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 Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the NC Quantum Apex™ PTCA Dilatation Catheter. It is not an AI/ML device, therefore the requested information regarding AI/ML studies is not applicable.

However, I can provide available information regarding the non-clinical testing performed to demonstrate substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes a range of non-clinical bench tests and biocompatibility tests. While specific acceptance criteria for each test (e.g., a specific numerical threshold for corrosion resistance or burst pressure) are not explicitly stated in this high-level summary, the general acceptance criterion is that the device demonstrates performance equivalent to the predicate device and is safe and effective for its intended use. The reported performance is that the device met these tests, providing reasonable assurance of conformance.

Test Category	Specific Tests Performed	Reported Device Performance
Bench Testing	Corrosion Resistance, Proximal Shaft Marks, Midshaft Bond Tensile, Proximal Mark Abrasion Resistance, Repeat Inflation, Shaft and Bond Burst Pressure	"The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing."
Biocompatibility and Chemical Characterization Tests	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Pyrogenicity, Mutagenicity, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physicochemical, Latex Assay, Nonvolatile Residue, SEM	"The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each non-clinical bench test or biocompatibility test. These are typically described in detail in the full test reports submitted to the FDA, but not in the 510(k) summary. The data provenance is from internal Boston Scientific Corporation testing, which is standard for premarket submissions. These are prospective tests conducted on manufactured device samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. This is a medical device for physical intervention, not an AI/ML diagnostic device requiring expert interpretation of outputs for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are bench tests or laboratory assays, not requiring human adjudication in the context of diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established engineering principles, industry standards (e.g., ISO standards for medical devices, USP for physicochemical tests, ASTM for material properties), and regulatory requirements. For example:

Bench tests: Performance metrics (like burst pressure, tensile strength, corrosion resistance) are compared against predetermined functional specifications derived from the predicate device's performance or engineering requirements.
Biocompatibility tests: Compliance with standards like ISO 10993 (Biological evaluation of medical devices) is the "ground truth" to ensure the materials are safe for human contact.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name and Information	Jane HoranSenior Regulatory Affairs SpecialistPhone: 763-494-2572Fax: 763-494-2222Email: Jane.Horan@bsci.com
Date Prepared	01 May 2016
Section 514 of the ActPerformance Standards	No performance standards have been established underSection 514 of the Food, Drug and Cosmetic Act forpercutaneous catheters.
Establishment Registration Numbers	Owner /Operator:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility:Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities:Boston Scientific Corporation – Coventry8 Industrial DriveCoventry, RI 02816ERN: 1000121056
SterilizationFacilities:	STERIS Isomedix Services3459 South Clinton AvenueSouth Plainfield, NJ 07080ERN: 2246552
	Synergy Health Ireland Ltd.(Tullamore)IDA Business & Technology ParkTullamore, County OffalyIrelandERN: 3002807314
	Synergy Health AST, SRLB13. 1 Street 4, Avenue 1El Coyol Free ZoneEl Coyol, Alajeula 20102Costa RicaERN: 3010273872
	Synergy Health VenloFaunalaan 38Venlo Limburg, Netherlands5928 RZERN: 3009337401
Predicate Device	NC Quantum Apex™ PTCA Dilatation Catheter, K121667,cleared 13 August 2012.
ReferenceDevice	NC Emerge™ PTCA Dilatation Catheter, K141236,cleared 7 August 2014
Intended Use/Indications forUse	NC Quantum Apex™ PTCA Dilatation Catheters areindicated for the balloon catheter dilatation of the stenoticportion of a native coronary artery or bypass graftstenosis for the purpose of improving myocardialperfusion NC Quantum Apex™ PTCA DilatationCatheters are also indicated for the post-deliveryexpansion of balloon expandable stents (bare metal anddrug-eluting).
Comparison ofRequiredTechnologicalCharacteristics	The proposed NC Quantum Apex™ PTCA DilatationCatheter is substantially equivalent to the existing NCQuantum Apex™ PTCA Dilation Catheter cleared by FDAunder premarket notification K121667 (August 13, 2012).NC Quantum Apex™ has the same intended use,scientific technology, design, sterilization method,packaging materials, and equivalent materials as theapplicable predicate device.

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Summary of Non-Clinical TestSummary	Bench testing was performed to support a determinationof substantial equivalence. The results of these testsprovide reasonable assurance that the proposed devicehas been designed and tested to assure conformance tothe requirements for its intended use. No new safety orperformance issues were raised during the device testing.
	The following performance tests were completed on theNC Quantum Apex™ PTCA Dilatation Catheter:
	Corrosion Resistance	Proximal Mark AbrasionResistance
	Proximal Shaft Marks	Repeat Inflation
	Midshaft Bond Tensile	Shaft and BondBurst Pressure
	The following biocompatibility and chemicalcharacterization tests were completed on the NCQuantum Apex™ PTCA Dilatation Catheter:
	Cytotoxicity	Partial ThromboplastinTime
	Sensitization	In Vitro Hemocompatibility
	Intracutaneous Reactivity	Complement Activation
	Acute Systemic Injection	USP Physicochemical
	Materials MediatedPyrogenicity	Latex Assay
	Mutagenicity	Nonvolatile Residue
	Hemolysis	SEM
Conclusion	Based on the indications for use, technologicalcharacteristics, and safety and performance testing, theproposed NC Quantum Apex™ PTCA Dilatation Catheterhas been shown to be appropriate for its intended useand is considered to be substantially equivalent to the NCQuantum Apex™ PTCA Dilatation Catheter (K121667).

Regulation Number and Section

§ 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.