The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

Device Description

The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.

A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.

The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.

A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.

The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.

AI/ML Overview

This document describes the regulatory clearance for a medical device called a "Distal Access Catheter," not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert ground truth, MRMC studies, and human-in-the-loop performance, are not applicable.

The acceptance criteria and the study that proves the device meets them are based on bench testing (physical and mechanical properties) and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Specification)	Reported Device Performance (Conclusion)
Bench Testing
Surface Inspection	External surface free from extraneous matter, process, and surface defects that could cause trauma to vessels.	The surface integrity is suitable for intended clinical use.
Surface Contamination	Free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. PTFE inner layer not delaminated.	The surface integrity is suitable for intended clinical use.
Dimensional	Meet specified dimensional requirements (catheter OD, ID, effective length, distal tip length, total accessories length).	The device met the dimensional and physical specifications.
Distal Tip	Smooth, rounded, tapered, or similarly finished to minimize trauma to vessels.	Distal tip is suitable for intended clinical use.
Radiodetectability	Tip of the catheter visible under fluoroscopy.	Device radiopacity is suitable for intended clinical use.
Corrosion Resistance	Metallic components show no signs of corrosion.	Corrosion resistance is suitable for intended clinical use and met requirements of ISO 10555-1.
Peak Tensile Force	6F Catheter: ≥15N for distal section and hub/catheter junction. 5F Catheter: ≥10N for distal section and hub/catheter junction.	Peak tensile force is suitable for intended clinical use and met requirements of ISO 10555-1.
Fluid Leakage	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Air Leakage	No air leakage at hub into syringe when negative pressure was applied for 15 seconds.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Gauging	Plane of maximum diameter at opening of female conical fitting lies between two limit planes of the gauge.	The device hub met the requirements of ISO 80369-7.
Separation Force	Mating parts separation force > 35 N.	The device hub met the requirements of ISO 80369-7.
Unscrewing Torque	Test article luer remains attached after applying unscrewing torque not less than 0.02 N·m for a minimum of 10 seconds.	The device hub met the requirements of ISO 80369-7.
Stress Cracking	No stress cracks on the test article hub.	The device hub met the requirements of ISO 80369-7.
Ease of Assembly	Components fit together securely with no resistance between test article luer and reference fitting.	The device hub met the requirements of ISO 80369-7.
Resistance to Overriding	Test article luer does not override reference fitting threads.	The device hub met the requirements of ISO 80369-7.
Particulate	Amount of particulate matter during simulated use determined and compared to predicate device.	The amount and size of particles from the subject device was comparable to the predicate device.
Static Burst Pressure	Evaluate burst pressure under static conditions per ISO 10555-1:2013(E) Annex F.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Lubricity and Durability	Frictional force equivalent to predicate device and less than 0.3N. No coating cracking or separation.	Frictional force is suitable for intended clinical use, no coating cracking or separation, and is equivalent to the predicate device.
Equipment Interface	Compatible with 0.035" guidewire, ≥ 0.088" ID guide catheter/introducer sheath, ≤ 0.027" OD microcatheters, and common hemostatic valve.	The device is compatible with the accessories as specified.
Tip Shapeability	Distal tip steam shapeable and equivalent to predicate devices.	Shapeability of the distal tip after steam shaping is equivalent to predicate device.
Kink Resistance	No kinks when wrapped around pin gauges of clinical use relevant radii. No kinks during simulated use. Equivalent to predicate devices.	The device is resistant to kinking around relevant radii turns.
Simulated Use	Catheter reaches target locations in tortuous vessel model; delivered and retracted smoothly with 0.035" guidewire; no device damage or defects after simulated use.	Device performs as intended under simulated use conditions.
Torque Response	Torque response no worse than the predicate device.	Device torque response is equivalent to the predicate device.
Torque Strength	No catheter breakage after 50 rotations.	Device torque strength is equivalent to the predicate device.
Pushability/Retractability	Pushability/retractability in tortuous vessel model no worse than the predicate device.	Device pushability/retractability is equivalent to the predicate device.
Catheter Stiffness	Catheter stiffness equivalent to the predicate devices.	The catheter stiffness is equivalent to the predicate device.
Catheter Flexural Fatigue	No flexural fatigue following repeated bending or hoop stress.	The catheter flexural fatigue is equivalent to the predicate device.
Dynamic Burst	Catheter does not burst under dynamic pressure of 300 psi for 30 seconds.	The device met the test acceptance criteria.
Flow Rate	Catheter withstands manual injection of contrast media and saline at clinically relevant flow rates.	The device can withstand flow rates suitable for intended clinical use.
Ethylene Oxide Residue	Residual amount of ethylene oxide in single package ≤ 10µg/g.	Ethylene Oxide Residue met the acceptance criteria per ISO 10993-7:2008.
Sterility	Product shall be sterile.	Sterility of the catheter met the acceptance criteria per ISO 11135:2014.
Bacterial Endotoxins	Endotoxin content ≤ 2.15 EU/kit.	Bacterial endotoxins met the acceptance criteria per USP <85/>.
Biocompatibility Testing
Cytotoxicity Test (ISO 10993-5)	Cell viability of 100% test article extract shall be acceptable (not cytotoxic).	The cell viability of 100% test article extract was 95.5%. (Conclusion: Non-cytotoxic)
Skin Sensitization Test (ISO 10993-10)	No significant evidence of skin sensitization.	The positive rate of the test article was 0%. (Conclusion: No significant evidence of skin sensitization)
Intracutaneous Reactivity Test (ISO 10993-10)	Non-irritant. Final test article score acceptable.	The final test article score was calculated to be 0. (Conclusion: Non-irritant)
Acute Systemic Toxicity Test (ISO 10993-11)	No significant evidence of systemic toxicity. Body weight data acceptable and equivalent between groups.	Body weight data were acceptable and equivalent between the corresponding test and control treatment groups. (Conclusion: No significant evidence of systemic toxicity)
Hemolytic Properties Test (ASTM F756)	No influence on hemolytic properties.	The hemolysis index was 0.44% (direct contact) and 0.00 (indirect contact). (Conclusion: No influence on hemolytic properties)
Partial Thromboplastin Time (PTT) Test (ISO 10993-4)	No effect on PTT—no significant differences between sample group and negative group.	No significant differences between the sample group and the negative group. (Conclusion: No effect on PTT)
In Vivo Thrombogenicity Test (ISO 10993-4)	Equivalent to the control article—no significant differences between test and control articles.	No significant differences between the test and control articles. (Conclusion: Equivalent to the control article)
Pyrogen Test (ISO 10993-11)	Non-pyrogenic—no rabbit shows an individual rise in temperature of 0.5 °C or more.	No rabbit shows an individual rise in temperature of 0.5 °C or more. (Conclusion: Non-pyrogenic)
Complement Activity (C3a, SC5b-9) Test (ISO 10993-4)	Equivalent to the negative control group—no significant difference between sample group and negative control group.	No significant difference between the sample group and negative control group. (Conclusion: Equivalent to the negative control group)

Study Proving Device Meets Acceptance Criteria:

The device met its acceptance criteria through a series of bench tests and biocompatibility evaluations.

Bench Test Study:

Study Design: The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. This standard specifies requirements for sterile, single-use intravascular catheters. The tests covered various physical and mechanical properties crucial for safe and effective device function.
Methodology: The document lists 24 distinct bench tests (e.g., Surface Inspection, Dimensional Verification, Corrosion Resistance, Peak Tensile Force, Fluid Leakage, Kink Resistance, Simulated Use, Dynamic Burst, Flow Rate, etc.). Each test had specific acceptance criteria derived from the ISO standard or established engineering specifications for the device. The results consistently concluded that the device was "suitable for intended clinical use," "met requirements," or was "equivalent to the predicate device."
Conclusion: The bench testing demonstrated that "the in vitro behavior of the device is well characterized within design specifications."

Biocompatibility Study:

Study Design: The biocompatibility evaluation was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
Methodology: The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. These tests included Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolytic Properties, Partial Thromboplastin Time (PTT), In Vivo Thrombogenicity, Pyrogen, and Complement Activity tests. Each test had specific criteria for acceptable biological response. The conclusions for these tests consistently indicated that the device was non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic, had no effect on hemolytic properties or PTT, was equivalent to control/predicate for thrombogenicity and complement activity, and was non-pyrogenic.
Conclusion: The biocompatibility testing confirmed the device material safety for its intended biological contact.

The following information is not applicable (N/A) as this is a traditional medical device (catheter) and not an AI/ML powered device.

Sample size used for the test set and the data provenance: N/A (for AI/ML test sets). These are physical and biological tests, not data-driven evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML expert annotation). Ground truth for physical/biological tests is based on objective measurements against established standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (for AI/ML expert adjudication).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (not an AI-assisted device).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI algorithm).
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" or acceptance standard is derived from established international medical device standards (e.g., ISO 10555-1, ISO 80369-7, ISO 10993 series, USP <85/>) and internal design specifications, verified through objective bench and biological testing.
The sample size for the training set: N/A (not an AI/ML device; no training set in this context).
How the ground truth for the training set was established: N/A (not an AI/ML device).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 31, 2022

Guangzhou Easycess Medical Co., Ltd Xingcheng Liu Manager of Registration Affairs Department Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District, Guangzhou. 510530 China

Re: K213065

Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: April 28, 2022 Received: May 5, 2022

Dear Xingcheng Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213065

Device Name Distal Access Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Option 1
Option 2

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K213065

I. SUBMITTER

Guangzhou Easycess Medical Co., Ltd Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District, Guangzhou, China, 510530 Phone: 020-31603990 Fax: 020-31603675 Contact Person: Xingcheng Liu Date of Preparation: May 30th, 2022

II. DEVICE

Name of Device: Distal Access Catheter Common or Usual Name: Distal Access Catheter Classification Name: Percutaneous catheter (21 CFR 870.1250) Regulatory Class: II Product Code: QJP, DQY

III. PREDICATE DEVICE

Primary predicate device: SOFIA PLUS/Distal Access Catheter (K150366) Secondary predicate device: SOFIA Distal Access Catheter (K131482, K142014) These predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal

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end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.

The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH

THE PREDICATE DEVICE

Technological Comparison:

Device name		SOFIA PLUS/DistalAccess Catheter(K150366, Primarypredicate device)	SOFIA Distal AccessCatheter(K131482, K142014,Secondary predicatedevice)	Distal Access Catheter(K213065, Subjectdevice)
Intended Use		The SOFIA PLUS/Distal Access Cathetersare indicated for generalintravascular use,including the neuro andperipheral vasculature.It can be used tofacilitate introduction ofdiagnostic andtherapeutic agents. It isnot intended for use incoronary arteries.	The SOFIA DistalAccess Catheter isintended for generalintravascular use,including the neuroand peripheralvasculature. It can beused to facilitate theintroduction ofdiagnostic andtherapeutic agents. It isnot intended for use incoronary arteries.	The Distal AccessCatheter is indicatedfor generalintravascular use,including the neuro andperipheral vasculature.It can be used tofacilitate introductionof diagnostic agents ortherapeutic devices. Itis not intended for use incoronary arteries.
	Catheterinner layer	PTFE, polyolefinelastomer	PTFE, polyolefinelastomer	PTFE
Material	Cathetermiddlelayer	Stainless steel braid/coil	Stainless steelbraid/coil	Same
	Catheterouter layer	Polyurethane elastomer,polyether block amide(Pebax) and polyamide	Polyurethaneelastomer, polyetherblock amide (Pebax)and polyamide	Same
	Marker	Platinum/Iridium	Platinum/Iridium	Same
	Hub	Nylon	Nylon	PC
Device name		SOFIA PLUS/Distal Access Catheter(K150366, Primary predicate device)	SOFIA Distal Access Catheter(K131482, K142014, Secondary predicate device)	Distal Access Catheter(K213065, Subject device)
Strain Relief		Polyurethane	Polyurethane	Pebax
Introducer		Pebax	Pebax	PTFE
Shaping Mandrel		Stainless steel	Stainless steel	Same
Hemostatic Valve		Not applicable	Not applicable	PC
Catheter Size		6F	5F	5F 6F
Inner Diameter (ID)		0.070 inch (1.78 mm)	0.055 inch (1.4 mm)	5F: 0.056" (1.42mm)6F: 0.071" (1.80mm)
Outer Diameter (OD)		0.0825 inch (2.1 mm)	0.068 inch (1.7 mm)	5F: 0.068" (1.73mm)6F: 0.083" (2.11mm)
Effective Length		115-135 cm	115-125 cm	115-135cm
Coating		Hydrophilic coating(Hydak®)	Hydrophilic coating(Hydak®)	Hydrophilic coating (Polyamide)
Tip Configuration		Steam shapeable by user	Steam shapeable by user	Same
Guidewire Compatibility		0.035 inch	0.035 inch or 0.038 inch	0.035 inch
Accessories		Introducer sheath and shaping mandrel	Introducer sheath and shaping mandrel	Introducer sheath, shaping mandrel and hemostatic valve
Method of Supply		Sterile and single use	Sterile and single use	Same
Sterilization Method		Ethylene Oxide	Ethylene Oxide	Same
Packaging Configuration		Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer and shaping mandrel placed on a polyethylene packaging card that isinserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box.	Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer and shaping mandrelplaced on a polyethylene packaging card that isinserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box.	Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer, shaping mandrel and hemostatic valveplaced on a polyethylene packaging card that isinserted into a Tyvek/PE/PET pouch.Pouch and IFU placed in bleached sulfate carton box.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

. Bench Testing and Sterility

The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. The testing demonstrates that the in vitro behavior of the device is well characterized within design specifications. The results of bench testing and sterility

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evaluation are listed in the table below:

Test	Specification	Conclusion
SurfaceInspection	The external surface of the catheter shall be freefrom extraneous matter. The external surface ofthe catheter, including the distal end, shall befree from process and surface defects whichcould cause trauma to vessels during use.	The surface integrity issuitable for intended clinicaluse.
SurfaceContamination	The test article shall be free from surfacecontaminants from uncured coating surfaceparticulates > 0.02 mm², embedded particulates.The distal tip shall be smooth and tapered. PTFEinner layer not delaminated.	The surface integrity issuitable for intended clinicaluse.
DimensionalVerification	The device shall meet the specified dimensionalrequirements, including catheter OD, catheterID, effective length, length of distal tip and totallength of accessories.	The device met thedimensional and physicalspecifications.
Distal Tip	The distal tip shall be smooth, rounded, tapered,or similarly finished to minimize trauma tovessels during use.	Distal tip is suitable forintended clinical use.
RadioDetectability	The tip of the catheter should be visible underfluoroscopy.	Device radiopacity is suitablefor intended clinical use.
CorrosionResistance	Metallic components of the catheter intended forfluid path contact shall show no signs ofcorrosion.	Corrosion resistance is suitablefor intended clinical use andmet requirements of ISO10555-1.
Peak TensileForce	6F Catheter force at break ≥15N for distalsection and hub/catheter junction.5F Catheter force at break ≥10N for distalsection and hub/catheter junction.	Peak tensile force is suitablefor intended clinical use andmet requirements of ISO10555-1.
Fluid leakageat > 46 psi	No liquid leakage from hub and catheter shaft at46 psi for 30 seconds.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.
Air Leakage	No air leakage at hub into syringe when negativepressure was applied for 15 seconds.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.
Guaging	The plane of the maximum diameter at theopening of the female conical fitting shall liebetween the two limit planes of the gauge.	The device hub met therequirements of ISO 80369-7.
SeparationForce	The mating parts separation force is greater than35 N.	The device hub met therequirements of ISO 80369-7.
UnscrewingTorque	Test article luer remains attached after applyingan unscrewing torque not less than 0.02 N·m fora minimum of 10 seconds.	The device hub met therequirements of ISO 80369-7.
StressCracking	No stress cracks on the test article hub.	The device hub met therequirements of ISO 80369-7.
EaseofAssembly	Components fit together securely with noresistance observed between the test article luerand reference fitting.	The device hub met therequirements of ISO 80369-7.
Resistance toOverriding	Test article luer does not override referencefitting threads.	The device hub met therequirements of ISO 80369-7.
Particulate	The amount of particulate matter that comes offthe device during simulated use testing shall bedetermined and compared to the predicatedevice.	The amount and size ofparticles from the subjectdevice was comparable to thepredicate device.
StaticBurstPressure	The catheter was tested to evaluate the burstpressure under static conditions per ISO 10555-1:2013(E) Annex F.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.

Lubricity andDurability	tester. The frictional force shall be equivalent tothe predicate device and be less than 0.3N.	coating cracking or separation,and is equivalent to thepredicate device.
EquipmentInterface	The catheter shall be compatible with 0.035"guidewire, ≥ 0.088" ID guide catheter/introducer sheath, ≤ 0.027" OD microcatheters,and common hemostatic valve.	The device is compatible withthe accessories as specified.
TipShapeability	The distal tip should be steam shapeable andequivalent to the predicate devices.	Shapeability of the distal tipafter steam shaping isequivalent to predicate device.
KinkResistance	No kinks when wrapped around pin gauges ofclinical use relevant radii.No kinks noted during simulated use testing.Shall be equivalent to the predicate devices.	The device is resistant tokinking around relevant radiiturns.
Simulated Use	The catheter should reach various targetlocations in the tortuous vessel model; thecatheter could be delivered and retractedsmoothly with a 0.035" guidewire in the model;no device damage or defects after simulated use.	Device performs as intendedunder simulated useconditions.
TorqueResponse	The torque response of the catheter should be noworse than the predicate device.	Device torque response isequivalent to the predicatedevice.
TorqueStrength	No catheter breakage after 50 rotations.	Device torque strength isequivalent to the predicatedevice.
Pushability/Retractability	The pushability/retractability of the catheter inthe tortuous vessel model shall be not worse thanthe predicate device.	Device pushability/retractability is equivalent tothe predicate device.
CatheterStiffness	The catheter stiffness shall be equivalent to thepredicate devices.	The catheter stiffness isequivalent to the predicatedevice.
CatheterFlexuralFatigue	No flexural fatigue following repeated bendingduring simulated use testing and repeated hoopstress following pressure and air aspirationtesting.	The catheter flexural fatigue isequivalent to the predicatedevice.
DynamicBurst	The catheter shall not burst under dynamicpressure of 300 psi for 30 seconds.	The device met the testacceptance criteria.
Flow Rate	The catheter should withstand manual injectionof contrast media and saline at the clinicallyrelevant flow rates.	The device can withstand flowrates suitable for intendedclinical use.
EthyleneOxide Residue	The residual amount of ethylene oxide in asingle package should not exceed 10µg/g.	Ethylene Oxide Residue metthe acceptance criteria per ISO10993-7:2008.
Sterility	The product shall be sterile.	Sterility of the catheter met theacceptance criteria per ISO11135:2014.
BacterialEndotoxins	Endotoxin content shall not be greater than 2.15EU/ kit.	Bacterial endotoxinsmetthe acceptance criteria per USP<85/>
Biocompatibility Test	Result	Conclusion
Cytotoxicity Test (ISO 10993-5)MTT Method, MEM with 10% FBS extract	The cell viability of 100%test article extract was95.5%.	Non-cytotoxic
Skin Sensitization Test (ISO 10993-10)Guinea Pig Maximization Test, 0.9% SodiumChloride Injection Extract and Sesame OilExtract	The positive rate of the testarticle was 0%.	No significantevidence of skinsensitization
Intracutaneous Reactivity Test (ISO 10993-10)0.9% Sodium Chloride Injection Extract andSesame Oil Extract	The final test article scorewas calculated to be 0.	Non-irritant
Acute Systemic Toxicity Test (ISO 10993-11)Intravenous 0.9% Sodium Chloride InjectionExtract and Sesame Oil Extract	Body weight data wereacceptable and equivalentbetween the correspondingtest and control treatmentgroups.	No significantevidence ofsystemictoxicity
Acute Systemic Toxicity Test (ISO 10993-11)Intraperitoneal Sesame Oil Extract	Body weight data wereacceptable and equivalentbetween the correspondingtest and control treatmentgroups.	No significantevidence ofsystemictoxicity
Hemolytic Properties Test (ASTM F756)Direct and Extract Contact Method RabbitBlood	The hemolysis index was0.44% (direct contact) and0.00 (indirect contact).	No influence onhemolyticproperties
Partial Thromboplastin Time (PTT) Test (ISO10993-4)In vitro Human Blood	No significant differencesbetween the sample groupand the negative group.	No effect onPTT
In Vivo Thrombogenicity Test (ISO 10993-4)Non-anticoagulated venous implant (NAVI)Model	No significant differencesbetween the test and controlarticles.	Equivalent tothe controlarticle
Pyrogen Test (ISO 10993-11)0.9% Sodium Chloride Injection Extract Rabbit	No rabbit shows anindividual rise in temperatureof 0.5 °C or more.	Non-pyrogenic
Complement Activity (C3a, SC5b-9) Test (ISO10993-4)In vitro Test	No significant differencebetween the sample groupand negative control group.	Equivalent tothe negativecontrol group

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• Г Biocompatibility

The biocompatibility evaluation for the Distal Access Catheter was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."

The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. The results of testing are listed in the table below:

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VIII. CONCLUSIONS

The data presented in this submission demonstrate the technological similarity and substantial equivalence of the Distal Access Catheter when compared with the predicate devices SOFIA PLUS/Distal Access Catheter(K150366) and SOFIA Distal Access Catheter (K131482, K142014).

The subject and predicate devices,

. have the same indications for use,
. use the same operating principle,
. incorporate the same basic design,
. are packaged and sterilized using similar materials and processes.

In summary, the Distal Access Catheter described in this submission is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).