CONQUEST 40 PTA DILATATION CATHETER
Device Facts
| Record ID | K120660 |
|---|---|
| Device Name | CONQUEST 40 PTA DILATATION CATHETER |
| Applicant | Bard Peripheral Vascular, Inc. |
| Product Code | LIT · Cardiovascular |
| Decision Date | Mar 15, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for Use
The Conquest® 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
Device Story
Conquest® 40 PTA Dilatation Catheter is a high-pressure, over-the-wire balloon catheter used for peripheral angioplasty. Device features a low-profile balloon at the distal tip, two radiopaque markers for placement, and a coaxial catheter design with an atraumatic tip. Operated by physicians in clinical settings. Input involves manual inflation via a luer-lock hub; device transforms hydraulic pressure into radial force to dilate stenotic vessels or post-dilate stents. Output is mechanical expansion of the balloon. Includes a profile-reducing sheath and re-wrapping tool to facilitate insertion. Benefits include restoration of blood flow in peripheral arteries and dialysis fistulae.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing only. In vitro performance testing included balloon burst strength, inflation/deflation time, fatigue, tensile force, trackability, and introducer sheath compatibility. Biocompatibility testing included cytotoxicity, chemical characterization, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility.
Technological Characteristics
High-pressure over-the-wire PTA balloon catheter. Materials are identical to predicate devices. Features: coaxial catheter, radiopaque markers, atraumatic tip, female luer-lock hubs. Balloon diameters: 4-12mm; lengths: 2-10cm. Sterilization: standard method (leveraged from predicates). No software or electronic components.
Indications for Use
Indicated for patients requiring percutaneous transluminal angioplasty of femoral, iliac, and renal arteries, or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and post-dilatation of peripheral stents/stent grafts. Contraindicated for use in coronary arteries.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- Conquest® PTA Balloon Dilatation Catheter (K083657)
- Dorado® PTA Balloon Dilatation Catheter (K072283)
Submission Summary (Full Text)
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Page 34
# Conquest® 40 PTA Dilatation Catheter
#### 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
#### Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-303-2664 |
| Fax: | 480-449-2546 |
| Contact: | Ashley Fickett, Regulatory Affairs Associate |
| Date | January 13, 2012 |
# Subject Device Name:
| Device Trade Name: | Conquest® 40 PTA Dilatation Catheter |
|-----------------------|-------------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250,<br>Product Code DQY, LIT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
#### Predicate Devices:
- Conquest® PTA Balloon Dilatation Catheter (K083657, cleared December . 24, 2008)
- Dorado® PTA Balloon Dilatation Catheter (K072283; cleared September . 19, 2007)
Image /page/0/Picture/14 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and sans-serif, with a geometric design. The word appears to be a logo or brand name.
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#### Device Description:
The Conquest® 40 PTA Dilatation Catheter is a high pressure percutaneous transluminal angioplasty (PTA) balloon catheter consisting of a 0.035" compatible over the wire catheter with a low profile balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the quidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.
| Attribute | Conquest® 40 PTA Dilatation Catheter<br>Product Offering |
|--------------------------------------------------------------------------------|----------------------------------------------------------|
| Balloon Diameter<br>(mm) | 4, 5, 6, 7, 8, 9, 10, 12 |
| Balloon Length<br>(cm) | 2, 3, 4, 6, 8, 10 |
| Catheter Shaft<br>Lengths (cm) | 50, 75 |
| Introducer Sheath<br>Compatibility<br>(compatible<br>balloon<br>diameters, mm) | 6F: (4, 5, 6, 7, 8)<br>7F: (9,10)<br>8F: (12) |
# Indications for Use of Device:
Conquest® 40 PTA Dilatation Catheter is recommended for use in Perculaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral This for use in coronary vasculature. catheter ાંડ not arteries.
Image /page/1/Picture/10 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, giving them a distinct and modern appearance. The font choice is sans-serif, contributing to the clean and contemporary aesthetic of the logo.
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#### Comparison of Indications for Use to Predicate Devices:
The indications for use statement for the subject device, the Conquest® 40 PTA Dilatation Catheter, is a combination of the two predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter. There are no new indications outside of the previously cleared predicate devices. Therefore, the Conquest® 40 PTA Dilatation Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter. Therefore, the subject device, the Conquest® 40 PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices.
### Technological Comparison to Predicate Devices:
The Conquest® 40 PTA Dilatation Catheter has the following similarities to the predicate devices:
- . Similar intended use (both predicates)
- Similar indications for use (combination of both predicates) .
- Same target population (both predicates) t
- Same fundamental scientific technology (both predicates) .
- Same operating principle (both predicates) .
- Same packaging materials and configuration (Dorado) .
- Same sterility assurance level and method of sterilization (both predicates) .
#### Performance Data:
To demonstrate substantial equivalence of the subject device, the Conquest® 40 PTA Dilatation Catheter to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:
- . Tip Length
- Balloon Outer Diameter .
- Shaft Outer Diameter t
- Balloon Distensibility .
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#### Traditional 510(k) Conquest 40 PTA Dilatation Catheter
- . Fatique
- Fatigue in a Stent/Stent Graft/Graft .
- Balloon Burst Strength in a Stent/Stent Graft and Balloon Removal .
- . Balloon Inflation and Deflation Time
- . Balloon Burst Strength and Burst Mode
- t Balloon to Shaft Tensile Force
- Catheter Shaft Elongation .
- Guidewire Extension to Bifurcate Tensile Force t
- Bifurcate to Shaft Tensile Force .
- Guidewire Hub to Guidewire Extension Tensile Force .
- Introducer Sheath Compatibility .
- Catheter Shaft Leaks .
- Trackability and Guidewire Compatibility .
- . Syringe Inflation Pressure Capability
The following in vitro tests were leveraged from the predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter:
- Balloon Operating Pressure t
- . Balloon Length
- . Marker Band Visibility
- . Marker Band Alignment
- Tip Taper .
- Tip Visibility .
- . Tip Tensile
- Shaft Visibility .
- Shaft Length .
- Balloon Hub to Balloon Extension Tensile Force .
- Balloon Extension to Bifurcate Tensile Force .
- . Media Interaction
- Guidewire Lumen ID .
- Equipment Interface .
- Packaging Tensile Strength .
Image /page/3/Picture/34 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and have a three-dimensional appearance due to the outline. The word is presented in all capital letters and is horizontally oriented.
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The results from these tests demonstrate that the technological characteristics and performance criteria of the Conquest® 40 PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.
#### Biocompatibility:
To demonstrate substantial equivalence of the subject device, the Conquest® 40 PTA Dilatation Catheter, to the predicate devices, the following biocompatibility testing was performed in accordance ISO 10993-1:2010, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process," and "Blue Book Memorandum - G95-1 Use of International Standard ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
- . Cytotoxicity
- Chemical Characterization .
Since all materials in the subject device, the Conquest® 40 PTA Dilatation Catheter, are utilized in the predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter, the following biocompatibility tests were leveraged from the predicate devices:
- . Irritation/Intracutaneous Reactivity
- . Sensitization
- Acute Systemic Toxicity .
- Material Mediated Pyrogenicity .
- . Hemocompatibility (Hemolysis and Thrombogenicity)
The results from these tests demonstrate that the subject device, the Conquest® 40 PTA Dilatation Catheter, is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use.
#### Conclusions:
The subject device, the Conquest® 40 PTA Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Conquest®
Image /page/4/Picture/17 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The overall impression is clean and modern.
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40 PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter.
Image /page/5/Picture/5 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and prominent appearance. The font style is unique, with sharp angles and a slightly futuristic feel.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 5- 2012
Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25" Street NW Buffalo, MN 55313
Re: K120660
Trade/Device Name: Conquest 40 PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 2, 2012 Received: March 5, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pressure is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices malliave been reclassified in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica You may, therefore, market the device, subject to the general controls provisions of the Act. The Y ou may, ulerelove, market me device, babyer to the more of manual registration, listing of general controls provisions of the flee labeling, and prohibitions against mistranding and devices, good manufacturing practice, taceming was not elated to contract liability.
adulteration. Please note: CDRH does not evaluate information related wat micleand adulteration. Flease not. CDICT doos not of artists and the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
e If your device is classified (sec above) . Existing major regulations affecting your device can be
may be subject to additional controls. Existing major regulations affective may be subject to additional Controls: "Existing may or 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parti 800 Register found in the Code of I edetal Regarations, cour device in the Federal Register.
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#### Page 2 - Mr. Mark Job
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: Conquest® 40 PTA Dilatation Catheter
Indications for Use: The Conquest® 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division/Sign-Off)
Division of Gastroenterology Devices
510(k) Number 420660
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Bard Peripheral Vascular, Inc.
