(142 days)
Unknown
The summary mentions "image software processing algorithms" for segmentation and registration, which could potentially utilize AI/ML. However, there is no explicit mention of AI, ML, deep learning, or any related terms, nor is there information about training or test sets typically associated with AI/ML development. The description is too general to definitively confirm or deny the presence of AI/ML.
No
The device provides navigation support for instruments, overlays imaging data, and allows for segmentation and visualization of anatomical structures. It does not directly provide therapy; rather, it aids in guiding therapeutic procedures.
No
The device is intended to provide navigation support for intra-cardiac instruments by overlaying pre-acquired anatomical image data over live fluoroscopic X-ray images. It is not used to diagnose a medical condition.
No
The device description explicitly states that the software processing algorithms are executed on a "PC based hardware platform" and that the system is "connected to an Allura Xper system," indicating reliance on specific hardware components beyond just the software itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device processes medical images: The EP navigator's intended use and description clearly state that it processes and overlays medical image data (CT, X-ray) to aid in navigation during interventional procedures. It does not analyze biological samples.
Therefore, the EP navigator falls under the category of medical imaging software or image-guided surgery systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy.
Patient population EP navigator is intended to be used with patients who suffer from heart rhythm disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.
Contact with body part / tissue type The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).
Operator profile The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist. Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.
Contra-indications Within the mentioned patient population, there are no contraindications.
EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ, LLZ
Device Description
EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions:
- segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG))
- superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system,
- . register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures.
- The 3D segmented data set can be displayed with a color map annotation received ● from an external source.
- position visual markers on the 3D volume ●
- visualize the inside of the 3D volume (EndoView) .
- certain buttons on the user interface control EP Logix functions; ●
- visual marker positions are transmitted to EP Logix; .
- color map information is received from EP Logix. .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM 3D CT or other image data, live fluoroscopic X-ray images
Anatomical Site
Heart and surrounding tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operator profile The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist. Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.
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
Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. Corresponding clinical evaluation report and test results are included in this submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical evaluation was performed to show safety and effectiveness to of EP-Navigator in the intended clinical environment. Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. Corresponding clinical evaluation report and test results are included in this submission.
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.
K062650, K042293, K042334, K040254, K060749
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
§ 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).
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Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the handwritten text "KL01311". The text is smaller than the word "PHILIPS" and is written in black ink.
510(k) Summary
, ৮
The following information is submitted in accordance with the requirements of 21CFR 807.92.
ldentification of manufacturer
| Company: | Philips Medical Systems Nederland B.V |
|---|---|
| Address: | Veenpluis 4-6, |
| 5684-PC, Best, The Netherlands | |
| Registration number: | 3003768277 |
ldentification of submitter
| Name: | Lynn Harmer |
|---|---|
| Position: | Senior Manager, Regulatory Affairs |
| Telephone: | (425) 487-7312\ |
| Fax: | (425) 487-8666 |
| Date prepared: | May 7, 2010 |
Device identification
| Trade name: | Philips |
|---|---|
| Device name: | EP navigator |
| Regulation description: | Picture archiving and communications system |
| Regulation number: | 21CFR 892.2050 |
| Class: | II |
| Product code: | 90L--LZ |
Legally marketed devices
| Trade names: | Philips EP navigator, Philips Brilliance CT,
Philips Allura 3D-CA, Philips Integris 3D-RA,
Philips Xper CT, GE Innova Vision Applications |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips and GE |
| 510(k) numbers: | K062650, K042293, K042334, K040254, K060749
K092639 |
1
Device description
EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions:
- segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG))
- superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system,
- . register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures.
- The 3D segmented data set can be displayed with a color map annotation received ● from an external source.
- position visual markers on the 3D volume ●
- visualize the inside of the 3D volume (EndoView) .
- certain buttons on the user interface control EP Logix functions; ●
- visual marker positions are transmitted to EP Logix; .
- color map information is received from EP Logix. .
Intended use
EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.
Indications for Use
Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-rav images of the same anatomy.
Patient population EP navigator is intended to be used with patients who suffer from heart rhythm disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.
Contact with body part / tissue type The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).
Operator profile The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist. Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.
Contra-indications Within the mentioned patient population, there are no contraindications.
510(k) Summary
2
Technological characteristics
EP navigator image software processing algorithms are executed on a PC based hardware platform
Summary of testing
EP navigator 3 complies with standards as detailed in annex 009 of this premarket submission. Clinical evaluation was performed to show safety and effectiveness to of EP-Navigator in the intended clinical environment. Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. Corresponding clinical evaluation report and test results are included in this submission.
Conclusion:...................................EP-Navigator is substantially equivalent to the currently legally marketed devices.
This opinion is based on the following:
- EP navigator does not introduce new indications for . use,
- . EP navigator has the same technological characteristics as the predicate devices,
- EP navigator does not introduce new potential haz-. ards or safety risks.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Evert Highway BOTHELL WA 98041-3003
SEP 3 O 2010
Re: K101311
Trade/Device Name: EP Navigator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2010 Received: May 11, 2010
Dear Ms. Harmer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Kl01311
Image /page/5/Picture/1 description: The image shows the word "Philips" in a stylized, bold font. The letters are black and have a slightly distressed or textured appearance. The word is presented in a single line and is centered in the image.
Appendix 005
Indications for Use Statement
Device Name
EP navigator
Indications for Use
Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as calheters and guidewires, during the interventional treatment of heart rhythm dlsorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic Xray images of the same anatomy.
Patient population EP navigator is intended to be used with panents who suffer from heart rhything disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.
Contact with body part / tissue type The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).
Operator profile The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist
Application EP navigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.
Contra-Indications Within the mentioned patient population, there are no contra-indications.
Intended use
EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.
Prescription Use __yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indications for Use Statement.docx
1/1
(Division Sign-Off) (Division of Radiological Devices Division of Radiological Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety
K101311
510K