(21 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with such technologies. The focus is on monitoring physiological parameters and software updates.
No.
The device is described as a patient monitor intended for monitoring and recording physiological parameters, and generating alarms. It is not intended for treatment or therapy.
No
The device is intended for "monitoring the physiological parameters of patients" and "generating alarms," but not for diagnosing medical conditions.
No
The device description explicitly refers to "Philips IntelliVue Patient Monitors" and describes modifications to these physical monitors, including the introduction of new models (MP2 and X2). This indicates the device is a hardware-based patient monitor with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 refers to "Patient Monitors," which are devices used to observe and track a patient's physiological state in real-time.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, screening, or monitoring based on laboratory analysis of samples.
The device described is a patient monitor, which is a type of medical device used for direct patient monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / 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 generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment.
Product codes
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 modified devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, with the introduction of software release F.00 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, 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, safety and performance tests, EMC and environmental tests, such 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)
K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K071426
p1/3
510 (k) Summary
JUN 1 3 2007
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.
-
l. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: markus.stacha@philips.com
This summary was prepared on May 16, 2007. -
- The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, 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 | |||
| - | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors |
1
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| $870.2910, II | DRG | Transmitters and Receivers, | |
| Physiological Signal, | |||
| Radiofrequency | |||
| Anesthesiology | |||
| Devices | $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 |
| Devices | $882.1420, I | GWS | Analyzer, Spectrum, |
| Electroencephalogram Signal |
-
- The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725.
-
- The modification is the introduction of the models MP2 and X2 IntelliVue Patient Monitors and the introduction of software release F.00 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.
-
- The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters
2
of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is 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, safety and performance tests, EMC and environmental tests, such 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.
K071426 4 3/3
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2007
Philips Medizin Systeme Bobligen GmbH c/o Mr. Markus Stacha Senior Regulatory Affairs Engineer, Cardiac and Monitoring Systems Postfach 1471 71004 Böblingen, Germany
Re: K071426
Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Software Revision F.00. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: May 23, 2007 Received: May 23, 2007
Dear Mr. Markus:
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. Markus Stacha
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,
Blyminima 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):
Device Name: Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision F.00.
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 generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment.
Prescription (Part 21 CFR 801 Subpart D)
yes
Use
- AND/OR
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumuma
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number k71424