(44 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or studies typically associated with AI/ML in medical devices.
No
The text describes the device as intended for "monitoring, recording, and alarming of multiple physiological parameters". Monitoring devices are typically diagnostic or for information gathering, not therapeutic.
No.
The device is intended for monitoring, recording, and alarming of physiological parameters, not for diagnosing medical conditions.
Unknown
The provided 510(k) summary does not contain a "Device Description" section, which is crucial for determining if the device is software-only. The information about monitoring physiological parameters and correlating to an auscultatory reference standard suggests potential hardware components for data acquisition, but this cannot be confirmed without a device description.
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 (e.g., heart rate, blood pressure, oxygen saturation).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on bodily fluids, or diagnosing conditions based on laboratory analysis.
The device described is a patient monitor, which is a type of medical device used for real-time physiological monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.
Product codes (comma separated list FDA assigned to the subject device)
74 MHX, 74 DSI, 74 MLD, 74 DRW, DSJ, DSK, DXN, 74 DRT, 74 FYW, 74 DXG, 74 DSA, 74 DRS, 73 CCK, 80 FLL
Device Description
The name of this device is Philips M2/M3/M4 Compact Portable 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
adults, pediatrics, and neonates
Intended User / Care Setting
hospital and medical transport 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)
The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients. The results of the validation study indicate that the device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
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.
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
K013427 p.1/2
NOV 2 9 2001
510 (k) Summary 8.0
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: 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 15 October, 2001
-
- The name of this device is Philips M2/M3/M4 Compact Portable Patient Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 74 | |||
| Cardiovascular | None | 74 MHX | Physiological |
| Monitor, Patient | |||
| Monitor | |||
| 870.1025, III | 74 DSI | Arrhythmia Detector | |
| and Alarm | |||
| 870.1025, III | 74 MLD | Monitor, ST Alarm | |
| 870.2350, II | 74 DRW | Electrocardiograph | |
| lead switching | |||
| adapter | |||
| 870.1100, II | DSJ | Alarm, Blood-Pressure | |
| 870.1110, II | DSK | Computer, Blood- | |
| Pressure | |||
| 870.1130, II | DXN | System, Measurement, | |
| Blood-Pressure, Non- | |||
| Invasive | |||
| 870.2300, II | 74 DRT | Cardiac Monitor | |
| 870.2340, II | 74 FYW | Electrocardiograph | |
| 870.1435, II | 74 DXG | Computer, Diagnostic, | |
| Pre-programmed, | |||
| Single Function | |||
| 870.2900, II | 74 DSA | Cable, Transducer and | |
| Electrode, including | |||
| Patient Connector | |||
| 870.2850, II | 74 DRS | Extravascular Blood | |
| Pressure Transducer | |||
| Panel 73 | |||
| Anesthesiology | 868.1400, II | 73 CCK | Carbon Dioxide Gas |
| Analyzer | |||
| Panel 80 | |||
| General | |||
| Hospital | 880.2910, II | 80 FLL | Clinical Electronic |
| Thermometer |
-
- The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
3.5
1
-
- The new device has the same intended use as the legally marketed predicate devices. M3 is used for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- The results of the validation study indicate that the device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2001
Mr. Dave Osborn Quality Program Manager Philips Medical Systems, Inc. Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01801
Re: K013427
Trade Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class III (three) Product Code: MHX Dated: November 12, 2001 Received: November 13, 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'Keefe Tiller
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Patient Monitor .
Intended for monitoring, recording, and alarming of multiple physiological Indications for Use: moreations for Ose. " - Intented rowneonates in hospital and medical transport environments.
(Please do not write below this line-continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Usc Use V V CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter
Division of Cardiovascular & Respiratory Devices
510(k) Number K013427