(54 days)
Not Found
Not Found
No
The summary describes standard image and data management, analysis, and reporting functions without mentioning AI, ML, or related concepts. The analysis and quantification mentioned are standard measurements (area, volume, etc.) and not indicative of AI/ML.
No
The device is described as an "integrated multimodality image and information system" for managing digital cardiovascular images, waveforms, and data. Its functions include import/export, storage, archiving, review, analysis, quantification, reporting, and database management, which are all related to information processing rather than direct therapeutic intervention.
Yes
The device performs analysis and quantification (e.g., area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) and reporting of digital cardiovascular images, waveforms, and data, which are functions typical of a diagnostic device in a clinical setting.
No
The description explicitly states that the software "runs on standard information technology hardware and software" and "will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components." This indicates the device is not solely software but relies on and integrates with specific hardware.
Based on the provided text, the Philips Xcelera software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that Xcelera is designed for processing, analyzing, and managing digital cardiovascular images, waveforms, and data. It does not mention the analysis of biological samples like blood, urine, or tissue.
- The functions described are related to image and data management and analysis. These are typical functions of medical imaging software, not IVD devices.
Therefore, based on the information provided, Philips Xcelera software is a medical imaging and information system, not an IVD.
N/A
Intended Use / Indications for Use
Philips Xcelera software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images.
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Product codes
90 LLZ
Device Description
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology,
Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Philips Medical Systems, Harmony, Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation
Reference Device(s)
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Koli995
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is presented in all capital letters and is horizontally oriented.
Philips Medical Systems
SEP - 6 2006
510(k) Summary
Philips Xcelera
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
I General Information
| Company Name: | Philips Medical Systems North America Company | |
|---|---|---|
| Address: | 22100 Bothell Everett Highway | |
| Bothell Washington 98021-8431 | ||
| USA | ||
| Contact Person | Lynn T. Harmer | |
| Telephone Number: | 425-478-7312 | |
| Prepared (date): | 2006 May 12 | |
| Manufacturing Site: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684 PC Best, The Netherlands | ||
| Device Name: | Philips Xcelera | |
| Classification Name: | Picture Archiving and Communication System | |
| Regulation number | 892.2050 | |
| Classification: | Class: II | |
| ProCode: | 90 LLZ | |
| Common/Usual Name: | Workstation | |
| Predicate Devices: | Philips Medical Systems, | |
| Harmony | ||
| Siemens Medical Systems Inc., | ||
| LEONARDO syngo Cardiology Workstation |
1
I I Information Supporting Substantial Equivalence Determination
System Description:
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology,
Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
Intended Use:
Philips Xcelera software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images.
General Safety and Effectiveness:
The Xcelera complies with ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Philips Xcelera does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Xcelera to be substantially equivalent to the Philips Medical Systems, Harmony (K022788) and the Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation (K042203).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 6 2006
Philips Medical Systems North America c/o Mr. Marc M. Mouser Program Reviewer Underwriters Laboratories, Inc. 2600 N. W. Lake Road CAMAS WA 98607-8542
K061995 Re:
Trade/Device Name: Philips Xcelera Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 4, 2006 Received: August 21, 2006
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booton's ro(t) predantially equivalent (for the indications for relerenced above and nave decemined anceted predicate devices marketed in interstate commerce use stated in the encrosury manations p Medical Device Amendments, or to devices that prob io May 26, 1770, the chaomistic date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosm have been recrassmed in accordance with and portication (PMA). You may, ACt (Act) that do flor require approval or a peneral controls provisions of the Act. The general therefore, mailier the device, subjoct to the general for annual registration, listing of devices, good controls provisions of also ing, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket II your device is classifica (see above) into entrols. Existing major regulations affecting your Approval), it thay be subject to such adamons. Title 21, Parts 800 to 898. In addition, FDA active can be round in the cements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo also features three stars at the bottom. The text is arranged around the circle's perimeter, and the FDA acronym is prominently displayed in the center.
d Promoting Public He
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of acressionation that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I bathar all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT Fart 6077, adoling (21 CFR Part 820); and if applicable, the electronic form in the quant) Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter wif anon you to ough finding of substantial equivalence of your device to a legally premaired predicated on: "The Dr. In a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rf you desire spoorned at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" / tion, prease note and regain other general information on your responsibilities under (21 CF R F art 60 : 37). I coof Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincercly yours,
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known):
Device Name: Philips Xcelera
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Hepson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
Page 1 of 1