HP PTA Balloon Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 20, 2023 Kossel Medtech (Suzhou) Co.,Ltd. Ron Lv Regulatory Affair Engineer Bldg 6, No. 8, Jinfeng Road Suzhou, Jiangsu Province 215163 China Re: K231402 Trade/Device Name: HP PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 13, 2023 Received: November 17, 2023 Dear Ron Lv: 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 (the 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 available 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. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Ariel G. Ariel G. Ash-shakoor -S shakoor -S Date: 2023.12.20 09:49:01 -05'00 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) K231402 Device Name HP PTA Balloon Dilatation Catheter ### Indications for Use (Describe) The HP PTA Balloon Dilation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, popliteal, tibial, peroneal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> | |----------------------------------------------|--------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </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." {3}------------------------------------------------ # 510(k) SUMMARY | 510(k) SUMMARY | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Kossel Medtech (Suzhou) Co., Ltd.<br>BLDG 6, No. 8 Jinfeng Road<br>Suzhou New District, Jiangsu Province, China | | Contact Person: | Ron Lv<br>F3, BLDG 6, No. 8 Jinfeng Road<br>Suzhou New District,<br>Jiangsu Province, China<br>Phone: +86 150 5142 9102<br>Mail: lvxin@kosselmed.com | | Date Prepared: | May 12, 2023 | | Trade Name: | HP PTA Balloon Dilatation Catheter | | Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter | | Classification<br>Name: | Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250),<br>Class II (special controls) | | Product Code: | LIT | | Predicate Device: | Predicate Device: | | | MustangTM Balloon Dilatation Catheter (K103751, cleared MAR 22, 2011) | | Device Description: | The 0.0350" HP PTA balloon dilatation catheter is mainly composed of tip<br>tube, inner tube, balloon, marker bands, double-lumen tube, stress diffusion<br>tube and hub. Among them the balloon is the most important part of the catheter.<br>In order to dilate different stenosis, the balloon should be dilated to different<br>dimensions by inflating to different pressures. The soft tip at the end of the<br>balloon is intended to make the balloon catheter more easy to push to the<br>stenosis position. The inner tube which connects to the tip tube is for guide wire<br>passage and the pushing rod. The two marker bands wrapped around the inner<br>tube are for positioning the balloon location with the use of in vitro monitoring<br>equipment. The proximal end of the double-lumen tube is connected with the<br>hub, which is used as the balloon filling channel and also as the push rod of the<br>catheter. The hub is used to connect with the external pressure equipment for<br>balloon filling. The stress diffusion tube can prevent the double-lumen tube<br>from being folded. | | Image: Diagram of the catheter with labels: Tip Tube, Balloon, Double-lumen Tube, Hub, Stress Diffusion Tube, Marker band, Inner Tube | | {4}------------------------------------------------ The HP PTA Balloon Dilatation Catheter is indicated for Percutaneous Intended Use: Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. 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. | Technological<br>Characteristics | HP PTA Balloon Dilatation Catheter | Predicate Device<br>Mustang™ Balloon Dilatation Catheter | Comparison | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | K103751 | | | Balloon material | Nylon, Pebax | Nylon, Pebax | Equivalent | | Balloon<br>Diameters<br>(mm) | 3.0~12.0 | 3.0~12.0 | Identical | | Balloon lengths<br>(mm) | 20~200 | 20~200 | Identical | | Balloon<br>compliance | Non-Compliant | Non-Compliant | Identical | | Catheter Type | OTW | OTW | Identical | | Guide wire size<br>(inch) | 0.035" | 0.035" | Identical | | Sheath<br>Compatibility | 8F | 7F | Different | | Double lumen<br>tube diameter | 5.3F(1.78mm) | unknown | / | | Catheter length<br>(cm) | 40/75/135 | 40/75/135 | Identical | | Rated burst<br>Pressure (atm) | 24atm (ø3.0-4.0mm);<br>22atm (ø5.0-6.0mm);<br>20atm (ø7.0×20-100mm);<br>18atm (ø7.0×120-200mm, ø8.0-<br>9.0mm)<br>14atm (ø10.0-12.0mm) | 24atm (ø3.0-5.0mm, ø6.0×20-<br>100mm);<br>22atm(ø6.0×120-200mm);<br>20atm (ø7.0×20-100mm, ø8.0×20-<br>100mm);<br>18atm (ø7.0×120-200mm, ø8.0×120-<br>200mm, ø9.0mm);<br>14atm (ø10.0-12.0mm) | Equivalent | | Nominal<br>pressure<br>(atm) | 8/10 | 8/10 | Equivalent | | Sterilization<br>Method | EO | EO | Identical | The following table lists the material and size comparisons between the subject device and the predicate device. {5}------------------------------------------------ The HP PTA Balloon Dilatation Catheter and predicate device have following same technological elements: - Operating principle balloon dilatation of stenotic portion by pressurization of inflation medium - Fundamental catheter design balloon, shaft, radiopaque marker, hub - Balloon Diameter and Length - Balloon compliance - Non-Compliant - Catheter type - OTW - Guide wire size - Catheter effective length - Nominal Pressure - Sterilization Ethylene oxide There are following minor technological differences between HP PTA Balloon Dilatation Catheter and predicate device: - Double lumen tube diameter ● - Sheath Compatibility ● - Rated Burst Pressure Any differences that exist between the HP PTA Balloon Dilatation Catheter and the predicate device did not raise any new questions of safety or effectiveness. Performance Data: Bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows: - Visual inspection - Dimensional verification - Hydration test - Leakage test - Balloon inflation and deflation time - Balloon fatigue - Radiopacity - Simulated use test/guidewire and introducer sheath compatibility test - Tip pull strength - . . . . . . . . . . . . . . . Catheter bond strength - Torque strength - Balloon rated burst pressure - Balloon compliance - Catheter body burst pressure - Flexibility and kinking - Corrosion resistance test - Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility) - Shelf life testing The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020). {6}------------------------------------------------ | Biocompatibility | To demonstrate the biological safety of the body-contacting materials, the<br>following biocompatibility testing, which was performed in accordance with<br>'Use of International Standard ISO 10993-1, Biological evaluation of medical<br>devices - Part 1: Evaluation and testing within a risk management process';<br>'ASTM F2888-19 Standard Practice for Platelet Leukocyte Count-An In- | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Vitro Measure for Hemocompatibility Assessment of Cardiovascular<br>Materials'; 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and | | | Specialty Catheters - Premarket Notification (510(k)) Submissions' were<br>followed. | | | Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic<br>toxicity, hemocompatibility (hemolysis, partial thromboplastin time,<br>complement activation, in vivo thromboresistance and thrombus electron<br>microscope scanning), material-mediated pyrogenicity and platelet<br>leukocyte count study were conducted. | | | The results of the testing show that the subject device included in this<br>submission met all acceptance criteria and the subject device is<br>biocompatible. | | Conclusion: | This information supports a determination of substantial equivalence<br>between the HP PTA Balloon Dilatation Catheter and the predicate devices<br>described above. |