NC Quantum Apex PTCA Dilatation Catheter

K160823 · Boston Scientific Corporation · LOX · Jun 23, 2016 · Cardiovascular

Device Facts

• Record ID: K160823
• Device Name: NC Quantum Apex PTCA Dilatation Catheter
• Applicant: Boston Scientific Corporation
• Product Code: LOX · Cardiovascular
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NC Quantum Apex PTCA Dilatation Catheter is a balloon catheter used by interventional cardiologists in a clinical setting (e.g., cath lab) to treat coronary artery stenosis. The device is inserted percutaneously to dilate stenotic lesions or expand stents. It functions via mechanical inflation of the balloon to restore vessel patency and improve myocardial perfusion. The device is a non-implantable, single-use accessory. It does not involve electronic processing, software, or AI/ML algorithms.

Clinical Evidence

Bench testing only. Performance testing included corrosion resistance, mark abrasion, inflation testing, tensile strength, and burst pressure. Biocompatibility testing included cytotoxicity, sensitization, reactivity, systemic injection, pyrogenicity, mutagenicity, hemolysis, hemocompatibility, and complement activation.

Technological Characteristics

PTCA dilatation catheter; mechanical balloon expansion; non-electronic; single-use. Materials and design are equivalent to the predicate. Sterilization via validated methods at specified facilities.

Indications for Use

Indicated for balloon catheter dilatation of stenotic native coronary arteries or bypass grafts to improve myocardial perfusion; also indicated for post-delivery expansion of bare metal and 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 (K121667)

Reference Devices

• NC Emerge™ PTCA Dilatation Catheter (K141236)

Submission Summary (Full Text)

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

June 23, 2016

Boston Scientific Corporation Jane Horan Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K160823

Trade/Device Name: NC Quantum Apex PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 23, 2016 Received: May 24, 2016

Dear Jane Horan:

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.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Kenneth J. Cavanaugh -S

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): K160823

#### Device Name:

NC Quantum Apex™ PTCA Dilatation Catheter

#### Indications for Use:

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

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|--------------------------------------------------------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | |

Concurrence of Center for Devices and Radiological Heath (CDRH)

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### 510k Summary

## Per 21 CFR §807.92

| Common or Usual Name | PTCA Dilatation Catheter |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | NC Quantum Apex™ PTCA Dilatation Catheter |
| Product Code | LOX - Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification of Device | Class II, 21 CFR 870.5100 |
| Submitter's Name and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name and Information | Jane Horan<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 01 May 2016 |
| Section 514 of the Act<br>Performance Standards | No performance standards have been established under<br>Section 514 of the Food, Drug and Cosmetic Act for<br>percutaneous catheters. |
| Establishment Registration Numbers | <b>Owner /Operator:</b><br>Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058<br><br><b>Manufacturing Facility:</b><br>Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265<br><br><b>Sterilization Facilities:</b><br>Boston Scientific Corporation – Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>ERN: 1000121056 |
| Sterilization<br>Facilities: | STERIS Isomedix Services<br>3459 South Clinton Avenue<br>South Plainfield, NJ 07080<br>ERN: 2246552 |
| | Synergy Health Ireland Ltd.<br>(Tullamore)<br>IDA Business & Technology Park<br>Tullamore, County Offaly<br>Ireland<br>ERN: 3002807314 |
| | Synergy Health AST, SRL<br>B13. 1 Street 4, Avenue 1<br>El Coyol Free Zone<br>El Coyol, Alajeula 20102<br>Costa Rica<br>ERN: 3010273872 |
| | Synergy Health Venlo<br>Faunalaan 38<br>Venlo Limburg, Netherlands<br>5928 RZ<br>ERN: 3009337401 |
| Predicate Device | NC Quantum Apex™ PTCA Dilatation Catheter, K121667,<br>cleared 13 August 2012. |
| Reference<br>Device | NC Emerge™ PTCA Dilatation Catheter, K141236,<br>cleared 7 August 2014 |
| Intended Use/<br>Indications for<br>Use | NC Quantum Apex™ PTCA Dilatation Catheters are<br>indicated for the balloon catheter dilatation of the stenotic<br>portion of a native coronary artery or bypass graft<br>stenosis for the purpose of improving myocardial<br>perfusion NC Quantum Apex™ PTCA Dilatation<br>Catheters are also indicated for the post-delivery<br>expansion of balloon expandable stents (bare metal and<br>drug-eluting). |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed NC Quantum Apex™ PTCA Dilatation<br>Catheter is substantially equivalent to the existing NC<br>Quantum Apex™ PTCA Dilation Catheter cleared by FDA<br>under premarket notification K121667 (August 13, 2012).<br>NC Quantum Apex™ has the same intended use,<br>scientific technology, design, sterilization method,<br>packaging materials, and equivalent materials as the<br>applicable predicate device. |

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| Summary of Non-<br>Clinical Test<br>Summary | Bench testing was performed to support a determination<br>of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device<br>has been designed and tested to assure conformance to<br>the requirements for its intended use. No new safety or<br>performance issues were raised during the device testing. | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | The following performance tests were completed on the<br>NC Quantum Apex™ PTCA Dilatation Catheter: | |
| | Corrosion Resistance | Proximal Mark Abrasion<br>Resistance |
| | Proximal Shaft Marks | Repeat Inflation |
| | Midshaft Bond Tensile | Shaft and Bond<br>Burst Pressure |
| | The following biocompatibility and chemical<br>characterization tests were completed on the NC<br>Quantum Apex™ PTCA Dilatation Catheter: | |
| | Cytotoxicity | Partial Thromboplastin<br>Time |
| | Sensitization | In Vitro Hemocompatibility |
| | Intracutaneous Reactivity | Complement Activation |
| | Acute Systemic Injection | USP Physicochemical |
| | Materials Mediated<br>Pyrogenicity | Latex Assay |
| | Mutagenicity | Nonvolatile Residue |
| | Hemolysis | SEM |
| Conclusion | Based on the indications for use, technological<br>characteristics, and safety and performance testing, the<br>proposed NC Quantum Apex™ PTCA Dilatation Catheter<br>has been shown to be appropriate for its intended use<br>and is considered to be substantially equivalent to the NC<br>Quantum Apex™ PTCA Dilatation Catheter (K121667). | |