Sapphire II PRO Balloon Dilatation Catheter

K180921 · Orbusneich Medical Trading, Inc. · LOX · Jun 28, 2018 · Cardiovascular

Device Facts

• Record ID: K180921
• Device Name: Sapphire II PRO Balloon Dilatation Catheter
• Applicant: Orbusneich Medical Trading, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) 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 The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

Device Story

Rapid exchange balloon dilatation catheter; used for coronary and peripheral angioplasty. Input: manual inflation via dilute contrast media through trailing hub. Operation: semi-compliant balloon expands to dilate stenotic vessels; compatible with 0.014 inch guidewires and 4F/5F guiding sheaths/catheters. Used in clinical settings by physicians. Output: mechanical dilation of vessel lumen. Benefits: improved myocardial perfusion; treatment of coronary artery occlusions. Features: PTFE-coated stainless steel hypotube; hydrophilic distal coating; radiopaque platinum marker bands for positioning.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included dimensional verification, balloon rated burst pressure, shaft burst, balloon fatigue, balloon compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kinking, torque strength, radiopacity, coating integrity, and visual inspection.

Technological Characteristics

Rapid exchange catheter; PTFE-coated stainless steel hypotube; semi-compliant balloon (1.0-4.0mm diameter, 5-30mm length); hydrophilic lubricious coating; platinum radiopaque marker bands; 0.014" guidewire compatible; EO sterilization; 14 atm rated burst pressure.

Indications for Use

Indicated for patients requiring balloon pre-dilatation or dilatation of stenotic coronary arteries, bypass grafts, or coronary artery occlusions (acute myocardial infarction) to improve myocardial perfusion; also indicated for percutaneous transluminal angioplasty in peripheral vasculature (renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries).

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

• Bard Ultraverse (K131199)

Reference Devices

• Abbott Armada 14 XT (K121352)
• Brosmed Castor NC (K160941)
• OrbusNeich Jade (K173894)
• OrbusNeich Sapphire II PRO (K173680)
• OrbusNeich Sapphire II PRO (K163114)

Submission Summary (Full Text)

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June 28, 2018

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

## Re: K180921

Trade/Device Name: Sapphire II PRO Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX, LIT Dated: April 6, 2018 Received: April 9, 2018

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 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.

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K180921

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory O'Connell 2018.06.28 13:35:53 -04'00'

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| | Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K180921 |
| Device Name | Sapphire II PRO Balloon Dilatation Catheter |
| Indications for Use (Describe) | The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: <ul><li>balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion.</li></ul> The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) 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></ul> The Sapphire® II PRO balloon dilatation catheter is also indicated for: <ul><li>percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.</li></ul> |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) Summary

| This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c). | |
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| Submitter: | OrbusNeich Medical Trading, Inc.<br>5363 NW 35th Avenue<br>Fort Lauderdale, FL 33309<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | John D. Pazienza |
| Date Prepared: | June 22, 2018 |
| Trade Name: | Sapphire II PRO Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous<br>21 CFR 870.5100(a) |
| Product Code: | LOX (primary)<br>LIT (secondary) |
| Device Class: | Class II |
| Predicate Device: | Bard Ultraverse (K131199; LIT; cleared May 30, 2013) |
| Reference Devices: | Abbott Armada 14 XT (K121352; LIT; cleared 15-Aug-2012)<br>Brosmed Castor NC (K160941; LIT; cleared 13-Dec-2016)<br>OrbusNeich Jade (K173894; LIT; cleared 9-Feb-2018)<br>OrbusNeich Sapphire II PRO (K173680; LOX; cleared 1-Mar-2018)<br>OrbusNeich Sapphire II PRO (K163114; LOX; cleared 5-Jan-2017) |
| Device Description: | The Sapphire II PRO balloon dilatation catheter is a rapid exchange<br>balloon catheter with a working length of 140cm design for both<br>coronary and peripheral indications. This catheter was previously<br>cleared for coronary use (K173680, K163114) and this submission is<br>intended to support the peripheral use of this balloon catheter. The<br>proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic<br>lubricious coatings are applied to the distal section. The semi-<br>compliant balloons, available in diameters from 1.0-4.0mm and lengths<br>from 5-30mm, can be inflated by injecting dilute contrast media<br>solution through the trailing hub of the catheter. Two radiopaque<br>platinum marker bands are located within the balloon segment (there is<br>only one centrally located marker band for the Ø1.0-1.5mm<br>configurations). The catheter is compatible with 4F or larger guiding<br>sheaths or 5F or larger guiding catheters. The internal lumen of the<br>catheter accepts a standard 0.014 inch guidewire. The proximal part of<br>the guidewire enters the catheter tip and advances coaxially out the<br>catheter proximal port, thereby allowing both coaxial guidance and<br>rapid exchange of catheters with a single standard length guidewire.<br>Two marked sections are located on the hypotube shaft to indicate<br>catheter position relative to the tip of either a guiding sheath or guiding<br>catheter. The design of this dilatation catheter does not incorporate a<br>lumen for distal dye injections or distal pressure measurements. |
| Intended Use: | The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.0-1.25mm configurations) is indicated for:<br>balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) is indicated for:<br>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 The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for:<br>percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries. |
| Technological Characteristics: | At a high level, the subject and predicate devices are based on the same technological elements:<br>the same indications for use rapid exchange catheter design hydrophilic coating semi-compliant balloon nominal pressure of 6 atm 0.014" guidewire compatibility EO sterilization The following technological differences exist between the subject and predicate device: specific materials selected exact dimensions of components and catheter balloon diameter and length range rated burst pressure of 14 atm (vs. 16 atm) |
| Performance Data: | Testing was leveraged from the reference device (K173680, K163114): Sterilization (Complete) Shelf-Life (Complete) Performance Testing (Partial) Dimensional Verification Balloon Rated Burst Pressure Shaft Burst Balloon Fatigue Balloon Compliance Balloon Inflation and Deflation Time Catheter Bond Strength Tip Pull Strength Flexibility and Kinking Torque Strength Radiopacity Coating Integrity |

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Additional testing was performed to support the peripheral use of the Sapphire II PRO balloon dilatation catheter:

- Performance Testing
.

- o Visual Inspection
- Balloon Preparation, Deployment, and Retraction O

The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the reference devices.

This information supports a determination of substantial equivalence between the Sapphire II PRO PTA balloon dilatation catheter and the predicate device described above.

Conclusion: