KardiFlexTM NC Coronary Dilatation Catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
· in-stent restenosis.
· post-delivery expansion of balloon expandable coronary stents.

Device Description

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).

The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

AI/ML Overview

This document describes the regulatory submission for the KardiFlex™ NC Coronary Dilatation Catheter (K202578). This is a physical device, not an AI/ML powered device, so many of the requested fields are not applicable.

Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass test" for each specified performance test. The reported device performance for all listed tests is "Pass test," indicating that the device met these criteria.

Acceptance Criteria (Test)	Reported Device Performance
Biocompatibility Testing:
In vitro cytotoxicity	Pass test
Intracutaneous reactivity	Pass test
Skin sensitization	Pass test
Acute systemic toxicity	Pass test
Hemocompatibility (Hemolysis, Coagulation, etc.)	Pass test
Material mediated pyrogenicity	Pass test
Bench Testing (Zero Time and Accelerated Aged):
Tip Configuration	Pass test
Surface	Pass test
Dimensional Verification	Pass test
Corrosion Resistance	Pass test
Radio-detectability of Balloon Position	Pass test
Freedom from Leakage	Pass test
Hub	Pass test
Balloon Rated Burst Pressure	Pass test
Balloon Failure Mode	Pass test
Balloon Fatigue	Pass test
Diameter at Nominal Pressure	Pass test
Balloon Compliance	Pass test
Inflation Time	Pass test
Deflation Time	Pass test
Catheter Bond Strength	Pass test
Entry Tip Crossing Profile	Pass test
Balloon Preparation, Deployment and Retraction	Pass test
Rated Burst Pressure (in stent)	Pass test
Balloon Fatigue (In stent)	Pass test
Tip Pull Test	Pass test
Flexibility and Kink Test	Pass test
Torque Strength	Pass test
Coating Integrity	Pass test
Particulate Evaluation	Pass test
Shaft Loose Part	Pass test
Package Labeling	Pass test
Shelf Life	Pass test
Package Seal Verification	Pass test
Shipping and Handling	Pass test
Chemical performance	Pass test
EtO Sterilization	Pass test
Sterility	Pass test
Bacterial Endotoxin	Pass test

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

The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "the subject device, KardiFlex™ NC Coronary Dilatation Catheter, was subjected to the following applicable testing." This implies that a sufficient number of device units (the "test set") were used for each test to demonstrate compliance with the relevant standards.

The data provenance is from bench testing and biocompatibility testing conducted by the manufacturer, Medcaptain Life Science Co., Ltd., based in Shenzhen, Guangdong, China. This is prospective testing, as it's performed on the device prototypes to demonstrate compliance before marketing.

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

This is not applicable as the evaluation involves physical device performance against established engineering and biological standards, not human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed are objective, quantitative technical assessments (e.g., measuring burst pressure, inflation time, etc.) against pre-defined thresholds from regulatory standards (ISO, FDA guidance). There is no "adjudication method" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. The KardiFlex™ NC Coronary Dilatation Catheter is a physical medical device (balloon catheter), not an AI/ML diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" used for these tests are the established performance specifications and safety requirements outlined in international standards (e.g., ISO 10993, ISO 10555) and FDA guidance documents. These are objective, quantifiable criteria that the device's physical properties and behavior must meet.

8. The Sample Size for the Training Set

This is not applicable. As a physical device, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing process are refined through engineering development and quality control, not by training on a dataset.

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

This is not applicable as there is no "training set" for a physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

May 6, 2021

Medcaptain Life Science Co., Ltd. David Xia Official Correspondent 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, Guangdong 518118 China

Re: K202578

Trade/Device Name: KardiFlexTM NC Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 3, 2020 Received: September 8, 2020

Dear David Xia:

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

Enclosure

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Indications for Use

510(k) Number (if known) K202578

Device Name

KardiFlex NC Coronary Dilatation Catheter

Indications for Use (Describe)

KardiFlex NC Coronary Dilatation Catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
· in-stent restenosis.
· post-delivery expansion of balloon expandable coronary stents.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 81 CFR 201 Subpart D)
Over-The-Counter Use (81 CFR 201 Subpart C)

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/1 description: The image shows the logo for MEDCAPTAIN. The text "MED" is in gray, and "CAPTAIN" is in blue. To the right of the text is an open quotation mark in blue and orange. Above the text is Chinese characters in gray.

MEDCAPTAIN LIFE SCIENCE CO., LTD. 601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Email: disposable@medcaptain.com Tel.: +86-755-28380626 Fax.: +86-755-84517910 Website: www.medcaptain.com

510(k) Summary

KardiFlexTM NC Coronary Dilatation Catheter 21 CFR §870.5100(a) Date prepared: May 1, 2021

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

I. Submitter/510(k) Holder

Submission:	Traditional 510(k) Premarket Notification
Submitter:	Medcaptain Life Science Co., Ltd.
Address:	601, Building C, Jinweiyuan Industrial Park, PingshanDistrict, Shenzhen, Guangdong, CN 518118.
Contact:	David Xia
Telephone:	+86-755-28380626
Telefax:	+86-755-84517910
Email:	david.xia@medcaptain.com

II. Device information

Device Trade Name:	KardiFlexTM NC Coronary Dilatation Catheter
Device Common Name:	Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheter
Classification Name:	Catheter, transluminal coronary angioplasty,percutaneous
Classification Regulation:	21 CFR 870.5100(a)
Product Code:	LOX
Device Class:	Class II
Classification Panel:	Cardiovascular
510(k) Number:	K202578

III. Predicate Device

The KardiFlex™ NC Coronary Dilatation Catheter is substantially equivalent to the following devices:

Predicate device: Sapphire NC Plus Coronary Dilatation Catheter (K192344, OrbusNeich Medical Trading, Inc.) cleared on September 19, 2019.

Reference device 1: Sapphire NC Coronary Dilatation Catheter (K103808,

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601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

OrbusNeich Medical, Inc.) cleared on September 1, 2011.

And, reference device 2: RX NC Takeru PTCA Balloon Dilatation Catheter (K170941, Kaneka Corporation) were used in this submission.

IV. Device Description

V. Indications for Use

KardiFlex™ NC Coronary Dilatation Catheter is indicated for:

balloon dilatation of the stenotic portion of a coronary artery or bypass graft . stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
balloon dilatation of a coronary artery occlusion for the treatment of acute . myocardial infarction.
in-stent restenosis. .
post-delivery expansion of balloon expandable coronary stents. ●

VI. Comparison to Predicate Device

The subject device, KardiFlex™ NC Coronary Dilatation Catheter, and the predicate device, Sapphire NC Plus Coronary Dilatation Catheter, are substantially equivalent in that these devices, at a high level, have same technological element: intended use, indications for use, operation principle and design (such as rapid exchange catheter

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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

design, hydrophilic coating applied in the distal section, non-compliant balloon, 0.014inch guidewire compatibility, EO sterilization and single use), prescription use, target user, use environment, main materials, nominal pressure, etc.

The technological differences between the subject and the predicate device include balloon diameter range, balloon length range, working length, rated burst pressure. Testing requirements for the subject device are based on upon the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).

Similarities and differences in technologies characteristics are captured in the substantial equivalence comparison of the subject device, KardiFlex™ NC Coronary Dilatation Catheter, and the predicate device, Sapphire NC Plus Coronary Dilatation Catheter, which are provided in Table 1.

Description	Sapphire NC PlusCoronary DilatationCatheter(Predicate Device)	Sapphire NCCoronary DilatationCatheter(Reference Device 1)	RX NC Takeru(Reference Device 2)	KardiFlexTM NCCoronary DilatationCatheter(Subject device)	Comparison topredicate/reference device
510(k) Number	K192344	K103808	K170941	K202578	N/A
Regulation Number	21 CFR 870.5100(a)	21 CFR 870.5100(a)	21 CFR 870.5100	21 CFR 870.5100(a)	Identical
Classification Name	Catheter, transluminalcoronary angioplasty,percutaneous	Catheter, transluminalcoronary angioplasty,percutaneous	PercutaneousTransluminal CoronaryAngioplasty (PTCA)Catheter	Catheter, transluminalcoronary angioplasty,percutaneous	Identical
Product Code	LOX	LOX	LOX	LOX	Identical
Device Class	Class II	Class II	Class II	Class II	Identical
Intended Use	Sapphire NC PlusCoronary DilatationCatheter is intendedfor use inpercutaneoustransluminalcoronaryangioplasty (PTCA)to treat patients withcoronary disease.	Sapphire NC CoronaryDilatation Catheter isintended for use inpercutaneoustransluminal coronaryangioplasty (PTCA) totreat patients withcoronary disease.	RX NC TakeruCoronary DilatationCatheter is intendedfor use inpercutaneoustransluminal coronaryangioplasty (PTCA) totreat patients withcoronary disease.	KardiFlexTM NCCoronary DilatationCatheter is intendedfor use inpercutaneoustransluminalcoronaryangioplasty (PTCA)to treat patients withcoronary disease.	Identical
Indications for use	Sapphire NC Plus	Sapphire NC Coronary	The RX NC Takeru	KardiFlexTM NC	Identical to
	Coronary DilatationCatheter is indicatedfor:	Dilatation Catheter isindicated for:• balloon dilatation ofthe stenotic portion ofa coronary artery orbypass graft stenosisin patients evidencingcoronary ischemia forthe purpose ofimproving myocardialperfusion.• balloon dilatation ofa coronary arteryocclusion for thetreatment of acutemyocardial infarction.•in-stent restenosis•post-deliveryexpansion of balloonexpandable coronarystents.	PTCA BalloonDilatation Catheter isindicated for balloondilatation of the stenoticportion in coronaryartery or bypass graftstenosis for the purposeof myocardialperfusion.This product is alsoindicated for thepost-delivery expansionof balloon expandablestents	Coronary DilatationCatheter is indicatedfor:• balloon dilatationof the stenoticportion of acoronary artery orbypass graft stenosisin patientsevidencing coronaryischemia for thepurpose ofimprovingmyocardialperfusion.• balloon dilatationof a coronary arteryocclusion for thetreatment of acutemyocardialinfarction.•in-stent restenosis•post-deliveryexpansion of balloonexpandable coronarystents.	predicate device
Operation principleand design	Sapphire NC PlusCoronary DilatationCatheterisapercutaneoustransluminal coronaryangioplasty (PTCA)balloon catheter witha working length of140cm.The proximalshaft is a polymercoated stainless steelhypotube. Lubriciouscoatings are applied tothe distal section. The	Sapphire NC CoronaryDilatation Catheter is apercutaneoustransluminal coronaryangioplasty (PTCA)balloon catheter with aworking length of140cm. The proximalshaft is a polymercoated stainless steelhypotube. Lubriciouscoatings are applied tothe distal section. Thenon-compliant balloons	RX NC Takeru PTCABalloon DilatationCatheter is apercutaneoustransluminal coronaryangioplasty (PTCA)balloon catheter with aworking length of145cm. RX NC Takeruis a rapid exchange typeof balloon dilatationcatheter, which consistsof a distal tube,guidewire transition	KardiFlexTM NCCoronary DilatationCatheter is apercutaneoustransluminal coronaryangioplasty (PTCA)balloon catheter witha working length of142.5cm design. Theproximal shaft is aPTFE coated stainlesssteel hypotube.Hydrophilic coatingsare applied to the	SubstantiallyequivalentDifferences donot raise new ordifferentquestionsregarding safetyor effectiveness.
non-compliant		can be inflated by	tube, balloon, radiopaque markers, mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. RX NC Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire. The maximum compatible diameter of a guidewire is 0.014inches. Guiding catheters with a diameter of 5 or 6Fr have been deemed to be compatible with the RX NC Tekeru.	distal section. The non-compliant balloons can be inflated by injection of dilute contrast media solution through the hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (only one centrally located marker band for 1.5 configurations).The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not
balloons can be inflated by injection dilute contrast media solution through the trailing hub of the catheter.Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire.The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure		injection dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
	measurements.			incorporate a lumenfor distal dyeinjections or distalpressuremeasurements.
Prescription/Over-the-Counter	Prescription	Prescription	Prescription	Prescription	Identical
Target User	Intended for use byphysicians	Intended for use byphysicians	Intended for use byphysicians	Intended for use byphysicians	Identical
Access/ Anatomicalsite:	Insertedpercutaneously intothe arterial circulationor bypass graftstenosis	Inserted percutaneouslyinto the arterialcirculation or bypassgraft stenosis	/	Insertedpercutaneously intothe arterial circulationor bypass graftstenosis	Identical topredicate device
Use environment:	Hospitals	Hospitals	/	Hospitals	Identical topredicate device
Materials:	/	/	/	/	/
Balloon material	Nylon	Nylon	/	Nylon	Substantially
Hypotube	Polymer coatedstainless steel	Polymer coatedstainless steel	/	Polymer (PTFE)coated stainless steel	equivalent
Marker bands	Platinum	Platinum	/	Platinum Alloys	Differences donot raise new ordifferentquestionsregarding safetyor effectiveness.
Performance:	/	/	/	/	/
Dimension	Balloon diameter:2.0-5.0mm	Balloon diameter:2.0-4.0mm	Balloon diameter:2.0-5.0mm	Balloon diameter:1.5-5.0mm	DifferenceDifferences donot raise new ordifferentquestionsregarding safetyor effectiveness.
	Balloon length:8-18mm	Balloon length: 8-18mm	Balloon length:6-30mm	Balloon length:6-30mm	Identical toreference device2
	Working length:	Working length: 140cm	Working length: 145cm	Working length:	Difference
	140cm			142.5cm
					Differences do
					not raise new or
					different
					questions
					regarding safety
					or effectiveness.
Balloon ratedburst pressure	22atm (2.0-4.0)20atm (4.5-5.0)	22atm (2.0-4.0)	20atm	22atm	Difference
					Differences do
					not raise new or
					different
					questions
					regarding safety
					or effectiveness.
Nominal pressure	12atm	12atm	12atm	12atm	Identical
Balloon fatigue	Pass test	Pass test	Pass test	Pass test	Identical
Ballooncompliance	Pass test,non-compliance	Pass test,non-compliance	Pass test,non-compliance	Pass test,non-compliance	Identical
Balloon inflationand deflation time	Pass test	Pass test	Pass test	Pass test	Identical
Catheter bondstrength	Pass test	Pass test	Pass test	Pass test	Identical
Tip pull test	Pass test	Pass test	Pass test	Pass test	Identical
Particulateevaluation	Pass test	Pass test	Pass test	Pass test	Identical
Visual inspection	Pass test	Pass test	Pass test	Pass test	Identical
Balloon preparation,deployment,and retraction	Pass test	Pass test	Pass test	Pass test	Identical
Balloon rated burstpressure (in stent)	Pass test	Pass test	Pass test	Pass test	Identical
Balloon fatigue (in stent)	Pass test	Pass test	Pass test	Pass test	Identical
Flexibility and kinking	/	Pass test	Pass test	Pass test	Identical
Torque strength	/	Pass test	Pass test	Pass test	Identical
Radiopacity	/	Pass test	Pass test	Pass test	Identical
Coating integrity	/	Pass test	Pass test	Pass test	Identical

Table 1: Substantial Equivalence

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601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.

Tel.: +86-755-28380626 Fax.: +86-755-84517910 Email: disposable@medcaptain.com Website: www.medcaptain.com

Page 4 of 9

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601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.

Tel.: +86-755-28380626 Fax.: +86-755-84517910 Email: disposable@medcaptain.com Website: www.medcaptain.com

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601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Email: disposable@medcaptain.com Tel.: +86-755-28380626 Fax.: +86-755-84517910 Website: www.medcaptain.com

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N.A N.A N.A Energy type: N.A Identical Biocompatibility: ISO 10993 ISO 10993 ISO 10993 ISO 10993 Identical Sterilization: Sterilized with Sterilized with ethylene Sterilized with ethylene Sterilized with Identical ethylene oxide gas. ethylene oxide gas. oxide gas. oxide gas. Non-pyrogenic. Non-pyrogenic. Non-pyrogenic. Non-pyrogenic. Single Use: Single use Single use Single use Single use Identical Shelf Life: 2 years 2 years 2 years Identical to predicate device

VII. Performance Data

The subject device, KardiFlex™ NC Coronary Dilatation Catheter, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters and ensure that the design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010):

Biocompatibility Testing:

Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.

In vitro cytotoxicity, per ISO 10993-5: 2009 ●
Intracutaneous reactivity, per ISO 10993-10: 2010 ●
Skin sensitization, per ISO 10993-10: 2010 ●
Acute systemic toxicity, per ISO 10993-11: 2017 ●
Hemocompatibility (Hemolysis, Coagulation, Platelet count or leukocyte ● count, In Vivo Thromboresistance and Complement), per ISO 10993-4: 2017
Material mediated pyrogenicity, per ISO 10993-11: 2017 and USP General ● Chapter <151>

Bench Testing (Zero Time and Accelerated Aged):

Per ISO 10555-1: 2013, ISO 10555-4: 2013, FDA guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)", etc., the following tests were performed for bench testing:

Tip Configuration, per ISO 10555-1: 2013. ●
Surface, per ISO 10555-1: 2013.
Dimentional Verification, per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance.

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MEDCAPTAIN

Corrosion Resistance, per ISO 10555-1: 2013.
Radio-detectability of Balloon Position, per ISO 10555-1: 2013, ISO ● 10555-4: 2013 and FDA guidance.
Freedom from Leakage, per ISO 10555-1: 2013 and product characteristics. ●
Hub, per ISO 10555-1: 2013. ●
Balloon Rated Burst Pressure, per ISO 10555-4: 2013 and FDA guidance. ●
Balloon Failure Mode, per ISO 10555-4: 2013.
. Balloon Fatigue, per ISO 10555-4: 2013 and FDA guidance.
. Diameter at Nominal Pressure, per ISO 10555-4: 2013.
. Balloon Compliance, per ISO 10555-4: 2013 and FDA guidance.
Inflation Time, per FDA guidance. ●
Deflation Time, per ISO 10555-4: 2013 and FDA guidance. ●
Catheter Bond Strength, per ISO 10555-1: 2013 and FDA guidance. ●
Entry Tip Crossing Profile.
Balloon Preparation, Deployment and Retraction, per FDA guidance. ●
Rated Burst Pressure (in stent), per FDA guidance. ●
Balloon Fatigue (In stent), per FDA guidance. ●
Tip Pull Test, per FDA guidance. ●
Flexibility and Kink Test, per FDA guidance.
Torque Strength, per FDA guidance.
Coating Integrity, per FDA guidance. ●
Particulate Evaluation, per FDA guidance, EN ISO 8536-4: 2020, USP . <788>.
. Shaft Loose Part.
Package Labeling, per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA ● guidance.
. Shelf Life, per FDA guidance.
Package Seal Verification, per ISO 11607-1: 2019 and ISO 11607-2: 2019. ●
Shipping and Handling, per ISTA 3A: 2018. .
Chemical performance, per ISO 8536-4: 2019. .
EtO Sterilization, per ISO 10993-7: 2008 and FDA guidance. ●
. Sterility, per ISO 11135: 2014 and FDA guidance.
Bacterial Endotoxin, per ANSI/AAMI ST72: 2011. ●

VIII. Conclusion

The results of these tests confirm that the KardiFlex™ NC Coronary Dilatation Catheter meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety and/or effectiveness and is substantially equivalent to the predicate devices, Sapphire NC Plus Coronary Dilatation Catheter (K192344, OrbusNeich Medical Trading Inc.).

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.