(231 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis" and "balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction," which are therapeutic interventions aimed at improving myocardial perfusion and treating medical conditions.
No
This device is a PTCA Balloon Dilatation Catheter, which is an interventional device used to dilate stenotic portions of coronary arteries or bypass grafts. Its purpose is therapeutic (improving myocardial perfusion and treating acute myocardial infarction) rather than diagnostic.
No
The device description clearly outlines a physical medical device (catheter, balloon, guidewire, etc.) and the performance studies focus on the physical and material properties of the device, not software functionality.
Based on the provided text, the KardiFlex™ PTCA Balloon Dilatation Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (in vivo) to dilate a coronary artery or bypass graft stenosis. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilatation. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter, biocompatibility, sterilization, and packaging. There are no studies related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as reagents, calibrators, controls, or the analysis of biological specimens.
Therefore, the KardiFlex™ PTCA Balloon Dilatation Catheter is a medical device used for a therapeutic procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LOX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use by physicians
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 KardiFlex™ PTCA Balloon Dilatation Catheter was subjected to biocompatibility testing per ISO 10993-1: 2018 and FDA guidance, including in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, hemocompatibility, and material mediated pyrogenicity.
Bench testing was also conducted at Zero Time and Accelerated Aged conditions, covering:
- Tip Configuration, per ISO 10555-1: 2013.
- Surface, per ISO 10555-1: 2013.
- Dimensional Verification, per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance.
- Corrosion Resistance, per ISO 10555-1: 2013.
- Radiodetectability 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.
- 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™ 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.
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.
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.
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.
0
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
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,
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
2
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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3
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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
4
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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
5
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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
6
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 Coronary
Dilatation Catheter
(Predicate Device) | Sapphire Coronary
Dilatation Catheter
(Reference Device 1) | Sapphire II PRO
Balloon Dilatation
Catheter
(Reference Device 2) | Selethru PTCA Balloon
Dilatation Catheter
(Reference Device 3) | KardiFlexTM PTCA
Balloon Dilatation
Catheter
(Subject device) | Comparison to
predicate/reference
device |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 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 coronary
angioplasty, percutaneous | Catheter, transluminal
coronary angioplasty,
percutaneous | Catheter, transluminal
coronary angioplasty,
percutaneous | Catheter, transluminal
coronary angioplasty,
percutaneous | Catheter, transluminal
coronary angioplasty,
percutaneous | Identical |
| Product Code | LOX | LOX | LOX(primary)
LIT(secondary) | LOX | LOX | Identical to predicate
device |
| Device Class | Class II | Class II | Class II | Class II | Class II | Identical |
| Intended Use | Sapphire II Pro Coronary
Dilatation Catheter is intended
for use in percutaneous
transluminal coronary
angioplasty (PTCA) to treat
patients with coronary disease. | Sapphire Coronary
Dilatation Catheter is
intended for use in
percutaneous transluminal
coronary angioplasty
(PTCA) to treat patients
with coronary disease. | Sappgire II Pro Balloon
Dilatation Catheter is
intended for use in
percutaneous
transluminal coronary
angioplasty (PTCA) to
treat patients with
coronary disease. | The Selethru PTCA
Balloon Dilatation
Catheter is indicated for
balloon dilatation of the
stenotic portion of a
coronary artery or
bypass graft stenosis for
the purpose of
improving myocardial
perfusion. | KardiFlexTM PTCA
Balloon Dilatation
Catheter is intended
for use in
percutaneous
transluminal coronary
angioplasty (PTCA) to
treat patients with
coronary disease. | Identical to predicate
device |
| Indications for use | The Sapphire II PRO coronary
dilatation catheter is indicated
for: | The Sapphire coronary
dilatation catheter is
indicated for: | The Sapphire® II PRO
balloon dilatation catheter | The Selethru PTCA
Balloon Dilatation | KardiFlexTM PTCA
Balloon Dilatation | Identical to predicate
device |
| | • 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. | • 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. | (1.5-4.0mm
configuration) 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. | Catheter is indicated for
balloon dilatation of the
stenotic portion of a
coronary artery or
bypass graft stenosis for
the purpose of
improving myocardial
perfusion. | 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. | |
| Operation principle
and design | Sapphire II PRO Coronary
Dilatation Catheter is a
percutaneous transluminal
coronary angioplasty (PTCA)
balloon catheter with a working
length of 140cm. The proximal
shaft is a PTFE coated stainless | Sapphire Coronary
Dilatation Catheter is a
percutaneous transluminal
coronary angioplasty
(PTCA) balloon catheter
with a working length of
140cm. The proximal shaft | Sapphire II PRO Balloon
Dilatation Catheter is a
rapid exchange balloon
catheter with a working
length of 140cm design
for both coronary and
peripheral indications. | The Selethru PTCA
Balloon Dilatation
Catheter is a rapid
exchange (RX) PTCA
Balloon Catheter, sterile,
single use, intravascular
medical device with a | KardiFlexTM PTCA
Balloon Dilatation
Catheter is a rapid
exchange balloon
catheter with a working
length of 142.5cm
design. The proximal | Substantially
equivalent
Differences do not
raise new or different
questions regarding
safety or effectiveness. |
7
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. Hydrophilic
lubricious coatings are applied
to the distal section. The
semi-compliant 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 (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 | is a polymer coated
stainless steel hypotube.
Hydrophilic lubricious
coatings are applied to the
distal section. The
semi-compliant 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 (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 | The proximal shaft is a
PTFE coated stainless
steel hypotube.
Hydrophilic lubricious
coatings are applied to the
distal section.
Semi-compliant 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 (only
one centrally located
marker band for 1.0-1.5
configurations). The
catheter is compatible
with 4F or larger sheaths
or 5F or larger guiding
catheters. The internal
lumen of the catheter
accepts a standard | working length of 142cm.
The proximal shaft is
PTFE coated stainless
steel tube, which allows
for exceptional
pushability and a smooth
transition to the distal
shaft, which is composed
of an outer tube, an inner
tube, and a balloon. A
hydrophilic coating is
applied to the distal
section.
The proximal shaft of the
catheter has two markers
sections that aid in
gauging dilatation
catheter position relative
to the guiding catheter
tip). The distal shaft of the
catheter has an integrated
shaft system. The shaft
has a combination of
single lumen and dual | shaft is a PTFE coated
stainless steel hypotube.
Hydrophilic coatings
are applied to the distal
section. The
semi-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 |
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
9
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 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. | 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. | 0.014inch 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. | lumen tubing. One lumen
is used for inflation of the
balloon with contrast
medium. The other lumen
in the distal shaft permits
the use of a guidewire to
facilitate advancement of
the catheter. The
guidewire enters the
catheter tip and advances
coaxially out the distal
RX port. Two marker
bands are located within
the balloon segment. The
design of this dilatation
catheter does not
incorporate a lumen for
distal dye injections or
distal pressure
measurements. | 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. | | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------|
| 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 different
questions regarding
safety or effectiveness. | |
| Balloon rated
burst pressure | 14atm | 14atm | 14atm | 16atm | 16atm | Identical to Reference
device 3 | |
| Shaft burst | No such information | No such information | Pass test | No such information | Pass test | Identical to Reference
device 2 | |
| Balloon fatigue | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Balloon
compliance | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Balloon inflation
and deflation time | Pass test | Pass test | Pass test | Pass test | Pass test | Identical | |
| Catheter bond
strength | 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 and
kinking | 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 | |
| Particulate
evaluation | 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 Reference
device 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 oxide
gas. Non-pyrogenic. | Sterilized with ethylene
oxide gas. Non-pyrogenic. | Sterilized with ethylene
oxide gas. Non-pyrogenic. | Sterility | Sterilized with ethylene
oxide 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 | |
10
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
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. ●
14
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 ● .
- 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.).