Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 4, 2015 Natec Medical Ltd. Mr. Xavier de Buchere Regulatory Affairs & Quality Manager Maeva Centre Building - Silicon Avenue Ebene Business Park Reduit, Mauritius 72201 Re: K143041 Trade/Device Name: Ebony PTA 0.014" OTW Catheter Ebony PTA 0.018" OTW Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: May 7, 2015 Received: May 8, 2015 Dear Mr. de Buchere: 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Kenneth J. Cavanaugh -S for for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143041 #### Device Name Ebony® PTA 0.014" Over the Wire Catheter Ebony® PTA 0.018" Over the Wire Catheter #### Indications for Use (Describe) The Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature. The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### 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." {3}------------------------------------------------ ## 510(k) SUMMARY This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92(c). | Applicant: | Natec Medical Ltd.<br>Maeva Centre Building - Ebene Business Park<br>Reduit, Mauritius | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Xavier De Buchere<br>Regulatory Affairs & Quality Manager<br>Tel: +230 466 30 54<br>FAX: +230 466 67 70<br>xdbuchere@natec-medical.com | | Summary Preparation Date: | October 10th, 2014 | |---------------------------|--------------------| |---------------------------|--------------------| ## Device Name: | Trade Name: | Ebony® PTA 0.014" over the wire Catheter<br>Ebony® PTA 0.018" over the wire Catheter | |----------------------|--------------------------------------------------------------------------------------| | Common/Usual Name: | Percutaneous Catheter 21 CFR 870.1250 | | Classification Name: | Catheters, Transluminal coronary angioplasty, Percutaneous | | Generic name: | PTA Catheter | | Regulation Number: | 870.1250 | | Product Code: | LIT | | Device Class: | Class II | ## Predicate Devices: - V Ebony® PTA .014" RX Peripheral Dilatation Catheter (K112513) - > Ebony® PTA 0.035 Peripheral Dilatation Catheter (K103354) ## DEVICE DESCRIPTION The Ebony ® PTA 0.014" over the wire catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated. Maximum guide wire diameter is 0.014" (0.36 mm). The usable catheter length for OTW is 120 cm and 150 cm. {4}------------------------------------------------ In order to correctly position the balloon under fluoroscopy, two radiopaque markers are placed on the shaft under the balloon itself, defining its cylindrical area. The catheter includes a smooth, soft and atraumatic tip to facilitate advancement of the catheter through the stenosis. In order to facilitate advancing through the vasculature, a hydrophilic coating is present on the distal shaft and the balloon. The Ebony ® PTA 0.014" over the wire catheter is available in 2 usable lengths: 120 and 150 cm; and in the balloon sizes shown in Table 1. The Ebony ® PTA 0.014" over the wire catheter will be supplied sterile and is intended for one time use. | | | | Catheter Length 120 cm and 150 cm | | | | | | |-----------|----|----|-----------------------------------|----|-----|-----|-----|-----| | Balloon | | | Balloon Length (mm) | | | | | | | Size (mm) | 20 | 40 | 60 | 80 | 100 | 120 | 150 | 200 | | 1.50 | ✓ | | | | | | | | | 2.00 | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 2.50 | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 3.00 | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 3.50 | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 4.00 | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ### Table 1 The Ebony® PTA 0.018" over the wire Catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated and it ends at the tip of the catheter. Maximum guide wire diameter is 0.018" (0.46 mm). The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. The Ebony® PTA 0.018" over the wire Catheter is available in two catheter lengths and the balloon sizes shown in Table 2 below. The Ebony® PTA 0.018" over the wire Catheter is supplied sterile and is intended for one time use. | Balloon<br>Size (mm) | Balloon Length (mm) | | | | | | | |----------------------|---------------------|----|----|-----|-----|-----|-----| | | 40 | 60 | 80 | 100 | 120 | 150 | 200 | | 2.00 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 2.50 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 3.00 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 3.50 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 4.00 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 5.00 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 5.50 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 6.00 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | 7.00 | ✓ | | | | | | | Table 2 {5}------------------------------------------------ ## DEVICE INTENDED USE The Ebony 0.014" PTA over the wire Catheter is intended for dilation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony 0.014" PTA over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature. The Ebony PTA .018" over the wire Catheter is intended for dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony PTA .018" OTW over the wire Catheter is not for use in coronary arteries or neuro-vasculature. # COMPARISON OF INDICATIONS FOR USE TO PREDICATE DEVICES & TECHNICAL CHARACTERISTICS The modified Ebony® PTA 0.014" OTW Catheter is manufactured using the same materials that were used to manufacture the predicate Ebony® PTA 0.014" RX Peripheral Dilatation Catheter and the predicate Ebony PTA 0.035" Peripheral Dilatation Catheter. The modified Ebony® PTA 0.014" OTW Catheter differs from the originally cleared Ebony® PTA 0.014" RX Peripheral Dilatation Catheter with respect to the intended use, device design, and the available balloon sizes and catheter lengths. The intended use of the modified Ebony catheter in the femoral, popliteal and infra popliteal arteries, is a more restricted indication from the originally cleared indication. As this is a subset of the original indication, safety and effectiveness would not be affected. The OTW and proximal connector design changes of the modified Ebony PTA 0.014" OTW Catheter are similar in design to the predicate Ebony PTA 0.035" Peripheral Dilatation Catheter. The available balloon sizes are an extension of the sizes for the predicate Ebony® PTA 0.035" Peripheral Dilatation Catheter. The performance of the modified catheter design and new balloon sizes is supported by the bench test results which found that all catheter test samples met the acceptance criteria for each of the performance tests. The modified Ebony® PTA 0.018" OTW Catheter has the same indication and uses the same materials that were used to manufacture the predicate Ebony PTA 0.035" Peripheral Dilatation Catheter and the predicate Ebony® PTA 0.014" RX Peripheral Dilatation Catheter. The modified Ebony® PTA 0.018" OTW Catheter differs from the originally cleared Ebony® PTA 0.035" Peripheral Dilatation Catheter with respect to the device design, available balloon sizes and catheter lengths. To accommodate 0.018" guidewires, the design of the modified Ebony® PTA 0.018" OTW Catheter has a smaller inner tubing than the predicate Ebony® PTA 0.035" Peripheral Dilatation Catheter. {6}------------------------------------------------ The available balloon sizes are expanded with the addition of balloon diameters 1.5mm and 2.0 to 5.0 mm diameter balloons. The rated burst pressure and catheter length are the same or fall within the range of the predicate Ebony® PTA 0.035" Peripheral Dilatation Catheter, and balloon lengths are expanded. The performance of the modified catheter design and new balloon sizes is supported by the bench test results which found that all catheter test samples met the acceptance criteria for each of the performance tests. # BIOCOMPATIBILITY All materials used in the Ebony ® PTA 0.014" over the wire catheter and Ebony® PTA 0.018" over the wire catheter are biocompatible based on the results of biocompatibility testing performed in accordance with ISO10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F75600 and 21 CFR 58 (GLP regulations). ## PERFORMANCE DATA The substantial equivalence of the Ebony ® PTA 0.014" over the wire catheter and Ebony® PTA 0.018" over the wire catheter has been demonstrated through data collected from in vitro bench tests and analyses. Testing results demonstrated equivalent performance of the Ebony® PTA 0.014" over the wire catheter and the Ebony® PTA 0.018" over the wire catheter with the predicate device. The testing included ■ balloon compliance - balloon burst pressure - 트 balloon fatigue - ' shaft resistance - 트 bond strength - 트 catheter dimensions - I deflation time - 트 coating verification - I kink testing - I deployment testing - I guide wire and introducer compatibility. # CONCLUSION The subject devices, the Ebony ® PTA 0.014" over the wire catheter and the Ebony® PTA 0.018" over the wire catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Natec Medical believes the Ebony ® PTA 0.014" over the wire catheter and Ebony® PTA 0.018" over the wire catheter are substantially equivalent to the predicate devices.