Sapphire II PRO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. March 1, 2018 OrbusNeich Medical Trading Inc. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33309 Re: K173680 Trade/Device Name: Sapphire II PRO Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 28, 2017 Received: December 1, 2017 Dear John 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. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |-----------------------------------------|----------------------------------| | Food and Drug Administration | Expiration Date: 06/30/2020 | | | See PRA Statement below. | **Indications for Use** | 510(k) Number (if known) | K173680 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Sapphire II PRO Coronary Dilatation Catheter | | Indications for Use (Describe) | The Sapphire II PRO coronary dilatation catheter (1.0-1.25mm 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. | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| AOTA mmoss.tr-0.tr OA9 II arinqques A0-10-(x)015-7102 976 to 88 {3}------------------------------------------------ # K173680 ## 510(k) Summary | This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c). | | |-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | OrbusNeich Medical Trading, Inc.<br>5363 NW 35th Avenue<br>Fort Lauderdale, FL 33309<br>Phone: 954.730.0711<br>Fax: 954.730.7601 | | Contact Person: | John D. Pazienza | | Date Prepared: | February 2, 2018 | | Trade Name: | Sapphire II PRO 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 II PRO (K163114; cleared January 5, 2017)<br>Mini Trek (K110617; cleared June 2, 2011)<br>Emerge (K130391; cleared July 10, 2013)<br>Sprinter Legend (K103095; cleared October 22, 2010) | | Device Description: | The Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter is a<br>percutaneous transluminal coronary angioplasty (PTCA) balloon<br>catheter with a working length of 140cm. The proximal shaft is a<br>PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings<br>are applied to the distal section. The semi-compliant balloons,<br>available in diameters from 1.0-1.25mm and lengths from 5-15mm,<br>can be inflated by injecting dilute contrast media solution through the<br>trailing hub of the catheter. One radiopaque platinum marker band is<br>centrally located within the balloon segment. The catheter is<br>compatible with 5F or larger guiding catheters. The internal lumen of<br>the catheter accepts a standard 0.014 inch PTCA guidewire. The<br>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 II PRO Coronary Dilatation Catheter (Ø1.0-1.25mm<br>configurations) is indicated for:<br>• balloon pre-dilatation of a stenotic portion of a coronary<br>artery or bypass graft stenosis (≥70% stenosis) for the<br>purposes of improving myocardial perfusion. | {4}------------------------------------------------ - Comparisons of the new and predicate devices show that the Technological Characteristics: technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices. - Performance Data: Both in vitro performance tests, such as dimensional verification, 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, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Ø1.0-1.25mm Sapphire II PRO 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). Clinical Data: Purpose The purpose of this study was to assess the acute safety and device procedural success of the Sapphire II PRO Ø1.0 and 1.25 mm coronary dilatation catheter in its intended use for the initial dilatation of coronary artery or by-pass graft stenosis. # Study Design The Sapphire II PRO Study was a prospective, open label, multicenter, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO Ø1.0 and 1.25 mm coronary dilatation catheters in patients with stenotic coronary arteries or bypass grafts (≥70% diameter stenosis) during percutaneous coronary intervention (PCI). Sixty-one (61) patients were treated at four (4) US sites with the Sapphire II PRO coronary dilatation catheter to pre-dilate coronary arteries or bypass grafts during their index procedure. All patients were screened according to the protocol inclusion and exclusion criteria and were followed through hospital discharge. The primary endpoint was Device Procedural Success consisting of a composite of: - Successful delivery, inflation, deflation and withdrawal of the . study balloon; - No evidence of vessel perforation, flow limiting dissection . (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon; - . Final TIMI flow grade of 3 at the conclusion of the PCI procedure. {5}------------------------------------------------ The secondary peri-procedure related endpoints of study device effectiveness included the individual components of the primary endpoint. along with the angiographic core lab determined improvement in the Minimum Lumen Diameter (MLD) following predilation of the lesion with the study balloon, and Lesion Success defined as successful PCI in the absence of vessel perforation, flow limiting dissection (grade C or higher), or reduction in TIMI flow from baseline related to the study balloon, or clinically significant arrhythmias. The secondary in-hospital clinical safety and efficacy endpoints reported through hospital discharge included: in-hospital Major Adverse Cardiac Events (MACE), defined as a composite of; all death (cardiac and non-cardiac), Myocardial Infarction (MI) and clinically indicated Target Lesion Revascularization (TLR). Also reported are the individual components of the MACE composite end-point, inhospital Target Lesion Failure (TLF), defined as a composite of cardiac death, target vessel MI, or clinically indicated TLR, along with in-hospital Stent Thrombosis (ST) within the target vessel, or clinically significant arrhythmias (requiring intervention). Both MI and ST were determined by the Academic Research Consortium (ARC) classification criteria. ### Demographics and Baseline Lesion Characteristics A total of 61 patients including 67 lesions were treated in accordance to the protocol at 4 U.S. sites. All patients were screened according to the protocol inclusion and exclusion criteria and were followed through hospital discharge. The analyses were performed on the intent-to-treat (ITT) population and were descriptive. The mean age of the study population was 67.26 ± 9.35 years and 11/61 (18.0%) were female. The prevalence of traditional cardiovascular risk factors in enrolled patients included 19/61 (31.1%) diabetes mellitus, 10/61 (16.4%) current smoking, and 51/61 (83.6%) hypertension. Angina status for the enrolled patients was reported as 21/61 (34.4%) unstable angina. 31/61 (50.8%) stable angina. 1/61 (1.6%) NSTEMI, and 8/61 (13.1%) were asymptomatic. A total of 67 lesions were treated in the study, of which 63/67 (94%) were located in native coronary arteries and 4/67 (6.0%) were located in bypass grafts. Treated vessels included: diagonal branch of the LAD 10/67 (14.9%), LAD 22/67 (32.8%), LCx 12/67 (17.9%), marginal branch of the LCx 1/67 (1.5%), posterior descending branch of RCA 2/67 (3.0%), and RCA 16/67 (23.9%). Total occlusion was observed in 9/67 (13.4%) lesions and severe calcification was observed in 24/67 (35.8%) of the lesions. Multi-vessel disease was present in 33/61 (54.1%) of the patients and the average lesion length was 18.42 ± 12.2 mm. ### Study Results As shown in Table 1, Device Procedural Success was site reported as achieved in 59/61 (96.7%) of the patients, including successful delivery, inflation, deflation and withdrawal of all the study balloons. No procedural complications were observed in the intent-to-treat patient population, this includes no vessel perforation, flow limiting dissection (grade C or higher), or reduction in TIMI flow from baseline {6}------------------------------------------------ related to the study balloon. Device procedural failure was reported in two subjects 2/61 (3.3%): i) one subject presented with a chronic total occlusion (CTO) and the lesion was not able to be successfully dilated with any device such that the final TIMI flow did not reach grade 3 at the conclusion of the PCI procedure, and ii) one subject where two study balloons pin-holed and ruptured at >12 atm inflation pressure however the lesions were able to be fully opened for a successful PCI. Table 1, Primary Endpoint Outcomes | Primary Endpoint | Sapphire II PRO | | |----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------| | | Patients (n=61) | Lesions (n=67) | | Device Procedural Success | 59/61 (96.7%) | 64/67 (95.5%) | | Success of delivery, inflation/deflation and withdrawal | 60/61 (98.4%) | 65/67 (97.0%) | | Absence of vessel perforation, flow limiting dissection (grade C or<br>higher), or reduction in TIMI flow from baseline related to the study<br>balloon. | 61/61 (100%) | 67/67 (100%) | | Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | 60/61 (98.4%) | 66/67 (98.5%) | As shown in Tables 2a and 2b, the secondary peri-procedure related endpoints of study device effectiveness and in-hospital clinical safety and efficacy measured through hospital discharge and included site reported successful delivery, inflation, deflation and withdrawal of the study balloon, with the absence of vessel perforation, flow limiting dissection (Grade C or Higher), and no reduction in TIMI flow from baseline related to the study balloon. In-hospital Major Adverse Cardiac Events (MACE) was observed in 1/61 (1.6%) of the patients. The peri-procedural, non-Q-wave MI event was characterized by elevation of post-procedure creatine kinase-myoglobin band (CK-MB) levels and did not require treatment. The all-cause death and TLR rates were 0.0% (0/61). There were no reports of TLR 0.0% (0/61), clinically indicated or in-hospital stent thrombosis (ST) 0.0% (0/61) within the target vessel. There were no clinically significant arrhythmias requiring intervention 0.0% (0/61) and no additional device observations reported in the conduct of the study. | | | Table 2a, Study Device Effectiveness Outcomes | | |--|--|-----------------------------------------------|--| |--|--|-----------------------------------------------|--| | Secondary Endpoint | Site Reported or<br>Angiographic Central Core<br>Lab Reported (QCA) | Overall<br>Population<br>(n=61 patients) | |--------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------| | Peri-procedural end-points of study device effectiveness | | | | Successful balloon delivery to the target lesion | Site Reported and Adjudicated | 61 (100.0%) | | Successful inflation at the target lesion | Site Reported and Adjudicated | 60 (98.4%) | | Successful deflation and withdrawal of the study balloon | Site Reported and Adjudicated | 61 (100.0%) | | Absence of vessel perforation | Core Lab Reported | 61 (100.0%) | | Absence of flow limiting dissection (Grade C or higher) | Core Lab Reported | 61 (100.0%) | | No reduction in TIMI flow from baseline related to the study<br>balloon* | Core Lab Reported | 51/51 (100.0%) | | Final TIMI flow grade of 3 at the conclusion of the PCI procedure | Core Lab Reported | 60 (98.4%) | | Absence of balloon rupture of the study balloon | Site Reported and Adjudicated | 60 (98.4%) | | Improvement in Minimum Lumen Diameter (measured by<br>QCA)** | Core Lab Reported | 49/51 (96.1%) | | Lesion success (patient based) | Core Lab Reported | 60 (98.4%) | | Clinically significant arrhythmia | Site Reported and Adjudicated | 0 (0.0%) | * The TIMI flow after study balloon was not analyzable in 10 patients by the Angiographic Core Lab. Theref reduction in TIMI flow from baseline related to the study balloon could only be analyzed in 51 patients *The Improvement in MLD after use of the study balloon as measured by OCA was not analyzable in 10 patients by the Angiographic Core Lab. Therefore, this value could only be analyzed in 51 patients. {7}------------------------------------------------ | Secondary Endpoint | Site Reported or Clinical<br>Event Committee (CEC)<br>adjudication | Overall<br>Population<br>(n=61 patients) | |--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------| | In-hospital clinical safety and efficacy | | | | In-hospital MACE - (composite of all death, target vessel MI or<br>clinically indicated TLR) | CEC adjudication | 1 (1.6%) | | Death | | 0 (0.0%) | | • Cardiac | CEC adjudication | 0 (0.0%) | | • Non-cardiac | CEC adjudication | 0 (0.0%) | | MI | | 1 (1.6%) | | • Target vessel MI | CEC adjudication | 1 (1.6%) | | • Non-target vessel MI | CEC adjudication | 0 (0.0%) | | Clinically indicated revascularization | | | | • TLR | CEC adjudication | 0 (0.0%) | | In-hospital Target Lesion Failure (TLF)<br>(composite of cardiac death, target vessel MI or clinically indicated<br>TLR) | CEC adjudication | 1 (1.6%) | | In-hospital stent thrombosis (ST) within the target vessel | CEC adjudication | 0 (0.0%) | | Clinically significant arrhythmias requiring intervention | CEC adjudication | 0 (0.0%) | #### Conclusion The results of the Sapphire II PRO Ø1.0 and 1.25 mm diameter clinical study support the acute safety and device success of the Sapphire II PRO Ø1.0 and 1.25 mm Coronary Dilatation Catheter and its intended use as a pre-dilatation catheter in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% diameter stenosis). Conclusion: This information supports a determination of substantial equivalence between the Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter and the predicate devices described above.