2D Perfusion assists in the diagnosis of perfusions of issues, based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series.

Device Description

The 2D Perfusion software medical device is a tool that assists the physician in the diagnosis of perfusion (i.e., passage of blood through blood vessels to an organ or a tissue) alterations by providing a color coded representation of a digital subtraction angiography (DSA) run. The 2D Perfusion software medical device can visualize multiple functional parameters related to the time-density function and also provides a comparison between pre-, peri-, and post-procedural color coded images.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 2D Perfusion device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of quantitative acceptance criteria or corresponding reported device performance metrics. Instead, it describes acceptance criteria in qualitative terms related to compliance with standards and functionality.

Acceptance Criteria Category	Description from Text	Reported Device Performance
Standards Compliance	"The 2D Perfusion software medical device complies with the following Summary of Noninternational and FDA-recognized consensus standards: - IEC 62304 Medical device software – Software life cycle processes (2006): - IEC 62366 Application of usability engineering to medical devices (2007): - ISO 14971 Application of risk management to medical devices (2007)."	"The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device complies with international and FDA-recognized consensus standards..."
Intended Use	"Non-clinical software verification and validation tests have been performed with regards to the intended use..."	"...the 2D Perfusion software medical device ... meets the acceptance criteria and is adequate for its intended use."
Technical Claims	"Non-clinical software verification and validation tests have been performed with regards to... the technical claims..."	"The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device ... meets the acceptance criteria..." (Implying technical claims were met).
Requirement Specifications	"Non-clinical software verification and validation tests have been performed with regards to... the requirement specifications..."	"The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device ... meets the acceptance criteria..." (Implying requirement specifications were met).
Risk Management	"Non-clinical software verification and validation tests have been performed with regards to... the risk management results."	"The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device ... meets the acceptance criteria..." (Implying risk management results were adequately addressed).
Safety & Effectiveness	(Implied through substantial equivalence) "The 2D Perfusion software medical device is substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness." and "...the 2D Perfusion is considered substantially equivalent to the currently marketed and secondary predicate AngioViz Option ... in terms of safety and effectiveness."	"The results of these tests demonstrate that the 2D Perfusion software medical device met the acceptance criteria and is adequate for this intended use." (This indirectly states that it meets the safety and effectiveness criteria by being substantially equivalent to a cleared device and undergoing proper V&V).

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The 2D Perfusion software medical device did not require clinical studies since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes: ... Non-clinical performance testing."

Therefore, there

No clinical test set was used.
The non-clinical performance testing (software verification and validation) would likely involve simulated data or internally generated test cases rather than patient data. The provenance of such data, if used, is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since no clinical studies or human-reviewed test sets were used for performance evaluation, there were:

No experts used to establish ground truth for a test set.
The ground truth for the software verification and validation would be based on predefined expected outputs for given inputs as per the software requirements Specification.

4. Adjudication Method for the Test Set

As no clinical test set with human reviewers was used:

No adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states no clinical studies were required. Therefore, no studies comparing human readers with and without AI assistance were conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

A standalone (algorithm-only) performance evaluation was conducted. This is evidenced by the "Non-clinical software verification and validation tests," which would assess the software's functionality and accuracy in generating the parametric images as specified. The results of these tests demonstated that the device met the acceptance criteria.

7. Type of Ground Truth Used

For the non-clinical software verification and validation, the ground truth would be:

Expected software output based on design specifications and engineering principles. This means engineers would have defined what the correct "arrival time," "time to peak," "wash-in rate," etc., should be for a given synthetic or recorded DSA run, and the software's output would be compared against these predefined correct values.

8. Sample Size for the Training Set

The document does not mention a training set. This is because:

The 2D Perfusion device is described as a tool that "provides a color coded representation of a digital subtraction angiography (DSA) run" and "visualize multiple functional parameters related to the time-density function."
It is not an AI/ML device in the modern sense that requires a "training set" to learn from data. Instead, it seems to be a deterministic algorithm that calculates parameters based on the time-intensity curve of a DSA input.
Therefore, no training set was used.

9. How the Ground Truth for the Training Set was Established

As no training set was used:

No ground truth was established for a training set.

Summary

{0}------------------------------------------------

KB2147
Page 1 of

EC 1 6 2013

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR $807.92.

Date Prepared: July 8, 2013 Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277 Contact Person: Ms. Liselotte Kornmann. PhD Regulatory Affairs Manager Phone: +31 40 2791111 Fax: +31 40 2769100 E-mail: Liselotte.Kornmann@philips.com Device Name: 2D Perfusion Classification Name: Image-intensified fluoroscopic x-ray system Classification: Classification Regulation: 21CFR 8892.1650 Radiology Classification Panel: Device Class: Class II Primary Product Code: OWB (Interventional x-ray system) Secondary Product Code: I_LZ (svstem, image processing, radiological) Primary Predicate Device 1: Trade Name: Allura Xper FD20 X-Ray Imaging Systems Manufacturer: Philips Medical Systems Nederland B.V. K033737 (December 9, 2003) 510(k) Clearance: Classification Regulation: 21 CFR, Part 892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Device Class: Class II OWB (interventional fluoroscopic x-ray system) Product Code: Primary Predicate Device 2: Trade Name: Allura Xper FD OR Table Series Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K102005 (August 9. 2010) Classification Regulation: 21 CFR. Part 892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Device Class: Class II Product Code: OWB (interventional fluoroscopic x-ray system)

{1}------------------------------------------------

Secondary Predicate Device:

Secondary Predicate Device:	Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code:	AW VolumeShare 5 with AngioViz OptionGE HealthcareK110834 (April 26. 2011)21CFR §892.1600Picture archiving and communications systemRadiologyClass IILLZ (system, image processing, radiological)
Note: The 2D Perfusion software medical device is considered an accessory to the following currently marketed and predicate devices and thus designated with the primary product code of OWB:Philips Allura Xper FD20 X-Ray Imaging Systems (K033737): and Philips Allura Xper FD OR Table Series (K102005). Since the 2D Perfusion is a software medical device and is an accessory to the currently marketed Philips Allura Xper X-ray Systems, substantial equivalence demonstration is not warranted.
Device description:	The 2D Perfusion software medical device is a tool that assists the physician in the diagnosis of perfusion (i.e., passage of blood through blood vessels to an organ or a tissue) alterations by providing a color coded representation of a digital subtraction angiography (DSA) run. The 2D Perfusion software medical device can visualize multiple functional parameters related to the time-density function and also provides a comparison between pre-, peri-, and post-procedural color coded images.
Indications for Use:	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.
	Note: The indication for use of the 2D Perfusion software medical device and the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) are similar as follows:Produces / provides parametric images from a DSA series to enable the user to more easily visualize vascular flow.
	The differences between the 2D Perfusion software medical device and the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) are:The currently marketed and secondary predicate AngioViz Option produces from a DSA series parametric images representing maximum (peak) opacification, time to peak, and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow. The 2D Perfusion software medical device provides the following

parameters to enable the user to more easily visualize characteristics related to vascular flow; arrival time, time to peak. wash-in rate, width. area under the curve, and means transit time.
.

{2}------------------------------------------------

The parameters provided with the 2D Perfusion does not affect the safety or effectiveness since they provide a different representation of information already present in the input DSA images to enable the user to more easily visualize characteristics related to vascular flow as compared to the parameters provided by the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 (GE Healthcare, K110834). Thus, the differences in the indications for use do not impact the safety and effectiveness of this product.

Based on the information provided above. 2D Perfusion is considered substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) in terms of indication for use.

The fundamental scientific technology of both the currently marketed and Technology: secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare. K110834) and 2D Perfusion software medical device, is as follows:

Execution on and comnection to an independent software hosting platform ! . workstation, which supports functions for image display, manipulation, and selective recording, import, export and data handling.
The 2D Perfusion software medical device is provided on the independent hosting software platform. Philips Interventional Workspot (K121296. January 2, 2013). The currently marketed Philips Interventional Workspot software platform. which support 510(k) cleared Philips Interventional Tools. provides common functionalities (e.g., import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the Interventional procedure.
. Provide visualization of parameters derived from the time intensity curve of a DS.4 input run.
Based on analysis of the time intensity curve of the input DSA. the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healtheare, K110834) provides images of the following derived parameters:
Peak opacification: the maximum intensity of the ime intensity . curve:
. Time to peak, the time between the first arrival of contrast medium and the moment it reaches its maximum concentration; and
. Peak opacification to time to peak ratio.

Based on analysis of the time intensity curve of the input DSA. 2D Perfusion provides images of the following derived parameters:

Time to peak: the time between the first arrival of contrast medium � and the moment it reaches its maximum concentration. This yields the same information as the time to peak provided by the predicate

{3}------------------------------------------------

AngioViz Option; and

Wash-in rate: the slope of the time intensity curve between arrival . time and time to peak. This yields similar information as the peak opacification to time to peak ratio provided by the predicate AngioViz Option.
In addition. 21) Perfusion provides images of the following derived parameters which are not provided by the predicate AngioViz Option:
Arrival time: the time between the start of the DSA run and the . moment of arrival of contrast medium;
Width: the time during which the time intensity curve is at least at . half its maximum intensity:
Area under the curve: the total accumulated intensity between the . first of arrival of contrast medium and the moment of leveling off after the contrast bolus has passed; and
Mean transit time: the time between the first of arrival of contrast . medium and the moment of leveling off after the contrast bolus has passed.

The additional parameters visualized by 2D Perfusion as well as the absence of the Peak opacification visualization do not affect the safety or effectiveness since both the predicate AngioViz Option and 21) Perfusion provide visualization of parameters derived from the time intensity curve. Thus. the differences in the technology do not impact the safety and effectiveness of this product.

The 2D Perfusion software medical device complies with the following Summary of Noninternational and FDA-recognized consensus standards: clinical Performance

Data:

. IEC 62304 Medical device software – Software life cvcle processes (2006):
IEC 62366 Application of usability engineering to medical devices (2007): .
ISO 14971 Application of risk management to medical devices (2007). .

Non-clinical software verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The non-clinical software verification and validation test results demonstrate that the 2D Perfusion software medical device complies with international and FDA-recognized consensus standards and meets the acceptance criteria and is adequate for its intended use. Therefore, the 2D Perfusion software medical device is substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of safety and effectiveness.

The 2D Perfusion software medical device did not require clinical studies since Summary of Clinical substantial equivalence to the currently marketed and predicate device was Data:

{4}------------------------------------------------

K132147
Pages of 5

demonstrated with the following attributes:

. Design features:
. Indication for use:
. Fundamental scientific technology:
. Non-clinical performance testing: and
. Safety and effectiveness.

Substantial Equivalence Conclusion:

The 2D Perfusion software medical device is substantially equivalent to the currently marketed and secondary predicate AngioViz Option provided with the AW VolumeShare 5 workstation (GE Healthcare, K110834) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with nonclinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that the 2D Perfusion software medical device met the acceptance criteria and is adequate for this intended use.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2013

Philips Medical Systems Nederland B.V. % Liselotte Kornmann, Ph.D. Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best THE NETHERLANDS

Re: K132147

Trade/Device Name: 2D Perfusion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: November 5, 2013 Received: November 7, 2013

Dear Dr. Kornmann:

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 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.

{6}------------------------------------------------

Page 2 - Liselotte Kornmann, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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.lda.gov/McdicalDevices/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132147

Device Name 2D Perfusion

Indications for Use (Describe)

2D Perfusion assists in the diagnosis of perfusions of issues, based on digital subtraction angiography (DSA), by providing color coded images generated from the DSA series.

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

{8}------------------------------------------------

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."

Regulation Number and Section

§ 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.