(51 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on software updates and labeling changes for existing patient monitors.
No
The device is a patient monitor, which is used for monitoring and recording physiological parameters, and generating alarms. While it is used by healthcare professionals, its primary function is monitoring, not directly treating a disease or condition.
No
The intended use states it is for "monitoring and recording of and to generate alarms for multiple physiological parameters of patients", but it does not mention diagnosing conditions.
No
The device description explicitly states it is a modification to "Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors," which are hardware devices. The modification is a change in labeling and a software revision for the entire family of these hardware monitors.
Based on the provided text, 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" and "monitoring and recording of and to generate alarms for multiple physiological parameters". This describes a device that measures and displays real-time physiological data from a living patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Mention of Samples: The description and intended use do not mention the analysis of any samples taken from the patient. The device directly monitors the patient's physiological state.
Therefore, the Philips IntelliVue Patient Monitors described are patient monitoring devices, not in vitro diagnostic devices.
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 patıents Intended for monıtorıng and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in 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 modification is a change of the labelling with regard to M1021A and the introduction of software revision G.06 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, 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 within hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally ıntended for use in transport sıtuatıons withın 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.
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, valıdatıon, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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, mazzoos, K040304, K040357, K041235, K042845, K050762, K051106, R053513, K040564, K016337, K061541, K061052, K061610, K062283, R052601, R062392, K063725, K071426, K082633
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: Andreas Suchi JAN 1 6 2009 Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Fax: ++49 7031 463-2442 Tel: ++49 7031 463-1291 e-mail: andreas.suchi@philips.com
This summary was prepared on November 21, 2008.
-
- The names of the devices are the Philips 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 | $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, mazzoos, K040304, K040357, K041235, K042845, K050762, K051106, R053513, K040564, K016337, K061541, K061052, K061610, K062283, R052601, R062392, K063725, K071426, K082633.
-
- The modification is a change of the labelling with regard to M1021A and the introduction of software revision G.06 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 of adults, pediatrics and neonates in hospital environments.
2
The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally ıntended for use in transport sıtuatıons withın 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 റ characteristics as the legally marketed predicate device
- 7 Verification, valıdatıon, 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
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Phılıps Medızın Systeme Boblıngen GmbH c/o Mr Andreas Suchi Senior Regulatory Affairs Engineer. Hewlett-Packard-Str 2 Boeblingen, 71034 GERMANY
Re K083517 Philips MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intelli Vue Patient Monitors, Software Revision G 06 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 DSI Dated January 7, 2009 Received January 9, 2009
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 adulteratıon
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 Andreas Suchı
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 requrements, 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
And Station Come of the Cameral Comment of the Comment
Sincerely Yours,
[signature]
Bram D Zuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K083517
Device Name Philips MP2, X2, MP5, MP20, M30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision ତ ତି
Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patıents Intended for monıtorıng and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments
| Prescription Use | yes |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Barrell links & Sell (and on Garters Hi
AND/OR
SHERE MILLE BOOK JUL 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 199
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
1/16/09
Division of Cardiovascular Devices
510(k) Number K083577