(137 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in the peripheral vasculature and for post-dilatation of stents/stent grafts, which are direct interventions to treat a medical condition.
No
The device description clearly states it is a "Balloon Dilatation Catheter" used for "Percutaneous Transluminal Angioplasty," which is a therapeutic procedure to open blocked vessels. While it uses fluoroscopy for guidance, its primary function is intervention, not diagnosis.
No
The device description clearly details a physical catheter with a balloon, guidewire compatibility, a dual lumen shaft, a Y-connector manifold, radiopaque marker bands, and a lubricious coating. These are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) outside of the body. They are used to provide information about a person's health status, diagnose diseases, or monitor treatment.
- The Athletis™ PTA Balloon Dilatation Catheter is a medical device used within the body. It is a catheter inserted into blood vessels to perform a procedure (angioplasty) to open up narrowed or blocked vessels.
The description clearly indicates it's an interventional device used directly on the patient's anatomy, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. 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.
The following biocompatibility tests were completed on the Athletis™ PTA Balloon Dilatation Catheter: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Direct Contact Hemolysis, Complement Activation, In Vitro Hemocompatiblity, Ames Mutagenincity, Mouse lymphoma Assays.
The following in vitro performance tests were completed for the Athletis™ Balloon Dilatation Catheter: Working Length, Shaft Outer Diameter, Balloon Crossing Profile, Preparation, Deployment, and 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 (including Tip Tensile), Balloon Protector Removal Force, Shaft Kink Resistance, Torque Strength, Radiopacity, Guidewire Compatibility, Sheath Insertion and Withdrawal Force, Coating Integrity, Particulate in Stent.
The Athletis™ PTA Balloon Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence. 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; therefore, this device may be considered substantially equivalent to the predicate device.
An Acute GLP Animal Study (porcine) was conducted to evaluate in vivo thrombogenicity and acute performance and safety of the Athletis™ PTA Balloon Dilatation Catheter.
The study provides evidence that the Athletis™ PTA Balloon Dilatation Catheter test articles, regardless of size, were usable, non-thrombogenic, and did not raise any new questions of safety in the arteries and veins of the porcine peripheral vasculature model. Therefore, this device may be considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Mustang Balloon Dilatation Catheter (K103751)
Reference Device(s)
Gladiator PTA Balloon Dilatation Catheter (K113681), Bard Conquest (K083657), Bard Conquest 40 (K120660)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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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 Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Jennifer Mrkvicka
Regulatory Affairs Specialist
3 Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-255-0917
Fax: 763-494-2222
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
2012
Bard Conquest (K083657), cleared 24 December 2008
Bard Conquest 40 (K120660), cleared 15 March 2012 |
| Device Description | 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. |
| Intended Use of
Device | The Athletis™ PTA Balloon Dilatation Catheter is intended to be used to treat
resistant lesions in the peripheral vasculature. |
| Indications for Use | 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. |
| Comparison of
Technological
Characteristics | The Athletis™ PTA Balloon Dilatation Catheter incorporates substantially
equivalent device materials and design, packaging materials and design,
fundamental technology, manufacturing processes, sterilization process and
intended 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 serving | |
| same function. | ||
| Pinch-off Tube | Similar material and design serving | |
| same function. | ||
| Strain Relief | Identical base resin and similar | |
| colorant serving same function. | ||
| Proximal Dual Lumen Shaft | Similar material and same design | |
| serving same function. | ||
| Distal Guidewire Lumen Shaft | Identical | |
| Bumper Tip | Identical base resin and similar | |
| colorant serving same function. | ||
| Balloon | Difference in design but serving | |
| 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 | |
| coiled configuration. | ||
| Mustang does not use a straight | ||
| configuration. | ||
| Nominal Balloon Diameters | Similar range serving same function | |
| and intended use. | ||
| Balloon lengths | Similar range serving same function | |
| and intended use. | ||
| Rated Burst Pressure (RBP) | Athletis is a higher pressure balloon | |
| than Mustang. Balloon construction | ||
| is a factor. All Athletis balloon | ||
| diameters were tested and | ||
| demonstrate with 95% confidence | ||
| that 99.9% of devices will not burst | ||
| at or below the rated burst pressure. | ||
| Effective Lengths | Similar ranges serving same | |
| function and intended use. | ||
| Recommended Introducer Sheath | ||
| Compatibility | Similar ranges serving same | |
| function and intended use. | ||
| Recommended Guidewire | Identical compatibility. | |
| Performance Data | Bench testing and biocompatibility testing were performed to support a | |
| determination of substantial equivalence. 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. | ||
| The following biocompatibility tests were completed on the Athletis™ PTA | ||
| 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 in vitro performance tests were completed for the Athletis™ | ||
| Balloon Dilatation Catheter: | ||
| Working Length | Device Tensile (including Tip | |
| Tensile) | ||
| Shaft Outer Diameter | Balloon Protector Removal Force | |
| Balloon Crossing Profile | Shaft Kink Resistance | |
| Preparation, Deployment, and | ||
| Retraction | Torque Strength | |
| Balloon Rated Burst Pressure and | ||
| Burst in Stent | Radiopacity | |
| Balloon Fatigue/Fatigue in Stent | Guidewire Compatibility | |
| Balloon Compliance and OD at | ||
| nominal | Sheath Insertion and Withdrawal | |
| Force | ||
| Balloon Inflation/Deflation Time | Coating Integrity | |
| Particulate Evaluation | Particulate in Stent | |
| The Athletis™ PTA Balloon Dilatation Catheter was subjected to testing | ||
| according to the requirements of Guidance for Industry and FDA Staff – Class | ||
| II special Controls for Certain Percutaneous Transluminal Coronary | ||
| Angioplasty (PTCA) Catheters, September 8, 2010. Bench, animal and | ||
| biocompatibility testing in accordance with ISO 10993 were performed to | ||
| support a determination of substantial equivalence. 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; | ||
| therefore, this device may be considered substantially equivalent to the | ||
| predicate device. | ||
| GLP Summary | An Acute GLP Animal Study (porcine) was conducted to evaluate in vivo | |
| thrombogenicity and acute performance and safety of the Athletis™ PTA | ||
| Balloon Dilatation Catheter. | ||
| The study provides evidence that the Athletis™ PTA Balloon Dilatation | ||
| Catheter test articles, regardless of size, were usable, non-thrombogenic, and | ||
| did not raise any new questions of safety in the arteries and veins of the | ||
| porcine peripheral vasculature model. Therefore, this device may be | ||
| considered substantially equivalent to the predicate device. | ||
| Conclusion | Based on the indications for use, technological characteristics, and safety and | |
| performance testing, the Athletis™ PTA Balloon Dilatation Catheter has been | ||
| shown to be appropriate for its intended use and is considered to be | ||
| substantially equivalent to the Mustang™ Balloon Dilatation Catheter | ||
| (K103751). |
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