(170 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on hardware and software updates for physiological monitoring.
No
The device is described as a patient monitor intended for monitoring and recording physiological parameters and generating alarms, not for treating conditions.
No
The device is intended for "monitoring and recording of and to generate alarms for multiple physiological parameters." It does not mention diagnosis or disease detection.
No
The device description explicitly states it is a modification to existing hardware (Philips Medical Systems MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors) and includes the introduction of new interfacing modules (IntelliBridge EC10 and EC5), indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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" and their function in monitoring physiological parameters.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly monitor the body's functions in real-time. This device falls under the category of patient monitoring equipment.
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 MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
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 modified devices are the Philips Medical Systems MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.01. The modification is the introduction of the new interfacing IntelliBridge EC10 and EC5 modules and the related introduction of software release G.01 for the entire IntelliVue Patient Monitors family, models MP40, MP50, MP60, MP70, MP80, and MP90.
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
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 at system level regression tests, safety and performance tests, EMC and environmental tests, and testing as required 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.
K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725, K071426
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.
KO82583
-
FEB 2 5 2009 1. The submitter of this premarket notification is: Herbert van Dyk 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 Feb 24, 2009. -
- The names of the devices are the Philips Medical Systems MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.01. 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 | |||
| $870.2910, II | DRG | Transmitters and Receivers, | |
| Physiological Signal, | |||
| Radiofrequency |
1
| Device Panel ' | Classification | ProCode | Description |
|---|---|---|---|
| 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, K071426.
- The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357,
-
- The modification is the introduction of the new interfacing IntelliBridge EC10 and EC5 modules and the related introduction of software release G.01 for the entire IntelliVue Patient Monitors family, models MP40, MP50, MP60, MP70, MP80, and MP90.
-
- Indications for Use:
Device Name: Philips Medical Systems MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision : G.01.
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 MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
Company Confidential
2
Intended Use:
The Philips Medical Systems MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Software Revision G.01 are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.
The new interfacing modules IntelliBridge EC10/EC5 and the modified IntelliVue patient monitors, Software Revision Rev. G.01 do not change the intended use.
-
- The modified devices have the same physical, technological and performance characteristics, the same functions, and the same scientific concepts 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 at system level regression tests, safety and performance tests, EMC and environmental tests, and testing as required 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" around the perimeter. Inside the circle is an emblem featuring a stylized eagle-like bird with three wing-like extensions.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Boeblingen GmbH c/o Mr. Herbert van Dyk Q & R Program Manager Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany 71034
FEB 2 5 2009
Re: K082583
Trade Name: Philips Medical Systems MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Software Revision G.01
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm)
Regulation Class: Class II (two)
Product Code: MHX
Dated: January 22, 2009
Received: January 26, 2009
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 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. Herbert van Dyk
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Mark Fellman 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
KOS2583 510(k) Number (if known):
Philips MP40, MP50, MP60, MP70, MP80, and MP90 Device Name: IntelliVue Patient Monitors, Software Revision G.Ol.
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 MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
Prescription
Use ves (Part 21 CFR 801 Subpart D)
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)
M. Mandela
(Division Sign-Off) Division of Cardiovascular Devices KOAJEB 510(k) Number