(18 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 alarmine of multiple physiological parameters of adults, pediatrics and memates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) 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.02 software into the IntelliVue Patient Monitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90.
This 510(k) summary (K060221) describes the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Release D.02. This submission is for a software modification (Release D.02) to existing, legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly states that the performance criteria for the modified devices were based on the predicate devices and other previously cleared submissions. The testing showed "substantial equivalence." However, explicit numerical acceptance criteria for specific physiological parameters are not provided in this summary. Instead, the focus is on demonstrating that the new software release maintains the safety and effectiveness of the previously cleared devices.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance |
|---|---|
| Maintain performance, functionality, and reliability consistent with predicate devices. | "Testing involved system level tests, performance tests, Pass/Fail tests, and safety testing from hardware and software analysis. The rebuild results showed substantial equivalence. The tests demonstrate that the Philips IntelliVue Patient Monitors meet the reliability requirements and performance claims." |
| No adverse impact on existing physiological monitoring capabilities (e.g., arrhythmia detection, ST segment monitoring, blood pressure, gas analysis). | The modified devices "have the same technological characteristics" and "the same intended use" as the legally marketed predicate devices, implying prior performance levels are maintained. |
| Compliance with relevant performance standards and regulations. | Results showed "substantial equivalence" to predicate devices, which implies compliance with relevant standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the test set used in "system level tests, performance tests, Pass/Fail tests, and safety testing."
- Data Provenance: Not specified. However, given that Philips Medizin Systeme Boeblingen GmbH (Germany) is the submitter, it is likely that parts of the testing were conducted in Germany. The nature of the testing (performance tests, safety tests) suggests a combination of simulated and possibly real-world data, but this is not explicitly stated. The study appears to be retrospective in the sense that it evaluates the new software's performance against existing benchmarks and predicate device performance, rather than a new, prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This submission is for a software modification to an existing device, focusing on demonstrating substantial equivalence to its predicate. The testing described (system level, performance, pass/fail, safety) would typically involve engineering and quality assurance personnel, not clinical experts establishing ground truth in a diagnostic context.
4. Adjudication Method for the Test Set:
Not applicable. The testing described does not involve human interpretation requiring adjudication. It's a technical verification of device functionality and performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI assists in that interpretation. The IntelliVue Patient Monitors are monitoring devices, and the submission is for a software update to ensure existing functionality is maintained.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The testing described (system level tests, performance tests, Pass/Fail tests, and safety testing from hardware and software analysis) is inherently a standalone assessment of the device's technical performance with the new software. It evaluates the algorithm and device's capabilities independent of a human operator's direct interpretation of the raw output for diagnostic purposes. The device is a "patient physiological monitor (with arrhythmia detection or alarms)," indicating algorithmic processing of physiological signals.
7. The Type of Ground Truth Used:
The ground truth for the performance tests would be based on:
- Known input signals: For performance and accuracy tests, the device would likely be fed known, precisely controlled physiological signals to verify its measurement accuracy, alarm thresholds, and data processing.
- Predicate device specifications: The performance of the modified device would be compared against the established specifications and performance characteristics of the legally marketed predicate devices.
- Safety standards: Compliance with relevant safety and electrical standards forms a critical part of the ground truth.
8. The Sample Size for the Training Set:
Not applicable. This document describes a software update for a physiological monitor, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" of the device's algorithms would have occurred during the development of the original predicate devices, if applicable.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of this software update. The algorithms for physiological monitoring (e.g., arrhythmia detection, ST segment analysis) are typically based on established medical science and engineering principles, not statistical learning from a large, annotated training dataset for this type of device at the time of this submission (2006).
{0}------------------------------------------------
K060221
p1/3
FEB 1 7 2006
510 (k) Summary 8.0
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe
is submitted in accordance with the requirements of the Safe 13 Submitted In accordinate 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 - 71054 Bocking - 463-1734 - Fax: ++49 7031 463-2442 e-mail: herbert.van_dyk@philips.com
This summary was prepared on January 27, 2006.
-
- The names of the devices are the Philips MP20, MP30, MP40,
MP40, MP30, Lunco, Lunco, Intellilly, Pations Monitor The Mames Of the devices a 8990 IntelliVue Patient Monitors. Classification names are as follows:
- The names of the devices are the Philips MP20, MP30, MP40,
| 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 |
COMPANY CONFIDENTIAL
{1}------------------------------------------------
| $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 | |
| $868.1880, 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 Use(12520) | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| Neurological(12513) | $882.1400, II | GWR | |
| $882.1420, I | GWS |
- The modified devices are substantially equivalent to 3. me modified dored Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K040337, K041259, K1273522, and to Respironics Novametrix Rostion, Ro32001 , Rossister and Accessories "PN 3468-3475" (K053174)
- The modification is the introduction of Release D.02 software 4 . The MOGILLEACION ID che Internitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90
- The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the regarry marketa ding, and alarming of multiple physiological Monicoring, recording, and trics, and neonates in hospital
COMPANY CONFIDENTIAL
{2}------------------------------------------------
environment and during transport within hospital environments .
- The modified devices have the same technological 6. The modified devices have the band elected predicate devices.
-
- Verification, validation, and testing activities establish verformance, functionality, and reliability the performance, functionally, mevice with respect to the characteristics of the modified as a level tests, performance
predicate. Testing involved system levely - Rang (Fail predicate. Testing involved bybeard analysis. Pass/Fail tests, and safety testing from hassisions cleared for the criteria were babed on storesults showed substantial predicate device and other demonstrate that the Philips equivalence. The rebuild acments and reliability requirements and performance claims.
- Verification, validation, and testing activities establish verformance, functionality, and reliability the performance, functionally, mevice with respect to the characteristics of the modified as a level tests, performance
COMPANY CONFIDENTIAL
{3}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Philips Medizinsysteme Boeblingen GmbH c/o Mr. Herbert van Dyk Sr. Regulatory Affairs Engineer Philips Medical Services 3000 Minuteman Road Andover, MA 01810
Re: K060221
文
K 060221
Trade Name: The Philips MP20, MP30, MP30, MP60, MP70, MP80 and MP90
Trade Name: The Philips MP30, Dalam Dalam D 02 Intellivue Patient Monitors, Release D.02 Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 870.1023
Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: January 27, 2006 Received: January 30, 2006
Dear Mr. Van Dyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics in the manufated (for the indications referenced and nave decimined the device are devices marketed in interstate for use stated in the encrosule) to regally manced provice Americal Device Ameralments, or to commerce prior to May 20, 1970, the chaouthore with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosmetic Act (Act) that do not require approvince approvisions of the Act. The Act. The You may, merelore, market the device, saloject to the greateration, listing of
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Are, Inc. Increase some in misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controlis. Entroling the 300 to 898. In addition, I'DA may be found in the Ood of Peachartergerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 – Mr. Herbert van Dyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or uny I 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 CI K Part 607), laoomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro begin marketing your device as described in your Section 510(k) This letter will and w yourse FDA finding of substantial equivalence of your device to a legally marketed predicated. " caresults 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 If you desire specific as not any 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 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/industry/support/index.html.
Sincerely yours,
Bhimmar fa
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.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, recording and alarmine of multiple physiological parameters of adults, pediatrics and memates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Prescription Use yes___________________________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenstor
n Sign-
§ 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.