K Number
K202578
Device Name
KardiFlex NC Coronary Dilatation Catheter
Date Cleared
2021-05-06

(240 days)

Product Code
Regulation Number
870.5100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

No
The summary describes a physical medical device (a balloon catheter) and its mechanical and material properties. There is no mention of software, algorithms, data processing, or any other components that would suggest the use of AI or ML. The performance studies focus on physical and biological testing.

Yes
The device 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," as well as for treating acute myocardial infarction and in-stent restenosis. These uses are directly aimed at improving patient health outcomes, classifying it as a therapeutic device.

No

Explanation: The device is a balloon dilatation catheter used for therapeutic purposes (e.g., to dilate stenotic coronary arteries), not for diagnosing conditions.

No

The device description clearly details a physical catheter with various material components and mechanical properties, indicating it is a hardware device, not software-only.

Based on the provided information, the KardiFlex™ NC Coronary Dilatation Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly describes a device used in vivo (within the body) for mechanical dilatation of coronary arteries and bypass grafts. This is a therapeutic intervention performed directly on the patient's anatomy.
  • Device Description: The description details a physical catheter with a balloon designed for insertion into the circulatory system. This is consistent with an interventional medical device, not a device used to examine specimens outside the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to test or examine samples of human origin (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.

Therefore, the KardiFlex™ NC Coronary Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an IVD.

N/A

Intended Use / 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.

Product codes

LOX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary artery or bypass graft stenosis

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended for use by physicians in Hospitals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

  • 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

Bench Testing (Zero Time and Accelerated Aged):

  • 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.
  • 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 . .
  • . 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. ●

Key Results: 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.).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192344

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K103808, K170941

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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

1

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

2

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, Pingshan
District, 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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Image /page/4/Picture/2 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is displayed in a sans-serif font, with "MED" in gray and "CAPTAIN" in blue. To the right of the word "CAPTAIN" is an orange graphic that resembles a speech bubble or a bracket. Above the logo are some gray Japanese characters.

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

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.

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

5

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 Plus
Coronary Dilatation
Catheter
(Predicate Device) | Sapphire NC
Coronary Dilatation
Catheter
(Reference Device 1) | RX NC Takeru
(Reference Device 2) | KardiFlexTM NC
Coronary Dilatation
Catheter
(Subject device) | Comparison to
predicate/refer
ence 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, transluminal
coronary angioplasty,
percutaneous | Catheter, transluminal
coronary angioplasty,
percutaneous | Percutaneous
Transluminal Coronary
Angioplasty (PTCA)
Catheter | Catheter, transluminal
coronary 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 Plus
Coronary Dilatation
Catheter is intended
for use in
percutaneous
transluminal
coronary
angioplasty (PTCA)
to treat patients with
coronary disease. | Sapphire NC Coronary
Dilatation Catheter is
intended for use in
percutaneous
transluminal coronary
angioplasty (PTCA) to
treat patients with
coronary disease. | RX NC Takeru
Coronary Dilatation
Catheter is intended
for use in
percutaneous
transluminal coronary
angioplasty (PTCA) to
treat patients with
coronary disease. | KardiFlexTM NC
Coronary Dilatation
Catheter is intended
for use in
percutaneous
transluminal
coronary
angioplasty (PTCA)
to treat patients with
coronary disease. | Identical | |
| Indications for use | Sapphire NC Plus | Sapphire NC Coronary | The RX NC Takeru | KardiFlexTM NC | Identical to | |
| | Coronary Dilatation
Catheter is indicated
for: | 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. | PTCA Balloon
Dilatation Catheter is
indicated for balloon
dilatation of the stenotic
portion in coronary
artery or bypass graft
stenosis for the purpose
of myocardial
perfusion.
This product is also
indicated for the
post-delivery expansion
of balloon expandable
stents | 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. | predicate device | |
| Operation principle
and design | Sapphire NC Plus
Coronary Dilatation
Catheteris
a
percutaneous
transluminal coronary
angioplasty (PTCA)
balloon catheter with
a working length of
140cm.The proximal
shaft is a polymer
coated stainless steel
hypotube. Lubricious
coatings are applied to
the distal section. The | Sapphire NC Coronary
Dilatation Catheter is a
percutaneous
transluminal coronary
angioplasty (PTCA)
balloon catheter with a
working length of
140cm. The proximal
shaft is a polymer
coated stainless steel
hypotube. Lubricious
coatings are applied to
the distal section. The
non-compliant balloons | RX NC Takeru PTCA
Balloon Dilatation
Catheter is a
percutaneous
transluminal coronary
angioplasty (PTCA)
balloon catheter with a
working length of
145cm. RX NC Takeru
is a rapid exchange type
of balloon dilatation
catheter, which consists
of a distal tube,
guidewire transition | KardiFlexTM NC
Coronary Dilatation
Catheter is a
percutaneous
transluminal coronary
angioplasty (PTCA)
balloon catheter with
a working length of
142.5cm design. The
proximal shaft is a
PTFE coated stainless
steel hypotube.
Hydrophilic coatings
are applied to the | Substantially
equivalent

Differences do
not raise new or
different
questions
regarding safety
or 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 lumen
for distal dye
injections or distal
pressure
measurements. | | |
| Prescription/
Over-the-Counter | Prescription | Prescription | Prescription | Prescription | Identical | |
| Target User | Intended for use by
physicians | Intended for use by
physicians | Intended for use by
physicians | Intended for use by
physicians | Identical | |
| Access/ Anatomical
site: | Inserted
percutaneously into
the arterial circulation
or bypass graft
stenosis | Inserted percutaneously
into the arterial
circulation or bypass
graft stenosis | / | Inserted
percutaneously into
the arterial circulation
or bypass graft
stenosis | Identical to
predicate device | |
| Use environment: | Hospitals | Hospitals | / | Hospitals | Identical to
predicate device | |
| Materials: | / | / | / | / | / | |
| Balloon material | Nylon | Nylon | / | Nylon | Substantially | |
| Hypotube | Polymer coated
stainless steel | Polymer coated
stainless steel | / | Polymer (PTFE)
coated stainless steel | equivalent | |
| Marker bands | Platinum | Platinum | / | Platinum Alloys | Differences do
not raise new or
different
questions
regarding safety
or 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 | Difference
Differences do
not raise new or
different
questions
regarding safety
or effectiveness. | |
| | Balloon length:
8-18mm | Balloon length: 8-18mm | Balloon length:
6-30mm | Balloon length:
6-30mm | Identical to
reference device
2 | |
| | 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 rated
burst 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 | |
| Balloon
compliance | Pass test,
non-compliance | Pass test,
non-compliance | Pass test,
non-compliance | Pass test,
non-compliance | Identical | |
| Balloon inflation
and deflation time | Pass test | Pass test | Pass test | Pass test | Identical | |
| Catheter bond
strength | Pass test | Pass test | Pass test | Pass test | Identical | |
| Tip pull test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Particulate
evaluation | 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 burst
pressure (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

6

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Page 4 of 9

7

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

8

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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

9

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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10

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

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

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.

11

MEDCAPTAIN

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

  • 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 . .
  • . 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.).