(25 days)
Not Found
No
The summary describes standard physiological monitoring and alarm generation without mentioning AI or ML capabilities. There is no mention of image processing, AI/ML terms, or details about training/test sets typically associated with AI/ML devices.
No
Explanation: The device is described as a patient monitor intended for monitoring and recording physiological parameters and generating alarms. It does not provide any therapy or treatment.
No
The device is intended for monitoring and recording physiological parameters and generating alarms, not for diagnosing medical conditions.
No
The device description explicitly states it is a "patient monitor" and lists several models, which are hardware devices used for monitoring physiological parameters. The summary also mentions "modified devices" and "system level and regression tests" related to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "monitoring the physiological parameters of patients." This involves measuring vital signs and other bodily functions directly from the patient.
- Device Description: The description explicitly states the monitors are for "monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates." This reinforces the direct patient monitoring function.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The provided text does not mention the analysis of any such specimens.
The device described is a patient monitor, which is a type of medical device used for direct patient observation and measurement of physiological parameters, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80, and MP90 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, 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.
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
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, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The modification is the introduction of software revision H.00 for the entire IntelliVue patient monitors family, models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90. Additionally a new model IntelliVue MP75 is introduced.
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, transport situations within hospital environments, patient transport outside of a hospital environment.
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 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.
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.
K013199, K031481, K032858, K040304, K050762, K053522, K062392, K71426, K081793, K082633, K083517, K091927
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
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:
APR 80 2010
100939 1/3
Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com
This summary was prepared on April 1, 2010.
-
- The names of the devices are the Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80, and MP90 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 | |||
| Neurological | |||
| Devices | $882.1400, II | GWR | Electroencephalograph |
| $882.1420, I | GWS | Analyzer, Spectrum, |
1
K100939
R2/3
-
- The modification is the introduction of software revision H.00 for the entire IntelliVue patient monitors family, models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 .
Additionally a new model IntelliVue MP75 is introduced.
2
-
- The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80, and MP90 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, 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.
(10093
$3/3
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 stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 3 0 2010
Philips Medizin Systeme Boeblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Boeblingen GERMANY 71034
Re: K100939
Trade/Device Name: Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80, and MP90 IntelliVue patient monitors, Release H.00 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: April 1, 2010 Received: April 5, 2010
Dear Mr. Suchi:
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.
4
Page 2 - Mr. Andreas Suchi
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); 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Prem D. Zuckerman, M.D.
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: Philips MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80, and MP90 IntelliVue patient monitors, Release H.00.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological paramenters of patients.
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
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. Wood
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K100939