(243 days)
No
The document explicitly states that the algorithms present are limited to ST/AR ECG and SpO2, and there are no mentions of AI, DNN, or ML.
No.
The device aggregates, processes, distributes, and displays physiological data for monitoring and informational purposes, and is not designed to directly treat or cure a disease or condition.
Yes
The intended use explicitly states "Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices."
Yes
The device description explicitly states it is "software Release C.03" and runs on "off-the-shelf Windows PCs and servers," indicating it is a software application that utilizes existing hardware platforms. While it interacts with other medical devices for data, the core device being described is the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device's intended use: The Philips Patient Information Center iX software application is primarily focused on receiving, aggregating, processing, distributing, and displaying physiologic waves, parameters, alarms, and events from medical devices connected to patients. It also performs diagnostic 12-Lead analysis and interpretation based on raw ECG data samples from these devices.
- Lack of specimen analysis: The device does not analyze specimens derived from the human body (like blood, urine, tissue, etc.). Its inputs are physiological data directly from medical devices monitoring the patient.
- Focus on data management and display: While it performs some analysis (like ST/AR ECG and SpO2 algorithms, and 12-Lead analysis), its core function is the management, display, and distribution of patient data collected by other medical devices.
- Support for medical professional judgment: The intended use explicitly states that the information provided is intended to support the judgement of a medical professional and is not intended to be the sole source of information for decision making. This aligns with a device that provides information for monitoring and review, rather than a definitive diagnostic test based on specimen analysis.
Therefore, the Philips Patient Information Center iX software application falls under the category of a medical device that processes and displays physiological data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Philips Patient Information Center iX software application is to:
- Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients.
- . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2.
- Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
- Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
- Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
- Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.
The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Rx only.
Product codes
MHX, DSI, MLD, MSX, OUG
Device Description
The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.
Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.
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
Adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Intended User / Care Setting
Professional healthcare professionals.
Professional healthcare facilities.
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)
Nonclinical Performance Data: The M3290B Patient Information Center iX software Release C.03 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.
Clinical Data: Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 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.
Conclusion: 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, safety testing from hazard analysis and the non-clinical testing which complied with the requirements specified in the international and FDA-recognized consensus standards. Risk assessment was conducted to identify potential hazards, to estimate and to mitigate the risks. The identified risk control measures have been implemented, verified. and finally evaluated. The identified risks have been found to be reduced to an acceptable level. The testing and the risk controls demonstrate the subject device is as safe, as effective and performs as well as its predicate devices without raising any new safety and/or effectiveness concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Medical Systems Peng Cui, Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810
Re: K183387
Trade/Device Name: M3290B Patient Information Center iX 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, DSI, MLD, MSX, OUG Dated: April 26, 2019 Received: April 29, 2019
Dear Peng Cui:
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/cfpmp/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 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
M3290B Patient Information Center iX Release C.03
Indications for Use (Describe)
The intended use of the Philips Patient Information Center iX software application is to:
- Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients.
- . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2.
- Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
- Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
- Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
- Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.
The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Rx only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a solid blue. The letters are evenly spaced and appear to be a logo or brand name.
M3290B Patient Information Center iX Release C.03
This summary of safety and effectiveness information is submitted in accordance with 21CFR 8807.92
1. Submitter's name, address, telephone number, contact person.
- Manufacturer: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810, USA
- Peng Cui, Contact person: Sr. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810, USA Email: peng.cui(@philips.com Tel: (978) 659-7966
Date prepared: July 10, 2019
-
- Name of the device, including the trade or proprietarv name if applicable, the common or usual name, and the classification name, if known:
Common/usual name: Central Station M3290B Patient Information Center iX Proprietary name: Classification panel: Cardiovascular
- Name of the device, including the trade or proprietarv name if applicable, the common or usual name, and the classification name, if known:
This device is classified as follows:
| Classification | Classification Name | Product Code |
|---|---|---|
| 870.1025, II | Physiological Monitor, Patient Monitor | MHX |
| 870.1025, II | Arrhythmia Detector and Alarm | DSI |
| 870.1025, II | Monitor, ST Alarm | MLD |
| 870.2800, II | Recorder, Magnetic Tape, Medical | DSH |
| 870.2300, II | System, Network and Communication, | |
| Physiological Monitors | MSX | |
| 880.6310 I | Medical Device Data System | OUG |
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. The overall impression is clean and professional, reflecting the brand's image.
3. Predicate device information
Philips Medical Device believes the M3290B Patient Information Center iX (PIC iX) Release C.03 is substantially equivalent to the following legally marketed device:
| Predicate device | Manufacturer | 510(k) |
|---|---|---|
| M3290B Patient Information | ||
| Center iX Release C.01 | Philips Medical Systems | K163584 |
4. Device description
The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.
Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.
5. Intended use/Indications for use
The intended use of the M3290B Patient Information Center iX software application is to:
- Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.
- Determine alarm conditions and generate alarm signals for Philips approved medical o devices, that send physiological data and do not have the ability to determine the alarm condition.
- 트 Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.
- Generate alarm signals for user notification, based on the alarm signal determined and ● sent by Philips approved medical devices.
- Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a medium blue. The letters are closely spaced together, creating a solid block of text.
- Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
- Provide connection to other systems not associated with active patient monitoring, such ● as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.
The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Rx only.
The intended use/indications for use of M3290B Patient Information Center iX Release C.03, provided above, are same as that of the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01 (K163584).
6. Comparison of technical Characteristics with the predicate device
The M3290B Patient Information Center iX Release C.03 and the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01(K163584), employ the same fundamental scientific technology. The primary difference is the change in the QRS detection threshold. In M3290B Patient Information Center iX Release C.01(K163584), the minimum QRS detection threshold is fixed at 150uV and is not user adjustable. In M3290B Patient Information Center iX Release C.03, a manual mode of QRS detection has been added so that the minimum QRS detection threshold can be user adjustable. Note that the user adjustable minimum QRS detective threshold feature was cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261).
A comparison of the proposed M3290B Patient Information Center iX Release C.03 to the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01(K163584), is provided in Table 1 below:
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| Key
characteristic | M3290B PIC iX C.01
K163584 | M3290B PIC iX C.03 | Comment |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | (Predicate Device) | (Subject Device) | |
| Intended Use/
Indications for
use | The intended use of the M3290B
Patient Information Center iX
software application is to:
Receive, aggregate, process,
distribute and display
physiologic waves,
parameters, alarms and
events at locations other
than at the patient, for
multiple patients. Determine alarm conditions
and generate alarm signals
for Philips approved
medical devices, that send
physiological data and do
not have the ability to
determine the alarm
condition. Algorithms present
in the software are
limited to the
ST/AR ECG (for
arrhythmia, ST
Segment and QT
Segment
Monitoring) and
SpO2. Generate alarm signals for
user notification, based on
the alarm signal determined
and sent by Philips
approved medical devices. Perform diagnostic 12-Lead
analysis and interpretation
based on raw ECG data
samples provided from
Philips approved medical
devices. Result may be
displayed, printed and/or
distributed to Philips
approved medical devices. Provide review and trend
application data, designed to | Same | No change |
| | contribute to the screening of patient condition All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Rx only. | | |
| Minimum QRS detection threshold | fixed at 150 $\mu$ V | User adjustable with the following choices: 150 $\mu$ V 200 $\mu$ V 250 $\mu$ V | User adjustable Minimum QRS detection threshold feature was cleared on |
| | | 300 μV 350 μV | Philips ST/AR,
ST and
Arrhythmia
Algorithm
Software
(K014261) |
| Applications | Retrospective Review
Caregiver Assignment
Surveillance Display Management Patient Alarm measurement and
device control | Same | No Change |
| Domain-
Specific
Service | Physiological Data Source
Controls Wave Rendering Data Storage SR/AR Algorithm Alarm management Patient & Equipment
Management | PIC iX Release C.03 supports the
software version N.0 of the
existing IntelliVue Patient
Monitor (IPM) family and the
software C.01 of the MX40
monitor. PIC Ix Release C.03 cam show
the body sites where the Masimo
measurements (SpO2
measurements) are taken can.
There is no change to the Masimo
measurements themselves. | Non-significant
change. There is
no new clinical
feature added nor
new risk
identified. |
| Common
Services | Logging Event Notification Watchdog Audit Trail User Management Licensing | Same | No change |
| Outbound
Data Services | HL7/PPIS Paging Bed to Bed Overview Web/Mobility 12 Lead Data Warehouse | With PIC iX Release C.03, the
system scalability is increased to
Support up to 1600 beds 1600 subscriptions to a
dedicated web server 1600 subscriptions to a
dedicated mobility server two Data Warehouse Connect
repositories Currently, PIC iX sends partial
alarm information to CareEvent
reports. PIC iX Release C.03 | Non-significant
changes. There is
no new clinical
feature added. |
| | | allows all alarm information be
sent to CareEvent reports.
The PIC IX Release C.03 allows
user to select which alarms from
3rd party devices to display on
PIC iX and propagate through
PIC iX to HL7 and
CareEvent. This feature have no
impact to the 3rd party devices.
The alarms are always available
on the 3rd party devices PIC iX Release C.03 enables 3rd
party devices to do HL7 export of
alarm limit information through it
to EMR, in addition to the
currently available function of
passing numerical data. | |
| Platform | Windows 8.1 OS Windows Server 2012 R2 | Windows 10 IoT Enterprise 2016
LTSB
Windows Server 2016 | MS OS update. |
| Patient
Monitoring
Database | Database Database Access | Same | No Change |
| Data
Acquisition
Services | MDIL TeleMDIL Network Services | The PIC iX Release C.03 further
improves the cybersecurity, including
PIC iX-to-PIC iX Encryption and
Node, Authentication and STIG
implementation. | Cybersecurity
improvement. |
| Reporting | Printing Recording | With PIC iX Release C.03, user can
select printers to print information
from PIC iX. | Minor SW
enhancement. |
Table 1: Comparison Table
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M3290B PIC iX Release C.03
510(k) Summary
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M3290B PIC iX Release C.03
510(k) Summary
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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. The overall impression is clean and professional, reflecting the brand's image.
M3290B PIC iX Release C.03
7. Nonclinical Performance Data
The M3290B Patient Information Center iX software Release C.03 was tested in accordance with Philips verification and validation processes.
Quality Assurance measures were applied to the system design and development, including:
- o Risk Analysis
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- Product Specifications
- Design Reviews ●
- Verification & Validations ●
8. Clinical Data
Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 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.
9. Conclusion
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, safety testing from hazard analysis and the non-clinical testing which complied with the requirements specified in the international and FDA-recognized consensus standards. Risk assessment was conducted to identify potential hazards, to estimate and to mitigate the risks. The identified risk control measures have been implemented, verified. and finally evaluated. The identified risks have been found to be reduced to an acceptable level. The testing and the risk controls demonstrate the subject device is as safe, as effective and performs as well as its predicate devices without raising any new safety and/or effectiveness concerns. Therefore, M3290B Patient Information Center iX software Release C.03 is substantially equivalent to the legally marketed predicate device Philips M3290B Patient Information Center iX software Release C.01 (K163584) in terms of design features, fundamental scientific technology, intended use, and safety and effectiveness.