(48 days)
No
The summary describes a physiological parameter monitor with updated software and module support, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a monitor that records, alarms, and monitors physiological parameters, which are diagnostic and monitoring functions, not therapeutic.
No
The device is described as a monitor of physiological parameters and does not mention diagnosis. Its intended use is for monitoring, recording, and alarming, not for determining the presence or absence of a disease or condition. While it monitors the "state of the brain" and "effects of certain anesthetic agents," this is still a monitoring function, not a diagnostic one.
No
The device description explicitly mentions hardware components (M1275B Component Compact Monitor, M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module) and the modification is an update to the software and the ability to support these hardware modules.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates." This involves measuring physiological signals directly from the patient's body (e.g., ECG, transcutaneous gas, EEG).
- Device Description: The description lists modules that measure physiological parameters (SvO2, EEG, BIS).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. IVDs are specifically designed for testing these types of samples.
The device described is a patient monitor, which is a type of medical device used to continuously measure and display vital signs and other physiological parameters of a patient. This is distinct from an IVD.
N/A
Intended Use / Indications for Use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only. Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*. * Gan TJ, Slass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg Bispectral Index Monitoring Allows Faster emergence and P. Improved Recovery from Propofol, Alfentanil, and Nitrous Oxide Anesthesia. Anesthesiology October 1997; (4) 87:808-15.
Product codes
CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, MSX, FLL, GWR, GWS
Device Description
Philips Medical Systems, M1275B Component Compact Monitor. The modification is updated software and the ability to support the Philips M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module as well as the M2385A Application Server.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain (EEG signals)
Indicated Patient Age Range
Adults, pediatrics, and neonates. Specific age range restrictions apply to certain monitoring functions: EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Intended User / Care Setting
Health care professionals, intensive care unit, operating room
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 new 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 Component Compact Monitor meets all reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K013199, K020531, K021300, K990125
Reference Device(s)
K942843, K992674, K003038, K021422
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
JUL 1 7 2002
510(k) Summary 9.0
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 CFR §807.92.
- The submitter of this premarket notification is: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
978 659 3178 Tel: Fax: 978 685 5624 Email: dosborn@hsgmed.com
This summary was prepared on 29 May, 2002
-
- The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Anesthesiology | |||
| and Respiratory | |||
| Therapy Devices | |||
| Panel (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 | |||
| Circulatory | |||
| System Devices | |||
| Panel (12625) | 870.1025, III | DSI | Detector and Alarm, |
| Arrhythmia | |||
| 870.1025, III | MLD | Monitor, ST Segment with | |
| Alarm | |||
| 870.1025, III | MHX | Monitor, Physiological, | |
| Patient (with arrhythmia | |||
| Detection or alarms) | |||
| 870.1100, II | DSJ | Alarm, Blood-Pressure | |
| 870.1110, II | DSK | Computer, Blood-Pressure |
1
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| 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 | |
| 870.2370, 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 | |
| MSX | System,Network and | ||
| Communication, | |||
| Physiological Monitors | |||
| General | |||
| Hospital and | |||
| Personal Use | |||
| Devices Panel | |||
| (12520) | 880.2910, II | FLL | Thermometer, electronic, |
| clinical | |||
| Neurological | |||
| Devices Panel | |||
| (12513) | 882.1400, II | GWR | Electroencephalograph |
| Neurological | |||
| Devices Panel | |||
| (12513) | 882.1420, I | GWS | Analyzer, Spectrum, |
| Electroencephalogram | |||
| Signal |
-
- The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A SvO2 Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, and the Philips M2391A PC Client marketed pursuant to K021422.
- The modification is updated software and the ability to support এ . to the Philips M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module as well as the M2385A Application Server.
-
- The new device has the same Indications for Use, for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients, as the legally marketed predicate device.
2
- The new device has the same technological characteristics as the 6. legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new 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 Component Compact Monitor meets all reliability requirements and performance claims.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
JUL 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dave Osborn Philips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810
Re: K021778
Philips Component Compact Monitor, Release A.04, M1275B Regulation Number: 870.2700, 882.1400, 870.1025 Regulation Name: Oximeter, Electroencephalograph, and Arrhythmia Detector and Alarm Regulatory Class: III Product Code: DQA, GWQ, and MHX Dated: May 29, 2002 Received: May 30, 2002
Dear Mr. Osborn:
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.
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.
4
Page 2 - Mr. Dave Osborn
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski
Timo Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page ______ of _______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.04, with M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*.
- Gan TJ, Slass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg Bispectral Index Monitoring Allows Faster emergence and P. Improved Recovery from Propofol, Alfentanil, and Nitrous Oxide Anesthesia. Anesthesiology October 1997; (4) 87:808-15.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V Use (Per 21 CFR 801.109)
OR Over-The-C
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device !- 10(k) Number