Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 13, 2016 BrosMed Medical Co., Ltd. Ms. Tina Yin Regulatory Affairs Manager 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China Re: K160941 Trade/Device Name: Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 31, 2016 Received: November 3, 2016 Dear Ms. Yin: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. 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, Brian D. Pullin -S 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) K160941 Device Name Castor NC PTA Balloon Dilatation Catheter Achilles NC PTA Balloon Dilatation Catheter Hermes NC PTA Balloon Dilatation Catheter Indications for Use (Describe) The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | <table><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr></table> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <table><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> 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 This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c). | Submitter: | BrosMed Medical Co., Ltd<br>15th Building, SMEs Venture Park<br>SongShan Lake Hi-Tech Industrial Development Zone<br>Dongguan 523808, China<br>Office: +86 (769) 2289 2018<br>Fax: +86 (769) 2289 2016 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tina Yin | | Date Prepared | December 2, 2016 | | Trade Name: | Castor NC PTA Balloon Dilatation Catheter<br>Achilles NC PTA Balloon Dilatation Catheter<br>Hermes NC PTA Balloon Dilatation Catheter | | Common Name: | PTA Balloon Dilatation Catheter | | Classification Name: | Percutaneous catheter (21 CFR 870.1250, Product Code LIT) | | Predicate Devices: | NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter<br>(K141118; cleared July 18, 2014)<br>Sterling Over-the-Wire (OTW) PTA Balloon Dilatation Catheter<br>(K132430; cleared October 17, 2013)<br>Mustang TM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) | | Device Description: | The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter<br>family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC<br>(0.035") PTA balloon catheter. The PTA (OTW type) device is an over the<br>wire (OTW) peripheral balloon catheter, specially designed for Percutaneous<br>Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and<br>150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work<br>length range from 10mm to 150mm. The three PTA balloon dilatation<br>catheters are filed in one 510(k) submission due to the similar/equivalent<br>construction and identical material of the products. The comparison of them<br>was summarized in Table 1. The differences only exist in the guide wire<br>compatibility and the balloon configuration which have been controlled by the<br>Design Verification. The balloon material is made of a non-compliant Nylon<br>material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22<br>atmospheres. It is a coaxial double lumen catheter with a balloon located near<br>the distal tip. One lumen is used for inflation of the balloon and accessed via<br>the side leg port. The second lumen, starting at the straight entry port, allows<br>access to the distal tip of the catheter for guide wire insertion. The three<br>products of the non-compliant PTA (OTW type) balloon catheter family have<br>different diameter of the guide wire port from max.0.014" to 0.035". The<br>guide wire compatibility was shown in table 1. The balloon has radiopaque<br>markers for positioning the balloon relative to the stenosis. The radiopaque<br>marker bands indicate the dilating section of the balloon and aid in balloon<br>placement. The balloon is dilated using the side leg port, at which the balloon<br>material expands to a known diameter at specific pressure. The working<br>pressure range for the balloon is between the nominal size pressure and the<br>rated burst pressure. All balloons distend to sizes above the nominal size at<br>pressures greater than the nominal pressure. The design of this dilatation | {4}------------------------------------------------ | | | catheter does not incorporate a lumen for distal dye injections or distal | | | | | |------------------------|--|---------------------------------------------------------------------------|--|--|--|--| | pressure measurements. | | | | | | | - Intended Use: The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature. - Comparisons of the new and predicate devices show that the technological Technological Characteristics: 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, particulate evaluation, balloon burst (in stents), balloon fatigue (in stents) and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genototocity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the PTA balloon catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use. - Conclusion: This information supports a determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above. {5}------------------------------------------------ | | Castor NC 0.014 | Achilles NC 0.018 | Hermes NC 0.035 | Difference | Control<br>Method | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------| | Device | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | Identical | | | Regulation<br>Description | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | | | Regulation Medical<br>Specialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | | | Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | | | Product Code | LIT | LIT | LIT | Identical | | | | Office of Device Evaluation<br>6(ODE) | Office of Device Evaluation<br>6(ODE) | Office of Device Evaluation<br>6(ODE) | Identical | n/a | | Premarket Review | Division of Cardiovascular<br>Devices (DCD) | Division of Cardiovascular<br>Devices (DCD) | Division of Cardiovascular<br>Devices (DCD) | Identical | | | | Peripheral Interventional<br>Devices Branch (PIDB) | Peripheral Interventional<br>Devices Branch (PIDB) | Peripheral Interventional<br>Devices Branch (PIDB) | Identical | | | Submission Type | 510(k) | 510(k) | 510(k) | Identical | | | Regulation Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | | | Device Class | 2 | 2 | 2 | Identical | | | Indications for Use | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | Identical | IFU | | Balloon<br>Characteristic | non-compliant | non-compliant | non-compliant | Identical | Design<br>Verification;<br>labeling | | Nominal<br>Pressure (Nom) | 12atm | 12atm | 12atm | Identical | Design<br>Verification;<br>labeling | | Rated Burst<br>Pressure (RBP) | 18, 20, 22atm | 18, 20, 22atm | 18, 20, 22atm | Identical | Design<br>Verification;<br>labeling | | Guide wire<br>Compatibility | Max. 0.014"(0.36mm) | Max. 0.018" (0.46mm) | Max. 0.035"(0.89mm) | Different | Design<br>Verification;<br>labeling | | Balloon<br>Diameter | 2.0-8.0mm | 2.0-8.0mm | 3.0-10.0mm | Different | Design<br>Verification:<br>labeling | | Balloon Length | 10-150mm | 10-150mm | 20-150mm | Different | Design<br>Verification:<br>labeling | | Shaft Length | 70, 90, 150 | 70, 90, 150 | 70, 90, 150 | Identical | Design<br>Verification:<br>labeling | Table 1, BrosMed PTA Balloon Dilatation Catheter Comparison Table