(231 days)
KardiFlex™ PTCA Balloon 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.
The KardiFlex™ PTCA Balloon 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 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.
The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) 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 "10 PTCA Balloon 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.
The acceptance criteria for the KardiFlex™ PTCA Balloon Dilatation Catheter are based on a comprehensive set of performance tests, as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010). These tests ensure the device's reliable design, performance, and suitability for its intended use.
Here's a breakdown of the acceptance criteria and reported device performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test / Acceptance Criteria | Reported Device Performance (KardiFlex™ PTCA Balloon Dilatation Catheter) |
|---|---|---|
| Material Properties | Biocompatibility: | |
| - In vitro cytotoxicity (per ISO 10993-5: 2009) | Performed, implied compliant | |
| - Intracutaneous reactivity (per ISO 10993-10: 2010) | Performed, implied compliant | |
| - Skin sensitization (per ISO 10993-10: 2010) | Performed, implied compliant | |
| - Acute systemic toxicity (per ISO 10993-11: 2017) | Performed, implied compliant | |
| - Hemocompatibility (Hemolysis, Coagulation, Platelet count or leukocyte count, In Vivo Thromboresistance and Complement, per ISO 10993-4: 2017) | Performed, implied compliant | |
| - Material mediated pyrogenicity (per ISO 10993-11: 2017 and USP General Chapter <151>) | Performed, implied compliant | |
| Physical Dimensions & | Dimensional Verification: | |
| Features | - Balloon diameter: 1.5-4.0mm (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Identical to predicate device |
| - Balloon length: Range from 6mm to 30mm (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Within range (6-30mm), Identical to Reference device 2 | |
| - Working length: 142.5cm | 142.5cm (Difference to predicate noted as not raising new safety/effectiveness questions) | |
| - Tip Configuration (per ISO 10555-1: 2013) | Performed, implied compliant | |
| - Surface (per ISO 10555-1: 2013) | Performed, implied compliant | |
| - Radio-detectability of Balloon Position (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Hub (per ISO 10555-1: 2013) | Performed, implied compliant | |
| Functional | Balloon Rated Burst Pressure: 16atm (per ISO 10555-4: 2013 and FDA guidance) | 16atm (Identical to Reference device 3) |
| Performance | - Balloon Failure Mode (per ISO 10555-4: 2013) | Performed, implied compliant |
| - Balloon Fatigue (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Diameter at Nominal Pressure (per ISO 10555-4: 2013) | Performed, implied compliant | |
| - Balloon Compliance (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Inflation Time (per FDA guidance) | Pass test | |
| - Deflation Time (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Catheter Bond Strength (per ISO 10555-1: 2013 and FDA guidance) | Pass test | |
| - Entry Tip Crossing Profile | Performed, implied compliant | |
| - Balloon Preparation, Deployment and Retraction (per FDA guidance) | Pass test | |
| - Tip Pull Test (per FDA guidance) | Pass test | |
| - Flexibility and Kink Test (per FDA guidance) | Pass test | |
| - Torque Strength (per FDA guidance) | Pass test | |
| - Coating Integrity (per FDA guidance) | Pass test | |
| - Particulate Evaluation (per FDA guidance, EN ISO 8536-4: 2020, USP <788>) | Pass test | |
| - Shaft Loose Part | Performed, implied compliant | |
| - Freedom from Leakage (per ISO 10555-1: 2013 and product characteristics) | Performed, implied compliant | |
| - Shaft burst | Pass test (Identical to Reference device 2) | |
| Sterilization & | EtO Sterilization: (per ISO 10993-7: 2008 and FDA guidance) | Performed, implied compliant |
| Packaging | - Sterility (per ISO 11135: 2014 and FDA guidance) | Performed, implied compliant |
| - Bacterial Endotoxin (per ANSI/AAMI ST72: 2011) | Performed, implied compliant | |
| - Package Labeling (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Performed, implied compliant | |
| - Shelf Life: 2 years (per FDA guidance) | 2 years (Identical) | |
| - Package Seal Verification (per ISO 11607-1: 2019 and ISO 11607-2: 2019) | Performed, implied compliant | |
| - Shipping and Handling (per ISTA 3A: 2018) | Performed, implied compliant | |
| - Chemical performance (per ISO 8536-4: 2019) | Performed, implied compliant |
The reported device performance consistently states "Pass test" or "Performed, implied compliant" for all listed tests, indicating that the KardiFlex™ PTCA Balloon Dilatation Catheter met the specified acceptance criteria for each test according to the FDA guidance and ISO standards.
2. Sample Size for the Test Set and Data Provenance
The provided document details various bench tests and biocompatibility tests. It does not mention clinical trials with human subjects or a "test set" in the context of diagnostic performance (e.g., imaging studies). Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods are not applicable to the type of testing described in this 510(k) summary, which focuses on the physical and biological characteristics of the medical device itself.
The tests are laboratory-based and include:
- Biocompatibility Testing: Performed per ISO 10993-1: 2018 and FDA guidance.
- Bench Testing (Zero Time and Accelerated Aged): Performed per various ISO standards (e.g., ISO 10555-1, ISO 10555-4) and FDA guidance.
The provenance of this data is from the manufacturer's (Medcaptain Life Science Co., Ltd.) internal testing or contracted laboratories, as part of their submission to the FDA. The country of origin for the submitter is China.
3. Number of Experts and Qualifications for Ground Truth
Not applicable, as this is a medical device (catheter) and the "ground truth" refers to the physical and biological properties being tested against established engineering and biocompatibility standards, not diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are quantitative measurements and qualitative assessments against predefined pass/fail criteria according to international standards and FDA guidance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (catheter) for interventional procedures, not a diagnostic AI algorithm that would typically undergo MRMC studies to compare human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm being evaluated. The device performance relates to its physical and biological attributes.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on established international standards (ISO, USP, ANSI/AAMI) and FDA guidance documents for physical, mechanical, and biological properties of PTCA catheters. For example, balloon burst pressure is measured against a specified atmosphere (16 atm), and biocompatibility is assessed against the criteria outlined in ISO 10993. These are objective scientific and engineering benchmarks.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm to be trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2021
Medcaptain Life Science Co., Ltd. David Xia Official Correspondent 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, Guangdong 518118 China
Re: K202619
Trade/Device Name: KardiFlex™ PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: March 30, 2021 Received: April 1, 2021
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 mav, 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Gregory W. O'connell. The date of the signature is 2021.04.29, and the time is 10:10:13 -04'00'.
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 (if known) K202619
Device Name KardiFlex PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
KardiFlex PTCA Balloon 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.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Website: www.medcaptain.com Fax.: +86-755-84517910
510(k) Summary
KardiFlex™ PTCA Balloon Dilatation Catheter 21 CFR §870.5100(a) Date prepared: April 29, 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: | KardiFlex™ PTCA Balloon 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: | K202619 |
III. Predicate Device
The KardiFlex™ PTCA Balloon Dilatation Catheter is substantially equivalent to the following device:
Predicate Device: Sapphire II Pro Coronary Dilatation Catheter (K163114, OrbusNeich Medical, Inc.) cleared on May 1, 2017.
The following reference devices are used in this submission: Reference Device 1: Sapphire Coronary Dilatation Catheter (K103657, OrbusNeich
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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building 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
Medical, Inc.) cleared on August 9, 2011.
Reference Device 2: Sapphire II PRO Balloon Dilatation Catheter (K180921, OrbusNeich Medical Trading, Inc.) cleared on June 28, 2018.
Reference Device 3: Selethru PTCA Balloon Dilatation Catheter (K182699, Kossel Medtech (Suzhou) Co., Ltd.) cleared on November 26, 2018.
IV. Device Description
The KardiFlex™ PTCA Balloon 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 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.
The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) 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 "10 PTCA Balloon 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™ PTCA Balloon 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.
VI. Comparison to Predicate Device
The subject device, KardiFlex™ PTCA Balloon Dilatation Catheter, and the predicate device, Sapphire II Pro Coronary Dilatation Catheter , are substantially equivalent in that these devices, at a high level, have the same technological characteristics: intended use, indications for use, operation principle and design (such as rapid exchange catheter design, hydrophilic coating applied in the distal section, semi-compliant balloon, 0.014inch guidewire compatibility, EO sterilization
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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building 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
and single use), prescription use, target user, use environment, balloon diameter, etc.
The differences between the subject and the predicate devices include balloon length range, working length, rated burst pressure 16 atm (vs. 14atm.), etc., do not raise new or different questions for regarding safety or effectiveness. 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™ PTCA Balloon Dilatation Catheter, and the predicate device, Sapphire II Pro Coronary Dilatation Catheter, which are provided in Table 1.
Table 1: Substantial Equivalence
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601Building 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
| Description | Sapphire II Pro CoronaryDilatation Catheter(Predicate Device) | Sapphire CoronaryDilatation Catheter(Reference Device 1) | Sapphire II PROBalloon DilatationCatheter(Reference Device 2) | Selethru PTCA BalloonDilatation Catheter(Reference Device 3) | KardiFlexTM PTCABalloon DilatationCatheter(Subject device) | Comparison topredicate/referencedevice |
|---|---|---|---|---|---|---|
| 510(k) Number | K163114 | K103657 | K180921 | K182699 | K202619 | N/A |
| Regulation Number | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | Identical |
| Classification Name | Catheter, transluminal coronaryangioplasty, percutaneous | Catheter, transluminalcoronary angioplasty,percutaneous | Catheter, transluminalcoronary angioplasty,percutaneous | Catheter, transluminalcoronary angioplasty,percutaneous | Catheter, transluminalcoronary angioplasty,percutaneous | Identical |
| Product Code | LOX | LOX | LOX(primary)LIT(secondary) | LOX | LOX | Identical to predicatedevice |
| Device Class | Class II | Class II | Class II | Class II | Class II | Identical |
| Intended Use | Sapphire II Pro CoronaryDilatation Catheter is intendedfor use in percutaneoustransluminal coronaryangioplasty (PTCA) to treatpatients with coronary disease. | Sapphire CoronaryDilatation Catheter isintended for use inpercutaneous transluminalcoronary angioplasty(PTCA) to treat patientswith coronary disease. | Sappgire II Pro BalloonDilatation Catheter isintended for use inpercutaneoustransluminal coronaryangioplasty (PTCA) totreat patients withcoronary disease. | The Selethru PTCABalloon DilatationCatheter is indicated forballoon dilatation of thestenotic portion of acoronary artery orbypass graft stenosis forthe purpose ofimproving myocardialperfusion. | KardiFlexTM PTCABalloon DilatationCatheter is intendedfor use inpercutaneoustransluminal coronaryangioplasty (PTCA) totreat patients withcoronary disease. | Identical to predicatedevice |
| Indications for use | The Sapphire II PRO coronarydilatation catheter is indicatedfor: | The Sapphire coronarydilatation catheter isindicated for: | The Sapphire® II PROballoon dilatation catheter | The Selethru PTCABalloon Dilatation | KardiFlexTM PTCABalloon Dilatation | Identical to predicatedevice |
| • balloon dilatation of thestenotic portion of a coronaryartery or bypass graft stenosisin patients evidencingcoronary ischemia for thepurpose of improvingmyocardial perfusion.• balloon dilatation of acoronary artery occlusion forthe treatment of acutemyocardial infarction. | • balloon dilatation of thestenotic portion of acoronary artery or bypassgraft stenosis in patientsevidencing coronaryischemia for the purposeof improving myocardialperfusion.• balloon dilatation of acoronary artery occlusionfor the treatment of acutemyocardial infarction. | (1.5-4.0mmconfiguration) is indicatedfor:• balloon dilatation ofthe stenotic portion of acoronary artery orbypass graft stenosis inpatients evidencingcoronary ischemia forthe purpose ofimproving myocardialperfusion.• balloon dilatation of acoronary arteryocclusion for thetreatment of acutemyocardial infarction. | Catheter is indicated forballoon dilatation of thestenotic portion of acoronary artery orbypass graft stenosis forthe purpose ofimproving myocardialperfusion. | Catheter is indicatedfor:• 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. | ||
| Operation principleand design | Sapphire II PRO CoronaryDilatation Catheter is apercutaneous transluminalcoronary angioplasty (PTCA)balloon catheter with a workinglength of 140cm. The proximalshaft is a PTFE coated stainless | Sapphire CoronaryDilatation Catheter is apercutaneous transluminalcoronary angioplasty(PTCA) balloon catheterwith a working length of140cm. The proximal shaft | Sapphire II PRO BalloonDilatation Catheter is arapid exchange ballooncatheter with a workinglength of 140cm designfor both coronary andperipheral indications. | The Selethru PTCABalloon DilatationCatheter is a rapidexchange (RX) PTCABalloon Catheter, sterile,single use, intravascularmedical device with a | KardiFlexTM PTCABalloon DilatationCatheter is a rapidexchange ballooncatheter with a workinglength of 142.5cmdesign. The proximal | SubstantiallyequivalentDifferences do notraise new or differentquestions regardingsafety or effectiveness. |
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601Building C, Jinweiyuan Industrial Park, Pingshan District,
Shenzhen, Guangdong, CN 518118.
Tel.: +86-755-28380626 Fax.: +86-755-84517910
{8}------------------------------------------------
601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.
MEDCAPTAIN LIFE SCIENCE CO., LTD.
Tel.: +86-755-28380626 Fax.: +86-755-84517910 Email: disposable@medcaptain.com
Website: www.medcaptain.com
| steel hypotube. Hydrophiliclubricious coatings are appliedto the distal section. Thesemi-compliant balloons can beinflated by injection dilutecontrast media solution throughthe trailing hub of the catheter.Two radiopaque platinummarker bands are located withinthe balloon segment (only onecentrally located marker bandfor 1.5 configurations). Thecatheter is compatible with 5For larger guiding catheters. Theinternal lumen of the catheteraccepts a standard 0.014inchPTCA guidewire. The proximalpart of the guidewire enters thecatheter tip and advancescoaxially out the catheterproximal port, thereby allowingboth coaxial guidance and rapidexchange of catheters with ssingle standard length | is a polymer coatedstainless steel hypotube.Hydrophilic lubriciouscoatings are applied to thedistal section. Thesemi-compliant balloonscan be inflated by injectiondilute contrast mediasolution through the trailinghub of the catheter. Tworadiopaque platinum markerbands are located within theballoon segment (only onecentrally located markerband for 1.5configurations). Thecatheter is compatible with5F or larger guidingcatheters. The internallumen of the catheteraccepts a standard0.014inch PTCA guidewire.The proximal part of theguidewire enters the | The proximal shaft is aPTFE coated stainlesssteel hypotube.Hydrophilic lubriciouscoatings are applied to thedistal section.Semi-compliant balloonscan be inflated byinjection dilute contrastmedia solution throughthe trailing hub of thecatheter Two radiopaqueplatinum marker bandsare located within theballoon segment (onlyone centrally locatedmarker band for 1.0-1.5configurations). Thecatheter is compatiblewith 4F or larger sheathsor 5F or larger guidingcatheters. The internallumen of the catheteraccepts a standard | working length of 142cm.The proximal shaft isPTFE coated stainlesssteel tube, which allowsfor exceptionalpushability and a smoothtransition to the distalshaft, which is composedof an outer tube, an innertube, and a balloon. Ahydrophilic coating isapplied to the distalsection.The proximal shaft of thecatheter has two markerssections that aid ingauging dilatationcatheter position relativeto the guiding cathetertip). The distal shaft of thecatheter has an integratedshaft system. The shafthas a combination ofsingle lumen and dual | shaft is a PTFE coatedstainless steel hypotube.Hydrophilic coatingsare applied to the distalsection. Thesemi-compliantballoons can be inflatedby injection of dilutecontrast media solutionthrough the hub of thecatheter. Tworadiopaque platinummarker bands arelocated within theballoon segment (onlyone centrally locatedmarker band for 1.5configurations). Thecatheter is compatiblewith 5F or largerguiding catheters. Theinternal lumen of thecatheter accepts astandard 0.014inch |
|---|---|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.
MEDCAPTAIN LIFE SCIENCE CO., LTD.
Tel.: +86-755-28380626 Fax.: +86-755-84517910
| guidewire. Two marked sectionsare located on the hypotubeshaft to indicate catheterposition. The design of thisdilatation catheter does notincorporate a lumen for distaldye injections or distal pressuremeasurements. | catheter tip and advancescoaxially out the catheterproximal port, therebyallowing both coaxialguidance and rapidexchange of catheters with ssingle standard lengthguidewire. Two markedsections are located on thehypotube shaft to indicatecatheter position. Thedesign of this dilatationcatheter does notincorporate a lumen fordistal dye injections ordistal pressuremeasurements. | 0.014inch guidewire. Theproximal part of theguidewire enters thecatheter tip and advancescoaxially out the catheterproximal port, therebyallowing both coaxialguidance and rapidexchange of catheterswith s single standardlength guidewire. Twomarked sections arelocated on the hypotubeshaft to indicate catheterposition. The design ofthis dilatation catheterdoes not incorporate alumen for distal dyeinjections or distalpressure measurements. | lumen tubing. One lumenis used for inflation of theballoon with contrastmedium. The other lumenin the distal shaft permitsthe use of a guidewire tofacilitate advancement ofthe catheter. Theguidewire enters thecatheter tip and advancescoaxially out the distalRX port. Two markerbands are located withinthe balloon segment. Thedesign of this dilatationcatheter does notincorporate a lumen fordistal dye injections ordistal pressuremeasurements. | PTCA guidewire. Theproximal part of theguidewire enters thecatheter tip andadvances coaxially outthe catheter proximalport, thereby allowingboth coaxial guidanceand rapid exchange ofcatheters with s singlestandard lengthguidewire. Two markedsections are located onthe hypotube shaft toindicate catheterposition. The design ofthis dilatation catheterdoes not incorporate alumen for distal dyeinjections or distalpressure measurements. | |||
|---|---|---|---|---|---|---|---|
| Prescription/Over-the-Counter | Prescription | Prescription | Prescription | Prescription | Prescription | Identical | |
| Target User | Intended for use by physicians | Intended for use by | Intended for use by | Intended for use by | Intended for use by | Identical | |
| physicians | physicians | physicians | physicians | ||||
| 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 | Inserted percutaneously into the arterial circulation or bypass graft stenosis | Identical | ||
| Use environment: | Hospitals | Hospitals | Hospitals | Hospitals | Identical | ||
| Materials: | / | / | / | / | / | ||
| Balloon material | Pebax | Pebax | Pebax | Pebax | Identical | ||
| Hypotube | PTFE coated stainless steel | PTFE coated stainless steel | PTFE coated stainless steel | PTFE coated stainless steel | Identical | ||
| Marker bands | Platinum | Platinum | Platinum | Platinum Alloys | Identical | ||
| Performance: | / | / | / | / | / | ||
| Dimensional verification | Balloon diameter: 1.5-4.0mm | Balloon diameter: 1.5-4.0mm | Balloon diameter: 1.5-4.0mm; | Balloon diameter: 1.5-4.0mm | Identical | ||
| Balloon length: 10-30mm | Balloon length: 10-30mm | Balloon length: 5-30mm | Balloon length: 6-30mm | Identical to Reference device 2 | |||
| Working length: 140cm | Working length: 140cm | Working length: 140cm | Working length: 142.5cm | Difference | |||
| raise new or differentquestions regardingsafety or effectiveness. | |||||||
| Balloon ratedburst pressure | 14atm | 14atm | 14atm | 16atm | 16atm | Identical to Referencedevice 3 | |
| Shaft burst | No such information | No such information | Pass test | No such information | Pass test | Identical to Referencedevice 2 | |
| Balloon fatigue | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Ballooncompliance | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Balloon inflationand deflation time | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Catheter bondstrength | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Tip pull test | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Flexibility andkinking | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Torque strength | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Radiopacity | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Coating integrity | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Particulateevaluation | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Visual inspection | No such information | No such information | Pass test | No such information | Pass test | Identical to Referencedevice 2 | |
| Balloon preparation,deployment,and retraction | Pass test | Pass test | Pass test | No such information | Pass test | Identical | |
| Energy type: | N.A | N.A | N.A | N.A | N.A | Identical | |
| Biocompatibility: | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 | Identical | |
| Sterilization: | Sterilized with ethylene oxidegas. Non-pyrogenic. | Sterilized with ethyleneoxide gas. Non-pyrogenic. | Sterilized with ethyleneoxide gas. Non-pyrogenic. | Sterility | Sterilized with ethyleneoxide gas.Non-pyrogenic. | Identical | |
| Single Use: | Single use | Single use | Single use | Single use | Single use | Identical | |
| Shelf Life: | 2 years | 2 years | 2 years | No such information | 2 years | Identical |
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601Building C, Jinweiyuan Industrial Park, Pingshan District,
Shenzhen, Guangdong, CN 518118.
Tel.: +86-755-28380626 Fax.: +86-755-84517910
{11}------------------------------------------------
601Building 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
{12}------------------------------------------------
601Building C, Jinweiyuan Industrial Park, Pingshan District,
Shenzhen, Guangdong, CN 518118.
Tel.: +86-755-28380626 Fax.: +86-755-84517910
517910 Website: www
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a sans-serif font, with "MED" in gray and "CAPTAIN" in blue. To the right of the text is an orange bracket. Above the text is the Chinese name for the company in gray.
MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building 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
VII. Performance Data
The subject device, KardiFlex™ PTCA Balloon 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):
- 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. ●
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Image /page/14/Picture/1 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a combination of gray and blue letters, with the "CAPTAIN" part in blue. To the right of the word "MEDCAPTAIN" is an orange graphic that resembles a speech bubble. Above the word "MEDCAPTAIN" are three Chinese characters in gray.
MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building 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
- 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™ PTCA Balloon 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 device, Sapphire II Pro Coronary Dilatation Catheter (K163114, OrbusNeich Medical, Inc.).
§ 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.