The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY ST catheter) is intended for the intravascular ultrasound examination of coronary arteries. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Description

The Refinity and Refinity Short Tip (ST) Rotational IVUS Imaging Catheter consists of two main assemblies: the imaging core and the catheter body. The catheter body is comprised of four sections: a distal section with a .014" compatible rapid exchange guide wire lumen and clear imaging window, a mid-shaft section, a braided proximal shaft, and a telescoping section. The distal, mid, and proximal sections comprise the usable length or working length of the catheter. The telescoping section remains outside of the guiding catheter. The telescoping section allows the imaging core to be advanced and retracted for up to 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the window portion of the distal section. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a distal outward looking ultrasonic transducer. An electromechanical connector interface at the proximal end makes the connection to the patient interface module (PIM). The PIM-catheter interface consists of an integrated mechanical drive assembly and electrical connection. A flushing port with a one-way valve is used to displace the air initially present within the catheter. The catheter must be flushed with sterile heparinized normal saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use. The catheter body has a distal guide wire lumen with a proximal exit port located 15.5mm (for the short tip model) or 22mm (for the standard tip model) from the distal end. One radiopaque (RO) marker band is embedded 0.5 cm from the tip. In addition, insertion depth indicators are located on the catheter body at 90 cm and 100 cm. The catheter is packaged with a sterile PIM cover, 3 cc and 10 cc syringes, and 13 in extension tubing with a 3-way stopcock. The catheter is for use with the Volcano s5 and CORE® imaging systems with software V3.x.x.

AI/ML Overview

The Volcano Corporation's REFINITY Rotational Intravascular Ultrasound (IVUS) Catheter and REFINITY Short Tip Rotational IVUS Catheter underwent a series of non-clinical device performance tests to demonstrate substantial equivalence to the predicate device, the Volcano Revolution® 45MHz Rotational Intravascular IVUS Imaging Catheter.

Here's an overview of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Visual Inspection	No visual defects (e.g., cracks, kinks, other damage) visible to the unaided eye and no extraneous surface matter using 10X magnification.	Sample catheters met product specifications.
Dimensional Verification	All tubing lengths and outer diameters must meet product specifications.	Sample catheters met product specifications.
Catheter Prep	Samples need to meet product specifications for flushing and leaks.	Sample catheters met product specifications.
Tensile Strength	Bond joint tensile strengths must meet product specifications.	Sample catheters met product specifications.
Monorail Tear Strength	The tear strength of the guide wire lumen must meet product specifications.	Sample catheters met product specifications.
Guide Wire Movement	Sample catheters must meet product specifications in regards to movement over a 0.014" guide wire.	Sample catheters met product specifications.
Torsion	Sample catheters must meet product specifications in regards to minimum turns to failure.	Sample catheters met product specifications.
Telescope Operation Force	Sample catheters must meet the product specification for the maximum force needed to operate the telescope after its initial opening (related to 15 cm linear movement of imaging core).	Sample catheters met product specifications.
Force to Overextend Telescope	The amount of force required to completely pull the telescope section out of the catheter must meet product specifications.	Sample catheters met product specifications.
Particulate (Hydrophilic Coating)	The number of particles counted (≥10 µm, ≥25 µm, and ≥50 µm in 50 ml of water) must meet product specifications per USP 788.	Sample catheters met product specifications.
Adhesion (Hydrophilic Coating)	Adhesion must meet product specifications, meaning no coating is removed by adhesive tape.	Sample catheters met product specifications.
Friction (Hydrophilic Coating)	The frictional force measured while pulling the catheter through pig aorta must meet product specifications.	Sample catheters met product specifications.
NURD (Non-Uniform Rotational Distortion)	The angular separation between diametrically opposed objects must meet product specifications.	Sample catheters met product specifications.
Rapid Deployment	The capacitance difference (before and after backward pull of telescope section) must meet product specifications.	Sample catheters met product specifications.
Tortuous Pullback	The device must continue to image per product specifications after a 15 cm pullback through a tortuous path at 1mm/sec.	Sample catheters met product specifications.
Image Life	The catheter must still image after completion of the Rapid Deployment and Tortuous Pullback tests.	Sample catheters met product specifications.
Drill Through	Device must meet product specifications in regards to Drill Through (simulated worst-case scenario with bent distal section and rotating transducer). The catheter is allowed to image for a maximum of 30 minutes or until the catheter stops imaging.	Sample catheters met product specifications.
Guide Catheter Compatibility	Refinity catheters must meet product specifications in regards to Guide Catheter compatibility with a 5F Guide Catheter (inner diameter 0.056").	Sample catheters met product specifications.
Image Assessment	Results must meet the acceptance criteria as stated in the test protocol for axial resolution, lateral resolution, NURD, depth of image penetration, and overall image aesthetics when compared to the predicate device.	Results met the acceptance criteria as stated in the test protocol.
Acoustic Emissions	As defined per Track 3 of the FDA requirements document ("Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers").	Sample catheters met acceptance criteria.
Thermal Dissipation	As defined in the test protocol, performed according to EN60601-2-37.	Sample catheters met acceptance criteria.
B-Mode Testing	As defined in the test protocol for six relevant B-mode parameters, and qualitative visual image brightness and integrity.	Sample catheters met acceptance criteria.
Biocompatibility Testing	Per ISO 10993 and test protocols, including: - Cytotoxicity: Non-cytotoxic compared to controls.- Sensitization: Grade of 0 at 24 and 48 hours.- Intracutaneous Reactivity: Primary Irritation Index 0-0.4 and difference between test article and control mean score < 1.0.- Acute Systemic Toxicity: No deaths or systemic toxicity.- Material Mediated Pyrogen: Temperature rise of <3.4°C.- USP Limulus Amebocyte Lysate (LAL): Endotoxin < 20EU/device, spike recovery 50%-200%.- In Vitro Hemolysis (Direct Contact & Extract): Hemolytic Index 0%-2%.- Plasma: Average recalcification time equivalent to negative/plasma controls and ≥50% of negative control.- C3a & SC5b-9 Complement Activation: Compared to positive and negative controls.- Thromboresistance: No or minimal thrombosis; vessel remains patent.- Platelet and Leukocyte Counts: Normal Human Ranges.- Latex Elisa for Antigenic Protein (LEAP) Test: Reporting Limit = 0.03µg/ml.	All biocompatibility tests met respective acceptance criteria.

2. Sample Size and Data Provenance

Test Set Sample Sizes (where specified):
- Visual Inspection: "Sample catheters" (specific number not provided).
- Catheter Prep: "Sample catheters" (specific number not provided).
- Guide Wire Movement: "Sample catheters" (specific number not provided).
- Torsion: "Sample catheters" (specific number not provided).
- Telescope Operation Force: "Sample catheters" (specific number not provided).
- Force to Overextend Telescope: "Sample catheters" (specific number not provided).
- Acoustic Emissions: Five Refinity catheters.
- Image Assessment: Fifteen sets of side-by-side pullback videos were compared by each reviewer.
Data Provenance: The studies described are non-clinical bench tests and assessments. They appear to be performed internally by Volcano Corporation. There is no mention of country of origin for data or whether it's retrospective or prospective, as these are typically not applicable to bench testing. The "Image Assessment" used "pullback videos of the same vessel," implying in vivo or ex vivo data, but the source (human, animal, phantom) is not specified.

3. Number of Experts and Qualifications for Ground Truth

Image Assessment: Five independent end-user reviewers and one internal reviewer were used. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, only that they are "end user reviewers."
B-Mode Testing: Three signal processing engineers assessed qualitative visual image brightness and integrity.

4. Adjudication Method

Image Assessment: The reviewers "compared the pullback images and rated" various parameters. The text doesn't specify an adjudication method used to combine or reconcile the reviewers' ratings (e.g., 2+1, 3+1 consensus). It simply states they compared and rated.

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

The document describes an "Image Assessment" where five independent end-user reviewers and one internal reviewer viewed side-by-side IVUS pullback videos of the same vessel taken with the Revolution (predicate) and Refinity (new device) catheters. They rated various image quality parameters without knowing which catheter produced which image.
Effect Size: The document only states that "Results must meet the acceptance criteria as stated in the test protocol" and "Results met the acceptance criteria as stated in the test protocol." It does not quantify the effect size of improvement for human readers with AI vs. without AI assistance, as this study was a comparison of two IVUS catheters, not an AI-assisted interpretation study.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device described is an Intravascular Ultrasound (IVUS) Catheter, a medical imaging device used by physicians, not an AI algorithm performing diagnostic tasks independently. The performance tests evaluate the physical and imaging characteristics of the catheter itself.

7. Type of Ground Truth Used

Bench Testing: For most physical and electrical performance tests (e.g., dimensions, tensile strength, NURD, acoustic emissions, thermal dissipation, B-mode parameters), the "ground truth" is defined by known standards or product specifications.
Biocompatibility: Ground truth is established by ISO 10993 standards and specific test protocols.
Image Assessment: The "ground truth" for comparison for image quality seems to be the subjective assessment of image quality parameters (axial resolution, lateral resolution, NURD, depth of image penetration, and overall image aesthetics) by expert reviewers in comparison to the predicate device. The text implies a comparative evaluation against the established performance of the predicate, but not a separate, absolute "ground truth" for the images themselves.

8. Sample Size for the Training Set

This information is not applicable, as this is a medical device, not an AI model that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable, as this is a medical device, not an AI model that requires a training set.

Summary

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Image /page/0/Picture/1 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 a stylized graphic of three human profiles facing to the right, stacked one behind the other, with a flowing, wave-like design connecting them.

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

October 26, 2016

Volcano Corporation Brian Park Regulatory Affairs Specialist 3721 Valley Centre Drive Suite 500 San Diego, California 92130

Re: K160583

Trade/Device Name: REFINITY Rotational Intravascular Ultrasound (IVUS) Catheter REFINITY Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, DQO Dated: September 21, 2016 Received: September 22, 2016

Dear Brian Park:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160583

Device Name

REFINITY Rotational Intravascular Ultrasound (IVUS) Catheter REFINITY Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image is a logo for Volcano Corporation. The logo consists of a gray triangle with a blue triangle inside of it, followed by the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters.

• 510(k) SUMMARY

The 510(k) Summary is submitted as required by section 807.92(a)

SPONSOR:	Volcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670
CONTACT/SUBMITTER:	Brian ParkRegulatory Affairs SpecialistVolcano Corporation3721 Valley Centre Dr. Suite 500San Diego, CA 92130Tel: (858) 720-4176Fax: (858) 481-1027
DATE OF SUBMISSION:	March 28, 2016
DEVICE:	Refinity Rotational Intravascular Ultrasound (IVUS) CatheterRefinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter
Trade Name:	Refinity Rotational IVUS CatheterRefinity Short Tip Rotational IVUS Catheter
Common Name:	IVUS Imaging Catheter
Classification:	Class II Device21 CFR Part 870.1200 Intravascular Ultrasound Catheter (OBJ)21 CFR Part 870.1200 Intravascular Ultrasound Catheter (DQO)
PREDICATE DEVICE:	Volcano Revolution® 45MHz Rotational Intravascular IVUS Imaging CatheterModel Number: 89000Product Code: OBJK080891, Cleared on May 12, 2008Secondary PredicateVolcano Eagle Eye® Platinum Short Tip CatheterModel Number: 85900PSTProduct Code: OBJ, ITXK120697, Cleared on April 5, 2012
DEVICE DESCRIPTION:	The Refinity and Refinity Short Tip (ST) Rotational IVUS ImagingCatheter consists of two main assemblies: the imaging core and thecatheter body. The catheter body is comprised of four sections: a distalsection with a .014" compatible rapid exchange guide wire lumen andclear imaging window, a mid-shaft section, a braided proximal shaft,and a telescoping section.
	The distal, mid, and proximal sections comprise the usable length orworking length of the catheter. The telescoping section remainsoutside of the guiding catheter. The telescoping section allows theimaging core to be advanced and retracted for up to 15 cm of linearmovement. The corresponding movement of the transducer occursfrom the proximal end of the guidewire exit port to the proximal end ofthe window portion of the distal section.
	The imaging core is composed of a hi-torque, flexible, rotating drivecable with a distal outward looking ultrasonic transducer. Anelectromechanical connector interface at the proximal end makes theconnection to the patient interface module (PIM). The PIM-catheterinterface consists of an integrated mechanical drive assembly andelectrical connection.
	A flushing port with a one-way valve is used to displace the air initiallypresent within the catheter. The catheter must be flushed with sterileheparinized normal saline prior to use, as this provides the acousticcoupling media required for ultrasonic imaging. The one-way valvehelps retain saline in the catheter during use.
	The catheter body has a distal guide wire lumen with a proximal exitport located 15.5mm (for the short tip model) or 22mm (for thestandard tip model) from the distal end. One radiopaque (RO) markerband is embedded 0.5 cm from the tip. In addition, insertion depthindicators are located on the catheter body at 90 cm and 100 cm. Thecatheter is packaged with a sterile PIM cover, 3 cc and 10 cc syringes,and 13 in extension tubing with a 3-way stopcock.
	The catheter is for use with the Volcano s5 and CORE® imaging systemswith software V3.x.x.
INDICATIONS FOR USE:	The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY orREFINITY ST) is intended for the intravascular ultrasound examination ofcoronary arteries. Intravascular ultrasound imaging is indicated inpatients who are candidates for transluminal interventional procedures.REFINITY (or REFINITY ST) catheters are designed for use as an adjunctto conventional angiographic procedures to provide an image of thevessel lumen and wall structures.

	The statement, “REFINITY (or REFINITY ST) catheters are designed foruse as an adjunct to conventional angiographic procedures to providean image of the vessel lumen and wall structures.” is being added to theIndications for Use in order to clarify that the device is not intended tobe used as a standalone device but needs to be placed in thevasculature under standard angiographic guidance. This is aclarification to the Indications for Use and not an expansion of its use ora substantive change.
COMPARISON OFCHARACTERISTICS:	The modified device is substantially equivalent to the currentlymarketed Revolution device. Both devices are rotational IVUS imagingcatheters. In fact, the proposed Refinity has the identical ultrasoundtransducer and rotational drive mechanism as the predicate Revolutionand differs in the outer polymer shaft design, hydrophilic coating andsterile pouch design. The working lengths are identical for both thepredicate and modified devices but the shaft of the modified device issmaller in diameter than the predicate. The indications for use areidentical for both devices.The outer materials of the Refinity differ from the Revolution. Ingeneral, the distal patient contacting portion of the Revolution catheteris made of tubing made of single and blended low, medium and highdensity polyethylenes. The distal patient contacting portion of theRefinity is made of tubing made of single and blended polyethylene,polyether block amide and polyimide materials. The Refinity tubingmaterials allow for smaller outer diameters. In the proximal portion ofthe catheter the Revolution has a proximal shaft made ofpolyetherimide and secondary telescope made of polyimide which theRefinity replaces with a shaft made of braided stainless steel inpolyimide sandwiched between an inner layer of blendedpolytetrafluoroethylene (PTFE) and polyimide and an outer layer ofpolyether block amide.The Revolution is coated with a silicone based lubricious coating whilethe Refinity is coated with a hydrophilic coating.Finally, the Revolution is packaged in a pouch that is made of mylar filmand Tyvek® while the Refinity is packaged in a pouch that is made of astronger nylon/low density polyethylene/high density polyethylene filmand Tyvek®.
PERFORMANCE DATA:	Non-clinical device testing was conducted to confirm the performanceof the device. Bench testing was conducted against known standards orthe product specification and evaluated the following:
•	Visual Inspection: Sample catheters were visually inspected for defects such as cracks, kinks or other damage visible to the unaided eye and for extraneous surface matter using 10X magnification. Acceptance criteria: No visual defects.
•	Dimensional Verification: Tubing lengths and outer diameters were measured. Acceptance criteria: All dimensions must meet product specifications.
•	Catheter Prep: Sample catheters were prepped for use by flushing the lumen with sterile saline. Acceptance criteria: Samples need to meet product specifications for flushing and leaks.
•	Tensile Strength: All bond joints were pull tested to assess their tensile strengths. Acceptance criteria: Bond joint tensile strengths must meet product specifications.
•	Monorail Tear Strength: The Refinity includes a monorail rapid exchange guide wire lumen that allows the catheter to be passed over a guide wire for delivery and placement within a vessel. The amount of force needed to tear through the entire length of the guide wire lumen was measured on sample catheters. Acceptance criteria: The tear strength of the guide wire lumen must meet product specifications.
•	Guide Wire Movement: The monorail guide wire lumen is designed to accommodate a 0.014" guide wire. The compatibility of the Refnity's guide wire lumen was tested on sample catheters. Acceptance criteria: Sample catheters must meet product specifications in regards to movement over a 0.014" guide wire.
•	Torsion: In clinical use, users may torque or twist the shaft of the Refinity catheter. The torsional strength of the Refinity was tested. Acceptance criteria: Sample catheters must meet product specifications in regards to minimum turns to failure.
•	The Refinity has a telescoping section that allows the user to pull back the imaging core up to 15 cm in length in order to image the inside of a vessel. The amount of force needed to operate the telescope after initial opening was measured. Acceptance criteria: Sample catheters must meet the product specification for the maximum force needed to operate the telescope after its initial opening.
•	Force to Overextend the Telescope: The force to completely pull out the telescope section of the Refinity catheter was measured. Acceptance criteria: The amount of force required to completely pull the telescope section out of the catheter must meet product specifications.
•	Particulate: Since the distal portion of the Refinity catheter is coated with a hydrophilic coating, particulate testing is performed to verify the integrity of the coating The catheter is
	prepped and placed into a water filled tube connected to a lightobscuration liquid particle counter. A reservoir of water isconnected to the proximal end of the water filled tube wherethe catheter is introduced to provide a constant supply of waterduring the test. The particle counter draws 10 ml of watersurrounding the catheter into a measurement chamber andautomatically counts the number of particles that are ≥10 µm,≥25 µm and ≥50 µm in size. The tester does this a total of 5times so that the particles in a total of 50 ml of water aretested. Acceptance criteria: The number of particles countedmust meet product specifications per USP 788.
•	Adhesion: Since the distal portion of the Refinity catheter iscoated with a hydrophilic coating, the integrity of the coating istesting with an adhesion test. The adhesion test uses adhesivetape which is applied to the coated section of the catheter. Theadhesive tape is then quickly pulled from the catheter andchecked to see if any coating has been removed. Acceptancecriteria: Adhesion must meet product specifications.
•	Friction: Since the distal portion of the Refinity catheter iscoated with a hydrophilic coating, the lubricity of the coating istested with a friction test. A pig aorta is cut open and twopieces are mounted to metal plates with the inside surface ofthe aorta facing up. The metal plates are mounted on thelower hydraulic jaws of a force tester. Sample catheters areclamped between the aortic tissues on the plates. The top endof the catheter is clamped in the upper clamps of the forcetester. The plates and test sample are placed in a water tank.The force tester is activated and pulls the test catheter throughthe aortic tissue mounted on the metal plates at a speed of12"/minute. The frictional force experienced by the catheter asit is pulled through the tissue mounted on the plates isautomatically recorded by the force tester. Acceptance criteria:The frictional force measured must meet productspecifications.
•	NURD (Non-Uniform Rotational Distortion): The Refinityincludes a rotating IVUS transducer that provides images insidea vessel. The NURD test verifies that the drive cable rotatessmoothly at a uniform speed while in a simulated tortuouspath. During the test, the transducer is placed in a fixture andimages are captured that allow the angular separation betweendiametrically opposed objects to be measured. Acceptancecriteria: The angular separation between diametricallyopposed objects must meet product specifications.
•	Rapid Deployment: The baseline capacitance of the Refinitycatheter is measured. The catheter is then placed in a testfixture. The fixture pulls back the telescope section in each test

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sample in a uniform fashion. After the pull back is performed the catheter is removed from the fixture and the capacitance is re-measured. Acceptance criteria: The capacitance difference must meet product specifications. Tortuous Pullback: The Refinity catheter is flushed and then ● tracked over a 0.014" wire through a tortuous path fixture. Once in place, the catheter is attached to a Patient Interface Module (PIM) that is attached to a Volcano imaging system. The imaging system displays the catheter serial number and the PIM is set to a pullback speed of 1mm/sec. The PIM is turned on to start imaging from the catheter. A catheter image is verified and then the PIM is activated to start a pullback. The PIM pulls back the imaging core a length of 15cm through the tortuous path with the catheter imaging. After pulling back the imaging core 15 cm, the PIM automatically stops. The imaging core is pushed back to its distal starting position within the tortuous path fixture. Acceptance criteria: The device must continue to image per product specifications. ● Image Life - Acceptance criteria: The catheter must still image after completion of the Rapid Deployment and Tortuous Pullback tests. o Drill Through: Since the transducer element of the Refinity catheter rotates, in a worst case situation, if the transducer is rotating and the user pushes the telescope forward and the distal portion of the catheter shaft is kinked, the transducer could drill through the wall of the catheter and potentially damage the inside of the vessel wall. The drill through test involves simulating this worst case situation. The catheter's telescope is pulled back completely and the catheter is flushed. The acoustic window portion of the distal end of the catheter is bent to a 90° angle. The bent distal section is placed in a test fixture that maintains the 90° bend. The catheter is connected to a PIM and is turned on to rotate the transducer. The rotating transducer is manually advanced to the bend and is manually pushed up against the kinked tubing to see if it can be pushed through the shaft like a drill. The catheter is allowed to image for a maximum of 30 minutes or until the catheter stops imaging. Acceptance criteria: Device must meet product specifications in regards to Drill Through. ● Guide Catheter Compatibility: Sample catheters are inserted in a 5F Guide Catheter with an inner diameter of 0.056". Acceptance criteria: Refinity catheters must meet product specifications in regards to Guide Catheter compatibility. ● lmage Assessment: Five independent end user reviewers and one internal reviewer viewed side by side IVUS pullback videos of the same vessel taken with the Revolution and Refinity

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	Catheters. The reviewers did not know which pullback wasfrom the Revolution Catheter and which was from the RefinityCatheter. Each reviewer compared a total of fifteen sets of sideby side pullback videos. The reviewers compared the pullbackimages and rated the axial resolution, lateral resolution, NURD,depth of image penetration and overall image aesthetics.Acceptance criteria: Results must meet the acceptance criteriaas stated in the test protocol.
•	Acoustic emissions: Acoustic emission testing was performedon five Refinity catheters in accordance with a 2008 FDAdocument, "Information for Manufacturers Seeking MarketClearance of Diagnostic Ultrasound Systems and Transducers".Acceptance criteria: As defined per Track 3 of the FDArequirements document.
•	Thermal dissipation: Thermal dissipation testing wasperformed in accordance with EN60601-2-37 using a J typethermocouple because the J type is more flexible and suitablefor wrapping around the very small diameter of the cathetersheath surrounding the imaging transducer and a tissuemimicking phantom. Acceptance criteria: As defined in the testprotocol.
•	B-Mode Testing: Six parameters that are relevant to B-modeperformance were measured. Also, qualitative visual imagebrightness and integrity were assessed by three signalprocessing engineers. Acceptance criteria: As defined in thetest protocol.
•	Biocompatibility testing: Biocompatibility of the raw materialsin the Refinity catheter were assessed per ISO 10993.Acceptance criteria: Per 10993 and test protocols.Cytotoxicity: Compared to positive and negative controls, testarticle must be non-cytotoxic.Sensitization: A grade of 0 at 24 and 48 hours.Intracutaneous Reactivity: Primary Irritation Index should be 0-0.4 (negligible). Difference between the mean score of the testarticle and control is less than 1.0.Acute Systemic Toxicity: No deaths or evidence of systemictoxicityMaterial Mediated Pyrogen: Temperature rise of <3.4°CUSP Limulus Amebocyte Lysate (LAL): Endotoxin < 20EU/deviceand Spike recovery between 50% - 200%In Vitro Hemolysis (Direct Contact): Hemolytic Index of 0% - 2%In Vitro Hemolysis (Extract): Hemolytic Index of 0% - 2%Plasma: The average recalcification time of the plasma afterexposure to the Refinity must be equivalent to the times for thenegative and plasma controls and ≥50% of the negative control
	C3a Complement Activation: The test article is compared to positive and negative controls
	SC5b-9 Complement Activation: The test article is compared to positive and negative controls
	Thromboresistance: No, or minimal thrombosis. No, or small amounts of thrombus and vessel remains patent.
	Platelet and Leukocyte Counts: Normal Human Ranges of Leukocyte count = 3.4-8.7 x 103/µL and Platelet count = 116 - 329 x 103/μL
	Latex Elisa for Antigenic Protein (LEAP) Test: Reporting Limit = 0.03µg/ml
	Completion of these tests concludes that the Refinity Rotational IVUS Catheter is substantially equivalent to the currently marketed Revolution 45MHz Rotational IVUS Imaging Catheter.
Consensus Standards	The Refinity Rotational IVUS Catheter complies with the following consensus standards:The ISO 10993 series of biocompatibility standards includingISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitizationISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicityIEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentISO 14971:2007 Medical devices - Application of risk management to medical devices
Conclusion	Completion of all performance tests concludes that the Refinity Rotational IVUS Catheter is substantially equivalent to the currently marketed Revolution 45MHz Rotational IVUS Imaging Catheter.

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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).