· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

Device Description

The Sapphire NC Plus coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0-4.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. This Special 510(k) describes the modification to the Sapphire NC PTCA catheters including a change to the hydrophilic coating and also a change in the brand name to Sapphire NC Plus.

AI/ML Overview

The provided text describes the Sapphire NC Plus Coronary Dilatation Catheter and its submission for 510(k) clearance by OrbusNeich Medical, Inc. It details the device's indications for use, description, and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "The test results met all acceptance criteria, were similar to the predicate device, and ensure that the Sapphire NC Plus coronary dilatation catheter design and construction are suitable for its intended use." However, it does not provide a specific table or quantified acceptance criteria values for each test. Instead, it lists the types of tests performed.

Acceptance Criteria Category (Implied)	Reported Device Performance
In Vitro Performance	Met all acceptance criteria; similar to predicate device
Rated Burst Pressure	Met all acceptance criteria; similar to predicate device
Balloon Fatigue	Met all acceptance criteria; similar to predicate device
Balloon Compliance	Met all acceptance criteria; similar to predicate device
Catheter Bond Strength	Met all acceptance criteria; similar to predicate device
Tip Pull Strength	Met all acceptance criteria; similar to predicate device
Coating Integrity	Met all acceptance criteria; similar to predicate device
Particulate Evaluation	Met all acceptance criteria; similar to predicate device
Biocompatibility (Cytotoxicity)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Sensitization)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Intracutaneous Reactivity)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Acute Systemic Toxicity)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Hemocompatibility - Hemolysis, Complement Activation, Prothromboplastin Time, Platelet and Leukocyte Counts, In Vivo Thromboresistance)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Pyrogenicity)	Met all acceptance criteria; similar to predicate device
Biocompatibility (Genotoxicity - Bacterial Mutagenicity, In Vitro Mouse Lymphoma)	Met all acceptance criteria; similar to predicate device

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

The document does not specify the sample size used for any of the performance tests.
The data provenance is for a medical device (catheter) and the tests conducted are in vitro (bench testing) and biocompatibility (laboratory testing) rather than clinical studies with patient data. Therefore, concepts like country of origin for patient data and retrospective/prospective don't directly apply in the usual clinical study sense. The data originates from the manufacturer's testing to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable in the context of this device submission. The "ground truth" for a medical device's engineering and biocompatibility performance is established by standardized testing methods and regulatory guidelines, not by expert consensus on individual cases or images.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involves objective measurements against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical data. This submission is for a medical catheter, where performance is evaluated through bench testing and biocompatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective measurements and laboratory analyses against predefined engineering specifications and international standards for medical devices and biocompatibility. This is distinct from pathology, expert consensus, or outcomes data typically associated with diagnostic or prognostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not described here.

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

Not applicable. No training set is mentioned or implied for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

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

October 6, 2016

OrbusNeich Medical, Inc. Mr. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33309

Re: K162209

Trade/Device Name: Sapphire NC Plus Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 9, 2016 Received: September 12, 2016

Dear Mr. Pazienza:

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 devicerelated 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,

Brian D. Pullin -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) K162209

Device Name

Sapphire NC Plus Coronary Dilatation Catheter

Indications for Use (Describe)

The Sapphire NC Plus Coronary Dilatation Catheter is indicated for:

· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents

Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

Submitter:	OrbusNeich Medical, Inc.5363 NW 35th AvenueFort Lauderdale, FL 33309Phone: 954.730.0711Fax: 954.730.7601
Contact Person:	John D. Pazienza
Date Prepared:	August 4, 2016
Trade Name:	Sapphire NC Plus Coronary Dilatation Catheter
Common Name:	Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Classification Name:	Catheters, transluminal coronary angioplasty, percutaneous (21 CFR870.5100(a), Product Code LOX)
Predicate Device:	Sapphire NC (K103808; cleared September 7, 2011)
Device Description:	The Sapphire NC Plus coronary dilatation catheter is a percutaneoustransluminal coronary angioplasty (PTCA) balloon catheter with aworking length of 140cm. The proximal shaft is a polymer coatedstainless steel hypotube. Lubricious coatings are applied to the distalsection. The non-compliant balloons, available in diameters from 2.0-4.0mm and lengths from 8-18mm, can be inflated by injecting dilutecontrast media solution through the trailing hub of the catheter. Tworadiopaque platinum marker bands are located within the balloonThe catheter is compatible with 5F or larger guidingsegment.catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters thecatheter tip and advances coaxially out the catheter proximal port,thereby allowing both coaxial guidance and rapid exchange ofcatheters with a single standard length guidewire. Two markedsections are located on the hypotube shaft to indicate catheter positionrelative to the tip of either a brachial or femoral guiding catheter. Thedesign of this dilatation catheter does not incorporate a lumen for distaldye injections or distal pressure measurements. This Special 510(k)describes the modification to the Sapphire NC PTCA cathetersincluding a change to the hydrophilic coating and also a change in thebrand name to Sapphire NC Plus.

510(k) Notification (21CFR 807.90(e))

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Intended Use:	The Sapphire NC Plus Coronary Dilatation Catheter is indicated for:balloon dilatation of the stenotic portion of a coronary arteryor bypass graft stenosis in patients evidencing coronaryischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for thetreatment of acute myocardial infarctionin-stent restenosispost-delivery expansion of balloon expandable coronarystentsNote: The subject device was tested on the bench with the OrbusNeichBlazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should bedeployed in accordance with the manufacturer's indications andinstructions for use.
Technological Characteristics:	Comparisons of the new and predicate device show that thetechnological characteristics such as product performance, design, andintended use are substantially equivalent to the currently marketedpredicate device.
Performance Data:	To support the hydrophilic coating change, both in vitro performancetests such as [balloon preparation, deployment, and retraction], balloonrated burst pressure, balloon fatigue, balloon compliance, catheterbond strength, tip pull strength, coating integrity, particulateevaluation, and also biocompatibility tests such as cytotoxicity,sensitization, intracutaneous reactivity, acute systemic toxicity,hemocompatibility (hemolysis, complement activation,prothromboplastin time, [platelet and leukocyte counts], and in vivothromboresistance), pyrogenicity, and genotoxicity (bacterialmutagenicity and in vitro mouse lymphoma) were conducted on theSapphire NC Plus coronary dilatation catheter. The test results met allacceptance criteria, were similar to the predicate device, and ensurethat the Sapphire NC Plus coronary dilatation catheter design andconstruction are suitable for its intended use as recommended by theClass II Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters(FDA; September 8, 2010).
Conclusion:	This information supports a determination of substantial equivalencebetween the Sapphire NC Plus coronary dilatation catheter and thepredicate device described above.

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.