SAPPHIRE NC

K103808 · Orbusneich Medical, Inc. · LOX · Sep 1, 2011 · Cardiovascular

Device Facts

• Record ID: K103808
• Device Name: SAPPHIRE NC
• Applicant: Orbusneich Medical, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Sep 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire NC 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

Sapphire NC Coronary Dilatation Catheter is a PTCA balloon catheter used by physicians in clinical settings to treat coronary artery disease. Device features a polymer-coated stainless steel hypotube proximal shaft and a non-compliant balloon distal section. Physician advances catheter over a 0.014-inch guidewire to the target lesion; balloon is inflated via dilute contrast media injection to dilate stenotic vessels or expand stents. Radiopaque platinum marker bands facilitate positioning under fluoroscopy. Rapid exchange design allows catheter replacement over a single guidewire. Device improves myocardial perfusion and treats acute myocardial infarction. No distal dye injection or pressure measurement capabilities.

Clinical Evidence

Bench testing only. Testing included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kinking, torque, radiopacity, coating integrity, particulate evaluation, and within-stent performance. Biocompatibility testing included cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, and intracutaneous reactivity.

Technological Characteristics

PTCA balloon catheter; 140cm working length. Materials: polymer-coated stainless steel hypotube, lubricious distal coating, platinum radiopaque marker bands. Non-compliant balloon (2.0-4.0mm diameter, 8-18mm length). Coaxial design for 0.014-inch guidewire. Compatible with 5F+ guiding catheters. Sterilized device.

Indications for Use

Indicated for patients with coronary artery stenosis, bypass graft stenosis, coronary artery occlusion (including acute myocardial infarction), in-stent restenosis, or requiring 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

• NC Sprinter RX (P790017 S095)
• Voyager NC (P810046 S226)
• Quantum Maverick (P860019 S182)
• NC Quantum Apex (P860019 S241)
• Dura Star (P880003 S089)

Submission Summary (Full Text)

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## 长103808

## SEP - 1 2011

## 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: | September 1, 2011 |
| Trade Name: | Sapphire NC 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 Devices: | NC Sprinter RX (P790017 S095; cleared October 10, 2008)<br>Voyager NC (P810046 S226; cleared august 21, 2008)<br>Quantum Maverick (P860019 S182; cleared October 1, 2002)<br>NC Quantum Apex (P860019 S241; cleared April 16, 2010)<br>Dura Star (P880003 S089; cleared August 29, 2007) |
| Device Description: | The Sapphire NC 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. |

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| Intended Use: | The Sapphire NC 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 perfusion<br>• balloon dilatation of a coronary artery occlusion for the<br>treatment of acute myocardial infarction<br>• in-stent restenosis<br>• post-delivery expansion of balloon expandable coronary<br>stents<br>Note: 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 devices show that the<br>technological characteristics such as product performance, design, and<br>intended use are substantially equivalent to the currently marketed<br>predicate devices. |
| Performance Data: | Both in vitro performance tests such as dimensional verification,<br>balloon preparation, deployment, and retraction, balloon rated burst<br>pressure, balloon fatigue, balloon compliance, balloon inflation and<br>deflation time, catheter bond strength, tip pull strength, flexibility and<br>kinking, torque strength, radiopacity, coating integrity, particulate<br>evaluation, within stent balloon burst pressure, within stent balloon<br>fatigue, and also biocompatibility tests such as cytotoxicity,<br>sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity,<br>and intracutaneous reactivity were conducted on the Sapphire NC<br>PTCA catheter. The test results met all acceptance criteria, were<br>similar to predicate devices, and ensure that the Sapphire NC PTCA<br>catheter design and construction are suitable for its intended use as<br>recommended by the Class II Special Controls Guidance Document for<br>Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)<br>Catheters (FDA; September 8, 2010). |
| Conclusion: | This information supports a determination of substantial equivalence<br>between the Sapphire NC PTCA catheter and the predicate devices<br>described above. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

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

OrbusNeich Medical, Inc. c/o Mr. John D. Pazienza Director, Product Development 5363 NW 35" Avenue Fort Lauderdale, FL 33309

SEP. - 1 2011

Re: K103808

Trade/Device Name: Sapphire NC Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheters Regulatory Class: Class II (two) Product Code: LOX Dated: August 26, 2011 Received: August 29, 2011

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.

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

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Page 2 – Mr. John D. Pazienza

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

KC

/B
D

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: | K103808 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sapphire NC Coronary Dilatation Catheter |
| Indications for Use: | The Sapphire NC Coronary Dilatation Catheter is indicated for: <ul><li>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</li><li>balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction</li><li>in-stent restenosis</li><li>post-delivery expansion of balloon expandable coronary stents</li></ul> 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. |

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)

LL

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K103808

Sapphire NC PTCA

⁵¹⁰⁽k) Notification (21CFR 807.90(e))