Sapphire NC Plus Coronary Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. September 19, 2019 OrbusNeich Medical Trading, Inc. Mr. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, FL 33309 Re: K192344 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: August 28, 2019 Received: August 29, 2019 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K192344 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 Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over The Counter Use (21 CFR 801 Subpart C) | | X Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ ## 510(k) Summary - K192344 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: | August 28, 2019 | | Trade Name: | Sapphire NC Plus Coronary 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 | | Device Class: | Class II (special controls) | | Predicate Device: | Sapphire NC Plus (K162209; LOX; cleared October 6, 2016) | | Reference Device: | NC Euphora (K141090; LOX; cleared August 14, 2014) | | 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>5.0mm 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>segment. The catheter is compatible with 5F (6F for Ø4.5-5.0mm) or<br>larger guiding catheters. The internal lumen of the catheter accepts a<br>standard 0.014 inch PTCA guidewire. The proximal part of the<br>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 brachial or femoral<br>guiding catheter. The design of this dilatation catheter does not<br>incorporate a lumen for distal dye injections or distal pressure<br>measurements. This Special 510(k) describes the addition of the Ø4.5-<br>5.0mm balloon configurations to the Sapphire NC Plus PTCA catheter<br>family. | | 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 perfusion balloon dilatation of a coronary artery occlusion for the<br>treatment of acute myocardial infarction in-stent restenosis post-delivery expansion of balloon expandable coronary<br>stents | | Technological Characteristics: | At a high level, the subject and predicate devices are based on the same<br>technological elements:<br>indications for use rapid exchange catheter design non-compliant balloon nominal pressure 0.014" guidewire compatibility specific materials selected catheter working length hydrophilic coating EO sterilization The following technological differences exist between the subject and<br>predicate device:<br>balloon diameter range exact dimensions of components and catheter rated burst pressure | | Performance Data: | Testing was performed to support the use of the Sapphire NC Plus:<br>Shelf-Life Performance Testing Visual Inspection Dimension Inspection Balloon Preparation, Deployment, and Retraction Balloon Rated Burst Pressure Balloon Fatigue Balloon Compliance Balloon Inflation and Deflation Time Catheter Bond Strength Tip Pull Strength Particulate Evaluation Balloon Rated Burst Pressure (within stent) Balloon Fatigue (within stent) The Sapphire NC Plus test results met all acceptance criteria and were<br>similar to the predicate devices. | | 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. | {4}------------------------------------------------