(25 days)
Not Found
No
The summary describes image processing software that visualizes functional parameters from DSA data. There is no mention of AI, ML, or related concepts like training or test sets for model development. The performance studies focus on software verification and validation against standards and predicate devices, not on evaluating AI/ML model performance.
No
The device is described as a software product that "assists in the diagnosis of perfusion of tissues," providing color-coded representations and comparative images based on DSA. Its function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "SmartPerfusion assists in the diagnosis of perfusion of tissues". This phrase directly indicates its role as a diagnostic aid.
Yes
The device description explicitly states "SmartPerfusion is a software product" and it is provided as an "accessory" to a Philips Interventional X-ray system, implying it is a software component that processes data from existing hardware. The performance studies focus on software verification and validation, not hardware performance.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states that SmartPerfusion "assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA)". This is a diagnostic aid based on imaging data from a medical imaging procedure performed on the patient's body.
- Device Description: It is described as a "software product (Interventional Tool)" that provides "color coded representation of a digital subtraction angiography (DSA)". This further reinforces its role in processing and visualizing imaging data.
- Input Imaging Modality: The input is "digital subtraction angiography (DSA)", which is an imaging technique performed on a living patient.
- Lack of Biological Samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis. There is no mention of the device analyzing any biological samples.
The device is clearly focused on processing and presenting imaging data obtained from a patient during a medical procedure, which falls under the category of medical imaging software or a diagnostic imaging aid, not an IVD.
N/A
Intended Use / Indications for Use
SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.
Product codes (comma separated list FDA assigned to the subject device)
OWB, LLZ
Device Description
SmartPerfusion is a software product (Interventional Tool) that provides color coded representation of a digital subtraction angiography (DSA). It can visualize multiple functional parameters related to the time density function. It also provides a comparison between pre-, peri-, and post-procedural color coded images. SmartPerfusion is provided as an accessory to the Philips Interventional X-ray system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital subtraction angiography (DSA), angiography X-ray images
Anatomical Site
any location in the body where DSA is used. Anatomical area – General vasculature. Not anatomy specific
Indicated Patient Age Range
SmartPerfusion is suitable for use with the entire human population.
Intended User / Care Setting
The Operator is a physician or other qualified healthcare professional who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure, for example: Interventional radiologist Interventional neuro-radiologist Vascular surgeon and Podiatrists Interventional Cardiologist Skilled radiology technician (or nurse) assisting the physician Oncologist
Clinical Environment: SmartPerfusion can be used in the control room and in the exam room of an interventional suite or operating room. SmartPerfusion is a software application and does not come in contact with the patient.
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)
Non-clinical performance testing has been performed on the proposed device SmartPerfusion and the proposed device demonstrates compliance with the following FDA recognized consensus standards and FDA guidance documents:
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life ● cycle processes. FDA/CDRH recognition number 13-79;
- IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 including corrigendum, 2015). FDA/CDRH recognition number 5-114;
- ISO 14971 Second Edition 2007-03-01 Medical devices Application ● of risk management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40;
- ISO15223-1 Third Edition 2016-11-01 Medical devices Symbols to ● be used with medical device labels, labelling and information to be supplied - Part 1: General requirement. FDA/CDRH recognition number 5-117:
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). FDA/CDRH recognition number 12-300
- "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);
- "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014 (document number 1825);
- "Guidance for Industry and FDA Staff The 510(k) Program: ● Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ", July 28, 2014 (document number 1766).
- Guidance for Industry. FDA Reviewers and Compliance on "Guidance . for Off-the-Shelf Software Use in Medical Devices, September 1999"
Software verification testing has been performed to verify the modifications as per pre-determined System Requirements Specification and acceptance criteria.The verification tests and acceptance criteria were identified based on Risk Assessent. Cybersecurity risks were assessed and privacy and Security requirements were identified and verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix and to verify the Privacy and Security requirements for SmartPerfusion have been implemented. Verification results demonstrated that all executed tests were passed.
Non clinical software validation testing has been performed to validate the intended use, claims, user needs, service user needs, effectiveness of safety messures and Instructions for use.
Software validation testing has been performed to validate that SmartPerfusion conforms to its intended use, claims and user needs.
All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartPerfusion:
- complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and
- meets the acceptance criteria and is adequate for its intended use.
Based on the information provided above, the proposed device SmartPerfusion is substantially equivalent to the predicate device 2D Perfusion (K132147) in terms of safety and effectiveness. SmartPerfusion does not require a clinical study as the substantial equivalence Summary of with the predicate device 2D Perfusion (K132147) is demonstrated with the following attributes: Indication for use; ● Technological characteristics; . . Non-clinical performance testing, including safety and effectiveness. Non-clinical performance data provides sufficient evidence that the subject device works as intended The verification and validation test results of the modified device SmartPerfusion described above 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 predicate device 2D Perfusion (K132147).
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.
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.
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
§ 892.1650 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
August 17, 2018
Philips Medical Systems Nederland B.V. % Chandrika Srinivasan Senior Regulatory Affairs Specialist Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K181966
Trade/Device Name: SmartPerfusion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, LLZ Dated: July 20, 2018 Received: July 23, 2018
Dear Chandrika Srinivasan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hsl. 2. Nils
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) K181966
Device Name SmartPerfusion
Indications for Use (Describe)
SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | Aug 14, 2018 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Chandrika Srinivasan | |
| Regulatory Affairs Officer | ||
| Phone: +9180 41894132 | ||
| E-mail: chandrika.s@philips.com | ||
| Secondary Contact | ||
| Person: | Marta Walker | |
| Head of Regulatory Affairs IGT Systems | ||
| Phone: +31 631978546 | ||
| E-mail: marta.walker@philips.com | ||
| Device: | Trade Name: | SmartPerfusion |
| Release Number: | Release 1.0 | |
| Classification Name: | Image intensified fluroscopic x-ray system | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | OWB (Interventional Fluoroscopic X-Ray system) | |
| LLZ (System, Image Processing, Radiological) | ||
| Predicate Device: | Trade Name: | 2D Perfusion |
| Manufacturer: | Philips Medical Systems Nederland B.V | |
| 510(k) Clearance: | K132147 (Dec 16, 2013) | |
| Classification Name: | Image intensified fluroscopic x-ray system | |
| Classification Regulation: | 21 CFR, Part 892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | OWB (Interventional Fluoroscopic X-Ray system) | |
| LLZ (System, Image Processing, Radiological) | ||
| Device description: | SmartPerfusion is a software product (Interventional Tool) that provides | |
| color coded representation of a digital subtraction angiography (DSA). It | ||
| can visualize multiple functional parameters related to the time density | ||
| function. It also provides a comparison between pre-, peri-, and post- | ||
| procedural color coded images. | ||
| SmartPerfusion is provided as an accessory to the Philips Interventional | ||
| X-ray system. | ||
| Indications for Use: | SmartPerfusion assists in the diagnosis of perfusion alterations of tissues | |
| based on digital subtraction angiography (DSA) and can be used for any | ||
| location in the body where DSA is used. | ||
| Patient Population | SmartPerfusion is suitable for use with the entire human population. | |
| Intended Operator | ||
| Profile | The Operator is a physician or other qualified healthcare professional | |
| who is fully skilled and responsible for sound clinical judgment and for | ||
| applying the best clinical procedure, for example: | ||
| Interventional radiologist Interventional neuro-radiologist Vascular surgeon and Podiatrists Interventional Cardiologist Skilled radiology technician (or nurse) assisting the physician Oncologist | ||
| General safety and | ||
| effectiveness | To facilitate safe and efficacious operation of the system by a trained | |
| healthcare professional, instructions for use are provided as part of the | ||
| device labeling, as well as training at system handover. | ||
| Clinical | ||
| Environment: | SmartPerfusion can be used in the control room and in the exam room of | |
| an interventional suite or operating room. | ||
| SmartPerfusion is a software application and does not come in contact | ||
| with the patient. |
4
5
| Predicate device
2D Perfusion (K132147) | Proposed device
SmartPerfusion | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2D Perfusion assists in the
diagnosis of perfusion
alterations of tissues, based
on digital subtraction
angiography (DSA) by
providing color coded
images generated from the
DSA series. | SmartPerfusion assists in the
diagnosis of perfusion
alterations of tissues based
on digital subtraction
angiography (DSA) and can
be used for any location in
the body where DSA is
used. | Identical,
Substantially
equivalent
Note: for ease of
review, the
differences have
been underlined.
SE analysis:
The additional
sentence is to
improve clarity of
the use of device. |
Table 1: Indications for Use comparison with predicate device
The Indications for use is same for both the predicate and proposed device.
There are differences in Technological characteristics between the Technological characteristics: predicate device 2D Perfusion (K132147) and the proposed device SmartPerfusion, however those different technological characteristics have been demonstrated to not affect a determination of Substantial Equivalence.
The following table provides comparison of the Technological characteristics.
| Parameter | Predicate device
2D Perfusion (K132147) | Proposed device
SmartPerfusion | Conclusion |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility
with currently
marketed
Philips X-ray
systems | Is a software accessory to
currently marketed Philips
Allura and Azurion
Interventional X-ray system
(K172822, K162859) | same | Substantially equivalent. |
| Image input | Uses angiography X-ray
images as input | same | Substantially equivalent. |
| Anatomy | Anatomical area – General
vasculature. Not anatomy
specific | same | Substantially equivalent |
| Parameter | Predicate device
2D Perfusion (K132147) | Proposed device
SmartPerfusion | Conclusion |
| Core
Algorithm &
Quantification | Algorithm for generation of
functional images | Same | Substantially equivalent |
| Parameters
provided to the
user | 1. Arrival Time
2. Time to Peak (TTP)
3. Wash-in Rate
4. Width
5. Area under Curve (AuC)
6. Mean Transit Time (MTT) | Same for parameters 1 to 6.
Additional 2 parameters are
provided.
7. Wash out Rate:
The Wash-out Rate is defined
by the slope of the wash-out
curve. The Wash-out Rate
gives an indication of the flow
rate.
8. Peak density
The Peak Density is the
highest density value of the
time density curve. | Substantially equivalent
SE analysis: The additional
parameters 7 & 8 are also
derived from the same
algorithm. These parameters
are not used for Clinical
decision making. |
| Instant
Overview | Functional parameters are
displayed for a region of
interest based on functional
parameters selected. | All functional parameters are
displayed instantly in one
screen. | Substantially equivalent
SE analysis: All functional
parameters are shown at
once to improve user
experience. |
| Configurable
parameters | Not provided. | Among the available
parameters, user can sub-select
the parameters that will be
displayed on the screen. | Substantially equivalent
SE analysis: User is provided
with an option to choose the
parameters to be shown to
improve User experience. |
| Feature
comparison:
Color coded
image | Provides color coded
representation of a digital
subtraction angiography
(DSA) run. | Same with additional color
coded image for Wash out rate
is shown. | Substantially equivalent
SE analysis: Both the
products use the same
algorithm. Additional color
coded image for wash out
rate is also derived from the
same Time Density curve. |
| On screen help | Not provided. | On screen acquisition guidance
is provided. | Substantially equivalent
SE analysis: SmartPerfusion
displays on screen
help/guidance to the user to
improve workflow. |
| Parameter | Predicate device
2D Perfusion (K132147) | Proposed device
SmartPerfusion | Conclusion |
| Comparison
View | Provides a side by side
comparison between pre-,
peri-, and post-procedural
color coded images and
quantified functional
parameters.
Provides visualization of
contrast density over time in a
graphical format for a user-
defined region of interest | Same with additional option
for peripheral acquisitions to
compare 3 series at the same
time. | Substantially equivalent
SE analysis: The additional
viewing option is provided
for ease of use. |
| Imaging tools | Provides basic image tools
(zoom, pan,
contrast/brightness) to
manipulate image data that is
shown in the viewers | same | Substantially equivalent |
| ROI | Provides a mechanism to the
user to mark a region of
interest on an X-ray run
within which all the flow
parameters derived by
analyzing contrast density
over time are computed. | Same with additional ROI
drawing options like automatic
ROI that are user
editable,manual ROI, multiple
ROI, different ROI shapes/free
form ROI/user defined ROI. | Substantially equivalent
SE analysis: SmartPerfusion
provides additional options
to improve user experience. |
| Snapshot | Provides a mechanism to the
user to take a snapshot of the
main display area. The
snapshot is stored as a JPEG
image (compatible with
DICOM Secondary Capture),
and can be selected in the
Export activity for export to
another workstation or
medium | Same with additional option to
take a snapshot of the whole
screen. | Substantially equivalent
SE analysis: Both tools
provide the functionality to
take snapshots. Along with
main display area,
SmartPerfusion also
provides a mechanism to
take a snapshot of the whole
screen. In both kinds of
snapshots, the data is stored
in the same format. This
additional mechanism is a
non-mandatory part of the
clinical workflow and only
helps the user in also
capturing task panel and all
viewports in a single
snapshot. |
| Parameter | Predicate device
2D Perfusion (K132147) | Proposed device
SmartPerfusion | Conclusion |
| Export | Provides a mechanism to
export the currently displayed
time density curves to USB
removable drive | Same with additional
information of functional
parameter values for ROI. | Substantially equivalent
SE analysis:
Additional information is
also exported. |
| Overlay pre-
series & Recall
catheter image | Not provided. | Provides functionality to
achieve the same anatomical
positioning in a new DSA run
as a previously acquired DSA
run.
Provides functionality to store
and recall the image of the
catheter position to make sure
the runs are comparable | Substantially equivalent
SE analysis: This additional
functionality helps the
interventionalist in achieving
the same catheter &
anatomical position as pre
series before acquisition of
the peri- or post- series. This
is a non-mandatory part of
the product workflow. |
| APC | Not provided. | Provides functionality to auto-
recall X-ray view orientations
used to achieve the same X-ray
view orientation as the loaded
pre-series. | Substantially equivalent
SE analysis: This additional
functionality is a non-
mandatory part of the
clinical workflow. |
| Table side
interaction | Not provided. | Table side interaction is
provided through Touch screen
module. | Substantially equivalent
SE analysis: This additional
functionality improves user
experience. This is a non-
mandatory part of the
clinical workflow. |
| Software
Architecture
improvements | Not provided. | Architecture improvements
to facilitate software
maintenance, reduce launch
time for acquisition
guidance, easy portability
on the hosting platform,
more memory efficient,
ability to handle more
number of frames. | Substantially equivalent
SE analysis: These technical
changes do not affect the
clinical workflow. |
| Software
platform | 2D Perfusion is a software
medical device, which runs
on Interventional Workspot
(K181177). | Same | Substantially equivalent |
Table 2: Technological characteristics comparison-Classification & Design attributes and functionality
6
7
8
9
Summary of Non-Clinical Performance Data: Non-clinical performance testing has been performed on the proposed device SmartPerfusion and the proposed device demonstrates compliance with the following FDA recognized consensus standards and FDA guidance documents:
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life ● cycle processes. FDA/CDRH recognition number 13-79;
- IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 including corrigendum, 2015). FDA/CDRH recognition number 5-114;
- ISO 14971 Second Edition 2007-03-01 Medical devices Application ● of risk management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40;
- ISO15223-1 Third Edition 2016-11-01 Medical devices Symbols to ● be used with medical device labels, labelling and information to be supplied - Part 1: General requirement. FDA/CDRH recognition number 5-117:
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). FDA/CDRH recognition number 12-300
- "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);
- "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014 (document number 1825);
- "Guidance for Industry and FDA Staff The 510(k) Program: ● Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ", July 28, 2014 (document number 1766).
- Guidance for Industry. FDA Reviewers and Compliance on "Guidance . for Off-the-Shelf Software Use in Medical Devices, September 1999"
Software verification testing has been performed to verify the modifications as per pre-determined System Requirements Specification and acceptance criteria.The verification tests and acceptance criteria were identified based on Risk Assessent. Cybersecurity risks were assessed and privacy and Security requirements were identified and verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix and to verify the Privacy and Security requirements for SmartPerfusion have been implemented. Verification results demonstrated that all executed tests were passed.
Non clinical software validation testing has been performed to validate the intended use, claims, user needs, service user needs, effectiveness of safety messures and Instructions for use.
Software validation testing has been performed to validate that SmartPerfusion conforms to its intended use, claims and user needs.
All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartPerfusion:
10
. complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and . meets the acceptance criteria and is adequate for its intended use. Based on the information provided above, the proposed device SmartPerfusion is substantially equivalent to the predicate device 2D Perfusion (K132147) in terms of safety and effectiveness. SmartPerfusion does not require a clinical study as the substantial equivalence Summary of with the predicate device 2D Perfusion (K132147) is demonstrated with the Clinical Performance Data: following attributes: Indication for use; ● Technological characteristics; . . Non-clinical performance testing, including safety and effectiveness. Non-clinical performance data provides sufficient evidence that the subject device works as intended The verification and validation test results of the modified device SmartPerfusion described above 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 predicate device 2D Perfusion (K132147). SmartPerfusion is substantially equivalent to the predicate device 2D Perfusion Substantial (K132147) in terms of indications for use, technological characteristics and Equivalence Conclusion: safety and effectiveness. The modifications made in the proposed device SmartPerfusion are within the controls and predetermined specifications. Additionally, non-clinical performance tests provided in this 510(k) premarket notification demonstrated substantial equivalence to the predicate device and ensured that the modifications are implemented successfully. Verification and Validation tests were conducted to verify the modifications listed and conformance to international and FDA-recognized consensus standards and guidance documents were provided. These tests demonstrate that SmartPerfusion is substantially equivalent to the predicate device and is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.