THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER

K134031 · Boston Scientific Corporation · LOX · Jul 21, 2014 · Cardiovascular

Device Facts

• Record ID: K134031
• Device Name: THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: LOX · Cardiovascular
• Decision Date: Jul 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Threader™ Micro-Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts.

Device Story

The Threader™ Micro-Dilatation Catheter is a sterile, single-use intravascular device featuring a shaft with a distal semi-compliant balloon (1.2 mm diameter, 12 mm length). Available in Monorail (MR) and Over-The-Wire (OTW) platforms, it includes a radiopaque marker band for positioning and specialized coatings to facilitate insertion and withdrawal. Used by physicians in clinical settings, the device is navigated through the coronary vasculature to the site of stenosis. The balloon is inflated to dilate the lesion, improving myocardial perfusion. The OTW version additionally supports guidewire exchange and contrast media injection. By facilitating access and pre-dilatation of tight stenoses, the device assists in preparing the vessel for subsequent interventional procedures, potentially improving patient outcomes in coronary artery disease management.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through biocompatibility testing (cytotoxicity, hemolysis, sensitization, complement activation, intracutaneous reactivity, coagulation, acute systemic toxicity, hemocompatibility, materials-mediated pyrogenicity, USP physicochemical) and in-vitro performance testing (effective length, bond strength, diameter, tip pull, balloon crossing profile, flexibility, kink, deployment, torque, retraction, radiopacity, burst pressure, coating integrity, fatigue, particulate evaluation, compliance, inflation/deflation time, and contrast flow).

Technological Characteristics

Sterile, single-use PTCA dilatation catheter. Features a semi-compliant balloon (1.2 mm x 12 mm) and radiopaque marker. Available in Monorail and Over-The-Wire configurations. Materials include specialized coatings for insertion/withdrawal. Testing conducted per FDA Class II Special Controls for PTCA Catheters (Sept 2010).

Indications for Use

Indicated for pre-dilatation of stenotic coronary artery or bypass graft lesions (≥ 70% stenosis) to improve myocardial perfusion. Intended to provide support for guidewire placement in coronary vasculature. Over-The-Wire version also indicated for guidewire exchange and hand-injection of contrast media.

Regulatory Classification

Identification

Standard PTCA Catheter: 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. Cutting/scoring PTCA Catheter: 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.

Special Controls

*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.

Predicate Devices

• Emerge™ PTCA Dilatation Catheter (1.20 mm) (K130391)
• CrossBoss™ Catheter (K102725)
• Coyote™ PTA Balloon Dilatation Catheter (K111295)
• Asahi Corsair Microcatheter (K083127)

Submission Summary (Full Text)

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## 510(k) Summary
per 21 CFR §807.92

## X134031 JIII 2 1 2014

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>Cardiovascular Division<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: [phone]<br>Fax: [phone] | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name<br>and<br>Information | Vicky L. Hagens<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | January 27, 2014 | | |
| Proprietary<br>Name(s) | Threader™ Monorail ™ Micro-Dilatation Catheter<br>Threader™ Over-The-Wire Micro-Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation<br>Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate<br>Devices | Emerge™ PTCA Dilatation<br>Catheter (1.20 mm) | K130391 | July 10, 2013 |
| | CrossBoss™ Catheter | K102725 | May 10, 2011 |
| | Coyote™ PTA Balloon Dilatation<br>Catheter | K111295 | May 31, 2011 |
| | Asahi Corsair Microcatheter | K083127 | February 3, 2009 |
| Device<br>Description | The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile,<br>single-use, intravascular medical device. The catheter consists of a shaft<br>with a semi-compliant balloon near the distal tip. The balloon is designed<br>to provide an inflatable segment of known diameter (1.2 mm) and length<br>(12 mm) at recommended pressures. The Threader™ Micro-Dilatation<br>Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW)<br>platforms. There is a single radiopaque marker band located in the center<br>of the balloon body to aid in positioning the system during the procedure.<br>Coatings are applied to the balloon and catheter to enhance insertion and<br>withdrawal performance. | | |
| Intended Use<br>of Device | The Threader™ Micro-Dilatation Catheter is intended for dilatation of<br>stenosis in coronary arteries or bypass grafts. | | |

510(k) Summary . Threader™ Micro-Dilatation Catheter

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:

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| Indications for Use | The Threader™ Micro-Dilatation Catheters are indicated for pre-dilatation<br>of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70%<br>stenosis) for the purpose of improving myocardial perfusion.<br><br>The Threader™ Micro-Dilatation Catheters are intended to provide<br>support to facilitate the placement of guidewires in the coronary<br>vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can<br>also be used to exchange one guidewire for another.<br><br>The Threader™ Over-The-Wire Micro-Dilatation Catheter is also intended<br>to allow hand-injection of contrast media into the coronary vasculature. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The Threader™ Micro-Dilatation Catheter incorporates substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process<br>and intended use as those featured in the predicate devices: Emerge™<br>PTCA Dilatation Catheter (1.20 mm), K130391 (cleared July 10, 2013);<br>CrossBoss™ Catheter, K102725 (cleared May 10, 2011); Coyote™ PTA<br>Dilatation Catheter, K111295 (cleared May 31, 2011); and Asahi Corsair<br>Microcatheter, K083127 (cleared February 3, 2009). |
| Performance<br>Data | The Threader™ Micro-Dilatation Catheter was subjected to testing<br>according to the requirements of Guidance for Industry and FDA Staff –<br>Class II Special Controls for Certain Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and<br>biocompatibility testing were performed to support a determination of<br>substantial equivalence. The results of these tests provide reasonable<br>assurance that the proposed device has been designed and tested to<br>assure conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the testing and,<br>therefore, these devices may be considered substantially equivalent to the<br>predicate devices.<br><br>The following biocompatibility and chemical characterization tests were<br>completed on the Threader™ Micro-Dilatation Catheter:<br> |
| | Cytotoxicity Hemolysis (Direct Contact & Extract)<br>Sensitization Complement Activation<br>Intracutaneous Reactivity Coagulation<br>Acute Systemic Toxicity In Vitro Hemocompatibility<br>Materials Mediated Pyrogenicity USP Physicochemical |
| | The following in-vitro performance tests were completed on the<br>Threader™ Micro-Dilatation Catheter:<br> |
| | Effective Length Catheter Bond Strength<br>Shaft Inner and Outer Diameter Tip Pull Test<br>Balloon Crossing Profile Flexibility and Kink<br>Balloon Preparation, Deployment, Torque Strength<br>and Retraction<br>Withdrawal into a Guide Catheter Radiopacity<br>Balloon Rated Burst Pressure Coating Integrity<br>Balloon Fatigue (Repeat Inflations) Particulate Evaluation<br>Balloon Compliance Catheter Body Burst Pressure<br>Balloon Inflation/Deflation Time Contrast Media Flow Rate |

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## Conclusion

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:

. .

Based on the indications for use, technological characteristics, and safety and performance testing, the Threader™ Micro-Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.

510(k) Summary Threader™ Micro-Dilatation Catheter

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-0002

July 21, 2014

Boston Scientific Corporation Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove. Minnesota 55311

Re: K 134031

> Trade/Device Name: Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: June 16, 2014 Received: June 17, 2014

Dear Ms. Hagens.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting 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 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

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Page 2 - Ms. Vicky Hagens

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.A. Hillemann

for 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): K134031

Device Name: Threader™ Monorail™ Micro-Dilatation Catheter Threader™ Over-The-Wire Micro-Dilatation Catheter

Indications for Use:

The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.

The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.

The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.

Prescription Use × (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)

M. G. Hillemann