(44 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the description focuses on software updates for physiological parameter monitoring.
No
The device is a patient monitor, indicated for monitoring, recording, and alarming of physiological parameters. While it provides critical information for patient care, it does not actively treat or effect a cure for a disease or condition.
Yes
The device is described as "Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates". Monitoring physiological parameters is a diagnostic function, as it helps healthcare professionals assess a patient's health status to make diagnostic decisions.
No
The device description explicitly states that the modification is the introduction of new software for existing hardware (Philips IntelliVue Patient Monitors). This indicates the device is a hardware device with updated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended 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, not analyzing samples taken from the patient outside the body.
- Device Description: The device is a "Patient Monitor." Patient monitors are designed to be connected to the patient to acquire real-time physiological data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are the defining characteristics of an IVD.
Therefore, this device falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities.
- The MP20, MP30, MP40 and MP50. are additionally intended for use in transport situations within healthcare facilities.
- ST Segment monitoring is restricted to adult patients only.
- The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.
Product codes (comma separated list FDA assigned to the subject device)
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, MSX, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The modification is the introduction of Release E.01 software for the IntelliVue patient monitor devices.
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. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.
Intended User / Care Setting
Health care professionals, in healthcare facilities and during transport within healthcare facilities.
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 device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitor meets 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, K033513, K040304, K041235, K042845, K050141, 050762, K051106, K052801, K053522, K060221, K060541, K061052
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 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 August 4, 2006.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | |||
| (12625) | $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) | |||
| $870.2300, II | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| $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 | |||
| $870.2450, II | DXJ | Display, Cathode-Ray Tube, | |
| Medical | |||
| $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 |
SEP 2 0 2006
1
| $870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient Connector | |
|---|---|---|---|
| $870.2910, II | DRG | Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| Anesthesiology | |||
| and Respiratory | |||
| Therapy (12624) | $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 | |
| $868.2375, 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 | |||
| (12520) | $880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Neurological | |||
| (12513) | $882.1400, II | GWR | |
| $882.1420, I | GWS | Analyzer, Spectrum, Electroencephalogram Signal |
-
- The modification is the introduction of Release E.01 software for the IntelliVue patient monitor devices.
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare facilities and during transport within healthcare facilities.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
2
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2006
Philips Medizin Systeme Boblingen GmbH c/o Ms. Linda Stone Philips Medical Systems 3000 Minuteman Road Andover. MA 01810
Re: K062283
Trade Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release E.01 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: August 21, 2006 Received: August 23, 2006
Dear Ms. Stone:
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 - Ms. Linda Stone
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 substantials squisvalence 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,
Bram D. Zuckerman, M.D.
Director
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: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release E.01
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, recording and alparming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50. are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.
Prescription Use (Part 21 CFR 801 Subpart D)
yes___________________________________________________________________________________________________________________________________________________________________________
AND/OR
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)
Bhumanna