(203 days)
No
The document describes a standard multi-parameter patient monitor and its accessories, focusing on physiological data acquisition, monitoring, and alarming. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is a patient monitor, which is used for monitoring and recording physiological parameters, not for providing therapy.
No
The device is described as a "patient monitor" intended for "monitoring and recording" physiological parameters and generating alarms. It does not state that it is used to diagnose a medical condition.
No
The device description explicitly states it is a "multi-parameter, battery operated patient monitor" and mentions hardware components like radios and compatibility with physical accessories (SpO2 and NBP Pods).
Based on the provided text, the device described (MX40) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics". This involves measuring physiological signals directly from the patient's body (e.g., oxygen saturation, pulse rate, blood pressure).
- Device Description: The description reinforces this by mentioning it's a "multi-parameter, battery operated patient monitor" that acquires "physiological data". It also mentions compatibility with accessories that measure "oxygen saturation, pulse rate and blood pressure".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are specifically designed to perform tests on samples taken from the body, not to directly monitor physiological parameters within the body. The MX40 is a patient monitor, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The intended use of the MX40 is to:
The device is 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.
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.
Rx only.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DOA, DRW, DSA, MSX, DRG, DRT, DSI, MLD
Device Description
The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the Intellivue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).
Previously cleared compatible Accessories are still in use, compatibility to additional Massimo accessories are documented in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.
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 in a 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)
Summary of Non-clinical testing
No performance standards have been issued under the authority of Section 514. The MX40 Release C.01 was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:
- . Risk Analysis
- Product Specifications
- . Design Reviews
- . Verification & Validations
Summary of Clinical Testing
Clinical Performance testing for MX40 Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence.
Conclusions drawn from the Non-clinical and Clinical testing
Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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 MX40 Release B.07 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.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2018
Philips Medical Systems Theresa Poole Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810
Re: K180017
Trade/Device Name: MX40 Release C.01 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DOA, DRW, DSA, MSX, DRG, DRT, DSI, MLD Dated: June 25, 2018 Received: June 27, 2018
Dear Theresa Poole:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Dilorali Castillo.
For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Philips MX40 Release C.01
Indications for Use (Describe)
The intended use of the MX40 is to:
The device is 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.
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, blue, bold letters. Below the word "PHILIPS" are the words "MX40 Release C.01" and "Special 510(k)". The words "MX40 Release C.01" and "Special 510(k)" are in a smaller font than the word "PHILIPS".
510(k) Summary MX40 Release C.01
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).
Date Prepared:
29 December 2017
l. Submitter's name and address
Manufacturer: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 USA
Contact Person: Theresa Poole Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Tel: 978 659 7621 Fax: 978 685 5624 Email: theresa.poole@philips.com
II. Device information
Device Name: MX40 Release C.01 Common Name: Physiological Monitor, Patient Monitor Classification panel: 74 - Cardiovascular
Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| §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 |
| §870.2300, II | DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
4
Image /page/4/Picture/0 description: The image shows the text "510(k) Summary K180017" in bold, black font. The text is horizontally aligned and appears to be a title or heading. The text likely refers to a summary related to a 510(k) premarket submission to the FDA, with "K180017" possibly being a reference or tracking number.
Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in a large, blue, sans-serif font. Below the word "PHILIPS" is the text "MX40 Release C.01" in a smaller, black, sans-serif font. Below that is the text "Special 510(k)" in the same font and color.
III. Predicate device information
| Trade name: | INTELLIVUE MX40 PATIENT MONITOR |
|---|---|
| Manufacturer: | Philips Medical Systems |
| 510(k) clearance: | K172226 |
| Classification name: | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) |
| Device class: | Class II |
| Classification regulation: | 21 CFR 870.1025 |
| Classification panel: | Cardiovascular |
| Product code: | MHX |
IV.Device Description
The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the litelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).
Previously cleared compatible Accessories are still in use, compatibility to additional Massimo accessories are documented in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.
V. Intended use/ Indications for Use
| MX40 Intended
Use/Indications for Use | The intended use of the MX40 is to:
The device is 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.
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.
Rx only. |
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in blue font at the top. Below that is the text "MX40 Release C.01" and "Special 510(k)". The text is in black font and is smaller than the word "PHILIPS".
Comparison of Technological Characteristics with the Predicate Device
The device has the same technological characteristics as the legally marketed predicate devices. The change summary includes items listed in the table starting on page 4.
6
Image /page/6/Picture/0 description: The image shows the Philips logo in blue, followed by the text "MX40 Release C.01" and "Special 510(k)" in black. The Philips logo is a stylized version of the company's name. The text below the logo appears to be related to a specific product or software release, possibly indicating a special version of the MX40 that complies with the 510(k) regulatory requirements. The text is centered below the logo.
| Key Characteristic | Predicate K172226 (9 November 2017)
Philips IntelliVue MX40 Release B.07 | MX40 Release C.01 |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Indications for Use
Intended Use
Statement | 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.
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. | Same |
| Target Patient
Population | Adult and pediatric | Same |
| Users | Trained health care professionals | Same |
| System Interface | Connects to the Philips IntelliVue
Information Center for transmission of
patient parameters | Same |
| Care and Cleaning | Available instructions in IFU | Same |
| Communication | Smart Hopping 1.4GHz (CTS) Radio
802.11a/b/g/h Radio
Short Range Radio 2.4 GHz | Same |
| Multi-Parameter
patient monitoring | ECG, Resp, SpO2, and NIBP (data
acquisition for NIBP is not done by the
MX40) | Same |
| Device Software,
Device safety,
environmental
specifications, and
all specifications of | Unchanged, as previously submitted | Masimo SET SpO2
measurement technology |
| measurement
characteristics | | |
| Device Accessories | Unchanged, as previously submitted | Masimo SET SpO2 Accessory
compatibility added |
| Device Hardware | Unchanged, as previously submitted | Same |
| Charging method | Unchanged, as previously submitted | Same |
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Image /page/7/Picture/0 description: The image shows the Philips logo in blue, followed by the text "MX40 Release C.01" and "Special 510(k)" in black. The Philips logo is in a bold, sans-serif font. The text below the logo is in a smaller, serif font. The image is likely a product label or a document header.
510(k) Summary K180017
Summary of Non-clinical testing
No performance standards have been issued under the authority of Section 514. The MX40 Release C.01 was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:
- . Risk Analysis
- Product Specifications ●
- . Design Reviews
- . Verification & Validations
Summary of Clinical Testing
Clinical Performance testing for MX40 Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence.
Conclusions drawn from the Non-clinical and Clinical testing
Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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 MX40 Release B.07 meets all defined reliability requirements and performance claims.
VI.Conclusion
In summary, there is no change in either intended use or in the fundamental scientific technology employed by the MX40 patient monitor in the modification for C.01. We consider these device modifications to be substantially equivalent to previously cleared devices. Additionally, substantial equivalence was demonstrated with non-clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.