(137 days)
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.
The Athletis™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW), non-compliant, high performance balloon catheter for peripheral indications. The catheter is compatible with 0.035 in (0.89 mm) guidewires.
The Athletis™ PTA Balloon Dilatation Catheter features a dual lumen shaft ending in a Y-connector manifold with luer lock fittings. The manifold port marked "WIRE" is used to deliver the catheter over a 0.035 in (0.89 mm) guidewire. The manifold port marked "BALLOON" is used to inflate and deflate the balloon during the procedure. Two radiopaque marker bands, in conjunction with fluoroscopy, aid in the visualization of the balloon. A lubricious hydrophobic coating is applied from the distal tip to just proximal of the balloon to assist with delivery of the device. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the treatment site. The working lengths of the balloon catheter are 50 cm, 75 cm and 135 cm to allow device selection for various anatomies.
The provided text describes a 510(k) premarket notification for a medical device, the Athletis™ PTA Balloon Dilatation Catheter. The document focuses on demonstrating substantial equivalence to a predicate device (Mustang Balloon Dilatation Catheter) through comparisons of technological characteristics and performance data (bench testing, biocompatibility, and animal study).
However, the provided text does not contain the kind of information requested in the prompt regarding acceptance criteria and study details for an AI/algorithm-based device. The prompt asks about elements typical for AI/ML medical devices, such as:
- Acceptance criteria table with reported device performance (e.g., accuracy, sensitivity, specificity, AUC).
- Sample sizes for test sets, data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes).
- Training set sample size and ground truth establishment for training.
Since the document is for a physical medical catheter (Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter) and not an AI/ML diagnostic or assistive device, the requested information about AI model performance, human reader improvement with AI assistance, and specific AI training/testing methodologies is not applicable and not found within the provided text.
The performance data mentioned in the document are related to the physical and biological characteristics of the catheter itself, such as:
- Bench testing: Working Length, Shaft Outer Diameter, Balloon Crossing Profile, Preparation/Deployment/Retraction, Balloon Rated Burst Pressure and Burst in Stent, Balloon Fatigue/Fatigue in Stent, Balloon Compliance and OD at nominal, Balloon Inflation/Deflation Time, Particulate Evaluation, Device Tensile, Balloon Protector Removal Force, Shaft Kink Resistance, Torque Strength, Radiopacity, Guidewire Compatibility, Sheath Insertion and Withdrawal Force, Coating Integrity, Particulate in Stent.
- Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Direct Contact Hemolysis, Complement Activation, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse lymphoma Assays.
- GLP Animal Study (porcine): Evaluation of in vivo thrombogenicity and acute performance and safety.
The summary states that "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implicitly serves as the "acceptance criteria" for this type of device – demonstrating that it performs as intended and is safe, comparable to the predicate, through these physical and biological tests.
In conclusion, I cannot provide the requested information because the input text describes the clearance of a physical medical device (a balloon catheter), not an AI/ML-based device, and therefore does not contain data related to AI model performance or associated study methodologies.
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Per 21 CFR §807.92
| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Name andInformation | Jennifer MrkvickaRegulatory Affairs Specialist3 Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-255-0917Fax: 763-494-2222e-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 January2012Bard Conquest (K083657), cleared 24 December 2008Bard Conquest 40 (K120660), cleared 15 March 2012 |
| Device Description | The Athletis™ Percutaneous Transluminal Angioplasty (PTA) BalloonDilatation Catheter is an over-the-wire (OTW), non-compliant, highperformance balloon catheter for peripheral indications. The catheter iscompatible with 0.035 in (0.89 mm) guidewires.The Athletis™ PTA Balloon Dilatation Catheter features a dual lumen shaftending in a Y-connector manifold with luer lock fittings. The manifold portmarked "WIRE" is used to deliver the catheter over a 0.035 in (0.89 mm)guidewire. The manifold port marked "BALLOON" is used to inflate anddeflate the balloon during the procedure. Two radiopaque marker bands, inconjunction with fluoroscopy, aid in the visualization of the balloon. Alubricious hydrophobic coating is applied from the distal tip to just proximal ofthe balloon to assist with delivery of the device. The catheter includes atapered tip to facilitate advancement of the catheter to and through thetreatment site. The working lengths of the balloon catheter are 50 cm, 75 cmand 135 cm to allow device selection for various anatomies. |
| Intended Use ofDevice | The Athletis™ PTA Balloon Dilatation Catheter is intended to be used to treatresistant lesions in the peripheral vasculature. |
| Indications for Use | The Athletis™ PTA Balloon Dilatation Catheter is indicated for PercutaneousTransluminal Angioplasty in the peripheral vasculature including upperextremity, renal, iliac, and infrainguinal vessels and the treatment ofobstructive 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. |
| Comparison ofTechnologicalCharacteristics | The Athletis™ PTA Balloon Dilatation Catheter incorporates substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization process andintended use as those featured in the Mustang™ Balloon Dilatation Catheter(K103751). |
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| Comparison to predicate device Mustang in Materials and Manufacturing | ||
|---|---|---|
| Characteristic | Comment | |
| Manifold | Similar material and design servingsame function. | |
| Pinch-off Tube | Similar material and design servingsame function. | |
| Strain Relief | Identical base resin and similarcolorant serving same function. | |
| Proximal Dual Lumen Shaft | Similar material and same designserving same function. | |
| Distal Guidewire Lumen Shaft | Identical | |
| Bumper Tip | Identical base resin and similarcolorant serving same function. | |
| Balloon | Difference in design but servingsame 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 forcoiled configuration. | |
| Mustang does not use a straightconfiguration. | ||
| Nominal Balloon Diameters | Similar range serving same functionand intended use. | |
| Balloon lengths | Similar range serving same functionand intended use. | |
| Rated Burst Pressure (RBP) | Athletis is a higher pressure balloonthan Mustang. Balloon constructionis a factor. All Athletis balloondiameters were tested anddemonstrate with 95% confidencethat 99.9% of devices will not burstat or below the rated burst pressure. | |
| Effective Lengths | Similar ranges serving samefunction and intended use. | |
| Recommended Introducer SheathCompatibility | Similar ranges serving samefunction and intended use. | |
| Recommended Guidewire | Identical compatibility. | |
| Performance Data | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the testing. | |
| The following biocompatibility tests were completed on the Athletis™ PTABalloon 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 in vitro performance tests were completed for the Athletis™Balloon Dilatation Catheter: | ||
| Working Length | Device Tensile (including TipTensile) | |
| Shaft Outer Diameter | Balloon Protector Removal Force | |
| Balloon Crossing Profile | Shaft Kink Resistance | |
| Preparation, Deployment, andRetraction | Torque Strength | |
| Balloon Rated Burst Pressure andBurst in Stent | Radiopacity | |
| Balloon Fatigue/Fatigue in Stent | Guidewire Compatibility | |
| Balloon Compliance and OD atnominal | Sheath Insertion and WithdrawalForce | |
| Balloon Inflation/Deflation Time | Coating Integrity | |
| Particulate Evaluation | Particulate in Stent | |
| The Athletis™ PTA Balloon Dilatation Catheter was subjected to testingaccording to the requirements of Guidance for Industry and FDA Staff – ClassII special Controls for Certain Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September 8, 2010. Bench, animal andbiocompatibility testing in accordance with ISO 10993 were performed tosupport a determination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device has been designedand tested to assure conformance to the requirements for its intended use.No new safety or performance issues were raised during the testing;therefore, this device may be considered substantially equivalent to thepredicate device. | ||
| GLP Summary | An Acute GLP Animal Study (porcine) was conducted to evaluate in vivothrombogenicity and acute performance and safety of the Athletis™ PTABalloon Dilatation Catheter. | |
| The study provides evidence that the Athletis™ PTA Balloon DilatationCatheter test articles, regardless of size, were usable, non-thrombogenic, anddid not raise any new questions of safety in the arteries and veins of theporcine peripheral vasculature model. Therefore, this device may beconsidered substantially equivalent to the predicate device. | ||
| Conclusion | Based on the indications for use, technological characteristics, and safety andperformance testing, the Athletis™ PTA Balloon Dilatation Catheter has beenshown to be appropriate for its intended use and is considered to besubstantially equivalent to the Mustang™ Balloon Dilatation Catheter(K103751). |
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§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).