MP30, MP40, MP50, MP60, MP70 and MP90 Patient Monitors, Release C.00 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: March 22, 2005 Received: March 24, 2005
Dear Mr. Pfeil:
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 mendments, 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 (1 writ), it has 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. Pfeil
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 and ifound (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicellents as 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), n 93se 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 yours,
Ginette Y. Michaud m.D.
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): ____________________________________________________________________________________________________________________________________________________
The Philips IntelliVue MP20, MP30, MP40, MP50, MP60, Device Name: MP70 and MP90 Patient Monitors, Release C.00.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters wforevients. Intended for monitoring, recording and alarming of or paciences. Ological 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/tcpC02) is restricted to neonatal patients only.
Over-The-Counter Use No Prescription Use 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)
Page of of _
Ainslie em
Livision Sign-Off Division of Anesthesiology, General Hospital, Infaction Control, Dental Devices
510(k) Number: K990162
§ 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.