(239 days)
Not Found
No
The summary describes a mechanical and electrical device for generating and transmitting ultrasound images, with no mention of AI or ML for image processing or analysis.
No.
The document states that the device is intended for "intravascular ultrasound examination" and to "provide an image of the vessel lumen and wall structures." This indicates a diagnostic or imaging purpose rather than a therapeutic one.
Yes
The device performs "intravascular ultrasound examination of coronary arteries" to provide an "image of the vessel lumen and wall structures," which are diagnostic activities.
No
The device description clearly details physical components like a catheter body, imaging core, transducer, and electromechanical connector, indicating it is a hardware device with associated software for imaging systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular ultrasound examination of coronary arteries" and provides "an image of the vessel lumen and wall structures." This is a diagnostic imaging procedure performed in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details a catheter designed to be inserted into blood vessels to acquire ultrasound images. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on these samples outside the body. The device's function is to generate images from within the body.
Therefore, the REFINITY (or REFINITY ST) Rotational IVUS Catheter is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OBJ, DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound (IVUS)
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards or the product specification for: Visual Inspection, Dimensional Verification, Catheter Prep, Tensile Strength, Monorail Tear Strength, Guide Wire Movement, Torsion, Telescope operation force, Force to Overextend the Telescope, Particulate, Adhesion, Friction, NURD (Non-Uniform Rotational Distortion), Rapid Deployment, Tortuous Pullback, Image Life, Drill Through, Guide Catheter Compatibility, Image Assessment, Acoustic emissions, Thermal dissipation, B-Mode Testing, Biocompatibility testing.
Image 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 Catheters. The reviewers did not know which pullback was from the Revolution Catheter and which was from the Refinity Catheter. Each reviewer compared a total of fifteen sets of side by side pullback videos. The reviewers compared the pullback images and rated the axial resolution, lateral resolution, NURD, depth of image penetration and overall image aesthetics. Acceptance criteria: Results must meet the acceptance criteria as stated in the test protocol.
Key Metrics
Not Found
Predicate Device(s)
Volcano Revolution® 45MHz Rotational Intravascular IVUS Imaging Catheter (K080891), Volcano Eagle Eye® Platinum Short Tip Catheter (K120697)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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)
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.
| 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 Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Brian Park
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Centre Dr. Suite 500
San Diego, CA 92130
Tel: (858) 720-4176
Fax: (858) 481-1027 |
| DATE OF SUBMISSION: | March 28, 2016 |
| DEVICE: | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter |
| Trade Name: | Refinity Rotational IVUS Catheter
Refinity Short Tip Rotational IVUS Catheter |
| Common Name: | IVUS Imaging Catheter |
| Classification: | Class II Device
21 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 Catheter
Model Number: 89000
Product Code: OBJ
K080891, Cleared on May 12, 2008
Secondary Predicate
Volcano Eagle Eye® Platinum Short Tip Catheter
Model Number: 85900PST
Product Code: OBJ, ITX
K120697, Cleared on April 5, 2012 |
| 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. |
| INDICATIONS FOR USE: | The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or
REFINITY ST) is intended for the intravascular ultrasound examination of
coronary arteries. Intravascular ultrasound 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. |
| | |
| | The statement, “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.” is being added to the
Indications for Use in order to clarify that the device is not intended to
be used as a standalone device but needs to be placed in the
vasculature under standard angiographic guidance. This is a
clarification to the Indications for Use and not an expansion of its use or
a substantive change. |
| COMPARISON OF
CHARACTERISTICS: | The modified device is substantially equivalent to the currently
marketed Revolution device. Both devices are rotational IVUS imaging
catheters. In fact, the proposed Refinity has the identical ultrasound
transducer and rotational drive mechanism as the predicate Revolution
and differs in the outer polymer shaft design, hydrophilic coating and
sterile pouch design. The working lengths are identical for both the
predicate and modified devices but the shaft of the modified device is
smaller in diameter than the predicate. The indications for use are
identical for both devices.
The outer materials of the Refinity differ from the Revolution. In
general, the distal patient contacting portion of the Revolution catheter
is made of tubing made of single and blended low, medium and high
density polyethylenes. The distal patient contacting portion of the
Refinity is made of tubing made of single and blended polyethylene,
polyether block amide and polyimide materials. The Refinity tubing
materials allow for smaller outer diameters. In the proximal portion of
the catheter the Revolution has a proximal shaft made of
polyetherimide and secondary telescope made of polyimide which the
Refinity replaces with a shaft made of braided stainless steel in
polyimide sandwiched between an inner layer of blended
polytetrafluoroethylene (PTFE) and polyimide and an outer layer of
polyether block amide.
The Revolution is coated with a silicone based lubricious coating while
the Refinity is coated with a hydrophilic coating.
Finally, the Revolution is packaged in a pouch that is made of mylar film
and Tyvek® while the Refinity is packaged in a pouch that is made of a
stronger nylon/low density polyethylene/high density polyethylene film
and Tyvek®. |
| PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm the performance
of the device. Bench testing was conducted against known standards or
the 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 light
obscuration liquid particle counter. A reservoir of water is
connected to the proximal end of the water filled tube where
the catheter is introduced to provide a constant supply of water
during the test. The particle counter draws 10 ml of water
surrounding the catheter into a measurement chamber and
automatically counts the number of particles that are ≥10 µm,
≥25 µm and ≥50 µm in size. The tester does this a total of 5
times so that the particles in a total of 50 ml of water are
tested. Acceptance criteria: The number of particles counted
must meet product specifications per USP 788. |
| • | Adhesion: Since the distal portion of the Refinity catheter is
coated with a hydrophilic coating, the integrity of the coating is
testing with an adhesion test. The adhesion test uses adhesive
tape which is applied to the coated section of the catheter. The
adhesive tape is then quickly pulled from the catheter and
checked to see if any coating has been removed. Acceptance
criteria: Adhesion must meet product specifications. |
| • | Friction: Since the distal portion of the Refinity catheter is
coated with a hydrophilic coating, the lubricity of the coating is
tested with a friction test. A pig aorta is cut open and two
pieces are mounted to metal plates with the inside surface of
the aorta facing up. The metal plates are mounted on the
lower hydraulic jaws of a force tester. Sample catheters are
clamped between the aortic tissues on the plates. The top end
of the catheter is clamped in the upper clamps of the force
tester. The plates and test sample are placed in a water tank.
The force tester is activated and pulls the test catheter through
the aortic tissue mounted on the metal plates at a speed of
12"/minute. The frictional force experienced by the catheter as
it is pulled through the tissue mounted on the plates is
automatically recorded by the force tester. Acceptance criteria:
The frictional force measured must meet product
specifications. |
| • | NURD (Non-Uniform Rotational Distortion): The Refinity
includes a rotating IVUS transducer that provides images inside
a vessel. The NURD test verifies that the drive cable rotates
smoothly at a uniform speed while in a simulated tortuous
path. During the test, the transducer is placed in a fixture and
images are captured that allow the angular separation between
diametrically opposed objects to be measured. Acceptance
criteria: The angular separation between diametrically
opposed objects must meet product specifications. |
| • | Rapid Deployment: The baseline capacitance of the Refinity
catheter is measured. The catheter is then placed in a test
fixture. 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
9
| | Catheters. The reviewers did not know which pullback was
from the Revolution Catheter and which was from the Refinity
Catheter. Each reviewer compared a total of fifteen sets of side
by side pullback videos. The reviewers compared the pullback
images and rated the axial resolution, lateral resolution, NURD,
depth of image penetration and overall image aesthetics.
Acceptance criteria: Results must meet the acceptance criteria
as stated in the test protocol. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Acoustic emissions: Acoustic emission testing was performed
on five Refinity catheters in accordance with a 2008 FDA
document, "Information for Manufacturers Seeking Market
Clearance of Diagnostic Ultrasound Systems and Transducers".
Acceptance criteria: As defined per Track 3 of the FDA
requirements document. |
| • | Thermal dissipation: Thermal dissipation testing was
performed in accordance with EN60601-2-37 using a J type
thermocouple because the J type is more flexible and suitable
for wrapping around the very small diameter of the catheter
sheath surrounding the imaging transducer and a tissue
mimicking phantom. Acceptance criteria: As defined in the test
protocol. |
| • | B-Mode Testing: Six parameters that are relevant to B-mode
performance were measured. Also, qualitative visual image
brightness and integrity were assessed by three signal
processing engineers. Acceptance criteria: As defined in the
test protocol. |
| • | Biocompatibility testing: Biocompatibility of the raw materials
in the Refinity catheter were assessed per ISO 10993.
Acceptance criteria: Per 10993 and test protocols.
Cytotoxicity: Compared to positive and negative controls, test
article 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 test
article and control is less than 1.0.
Acute Systemic Toxicity: No deaths or evidence of systemic
toxicity
Material Mediated Pyrogen: Temperature rise of