The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

Device Description

The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.

AI/ML Overview

This document, a 510(k) Summary, describes the Vericor Support Catheter and its substantial equivalence to a predicate device. This is a medical device, not an AI/ML product, so the questions regarding AI/ML clinical studies are not applicable.

Here's the breakdown of the acceptance criteria and the study (non-clinical) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) Summary details numerous non-clinical tests. The column "Test Method Summary" indirectly describes the acceptance criteria by outlining what the test aims to demonstrate (e.g., "To demonstrate that the device meets the corrosion resistance"). The "Results and Conclusion" column reports that the device met these criteria.

Test	Acceptance Criteria (Implied from "Test Method Summary")	Reported Device Performance
Visual inspection	No structural or mechanical damage under x2.5 magnification	The catheter met acceptance criteria.
Corrosion Resistance	Meets ISO 10555-1:2013 corrosion resistance requirements	Corrosion resistance met acceptance criteria.
Dimensional verification	Meets specified dimensions	Size verification met acceptance criteria.
Flowrate determination test	Meets ISO 10555-1:2013 flowrate requirements	The flowrate of the Vericor catheter size verification met acceptance criteria.
Compatibility test	Can be used as intended with compatible devices in a vascular model	The device can be used as intended.
Simulated use	Can be used as intended in a vascular model	The device can be used as intended.
Power injection	Free of leakage, rupture, or other failure modes during power injection	The catheters were free of leakage, rupture or other failure modes during power injection test, and the test result met acceptance criteria.
Torque transmission	Meets torque transmission requirements	Torque transmission met acceptance criteria.
Air leakage	No air leakage during hub aspiration	No air leakage
Liquid leakage	No liquid leakage under pressure	No liquid leakage
Static burst pressure	Meets burst pressure requirements (greater than maximum injection pressures)	Burst pressure met acceptance criteria.
Friction of coating	Acceptable change in coating friction before and after use	Friction met acceptance criteria
Coating integrity	No coating defects with magnification after simulated use	Coating integrity met acceptance criteria.
Flexibility	Meets ASTM F2606-2008 flexibility requirements	Tip flexibility met acceptance criteria.
Kink resistance	Meets kink resistance requirements (implied by method)	Kink resistance met acceptance criteria
Peak tensile force	Meets maximum tensile force acceptance criteria	Peak tensile force met acceptance criteria.
Catheter tip twist to damage test	Meets tip twist acceptance criteria (e.g., no deformation/failure under specified rotation)	Tip twist met acceptance criteria
Radiopacity	Radiopaque marker on the catheter tip divisible under X-ray	The radiopaque marker on the catheter tip is visible under X - ray.
Catheter body axial compression test	Meets catheter body axial force acceptance criteria	Catheter body axial force met acceptance criteria.
Delivery and retrieval forces test	Meets FDA Guidance delivery and retrieval requirements	Deliver and retrieval force met acceptance criteria.
Particulate testing	Quantity and size of generated particles meet acceptance criteria after simulated use	The number and size of the particles met acceptance criteria.
Connector performance	Meets ISO 80369-7 requirements for small bore connectors	Connector performance met acceptance criteria.
Cytotoxicity	No cytotoxicity	No cytotoxicity
Skin Sensitization	No skin sensitization	No skin sensitization
Intracutaneous Reactivity	No irritation	No irritation
Systemic Toxicity	No systemic toxicity	No systemic toxicity
Pyrogen	No pyrogen	No pyrogen
Complement Activation	No significant difference to control group	No significant difference to control group
In Vivo Thromboresistance	Minimal thrombosis	Minimal thrombosis
Hemolysis	No hemolysis	No hemolysis
Partial Thromboplastin Time	No significant difference to control group	No significant difference to control group

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

The document does not explicitly state the sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not applicable in terms of country of origin or retrospective/prospective for these non-clinical, laboratory-based tests. The tests were performed on the Vericor Support Catheter itself.

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

This is not applicable as the studies are non-clinical, laboratory-based performance tests, not studies involving human interpretation or clinical data. Ground truth in this context is established by adherence to specified standards and measurement techniques.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and adherence to established standards, not expert adjudication of subjective interpretations.

5. 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

Not applicable. This is a conventional medical device (support catheter), not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For these non-clinical tests, the "ground truth" is defined by the objective criteria within the referenced international and national standards (e.g., ISO 10993, ISO 10555-1, ASTM standards, USP). Performance is measured against these established technical specifications and benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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

Not applicable. This device does not involve a training set.

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.

November 7, 2022

VascuPatent Medical (Shenzhen) Co. Ltd. c/o Dr. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Guangdong 200120 China

Re: K222679

Trade/Device Name: Vericor Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 14, 2022 Received: September 14, 2022

Dear Diana Hong:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.11.07

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K222679

Device Name Vericor Support Catheter

Indications for Use (Describe)

The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K222679

1. Date of Preparation: 09/02/2022
1. Sponsor Identification

VascuPatent Medical (Shenzhen) Co. Ltd.

Room 314 & 316, Building A, Branch 3, Leibai Zhongcheng Life Science Park, No.22 Jinxiu East Road, Jinsha Community, Pingshan District, Shenzhen, Guangdong Province, P.R.China

Establishment Registration Number: Not registered

Contact Person: Heather Li Position: Director of QA & RA Tel: +86- 18922846103 Fax: +86- 755-89666170 Email: hli@vascupatent.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Vericor Support Catheter Common Name: Continuous Flush Catheter

Regulatory Information Classification Name: Continuous flush catheter Classification: II Product Code: KRA Regulation Number: 21CFR 870.1210 Review Panel: Cardiovascular

Indication for Use:

The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

Device Description

న. Identification of Predicate Devices
Predicate Device 510(k) Number: K160884 Product Name: CXI Support Catheter
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications and was found to be Substantially Equivalent (SE) to the predicate device. The testing was conducted with methods and criteria (as applicable) for compliance with the following standards:
ISO 10993-4: 2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity

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A ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
USP <85> Bacterial Endotoxins Test
ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F2382-18, Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on PTT
A ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and System
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
A ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
A ISO 10555-1: 2013, Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
ISO 80369-7: 2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
A USP<151>, Pyrogen Test
USP<788>, Particulate Matter in Injections
ASTM F640-20, Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F2606-08, Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

The results of performance testing conducted on the Vericor Support Catheter demonstrate that it performs as designed, is suitable for its indication for use and is equivalent in performance to the identified predicate device. A summary of the tests performed is provided in the table below:

Test	Test Method Summary	Results and Conclusion
Visual inspection	Observe the catheter by naked eyes or under microscope of X2.5 magnification for any structural or mechanical damage.	The catheter met acceptance criteria.
Corrosion Resistance	The proposed device was evaluated per ISO 10555 - 1:2013. To demonstrate that the device meets the corrosion resistance.	Corrosion resistance met acceptance criteria.
Dimensional verification	Verify dimensions using specified measurement tools. Record measurements.	Size verification met acceptance criteria.
Flowrate	The proposed device was evaluated per ISO 10555-1:2013. To demonstrate that the device	The flowrate of the Vericor catheter size verification met
determination test	meets the flowrate requirements.	acceptance criteria.
Compatibility test	Simulated use testing with compatible devices in a vascular model was performed.	The device can be used as intended.
Simulated use	Simulated use testing in a vascular model was performed	The device can be used as intended.
Power injection	The proposed device was evaluated per ISO 10555 - 1:2013. To demonstrate that the device meets the power injection requirements.	The catheters were free of leakage, rupture or other failure modes during power injection test, and the test result met acceptance criteria.
Torque transmission	Fix the distal end of the catheter and rotate the proximal.	Torque transmission met acceptance criteria.
Air leakage	The proposed device was evaluated per ISO 10555 - 1 to demonstrate that the product meets the hub aspiration air leakage requirements.	No air leakage
Liquid leakage	The proposed device was evaluated per ISO 10555 - 1. To demonstrate that the device meets the liquid leakage under pressure requirements.	No liquid leakage
Static burst pressure	Burst pressure tests were performed at pressures greater than the maximum injection pressures.	Burst pressure met acceptance criteria.
Friction of coating	The test simulates the change in coating friction of the product before and after use	Friction met acceptance criteria
Coating integrity	After simulating the use with compatible devices, the coating is dyed and observe coating defects with magnification.	Coating integrity met acceptance criteria.
Flexibility	The proposed device was evaluated per ASTM F2606-2008. To demonstrate that the device meets the flexibility requirements.	Tip flexibility met acceptance criteria.
Kink resistance	One end of the test piece was fixed on the stator of kink resistance fixture, and the other was fixed on the mover that could move axially in a fixture. The radius gradually decreased when the mover moves axially. Recorded the total length of the catheter body with fixed ends.	Kink resistance met acceptance
Peak tensile force	Use a tensile test machine to apply a tensileload to the sample and determine whether themaximum tensile force meets the acceptancecriteria.	Peak tensile force metacceptance criteria.
Catheter tip twist todamage test	Fixed the end of the tip with a TorsionalMeter. Rotated the proximal end of thecatheter until the tip or body deformed orfailed	Tip twist met acceptance
Radiopacity	The radiopaque marker on the catheter tipshould be visible under X - ray.	The radiopaque marker onthe catheter tip is visibleunder X - ray.
Catheter body axialcompression test	The lower jaw clamped the fixture, and theupper jaw clamped one test piece of thecatheter. Recorded the force-deflection curveand peak force value of the catheter bodyduring test.	Catheter body axial force metacceptance criteria.
Delivery and retrievalforces test	The proposed device was evaluated per FDAGuidance - Non-Clinical Engineering Tests andRecommended Labeling for IntravascularStents and Associated Delivery Systems. Todemonstrate that the device meets the deliveryand retrieval requirements.	Deliver and retrieval forcemet acceptance criteria.
Particulate testing	After simulating the use with compatibledevices, determine the quantity and size of theparticles generated.	The number and size of theparticlesmetacceptancecriteria.
Connectorperformance	The proposed device was evaluated per ISO80369-7 to demonstrate that the product meetsthe requirements for small bore connectors.	Connector performance metacceptance criteria.

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1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item		Proposed Device	Predicate Device K160884	Remark
Classification		II	II	Same
Product Code		KRA	KRA	Same
	Regulation Number	21 CFR 870.1210	21 CFR 870.1210	Same
Indication for Use		The Vericor Support Catheter isintended for use in small vessel orsuperselective anatomy for diagnosticand interventional procedures,including peripheral use.	The CXI TM Support Catheter isintended for use in small vessel orsuperselective anatomy fordiagnostic and interventionalprocedures, including peripheral use.	Same
Component		HubStrain reliefDistal shaftProximal shaftMarker bandsRadiopaque tip	Multi layers with hydrophiliccoatingDistal tip and hub	Different
Inner Diameter		0.0215inch	0.0215inch	Same
Outer Diameter		Proximal: 2.5Fr (0.83mm)Distal: 2.4Fr (0.80mm)	2.6Fr (0.87mm)4.0Fr (1.23mm)	Different
Effective length		90cm, 135cm, 150cm	65cm, 90cm, 135cm, 150cm	Similar
	Maximum Guidewire	0.018inch	0.018inch	Same
Radiopaque Marker		Yes	Yes	Same
Single Use		Yes	Yes	Same
Labeling		Conform with Part 801	Conform with Part 801	Same
	Patient-contact Material
Tip	Tip OuterBody	Polyether block amide (PEBA)Tungsten		Different
	Tip InnerBody	Polyether block amide (PEBA)
	PTFE	Poly tetra fluoroethylene (PTFE)
	Liner	Poly tetra fluoroethylene (PTFE)	Unknown
Marker Band		PolyamideTungsten
Proximal Shaft	ProximalOuterBody	Polyethylene terephthalate (PET)
	PTFE	Poly tetra fluoroethylene (PTFE)

	Liner
	Distal	Polyamide
DistalShaft	OuterBody 1	Polyether block amide (PEBA)
	DistalOuterBody 2	Polyamide
	PTFELiner	Poly tetra fluoroethylene (PTFE)
	Hydrophilic Coating	Ethanol
		2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone
		Ethanol
		Water
		Polyvinylpyrrolidone
	Hub	Polycarbonate (PC)
Biocompatibility
	Cytotoxicity	No cytotoxicity		Same
	Skin Sensitization	No skin sensitization
	IntracutaneousReactivity	No irritation
	Systemic Toxicity	No systemic toxicity
	Pyrogen	No pyrogen
	ComplementActivation	No significant difference to controlgroup	Conform with ISO 10993 standards
	In VivoThromboresistance	Minimal thrombosis
	Hemolysis	No hemolysis
	PartialThromboplastin Time	No significant difference to controlgroup
	Sterilization	Ethylene oxide	Ethylene oxide	Same
	SAL	10-6	10-6	Same

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Analysis Different - Component

The components for the proposed device are different from predicate device. The component name for different manufacturer maybe different from each other. Each component of the proposed device is written in more detail. However, the differences in component name will not affect indication for use or raise any safety issues. In addition, a comparative performance test was conducted between the proposed device and the predicate device, and the test results showed that the performance of the two devices was

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similar. Therefore, this difference does not raise new safety and efficacy issues.

Analysis Different -Outer Diameter

The outer diameter of the proposed device is different from predicate device. The proposed device is designed with unequal outer diameter, while the predicate device is designed with equal outer diameter. The predicate device has two sizes of outer diameter, while the proposed device has only one. However, the proposed proximal outer diameter is very similar to the predicate device and this difference is small. The comparative performance test was conducted between the proposed device and the predicate device, and the test results showed that the performance of the two devices was similar. Therefore, this difference does not raise new safety and efficacy issues.

Analysis Similar-Effective length

The outer diameter of the proposed device is similar to predicate device. The proposed devices are available in three effective lengths, which are 90cm, 135cm and 150cm. The predicate devices are available in four effective lengths, which are 65cm, 90cm, 135cm and 150cm. The effective length for the proposed device is covered by the range of lengths for the predicate device. Therefore, this difference does not raise new safety and efficacy issues.

Analysis Different- Patient-contact Material

The materials of subject device may be different from predicate device. However, biocompatibility and other bench tests were performed on the proposed device and the test results showed that there was no adverse effect. Therefore, this difference does not raise new safety and efficacy issues.

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).