(28 days)
Not Found
No
The document describes a standard patient monitoring system and does not mention AI, ML, or related concepts.
No.
The device is described as a "Patient Monitor" and its intended use is for "monitoring and recording of and to generate alarms for multiple physiological parameters" of patients. It measures parameters like ECG and pressure, but does not state it provides any treatment or therapy.
No
This device is described as a patient monitor that measures and records physiological parameters and generates alarms, which are functions of monitoring rather than diagnosing a specific condition.
No
The device description explicitly states that the Philips IntelliVue Patient Monitor family comprises multi-parameter patient monitor models that consist of display units, central processing units (CPU), and physiological measurement modules, indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters of patients (ECG, pressure, etc.). These are measurements taken directly from the patient's body, not from samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description details a patient monitor that measures physiological parameters and generates alarms. This aligns with a device used for direct patient monitoring.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Philips MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue patient monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor.
The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive generate alarms, record physiological etc., pressure, signals, store derived data, and communicate derived data and alarms to central stations via the Intellivue Clinical Network.
The subject modification is the introduction of the models MX600 and MX700 together with a new model of the flexible module server. Additionally the software revision H.04 is made available for the entire IntelliVue Patient Monitors family.
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, hospital environments
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
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results demonstrate that the Philips IntelliVue patient monitors meet 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.
K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072070, K071426, K063725, K063315, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K033513, K033444, K032858, K031481, K030038, K023871, K021778
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
MAR 3 1 2011
KI10622 PI/3
",
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:
Herbert van Dvk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1734 Fax: ++49 7031 463-2442 e-mail: herbert.van dyk@philips.com
This summary was prepared on March 01, 2011.
-
- The names of the devices are the Philips MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue patient monitors Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | |||
| Devices | §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 or | |||
| alarms) | |||
| §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 Signal | |
| Conditioner, 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, Lead | |
| Switching Adapter | |||
| §870.2370, II | KRC | Tester, Electrode, Surface, | |
| Electrocardiograph | |||
| §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 Pressure | |
| Transducer | |||
| §870.2900, I | DSA | Cable, Transducer and | |
| Electrode, incl. Patient | |||
| Connector | |||
| Device Panel | Classification | ProCode | Description |
| - | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| Anesthesiology | |||
| Devices | $870.2910, II | DRG | Transmitters and Receivers, |
| Physiological Signal, | |||
| Radiofrequency | |||
| §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 | |||
| §868.1880, 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, for | |
| Infant not under Gas Anesthesia | |||
| General Hospital | |||
| and Personal Use | |||
| Devices | §880.2910, II | FLL | Thermometer, Electronic, |
| Clinical | |||
| §882.1400, II | GWR | Electroencephalograph | |
| Neurological | |||
| Devices | $882.1420, I | GWS | Analyzer, Spectrum, |
| Electroencephalogram Signal |
1
-
- The modified devices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072070, K071426, K063725, K063315, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K033513, K033444, K032858, K031481, K030038, K023871, and K021778
-
- The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel
2
KI10622 P3/2
displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor.
The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive generate alarms, record physiological etc., pressure, signals, store derived data, and communicate derived data and alarms to central stations via the Intellivue Clinical Network.
The subject modification is the introduction of the models MX600 and MX700 together with a new model of the flexible module server. Additionally the software revision H.04 is made available for the entire IntelliVue Patient Monitors family.
-
- The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue patient monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.
-
- The modified devices have the same technological characteristics as the legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue patient monitors meet all reliability requirements and performance claims.
3
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 3 1 2011
Philips Medical Systems. c/o Mr. Herbert van Dyk Sr. Regulatory Affairs Engineer Patient Monitoring Philips Medizin Systeme Boeblingen GmbH I-lewlett-Packard-Str. 2 D-71034 Boeblingen. Germany
Re: K110622
Trade/Device Name: Philips MX600 and MX700 and Software Revision H.04 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Codes: MHX Dated: March 1, 2011 Received: March 3, 2011
Dear Mr. van Dyk:
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 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.
- 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
4
Page 2 – Mr. Herbert van Dyk
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Bram D. Zuckerman, M.D.
for
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): KII 0622
Philips MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, Device Name: MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 Intellivue patient monitors, software revision H.04.
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 and recording of and to qenerate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, MP5, MP5T, MP5SC, X2, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.
Prescription Use Y es (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C) No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign Off)
Division Sign-Off) vision of Cardiovascular Devices 10-
510(k) Number