← Product Code [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT) · K201170 # Athletis PTA Balloon Dilatation Catheter (K201170) _Boston Scientific Corporation · LIT · Sep 15, 2020 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K201170 ## Device Facts - **Applicant:** Boston Scientific Corporation - **Product Code:** [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT.md) - **Decision Date:** Sep 15, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The Athletis™ PTA Balloon Dilatation Catheter is intended to be used to treat resistant lesions in the peripheral vasculature. ## Device Story Athletis™ PTA Balloon Dilatation Catheter is an over-the-wire (OTW), non-compliant, high-performance balloon catheter for peripheral vascular interventions. Device features dual-lumen shaft, Y-connector manifold, and tapered tip. Two radiopaque marker bands facilitate fluoroscopic visualization. Lubricious hydrophobic coating applied to distal portion. Compatible with 0.035 in guidewires. Used by physicians in clinical settings to dilate resistant lesions or post-dilate stents/stent grafts. Inflation/deflation performed via balloon port on manifold. Device provides mechanical dilation of vessels, improving blood flow and potentially resolving obstructive lesions. No software or electronic components. ## Clinical Evidence No human clinical data. Evidence includes extensive bench testing (tensile strength, kink resistance, balloon fatigue, burst pressure, particulate evaluation) and an acute GLP porcine animal study evaluating in vivo thrombogenicity and acute performance. Biocompatibility testing performed per ISO 10993. ## Technological Characteristics Over-the-wire (OTW) balloon catheter; non-compliant balloon; dual-lumen shaft; radiopaque marker bands; lubricious hydrophobic coating; tapered tip. Materials include standard medical-grade resins. Sterilization via ethylene oxide (SAL 10^-6). Mechanical operation; no energy source or software. ## Regulatory Identification A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. ## Predicate Devices - Mustang Balloon Dilatation Catheter ([K103751](/device/K103751.md)) ## Reference Devices - Gladiator PTA Balloon Dilatation Catheter ([K113681](/device/K113681.md)) - Bard Conquest ([K083657](/device/K083657.md)) - Bard Conquest 40 ([K120660](/device/K120660.md)) ## Related Devices - [K093965](/device/K093965.md) — ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS · C.R. Bard, Inc. · Mar 17, 2010 - [K120971](/device/K120971.md) — ATLAS PTA BALLOON DILATATION CATHETER · Bard Peripheral Vascular, Inc. · Apr 19, 2012 - [K220410](/device/K220410.md) — Ebony HP PTA OTW 0.035 Catheter · Natec Medical , Ltd. · Jun 29, 2022 - [K120722](/device/K120722.md) — RIVAL PTA DILATATION CATHETER · Bard Peripheral Vascular, Inc. · Apr 19, 2012 - [K132810](/device/K132810.md) — GLADIATOR ELITE PTA BALLOON DILATATION CATHETER · Boston Scientific Corp · Feb 28, 2014 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 15, 2020 Boston Scientific Corporation Jennifer Mrkvicka Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311 Re: K201170 Trade/Device Name: Athletis™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: September 2, 2020 Received: September 3, 2020 ## Dear Jennifer Mrkvicka: 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. 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 {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, 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) K201170 Device Name Athletis™ PTA Balloon Dilatation Catheter #### Indications for Use (Describe) The Athletis™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Athletis™ PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </div>Over-The-Counter Use (21 CFR 801 Subpart C)</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 Per 21 CFR §807.92 | Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and<br>Information | Jennifer Mrkvicka<br>Regulatory Affairs Specialist<br>3 Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: 763-255-0917<br>Fax: 763-494-2222<br>e-mail: Jennifer.Mrkvicka@bsci.com | | Date Prepared | 30 April 2020 | | Proprietary Name | Athletis™ PTA Balloon Dilatation Catheter | | Common Name | PTA Balloon Dilatation Catheter | | Product Code | LIT | | Classification | Class II, 21 CFR Part 870.1250 | | Predicate Device | Mustang Balloon Dilatation Catheter (K103751), cleared 22 March 2011 | | Reference Devices | Gladiator PTA Balloon Dilatation Catheter (K113681), cleared 11 January<br>2012<br>Bard Conquest (K083657), cleared 24 December 2008<br>Bard Conquest 40 (K120660), cleared 15 March 2012 | | Device Description | The Athletis™ Percutaneous Transluminal Angioplasty (PTA) Balloon<br>Dilatation Catheter is an over-the-wire (OTW), non-compliant, high<br>performance balloon catheter for peripheral indications. The catheter is<br>compatible with 0.035 in (0.89 mm) guidewires.<br><br>The Athletis™ PTA Balloon Dilatation Catheter features a dual lumen shaft<br>ending in a Y-connector manifold with luer lock fittings. The manifold port<br>marked "WIRE" is used to deliver the catheter over a 0.035 in (0.89 mm)<br>guidewire. The manifold port marked "BALLOON" is used to inflate and<br>deflate the balloon during the procedure. Two radiopaque marker bands, in<br>conjunction with fluoroscopy, aid in the visualization of the balloon. A<br>lubricious hydrophobic coating is applied from the distal tip to just proximal of<br>the balloon to assist with delivery of the device. The catheter includes a<br>tapered tip to facilitate advancement of the catheter to and through the<br>treatment site. The working lengths of the balloon catheter are 50 cm, 75 cm<br>and 135 cm to allow device selection for various anatomies. | | Intended Use of<br>Device | The Athletis™ PTA Balloon Dilatation Catheter is intended to be used to treat<br>resistant lesions in the peripheral vasculature. | | Indications for Use | The Athletis™ PTA Balloon Dilatation Catheter is indicated for Percutaneous<br>Transluminal Angioplasty in the peripheral vasculature including upper<br>extremity, renal, iliac, and infrainguinal vessels and the treatment of<br>obstructive lesions of native or synthetic arteriovenous dialysis fistulae.<br><br>The Athletis™ PTA Balloon Dilatation Catheter is also indicated for post-<br>dilatation of stents and stent grafts in the peripheral vasculature. | | Comparison of<br>Technological<br>Characteristics | The Athletis™ PTA Balloon Dilatation Catheter incorporates substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process and<br>intended use as those featured in the Mustang™ Balloon Dilatation Catheter<br>(K103751). | {4}------------------------------------------------ | Comparison to predicate device Mustang in Materials and Manufacturing | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Characteristic | Comment | | | Manifold | Similar material and design serving<br>same function. | | | Pinch-off Tube | Similar material and design serving<br>same function. | | | Strain Relief | Identical base resin and similar<br>colorant serving same function. | | | Proximal Dual Lumen Shaft | Similar material and same design<br>serving same function. | | | Distal Guidewire Lumen Shaft | Identical | | | Bumper Tip | Identical base resin and similar<br>colorant serving same function. | | | Balloon | Difference in design but serving<br>same function and intended use. | | | Balloon Bonding Method | Identical | | | Markerbands | Identical | | | Coating | Identical | | | Balloon Protector | Identical | | | Sterilization Method | Identical | | | SAL | Identical | | | Packaging | Identical design and materials for<br>coiled configuration. | | | | Mustang does not use a straight<br>configuration. | | | Nominal Balloon Diameters | Similar range serving same function<br>and intended use. | | | Balloon lengths | Similar range serving same function<br>and intended use. | | | Rated Burst Pressure (RBP) | Athletis is a higher pressure balloon<br>than Mustang. Balloon construction<br>is a factor. All Athletis balloon<br>diameters were tested and<br>demonstrate with 95% confidence<br>that 99.9% of devices will not burst<br>at or below the rated burst pressure. | | | Effective Lengths | Similar ranges serving same<br>function and intended use. | | | Recommended Introducer Sheath<br>Compatibility | Similar ranges serving same<br>function and intended use. | | | Recommended Guidewire | Identical compatibility. | | Performance Data | Bench testing and biocompatibility testing were performed to support a<br>determination of substantial equivalence. The results of these tests provide<br>reasonable assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the testing. | | | | The following biocompatibility tests were completed on the Athletis™ PTA<br>Balloon Dilatation Catheter: | | | | Cytotoxicity | Direct Contact Hemolysis | | | Sensitization | Complement Activation | | | Intracutaneous Reactivity | In Vitro Hemocompatiblity | | | Acute Systemic Toxicity | Ames Mutagenincity | | | Materials Mediated Pyrogenicity | Mouse lymphoma Assays | | | USP Physicochemical | | | | The following <i>in vitro</i> performance tests were completed for the Athletis™<br>Balloon Dilatation Catheter: | | | | Working Length | Device Tensile (including Tip<br>Tensile) | | | Shaft Outer Diameter | Balloon Protector Removal Force | | | Balloon Crossing Profile | Shaft Kink Resistance | | | Preparation, Deployment, and<br>Retraction | Torque Strength | | | Balloon Rated Burst Pressure and<br>Burst in Stent | Radiopacity | | | Balloon Fatigue/Fatigue in Stent… --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K201170](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K201170) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K201170