(24 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring and alarm generation without mentioning any advanced analytical capabilities.
No.
The device is indicated for monitoring and recording physiological parameters, which is diagnostic, not therapeutic.
No
The device is a patient monitor, indicated for monitoring and recording physiological parameters and generating alarms. It does not state that it is used to diagnose diseases or conditions, but rather to monitor existing physiological states.
No
The device description explicitly names the device as the "MX40 patient monitor," which is a hardware device. The summary also mentions "system level tests, performance tests, and safety testing from hazard analysis" and "reliability requirements and performance claims," which are typical for hardware devices. The predicate devices listed are also hardware patient monitoring systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the physiological parameters of patients" and "monitoring and recording of, and to generate alarms for, multiple physiological parameters". This describes a device that interacts directly with the patient to measure their vital signs, not a device that analyzes samples taken from the body (which is the core function of an IVD).
- Device Description: The description "MX40 patient monitor" further supports that it's a device used for patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the MX40 patient monitor is a patient monitoring device, not 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 of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Product codes (comma separated list FDA assigned to the subject device)
74 MHX, DSI, MLD, DRW, DQA, DSA, MSX, DRG
Device Description
The new device is substantially equivalent to the previously cleared TRx4841A, IntelliVue Telemetry System Transceiver marketed pursuant to K040357, K041741, K081793, K062392, and K063725.
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 and pediatrics
Intended User / Care Setting
health care professionals / hospital environment and during patient transport inside hospitals. Not intended for home use.
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 MX40 patient monitor meets all defined 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.
K040357, K041741, K081793, K062392, K063725
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
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:
…
Claire Arakaki Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems . 3000 Minuteman Road, MS0480 Andover, MA 01810-1099 Tel: 978 659 4348 Fax: 978 685 5624 Email: claire.arakaki@philips.com
This summary was prepared on 10 December 2010.
The name of this device is the MX40 patient monitor. Classification names are as follows:
. "
. . . . . . . . . . .
| Classification | ProCode | Description |
|---|---|---|
| none | 74 MHX | Physiological Monitor, Patient Monitor |
| §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) | ||
| §870.2350, II | DRW | Electrocardiograph, Lead Switching Adapter |
| §870.2700, II | DQA | Oximeter |
| §870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient |
| Connector | ||
| §870.2300, II | MSX | System, Network and Communication, Physiological |
| Monitors | ||
| §870.2910, II | DRG | Transmitters and Receivers, Physiological Signal, |
| Radiofrequency |
The new device is substantially equivalent to the previously cleared TRx4841A, IntelliVue Telemetry System Transceiver marketed pursuant to K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.
The new device has the same Indications for Use and Intended Use as the legally marketed predicate devices.
The new device has the same technological characteristics as the legally marketed predicate devices. .
JAN - 7 2011
1
K103646
p2/2
JAN - 7 2011
. "…
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 MX40 patient monitor meets all defined reliability requirements and performance claims.
11.00 . . . .
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Page 70
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized symbol with three curved lines resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically along the left side of the symbol. The text is in a smaller font size compared to the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
JAN - 7 2011
Philips Medical Systems c/o Ms. Claire Arakaki Regulatory Affairs Specialist 3000 Minuteman Road, MS 0480 Andover, MA 01810-1099
Re: K103646
Trade/Device Name: Philips MX40 IntelliVue patient monitors Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: December 10, 2010 Received: December 14, 2010
Dear Ms. Arakaki:
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 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 - Ms. Claire Arakaki
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
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
JAN - 7 2011
510(k) Number (if known):
Device Name: _ _ _ _ MX40 IntelliVue 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 for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Prescription Use .. Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K103646 |