Sapphire NC Plus

K162209 · Orbusneich Medical, Inc. · LOX · Oct 6, 2016 · Cardiovascular

Device Facts

• Record ID: K162209
• Device Name: Sapphire NC Plus
• Applicant: Orbusneich Medical, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Oct 6, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

Device Story

The Sapphire NC Plus is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter used by physicians in clinical settings. It features a polymer-coated stainless steel hypotube proximal shaft and a non-compliant balloon (2.0-4.0mm diameter, 8-18mm length) at the distal end. The device is compatible with 5F or larger guiding catheters and accepts a 0.014-inch PTCA guidewire for coaxial guidance and rapid exchange. Operation involves inflating the balloon with dilute contrast media to dilate stenotic coronary arteries or bypass grafts, treat occlusions, or expand stents. Two radiopaque platinum marker bands facilitate positioning under fluoroscopy. The device modification includes a new hydrophilic coating. By improving myocardial perfusion or expanding stents, the catheter aids in treating coronary artery disease and acute myocardial infarction.

Clinical Evidence

Bench testing only. No clinical data. Testing included in vitro performance (balloon preparation, deployment, retraction, rated burst pressure, fatigue, compliance, bond/tip pull strength, coating integrity, particulate evaluation) and comprehensive biocompatibility testing (cytotoxicity, sensitization, reactivity, systemic toxicity, hemocompatibility, pyrogenicity, genotoxicity). All results met acceptance criteria.

Technological Characteristics

PTCA balloon catheter; 140cm working length; polymer-coated stainless steel hypotube; non-compliant balloon; two radiopaque platinum marker bands; hydrophilic coating; compatible with 0.014-inch guidewire and 5F+ guiding catheters. No electronic components or software.

Indications for Use

Indicated for patients with coronary ischemia or acute myocardial infarction requiring balloon dilatation of stenotic coronary arteries, bypass grafts, or coronary artery occlusions; also indicated for in-stent restenosis and post-delivery expansion of balloon-expandable coronary 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

• Sapphire NC (K103808)

Reference Devices

• OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent

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

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 [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,

# 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.<br>5363 NW 35th Avenue<br>Fort Lauderdale, FL 33309<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 CFR<br>870.5100(a), Product Code LOX) |
| Predicate Device: | Sapphire NC (K103808; cleared September 7, 2011) |
| Device Description: | The Sapphire NC Plus coronary dilatation catheter is a percutaneous<br>transluminal coronary angioplasty (PTCA) balloon catheter with a<br>working length of 140cm. The proximal shaft is a polymer coated<br>stainless steel hypotube. Lubricious coatings are applied to the distal<br>section. The non-compliant balloons, available in diameters from 2.0-<br>4.0mm and lengths from 8-18mm, can be inflated by injecting dilute<br>contrast media solution through the trailing hub of the catheter. Two<br>radiopaque platinum marker bands are located within the balloon<br>The catheter is compatible with 5F or larger guiding<br>segment.<br>catheters. The internal lumen of the catheter accepts a standard 0.014<br>inch PTCA guidewire. The proximal part of the guidewire enters the<br>catheter tip and advances coaxially out the catheter proximal port,<br>thereby allowing both coaxial guidance and rapid exchange of<br>catheters with a single standard length guidewire. Two marked<br>sections are located on the hypotube shaft to indicate catheter position<br>relative to the tip of either a brachial or femoral guiding catheter. The<br>design of this dilatation catheter does not incorporate a lumen for distal<br>dye injections or distal pressure measurements. This Special 510(k)<br>describes the modification to the Sapphire NC PTCA catheters<br>including a change to the hydrophilic coating and also a change in the<br>brand 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:<br>balloon dilatation of the stenotic portion of a coronary artery<br>or bypass graft stenosis in patients evidencing coronary<br>ischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for the<br>treatment of acute myocardial infarctionin-stent restenosispost-delivery expansion of balloon expandable coronary<br>stentsNote: The subject device was tested on the bench with the OrbusNeich<br>Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be<br>deployed in accordance with the manufacturer's indications and<br>instructions for use. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | Comparisons of the new and predicate device show that the<br>technological characteristics such as product performance, design, and<br>intended use are substantially equivalent to the currently marketed<br>predicate device. |
| Performance Data: | To support the hydrophilic coating change, both in vitro performance<br>tests such as [balloon preparation, deployment, and retraction], balloon<br>rated burst pressure, balloon fatigue, balloon compliance, catheter<br>bond strength, tip pull strength, coating integrity, particulate<br>evaluation, and also biocompatibility tests such as cytotoxicity,<br>sensitization, intracutaneous reactivity, acute systemic toxicity,<br>hemocompatibility (hemolysis, complement activation,<br>prothromboplastin time, [platelet and leukocyte counts], and in vivo<br>thromboresistance), pyrogenicity, and genotoxicity (bacterial<br>mutagenicity and in vitro mouse lymphoma) were conducted on the<br>Sapphire NC Plus coronary dilatation catheter. The test results met all<br>acceptance criteria, were similar to the predicate device, and ensure<br>that the Sapphire NC Plus coronary dilatation catheter design and<br>construction are suitable for its intended use as recommended by the<br>Class II Special Controls Guidance Document for Certain<br>Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters<br>(FDA; September 8, 2010). |
| Conclusion: | This information supports a determination of substantial equivalence<br>between the Sapphire NC Plus coronary dilatation catheter and the<br>predicate device described above. |