(141 days)
Not Found
No
The description focuses on "motion compensated average stent image" and "radiopaque balloon markers" for enhanced visualization, which are traditional image processing techniques, not explicitly AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The explanation states it assists the physician by visualizing stent placement and deployment; it does not directly treat a disease or condition.
No
StentBoost Live is intended to assist the physician during percutaneous coronary interventions by providing enhanced visualization of stents and their relation to coronary vessels, and visualizing the placement and deployment of coronary stents. It supports treatment decisions but does not provide a diagnosis itself.
Yes
The device description explicitly states "StentBoost Live is a software medical device" and "does not come in contact with a human subject." While it connects to an X-ray system, the device itself is described as software that processes data from that system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
- StentBoost Live's Function: StentBoost Live is a software medical device that processes real-time X-ray data to enhance the visualization of stents within the patient's body during a medical procedure. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it assists the physician during percutaneous coronary interventions by visualizing the placement and deployment of coronary stents. This is an in-vivo (within the body) application.
- Device Description: The description confirms it's connected to an X-ray system and uses X-ray data as input, further supporting its in-vivo nature. It also explicitly states it "does not come in contact with a human subject," which is consistent with a software device processing imaging data, but not with an IVD that interacts with patient specimens.
Therefore, based on the provided information, StentBoost Live is a medical device used for image processing and visualization during a medical procedure performed on a patient, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
StentBoost Live is intended to assist the physician during percutaneous coronary interventions.
StentBoost Live provides real-time enhanced visualization of stents.
StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels.
StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents.
StentBoost Live is suitable for use with the entire adult human population.
StentBoost Live is a software medical device and does not come in contact with a human subject.
Product codes
OWB, LLZ
Device Description
StentBoost Live is a software medical device intended to provide enhanced visualization of stents in coronary vessels in real-time. It supports the physician in placing and deploying stents.
The StentBoost Live is connected to a Philips interventional X-ray System and uses X-ray generated data as input.
StentBoost Live uses radiopaque balloon markers to provide real-time stent enhanced visualization by displaying a motion compensated average stent image.
StentBoost Live provides X-ray System integration with the Philips interventional X-ray System to allow automatic power on and off of StentBoost Live. In addition the user interactions can be controlled from the table-side of the X-ray System.
StentBoost Live provides the option for the physician to create DICOM compatible snapshots and movies of the enhanced image for reporting and archiving when connected to a picture archiving and communication system (PACS).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray generated data
Anatomical Site
coronary vessels
Indicated Patient Age Range
entire adult human population
Intended User / Care Setting
Physician during percutaneous coronary interventions. Controlled in the exam room.
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
Algorithm verification testing: Dedicated algorithm verification testing has been performed with previously acquired x-ray data to ensure sufficient functioning of the algorithms. Verification consisted of determining marker pair detection performance and benchmark testing against the predicate device, StentBoost R4.
Usability validation: Was performed with representative intended users in a a) simulated environment.
Expert opinion Validation: The expert opinion validation was performed in a simulated environment with certified interventional cardiologists. Previously acquired x-ray data was used to allow the expert to evaluate a wide range of variance e.g. region to treat, detector format, patient, acquisition angles.
In-house simulated Validation: Validation protocols were created to address each clinical user need in the form of a device navigation workflow. Additional protocols were created to ensure that the Instructions for Use is written on the correct detail level as well as the verification of the effectiveness of the safety mitigations. The protocols were executed in a simulated clinical setting. The validation protocols have been performed by experienced Clinical Marketing Specialists with clinical knowledge gained from work experience and hospital visits. All test participants have experience in the relevant clinical area and therefore are considered equivalent to the intended operator profiles as defined in the Intended use.
Summary of Performance Studies
Non-clinical performance testing has been performed on StentBoost Live and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- IEC 62304 Medical device software - Software life cycle processes (Ed. 1.1, 2015-06).
- IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Ed. 1.0, 2015-02).
- ISO 14971 Medical devices – Application of risk management to medical devices (Ed. 2.0, 2007).
- ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Second Edition 2012-07-01).
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
- Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
- Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757).
The following software verification and validation activities have been performed for StentBoost Live:
- General verification testing: software verification has been performed to cover the system level requirements of the System Requirements Specification as well as the identified risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements. These protocols address functional and non-functional aspects of StentBoost Live such as reliability, performance and interoperability.
- Algorithm verification testing: Dedicated algorithm verification testing has been performed with previously acquired x-ray data to ensure sufficient functioning of the algorithms. Verification consisted of determining marker pair detection performance and benchmark testing against the predicate device, StentBoost R4.
Non-clinical software validation testing provided evidence for the intended use, user needs and claims:
- Usability validation: Was performed with representative intended users in a a) simulated environment.
- Expert opinion Validation: The expert opinion validation was performed in a simulated environment with certified interventional cardiologists. Previously acquired x-ray data was used to allow the expert to evaluate a wide range of variance e.g. region to treat, detector format, patient, acquisition angles.
- In-house simulated Validation: Validation protocols were created to address each clinical user need in the form of a device navigation workflow. Additional protocols were created to ensure that the Instructions for Use is written on the correct detail level as well as the verification of the effectiveness of the safety mitigations. The protocols were executed in a simulated clinical setting. The validation protocols have been performed by experienced Clinical Marketing Specialists with clinical knowledge gained from work experience and hospital visits. All test participants have experience in the relevant clinical area and therefore are considered equivalent to the intended operator profiles as defined in the Intended use.
StentBoost Live did not require clinical trials to establish substantial equivalence to the currently marketed StentBoost R4. Substantial equivalence was demonstrated with the following attributes:
- Indication for use;
- Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness.
The verification and validation test results of StentBoost Live, comprising of verification testing, usability validation, validation of the user needs and specific claims, and expert opinion validation are passed and support the safety and effectiveness of the product. It conforms to the intended use, the user needs and the claims and is therefore considered substantially equivalent to the currently marketed device StentBoost R4.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
Philips Medical Systems Nederland B.V. % Ms. Elaine Alan Regulatory Affairs Specialist Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K170144
Trade/Device Name: StentBoost Live Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: May 9, 2017 Received: May 10, 2017
Dear Ms. Alan:
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. 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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170144
Device Name
StentBoost Live
Indications for Use (Describe)
StentBoost Live is intended to assist the physician during percutaneous coronary interventions.
StentBoost Live provides real-time enhanced visualization of stents.
StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels.
StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents.
StentBoost Live is suitable for use with the entire adult human population.
StentBoost Live is a software medical device and does not come in contact with a human subject.
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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3
Image /page/3/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 word is centered and takes up most of the frame. The background is white.
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | January 13, 2017 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Veenpluis 4-6 | |
| 5684 PC Best | |
| The Netherlands | |
| Establishment Registration Number: 3003768277 | |
| Primary Contact | |
| Person: | Ms. Elaine Alan |
| Regulatory Affairs Specialist | |
| Phone: +1 858 764 1281 | |
| E-mail: elaine.alan@philips.com | |
| Secondary Contact | |
| Person: | Ms. Liselotte Kornmann, PhD |
| Senior Manager Regulatory Affairs | |
| Phone: +31 611621238 | |
| E-mail: liselotte.kornmann@philips.com | |
| Device: | |
| Trade Name: | StentBoost Live |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Regulation: | 21 CFR, Part 892.1650 |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Primary Product Code: | OWB (Interventional Fluoroscopic X-Ray system) |
| Secondary Product Code: | LLZ (System, Image Processing, Radiological) |
| Predicate Device: | |
| Trade Name: | StentBoost Rel. 4 |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) Clearance: | K132305 (October 30, 2013) |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Regulation: | 21 CFR, Part 892.1650 |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | OWB, LLZ |
4
| Device description: | StentBoost Live is a software medical device intended to provide enhanced
visualization of stents in coronary vessels in real-time. It supports the physician
in placing and deploying stents.
The StentBoost Live is connected to a Philips interventional X-ray System and
uses X-ray generated data as input.
StentBoost Live uses radiopaque balloon markers to provide real-time stent
enhanced visualization by displaying a motion compensated average stent
image.
StentBoost Live provides X-ray System integration with the Philips
interventional X-ray System to allow automatic power on and off of StentBoost
Live. In addition the user interactions can be controlled from the table-side of
the X-ray System.
StentBoost Live provides the option for the physician to create DICOM
compatible snapshots and movies of the enhanced image for reporting and archiving when connected to a picture archiving and communication system (PACS). |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | StentBoost Live, provided as accessory to the Philips Interventional X-ray
system, has the following indications for use:
StentBoost Live is intended to assist the physician during percutaneous coronary
interventions.
StentBoost Live provides real-time enhanced visualization of stents.
StentBoost Live provides real-time enhanced visualization of stents in relation to
coronary vessels.
StentBoost Live assists in the treatment of cardiovascular diseases by visualizing
the placement and deployment of coronary stents.
StentBoost Live is suitable for use with the entire adult human population.
StentBoost Live is a software medical device and does not come in contact with
a human subject. |
| | The indications for use of StentBoost Live are similar to the currently marketed
and predicate device StentBoost Rel. 4 except that:
The use of StentBoost Live is restricted to cardiovascular procedures
instead of both vascular and cardiovascular procedures. StentBoost Live provides real-time enhanced visualization of stents. |
| | However, the difference does not alter the intended use of the device nor does
it affect the safety and effectiveness of the device relative to the predicate
device. Both devices have the same intended use: they are accessories to the
currently marketed Philips Interventional X-ray system and both are X-ray
interventional applications which provide enhanced visualization of stents in relation to vessels and assist in the treatment of cardiovascular diseases through |
| Technological
characteristics: | StentBoost Live employs comparable technology as implemented in the
predicate device StentBoost Rel. 4 :
Both tools provide enhanced (i.e. motion-compensated average) stent
visualization of both a pre and post stent deployment created from markers
found in a 2D image sequence acquired on the interventional X-ray system Both tools provide full integration with the interventional X-ray system Both tools have Picture Archiving Communication System compatibility The technological differences between StentBoost Live and its predicate device
StentBoost Rel. 4 are noted below: For StentBoost Rel. 4 the enhanced image is only available once the
acquisition is completed where for StentBoost Live the enhanced image
visualization of the placement and deployment of the stent in the exam
room is in real-time. StentBoost Rel. 4 provides StentBoost Subtract mode of operation which is
not needed in StentBoost Live . StentBoost Rel. 4 provides StentBoost Vascular mode of operation which is
not supported in StentBoost Live . StentBoost Live provides improved workflow guidance. StentBoost Live is automatically switched on and off with the X-ray system
which is not available in the StentBoost Rel 4 . StentBoost Rel. 4 provides a manual measurement tool to measure the
diameter of a deployed stent which is not available in the StentBoost Live
since providing post-deployment stent measurements is not essential for
the workflow. The measurement functionality is still available through
other software tools provided by the Philips Interventional X-ray system. StentBoost Live can only be controlled in the exam room where StentBoost
Rel. 4 can be controlled in both the exam and control room. Due to the real-
time workflow of StentBoost Live , use outside of the exam room is not
needed. StentBoost Rel. 4 allows optional manual indication of the marker position
where StentBoost Live allows the user to indicate the marker search region
using the collimation feature of the Philips interventional X-ray system. The differences between StentBoost Live and the predicate device StentBoost
Rel. 4 do not raise any new questions regarding safety or effectiveness.
Based on the information provided above, StentBoost Live is considered
substantially equivalent to the primary currently marketed and predicate device
in terms of technological characteristics |
visualization of the placement and deployment of coronary stents.
5
Based on the information provided above, StentBoost Live is considered substantially equivalent to the predicate device StentBoost Rel. 4 in terms of Indications for Use.
6
Summary of Non-Clinical Performance Data:
Non-clinical performance testing has been performed on StentBoost Live and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- IEC 62304 Medical device software - Software life cycle processes (Ed. 1.1, 2015-06).
- . IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Ed. 1.0, 2015-02).
- ISO 14971 Medical devices – Application of risk management to medical devices (Ed. 2.0, 2007).
- . ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Second Edition 2012-07-01).
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
- Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
- . Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757).
The following software verification and validation activities have been performed for StentBoost Live:
- . General verification testing: software verification has been performed to cover the system level requirements of the System Requirements Specification as well as the identified risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements. These protocols address functional and non-functional aspects of StentBoost Live such as reliability, performance and interoperability.
- Algorithm verification testing: Dedicated algorithm verification testing has been performed with previously acquired x-ray data to ensure sufficient functioning of the algorithms. Verification consisted of determining marker pair detection performance and benchmark testing against the predicate device, StentBoost R4.
General Validation Results
Non-clinical software validation testing provided evidence for the intended use, user needs and claims:
- Usability validation: Was performed with representative intended users in a a) simulated environment.
- b) Expert opinion Validation: The expert opinion validation was performed in a
7
simulated environment with certified interventional cardiologists. Previously acquired x-ray data was used to allow the expert to evaluate a wide range of variance e.g. region to treat, detector format, patient, acquisition angles.
- c) In-house simulated Validation: Validation protocols were created to address each clinical user need in the form of a device navigation workflow. Additional protocols were created to ensure that the Instructions for Use is written on the correct detail level as well as the verification of the effectiveness of the safety mitigations. The protocols were executed in a simulated clinical setting. The validation protocols have been performed by experienced Clinical Marketing Specialists with clinical knowledge gained from work experience and hospital visits. All test participants have experience in the relevant clinical area and therefore are considered equivalent to the intended operator profiles as defined in the Intended use.
| Summary of Clinical | StentBoost Live did not require clinical trials to establish substantial equivalence |
|---|---|
| Performance Data: | to the currently marketed StentBoost R4. Substantial equivalence was |
| demonstrated with the following attributes: | |
- Indication for use;
- . Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness.
Verification and validation tests as described above were performed on the StentBoost Live according to the following FDA-recognized consensus standards and FDA guidance documents:
- . IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79,
- IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0, 2015-02). FDA/CDRH recognition number 5-95,
- . Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757),
- . Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Conclusion: The verification and validation test results of StentBoost Live, comprising of verification testing, usability validation, validation of the user needs and specific claims, and expert opinion validation are passed and support the safety and effectiveness of the product. It conforms to the intended use, the user needs and the claims and is therefore considered substantially equivalent to the currently marketed device StentBoost R4.
StentBoost Live is substantially equivalent to the predicate device StentBoost Substantial Rel. 4 in terms of indications for use, technological characteristics and safety and Equivalence
8
Conclusion:
effectiveness.
Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that StentBoost Live complies with the requirements specified in the international and FDA-recognized consensus standards and is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness questions.