NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)

K121667 · Boston Scientific Corp · LOX · Aug 13, 2012 · Cardiovascular

Device Facts

• Record ID: K121667
• Device Name: NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
• Applicant: Boston Scientific Corp
• Product Code: LOX · Cardiovascular
• Decision Date: Aug 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for post-delivery expansion of balloon expandable stents (bare metal and drug-eluting.)

Device Story

Sterile, single-use, intravascular PTCA dilatation catheter; consists of shaft with distal inflatable balloon. Radiopaque marker bands under balloon aid positioning; coatings enhance insertion/withdrawal. Used in clinical settings by physicians for coronary artery/bypass graft stenosis dilatation and stent expansion. Device provides inflatable segment of known diameter/length at recommended pressures. Benefits patient by restoring blood flow through stenotic vessels and ensuring proper stent apposition. No electronic components or software.

Clinical Evidence

Bench testing only. No clinical data. Testing included effective length, balloon deflation time, proximal shaft profile, corrosion resistance, shaft/bond burst pressure, torque strength, catheter bond strength, flexibility/kink, particulate evaluation, and biocompatibility per FDA Class II Special Controls guidance.

Technological Characteristics

Intravascular PTCA dilatation catheter; Monorail design. Materials include hypotube, midshaft components, and radiopaque marker bands. Balloon diameters 2.00-5.00 mm; lengths 6-30 mm. Sterilization method not specified. No electronic or software components.

Indications for Use

Indicated for balloon catheter dilatation of stenotic native coronary arteries or bypass grafts to improve myocardial perfusion, and for post-delivery expansion of bare metal or drug-eluting balloon-expandable stents.

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

• NC Quantum Apex™ PTCA Dilatation Catheter (P860019/S241)

Reference Devices

• Emerge™ PTCA Dilatation Catheter (K113220)
• Quantum™ Maverick™ PTCA Dilatation Catheter (P860019/S182)

Submission Summary (Full Text)

{0}------------------------------------------------

## K121667
P. 1082

## 510(k) Summary
per 21 CFR §807.92

AUG 1 3 2012

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>Cardiovascular, Rhythm and Vascular Division<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: [phone]<br>Fax: [phone] | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------|
| Contact Name<br>and<br>Information | Margo J. Anderson<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared | 19 July 2012 | | |
| Proprietary<br>Name | NC Quantum Apex™ Monorail™ PTCA 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>Device | NC Quantum Apex™ PTCA<br>Dilatation Catheter | P860019<br>/S241 | 16 April 2010 |
| Reference<br>Devices | Emerge™ PTCA Dilatation<br>Catheter | K113220 | 22 March 2012 |
| | Quantum™ Maverick™ PTCA<br>Dilatation Catheter | P860019<br>/S182 | 01 October 2002 |
| Device<br>Description | The Boston Scientific NC Quantum Apex™ Monorail™ PTCA Dilatation<br>Catheter is a sterile, single-use, intravascular medical device. The<br>catheter consists of a shaft with a balloon near the distal tip. The balloon<br>is designed to provide an inflatable segment of known diameter and<br>length at recommended pressures. There are radiopaque marker bands<br>located under the balloon to aid in positioning the system during the<br>procedure. Coatings are applied to the balloon and catheter to enhance<br>insertion and withdrawal performance.<br>The NC Quantum Apex Monorail PTCA Dilatation Catheter is available<br>with balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6<br>mm to 30 mm. | | |
| Intended Use<br>of Device | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is<br>intended for dilatation of stenosis in coronary arteries or bypass grafts and<br>for post-delivery expansion of balloon expandable stents (bare metal and<br>drug-eluting.) | | |

{1}------------------------------------------------

| Indications for Use | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheters are<br>indicated for the balloon catheter dilatation of the stenotic portion of a<br>native coronary artery or bypass graft stenosis for the purpose of<br>improving myocardial perfusion. NC Quantum Apex Monorail PTCA<br>Dilatation Catheters are also indicated for the post-delivery expansion of<br>balloon expandable stents (bare metal and drug-eluting). | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Comparison of<br>Technological<br>Characteristics | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter was<br>modified to incorporate the same device design for the hypotube, midshaft<br>component and proximal shaft marks as referenced devices Emerge™<br>PTCA Dilatation Catheter (K113220, cleared March 22, 2012) and<br>Quantum™ Maverick™ PTCA Dilatation Catheter (P860019/S182,<br>approved October 1, 2002).<br>The modified NC Quantum Apex Monorail PTCA Dilatation Catheter<br>differs from the Boston Scientific predicate device, NC Quantum Apex™<br>PTCA Dilatation Catheter (P860019/S241,approved April 16, 2010), by<br>the removal of an accessory kit pouch, flushing needle and one CLIP-IT™<br>hypotube clip. Otherwise the NC Quantum Apex Monorail PTCA Dilatation<br>Catheter incorporates substantially equivalent device materials, design,<br>packaging materials, fundamental technology, manufacturing processes,<br>sterilization process and intended use as those featured in the predicate<br>device. | |
| Summary of<br>Non-Clinical<br>Performance<br>Data | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter was<br>subjected to testing according to the requirements of Guidance for<br>Industry and FDA Staff - Class II Special Controls for Certain<br>Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters,<br>September 8, 2010. Design verification testing was performed to<br>demonstrate that the performance of the modified NC Quantum Apex<br>Monorail PTCA Dilatation Catheter remains substantially equivalent to the<br>predicate device.<br>Specifically, the following tests were evaluated to support changes for the<br>modified NC Quantum Apex Monorail PTCA Dilatation Catheter: | |
| | Effective Length | Balloon Deflation Time |
| | Proximal Shaft Profile | Corrosion Resistance |
| | Shaft and Bond Burst Pressure | Torque Strength |
| | Catheter Bond Strength<br>Flexibility and Kink | Particulate Evaluation |
| | | Biocompatibility |
| Conclusion | Based on the indications for use, technological characteristics, and safety<br>and performance testing, the NC Quantum Apex™ Monorail™PTCA<br>Dilatation Catheter has been shown to be appropriate for its intended use<br>and is considered to be substantially equivalent to the Boston Scientific<br>predicate device, NC Quantum Apex™ PTCA Dilatation Catheter. | |

quantam?

.

{2}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 3 2012

Boston Scientific Corp. Ms. Laura Lind Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K121667

Trade/Device Name: NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: Class II Product Code: LOX Dated: July 19, 2012 Received: July 20, 2012

Dear Ms. Lind:

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, 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.

{3}------------------------------------------------

Page 2 – Ms. Laura Lind

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MG Hillen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K121667

Device Name: NC Quantum Apex "Monorail" PTCA Dilatation Catheter

(

Indications for Use:

The NC Quantum Apex Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).

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)

CMA Zkillelu

(Division Sign-Off) Division of Cardiovascular Devices

K121667 510(k) Number_