(203 days)
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.
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.
The provided text is a 510(k) summary for the Philips MX40 Release C.01, a physiological patient monitor. It describes the device, its intended use, and a comparison with a predicate device (Philips IntelliVue MX40 Release B.07).
However, this document does not contain the specific information required to answer your request regarding acceptance criteria and the study proving the device meets them.
The document states:
- "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."
- "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."
- "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."
This indicates that the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing (system level tests, performance tests, and safety testing based on hazard analysis) and adherence to Philips' internal verification and validation processes, rather than conducting a new clinical study with specific acceptance criteria as one might expect for a novel device or a device with new clinical applications.
Therefore, I cannot provide the requested information from this document for the following reasons:
- A table of acceptance criteria and reported device performance: This document explicitly states that "No performance standards have been issued." While it mentions "Pass/Fail criteria were based on the specifications cleared for the predicate device," these specific criteria and the detailed performance results are not provided in this summary.
- Sample size used for the test set and data provenance: The document mentions "non-clinical performance testing" and "system level tests, performance tests, and safety testing," but does not specify sample sizes or data provenance (e.g., number of patients, records, or the nature of the test data).
- Number of experts used to establish ground truth and qualifications: This information would typically be relevant for clinical studies or studies establishing ground truth, which were not performed for this 510(k) as per the document.
- Adjudication method for the test set: Not applicable as a clinical study for establishing ground truth was not performed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states, "Clinical Production testing for MX40 Release C.01 was not performed." Therefore, no MRMC study was conducted.
- Standalone (algorithm only without human-in-the-loop performance) study: This would typically refer to AI/ML device performance. The MX40 is a physiological monitor, not an AI/ML algorithm in the context typically discussed for standalone performance. Its functions are monitoring and alarm generation for vital parameters. The document focuses on hardware, software, and accessory changes.
- Type of ground truth used: Not explicitly stated, as clinical performance testing was not performed. The "ground truth" for the non-clinical testing would be the established specifications and expected performance of the predicate device.
- Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) pertains to a modification of an existing physiological monitor, and its acceptance criteria and proof of performance are based on demonstrating substantial equivalence through non-clinical verification and validation against the predicate device's established specifications, rather than a new clinical study with the type of data points you are requesting.
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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
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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
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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) |
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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 IntendedUse/Indications for Use | The intended use of the MX40 is to:The device is intended for monitoring and recording of and to generatealarms for, multiple physiological parameters of adults and pediatrics in ahospital environment and during patient transport inside hospitals. Notintended for home use. Intended for use by health care professionals.Indications for UseIndicated for use by health care professionals whenever there is a needfor monitoring the physiological parameters of patients. Intended formonitoring and recording of, and to generate alarms for, multiplephysiological parameters of adults and pediatrics in hospitalenvironments 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.
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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 UseIntended UseStatement | Indicated for use by health careprofessionals whenever there is a needfor monitoring the physiologicalparameters of patients. Intended formonitoring and recording of, and togenerate alarms for, multiplephysiological parameters of adults andpediatrics in hospital environmentsand during transport inside hospitals.Intended for monitoring and recordingof and to generate alarms for, multiplephysiological parameters of adults andpediatrics in a hospital environmentand during patient transport insidehospitals. Not intended for home use.Intended for use by health careprofessionals. | Same |
| Target PatientPopulation | Adult and pediatric | Same |
| Users | Trained health care professionals | Same |
| System Interface | Connects to the Philips IntelliVueInformation Center for transmission ofpatient parameters | Same |
| Care and Cleaning | Available instructions in IFU | Same |
| Communication | Smart Hopping 1.4GHz (CTS) Radio802.11a/b/g/h RadioShort Range Radio 2.4 GHz | Same |
| Multi-Parameterpatient monitoring | ECG, Resp, SpO2, and NIBP (dataacquisition for NIBP is not done by theMX40) | Same |
| Device Software,Device safety,environmentalspecifications, andall specifications of | Unchanged, as previously submitted | Masimo SET SpO2measurement technology |
| measurementcharacteristics | ||
| Device Accessories | Unchanged, as previously submitted | Masimo SET SpO2 Accessorycompatibility 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.
§ 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.