(21 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on software updates for a patient monitor.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for treating conditions.
No
The device is indicated for "monitoring, recording and alarming of multiple physiological parameters," not for diagnosing conditions.
No
The device description explicitly states it is a "Compact Portable Patient Monitor" and the modification is a software release for this monitor, implying the existence of hardware. The testing also mentions system-level tests and safety testing from hazard analysis, which are typically associated with hardware devices.
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 of adults, pediatrics and neonates". This involves measuring physiological signals directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation), not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description refers to a "Patient Monitor", which is a device used to directly measure and display physiological parameters from a living patient.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly monitors the patient's physiological state.
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 patients.
Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.
Product codes
MHX, DSJ, DSK, DXN, DXG, DRT, DPS, DQA, DRS, DSA, CCK, FLL
Device Description
The names of the devices are the Philips M3046B Compact Portable Patient Monitors.
The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and Accessories.
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, pediatric, and neonates
Intended User / Care Setting
health care professionals, in healthcare environments and during transport within healthcare 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)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testinq 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 M3046B Compact Portable Patient Monitors meets all reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971910, К981576, К990972, К991773, К992273, К993383, К000822, К001057, K001333, K003621
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K052707 p.112
7.0 510(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 CFR 807-92.
- The submitter of this pre-market notification is: Michael J. Doyle Philips Medical Systems - Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810 United States Tel: 978-659-3198 Fax: 978-659-3819 Email: mike.doyle@philips.com
This summary was prepared on September 26, 2005.
- The names of the devices are the Philips M3046B Compact Portable Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | 870.1025, II | MHX | Monitor, Physiological, |
| Patient (with arrhythmia | |||
| detection or alarms) | |||
| 870.1110, 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 | |||
| 870.2300, II | DRT | Monitor, Cardiac (incl. | |
| Cardiotachometer & Rate | |||
| Alarm | |||
| 870.2340, II | DPS | Electrocardiograph | |
| 870.2700, II | DQA | Oximeter | |
| 870.2850, II | DRS | Extravascular Blood | |
| Pressure Transducer | |||
| 870.2900, I | DSA | Cable, Transducer and | |
| Electrode, incl. Patient | |||
| connector | |||
| Anesthesiology | |||
| & Respiratory | |||
| Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| General | |||
| Hospital and | |||
| Personal Use | 880.2910, II | FLL | Thermometer, Electronic, |
| Clinical |
- The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K971910,
1
К981576, К990972, К991773, К992273, К993383, К000822, К001057, K001333, and K003621.
-
The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and Accessories.
-
The modified devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatric, and neonates in healthcare environments and during transport within healthcare environments.
-
The modified devices have the same technological characteristics as the legally marketed predicate devices.
-
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testinq 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 M3046B Compact Portable Patient Monitors meets all reliability requirements and performance claims.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Mr. Michael J. Doyle Regulatory Specialist 3000 Minuteman Road Andover, MA 01810
Re: K052707
Trade Name: M3046B Compact Portable Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: September 27, 2005 Received: September 29, 2005
Dear Mr. Doyle:
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. Michacl J. Doyle
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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mesa Aoy
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052707
Device Name: Philips M3046B Compact Portable Patient Monitor
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.
| Prescription Use: | Yes |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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)
Moth
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K052707
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