SAPPHIRE

K103657 · Orbusneich Medical, Inc. · LOX · Aug 9, 2011 · Cardiovascular

Device Facts

• Record ID: K103657
• Device Name: SAPPHIRE
• Applicant: Orbusneich Medical, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Aug 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire 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

Device Story

Percutaneous transluminal coronary angioplasty (PTCA) balloon catheter; 140cm working length. Proximal shaft: polymer-coated stainless steel hypotube; distal section: lubricious coating. Semi-compliant balloons (1.5-4.0mm diameter; 10-30mm length) inflated via dilute contrast media. Radiopaque platinum marker bands (single or dual depending on size). Compatible with 5F+ guiding catheters; accepts 0.014 inch PTCA guidewire. Coaxial design allows rapid exchange. Used by physicians in clinical settings for coronary artery stenosis or occlusion treatment. Output: mechanical balloon expansion to dilate vessels; improves myocardial perfusion. No distal dye injection or pressure measurement lumens.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond/tip pull strength, flexibility, kinking, torque, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity, and genotoxicity.

Technological Characteristics

Materials: stainless steel hypotube, polymer coating, platinum marker bands. Energy: hydraulic (contrast media inflation). Dimensions: 140cm length, 1.5-4.0mm balloon diameter, 10-30mm balloon length. Compatibility: 5F+ guiding catheters, 0.014 inch guidewire. Sterilization: not specified. Design: semi-compliant balloon, coaxial rapid exchange. Class II device per 21 CFR 870.5100.

Indications for Use

Indicated for balloon dilatation of stenotic coronary arteries or bypass grafts in patients with coronary ischemia to improve myocardial perfusion, and for balloon dilatation of coronary artery occlusions in patients with acute myocardial infarction.

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

• Sprinter Legend RX (P790017 S096)
• Voyager RX (P810046 S216)
• Maverick (P860019 S160)
• Apex (P860019 S208)
• Fire Star (P880003 S090)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

AUG - 9 2011

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 | July 20, 2011 |
| Trade Name: | Sapphire 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: | Sprinter Legend RX (P790017 S096; cleared October 31, 2008)<br>Voyager RX (P810046 S216; cleared June 18, 2004)<br>Maverick (P860019 S160; cleared September 27, 2000)<br>Apex (P860019 S208; cleared November 7, 2008)<br>Fire Star (P880003 S090; cleared August 31, 2007) |
| Device Description: | The Sapphire 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 semi-compliant balloons, available in diameters from 1.5-<br>4.0mm and lengths from 10-30mm, 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>segment with the exception of balloon diameters less than 2.0mm<br>which incorporate a centrally positioned single marker band. The<br>catheter is compatible with 5F or larger guiding catheters. The internal<br>lumen of the catheter accepts a standard 0.014 inch PTCA guidewire.<br>The proximal part of the guidewire enters the catheter tip and advances<br>coaxially out the catheter proximal port, thereby allowing both coaxial<br>guidance and rapid exchange of catheters with a single standard length<br>guidewire. Two marked sections are located on the hypotube shaft to<br>indicate catheter position relative to the tip of either a brachial or<br>femoral guiding catheter. The design of this dilatation catheter does<br>not incorporate a lumen for distal dye injections or distal pressure<br>measurements. |
| Intended Use: | The Sapphire 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 |

{1}------------------------------------------------

- Technological Characteristics: Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- Both in vitro performance tests, such as dimensional verification, Performance Data: balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation, and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility (hemolysis, complement activation, in vivo thromboresistance, prothromboplastin time, and platelet and leukocyte counts), pyrogenicity, acute systemic toxicity. intracutaneous reactivity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire coronary dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire coronary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
- Conclusion: This information supports a determination of substantial equivalence between the Sapphire coronary dilatation catheter and the predicate devices described above.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with a stylized caduceus-like symbol consisting of three wavy lines. The seal also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the emblem in a circular fashion.

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

JUN 26 2012

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

Re: K103657

> Trade Name: Sapphire Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: II (two) Product Code: LOX Dated: July 21, 2011 Received: July 22, 2011

Dear Mr. Pazienza:

This letter corrects our substantially equivalent letter of August 9, 2011.

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.

{3}------------------------------------------------

Page 2 - Mr. John D. Pazienza

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.

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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cmg. Hillebean

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

## Indications for Use

510(k) Number:

K103657

Device Name

Sapphire Coronary Dilatation Catheter

Indications for Use:

The Sapphire 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

Prescription Use
(Part 21 CFR 801 Subpart D)

1

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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K103657 |