(30 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard physiological monitoring components.
No
The device is intended for monitoring, recording, and alarming of physiological parameters, which is diagnostic or assistive, not therapeutic.
No.
The device is used for "monitoring, recording, and alarming of multiple physiological parameters," which indicates a monitoring function rather than a diagnostic one. Diagnostic devices are typically used to identify or determine the nature of a disease or condition.
No
The device description explicitly mentions "Philips M1175A/76A/77A Component Monitoring System" and "Philips V24/V26 patient monitor," which are hardware components. The summary also describes system-level and integration tests, further indicating a hardware-software system.
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, recording, and alarming of multiple physiological parameters." This describes a device that measures physiological signals directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation).
- Device Description: The description mentions a "Component Monitoring System" and "patient monitor." These are typical descriptions of devices used for direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, or tissue) or performing tests in vitro (in a lab setting). IVDs are specifically designed for these types of analyses.
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. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
Product codes
CCK, BZQ, LKD, KLK, DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, MSX, FLL
Device Description
- Philips M1175A/76A/77A Component Monitoring System
- Philips V24/V26 patient monitor
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
adult, pediatric, or neonatal
Intended User / Care Setting
healthcare facilities by healthcare professionals
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 established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from 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 modified devices 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.
K003038, K001333, K990125, K981576, K971910, K903771
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
KO14159 JAN 1 8 2002
p/12
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
Tel: 978 659 3178 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 17 December, 2001
-
- The names of these devices are:
- Philips M1175A/76A/77A Component Monitoring System ●
- Philips V24/V26 patient monitor .
Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 73 | |||
| Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon- |
| Dioxide, 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 | |||
| Panel 74 | |||
| Cardiovascular | 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 | |
| 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 |
1
| | 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 |
| Panel 80
General
Hospital | 880.2910, II | FLL | Thermometer, electronic,
clinical |
-
- The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
-
- The new devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
-
- The new devices have the same technological characteristics as the legally marketed predicate devices.
-
- Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from 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 modified devices meet all reliability requirements and performance claims.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JAN 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dave Osborn Ouality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K014159
Trade Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 Patient Monitor with M1008B and software release CMS C.1 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: December 17, 2001 Received: December 19, 2001
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.
3
Page 2 - Mr. Dave Osborn
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,
N. O'Neill
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ of _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 patient monitor with M1008B and software release CMS C.1
Indications for Use: Intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter
Division of Cardiovascular & Respiratory Devices
510(k) Number K01454
1 1