K Number
K061610
Device Name
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
Date Cleared
2006-08-14

(66 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
Device Description
The modification is the introduction of Release D.05 software for the IntelliVue patient monitor devices.
More Information

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software release for monitoring physiological parameters, with no indication of AI/ML capabilities.

No
The device is a patient monitor used for monitoring physiological parameters, not for therapeutic intervention.

Yes.
The device is intended for "monitoring, recording and alarming of multiple physiological parameters," which are functions of a diagnostic device used to assess a patient's health status.

No

The device description explicitly states the modification is software for "IntelliVue patient monitor devices," which are hardware devices. The summary also mentions system-level tests and safety testing from hazard analysis, which are typical for hardware-inclusive medical devices.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "monitoring, recording and alarming of multiple physiological parameters of patients." This describes a device that measures physiological signals directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation).
  • Device Description: The device is a "patient monitor." Patient monitors are used to observe and track a patient's vital signs in real-time.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This description does not mention any analysis of biological specimens.

Therefore, this device falls under the category of a patient monitoring device, which is distinct from an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.05

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 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.

Product codes (comma separated list FDA assigned to the subject device)

DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, MSX, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS

Device Description

The modification is the introduction of Release D.05 software for the IntelliVue patient monitor devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults, pediatrics and neonates

Intended User / Care Setting

health care professionals / healthcare facilities and during transport within healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541 and K061052

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

AUG 1 4 2006

510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the mate Medical Devices Act of 1990 and 21 C.F.R. §807.92.

  1. 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 13, 2006.

    1. The names of the devices are the Philips MP20, MP30, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellibury Mr30, MP30, MP50, MP40, Classification names are as follows:
Device PanelClassificationProCodeDescription
Circulatory
System Devices
(12625)$870.1025, IIDSIDetector and alarm, arrhythmia
$870.1025, IIMLDMonitor, ST Segment with Alarm
$870.1025, IIMHXMonitor, Physiological, Patient
(with arrhythmia detection or
alarms)
$870.1100, IIDSJAlarm, Blood Pressure
$870.1110, IIDSKComputer, Blood Pressure
$870.1130, IIDXNSystem, Measurement, Blood-
Pressure, Non-Invasive
$870.1435, IIDXGComputer, Diagnostic, Pre-
Programmed, Single-Function
$870.1915, IIKRBProbe, Thermodilution
$870.2060, IIDRQAmplifier and Signal
Conditioner, Transducer Signal
$870.2300, IIDRTMonitor, Cardiac (incl.
Cardiotachometer & Rate Alarm)
$870.2300, IIMSXSystem, Network and
Communication, Physiological
Monitors
$870.2340, IIDPSElectrocardiograph
$870.2340, IIMLCMonitor, ST Segment
$870.2350, IIDRWElectrocardiograph, Lead
Switching Adapter
$870.2370, IIKRCTester, Electrode, Surface,
Electrocardiograph
$870.2450, IIDXJDisplay, Cathode-Ray Tube,
Medical
$870.2600, IDRJSystem, Signal Isolation
$870.2700, IIDQAOximeter
$870.2770, IIDSBPlethysmograph, Impedance
$870.2800, IIDSHRecorder, Magnetic tape,
Medical
$870.2810, IDSFRecorder, Paper Chart
$870.2850, IIDRSExtravascular Blood Pressure
Transducer

ಳ 8

1

| | $870.2900, I | DSA | Cable, Transducer and
Electrode, incl. Patient
Connector |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | $870.2910, II | DRG | Transmitters and Receivers,
Physiological Signal,
Radiofrequency |
| Anesthesiology
and Respiratory
Therapy (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 |
| | $868.2375, 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 Hospital
and 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 |

    1. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, 050762, K051106, K052801, K053522, K060221, K060541 and K061052
    1. The modification is the introduction of Release D.05 software for the IntelliVue patient monitor devices.
    1. 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 healthcare facilities and during transport within healthcare facilities.
    1. The modified devices have the same technological characteristics as the legally marketed predicate devices.

2

    1. 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.

3

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 lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. (USA)" in a sans-serif font. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

Philips Medizinsysteme Boeblingen G c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen Germany D-71034

Re: K061610

Trade/Device Name: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: July 13, 2006 Received: July 26, 2006

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.

4

Page 2 -- Mr. Hauke 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Luckerman, M.D. Bram 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):_____________________________________________________________________________________________________________________________________________________

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 Device Name: and MP90 IntelliVue Patient Monitors, Release D.05

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 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 (Part 21 CFR 801 Subpart D)yes
---------------------------------------------------

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)No
-------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)
Division of Cardiovascular

510(k) NumberK061610
------------------------