The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.

Device Description

The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon catheter with a retractable sheath allowing a variable length inflatable balloon; up to 250mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with radiopaque marker bands denoting 0mm, 100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a 6Fr catheter system with a shaft working length of 150cm. The device uses a semi-compliant balloon with a rated burst pressure of 15atm and an indicated clinical use range of 4atm - 12atm. The balloon expands to a nominal diameter of 5.0 to 5.5mm.

AI/ML Overview

This document, K192399, is a 510(k) premarket notification for the Infinity Angioplasty Balloon Catheter. It establishes substantial equivalence to a predicate device (Boston Scientific Corporation Sterling Over-the-Wire PTA Balloon Catheter, K141112) through a comparison of technological characteristics and performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical study report might. Instead, it lists the types of functional and performance bench testing performed and an overall conclusion of equivalence to the predicate device. The "Acceptance Criteria" are implied to be the successful demonstration that the device's performance is comparable to or better than the predicate, or that any differences do not raise new questions of safety or effectiveness.

Below is a reconstructed table based on the "Functional Testing" section, inferring the acceptance criteria from the nature of the tests and the overall conclusion:

Acceptance Criteria (Inferred)	Reported Device Performance (Implied)
Functional/Performance Requirements:	Demonstrated through testing:
Balloon compliance meets specifications	Tested (details not provided)
Balloon nominal diameter meets specifications	Tested (details not provided)
Balloon length meets specifications	Tested (details not provided)
Balloon fatigue resistance is adequate	Tested (details not provided)
Marker band visibility is adequate	Tested (details not provided)
Inflation and deflation time meet specifications	Tested (details not provided)
Device tracking, delivery, and retrieval are adequate	Tested (details not provided)
Torque strength is adequate	Tested (details not provided)
Kink resistance is adequate	Tested (details not provided)
Joint strength meets specifications	Tested (details not provided)
Rated burst pressure meets specifications	Tested (details not provided)
Simulated use demonstrates safety and effectiveness	Performed, results indicate no new risks
Material/Process Standards Compliance:	Demonstrated through compliance:
Sterilization process validated (ISO 11135:2018)	Compliant
Biocompatibility evaluated (ISO 10993-1:2018)	Compliant
Intravascular catheter standards met (ISO 10555:2018)	Compliant
No new risks of safety and effectiveness compared to predicate	Conclusion: "Performance bench testing and pre-clinical testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each functional and performance test. It states "representative samples of the device underwent performance bench testing and pre-clinical animal testing."

Test Set Sample Size: Not specified.
Data Provenance: The testing appears to be primarily laboratory-based bench testing and pre-clinical animal testing. The location of these tests or the origin of the animal subjects is not specified. It is inherently prospective data as it was generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve clinical studies with human patients or expert interpretation of medical images/data where "ground truth" would be established by multiple experts. The "ground truth" for this device's performance is established through engineering specifications, direct measurements, and a comparison to the established performance of the predicate device.

Therefore, questions about the number of experts used for ground truth or their qualifications are not applicable in the context of this 510(k) submission and the types of studies performed (bench and preclinical animal testing).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study involving human interpretation or subjective assessment that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images. This 510(k) submission is for an angioplasty balloon catheter, a physical medical device, and its evaluation relies on bench, animal, and biocompatibility testing, not diagnostic image interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (angioplasty balloon catheter), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth for this device's performance is primarily based on:

Engineering Specifications and Design Requirements: The device must meet predefined physical and functional parameters.
Predicate Device Performance: The device's performance is evaluated against the well-established safety and effectiveness profile of the predicate device.
Standardized Test Methods: Adherence to recognized international standards (ISO 11135, ISO 10993-1, ISO 10555) provides a validated basis for assessing performance.
Direct Measurement and Observation: Bench testing involves direct measurement of parameters (e.g., balloon diameter, pressure, inflation/deflation time) and observation of physical characteristics (e.g., kinking, tracking).
Pre-clinical Animal Outcomes: Animal testing provides in-vivo data on the device's interaction with biological systems, serving as part of the ground truth for safety (e.g., non-toxic, non-irritating) and functionality.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2020

Infinity Angioplasty Balloon Company, LLC Ms. Tiffini Wittwer Regulatory Affairs 6865 N. Reynolds Rd Suite 200 Toledo, Ohio 43615

Re: K192399

Trade/Device Name: Infinity Angioplasty Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 13, 2020 Received: April 15, 2020

Dear Ms. Wittwer:

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 medical devices and radiation-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,

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

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Indications for Use

510(k) Number (if known) K192399

Device Name INFINITY Angioplasty Balloon Catheter

Indications for Use (Describe)

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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Submitter:	INFINITY Angioplasty Balloon Company, LLC		INFINITY AngioplastyBalloon Catheter(Subject Device)	Boston ScientificCorporationSterling™ Over-the-Wire PTA BalloonDilation Catheter(Predicate Device)	Comment
Contact Person:	Tiffini WittwerRegulatory Affairs	510(k) Number	K192399	K141112
	Phone: 707.799.6732E-mail: twittwer@mededge.io	Manufacturer	INFINITY AngioplastyBalloon Co., LLC	Boston ScientificCorporation
Trade Name:	INFINITY Angioplasty Balloon Catheter	Classification	Class II	Class II	Same
Common Name:	Percutaneous catheter	Product Code	LIT	LIT	Same
Classification:	Class II	Regulation	21 CFR 870.1250	21 CFR 870.1250	Same
Product Code:	LIT	Indications for Use	The INFINITYAngioplasty BalloonCatheter is indicated forPercutaneousTransluminal Angioplasty(PTA) in the peripheralvasculature, includingiliac, femoral,popliteal, infra-poplitealarteries, and for thetreatment of obstructivelesions of native orsynthetic arteriovenousdialysis fistulae. Thiscatheter is not for use incoronary orcerebrovascular arteries.	The Sterling OTW PTABalloon DilatationCatheter is indicated forPercutaneousTransluminal Angioplasty(PTA) in the peripheralvasculature, includingiliac, femoral,popliteal, infra-popliteal.and renal arteries, and forthe treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. This device isalso indicated for post-dilatationof balloon expandable andself-expanding stents inthe peripheral vasculature.	Subject device hasnarrower indication foruse than the predicate.This difference limits useof the device compared tothe predicate and does notraise new questions ofsafety or effectiveness.
Regulation	21 CFR 870.1250	Principle of operation	Inflation of semi-compliant balloon fordilation	Inflation of semi-compliant balloon fordilation	Same
Predicate Device(s):	The subject device is substantially equivalent to the following device:● Boston Scientific Corporation Sterling Over-the-Wire PTABalloon Catheter (K141112)	Balloon Diameter (mm)	5.0	2.0, 2.5, 3.0, 3.5, 4.0, 5.0,6.0, 7.0, 8.0, 9.0, 10.0	Same as one predicatedevice size
Device Description:	The INFINITY Angioplasty Balloon Catheter is a intravascularangioplasty balloon catheter with a retractable sheath allowing avariable length inflatable balloon; up to 250mm. The over the wire(OTW) catheter has a retractable sheath allowing the balloon to beinflated at various lengths as determined by the physician. The balloonlengths are graduated with radiopaque marker bands denoting 0mm,100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a6Fr catheter system with a shaft working length of 150cm.The device uses a semi-compliant balloon with a rated burst pressureof 15atm and an indicated clinical use range of 4atm - 12atm. Theballoon expands to a nominal diameter of 5.0 to 5.5mm.	Balloon Length (mm)	VariableMarker bands located at100mm, 200mm, and250mm on balloon length	20, 30, 40, 60, 80, 100,200, 220	Dimensional testing,simulated use, rated burstpressure, and in vivotesting demonstrates thedifference does not createadditional risk to safetyand effectiveness of thesubject device
Indication for Use:	The INFINITY Angioplasty Balloon Catheter is indicated forPercutaneous Transluminal Angioplasty (PTA) in the peripheralvasculature, including iliac, femoral, popliteal, infra-popliteal arteries,and for the treatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This catheter is not for use in coronaryor cerebrovascular arteries.	Balloon Length Variability	Yes	No 1 fixed balloon lengthper device size	Simulated use and in vivotesting demonstrate the

INFINITY Angioplasty Balloon Company, LLC

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Premarket Notification for the INFINITY Angioplasty Balloon Catheter™

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INFINITY Angioplasty Balloon Company, LLC

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	Balloon length controlledby outer sheath placementrelative distal tip of theballoon.		difference does not createadditional risk to safetyand effectiveness of thesubject device
Outer Sheath	Yes	Yes	Same
Number of radiopaquemarkerbands	5Proximal and distal endsof balloon, 100mm and200mm balloon length,and distal tip of outersheath	2Proximal and distal endsof balloon	Visibility, marker band toballoon alignment, and invivo testing demonstratethe difference does notcreate additional risk tosafety and effectivenessof the subject device
Location markers	Yes Markers designatelocation of the sheathrelative to the cathetershaft	Markers designatelocations on catheter tip tothe guiding catheter	Marker band to balloonalignment, and simulateduse demonstrate thedifference does not createadditional risk to safetyand effectiveness of thesubject device
Catheter Shaft Lengths(cm)	150	40, 90, 135, 150	Same
Guidewire compatibility	0.018"	0.014", 0.018"	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same

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Functional Testing:	To verify that the device design meets its functional andperformance requirements, representative samples of thedevice underwent performance bench testing and pre-clinicalanimal testing. As a result of verification and validationactivities and risk assessment, testing ensures the devicedesign meets its functional and performance requirements. Thefollowing tests were performed:• Balloon compliance• Balloon nominal diameter• Balloon length• Balloon Fatigue• Marker band visibility• Inflation and deflation time• Device tracking, delivery, and retrieval• Torque strength• Kink resistance• Joint strength testing• Rated burst pressure• Simulated useThe following standards were used in testing:• ISO 11135:2018, Sterilization of health-care products - Ethyleneoxide - Requirements for the development, validation and routinecontrol of a sterilization process for medical devices• ISO 10993-1:2018, Biological evaluation of medical devices• ISO 10555:2018, Intravascular catheters – Sterile and single useintravascular catheters.
Conclusion:	The INFINITY Angioplasty Balloon Catheter™ intended use, indicationfor use, materials, and fundamental scientific technology is similar to thepredicate device. Performance bench testing and pre-clinical testingdemonstrate that the differences between the subject device and thepredicate device do not raise new risks of safety and effectiveness.

Functional Testing:

To verify that the device design meets its functional andperformance requirements, representative samples of thedevice underwent performance bench testing and pre-clinicalanimal testing. As a result of verification and validationactivities and risk assessment, testing ensures the devicedesign meets its functional and performance requirements. Thefollowing tests were performed:• Balloon compliance• Balloon nominal diameter• Balloon length• Balloon Fatigue• Marker band visibility• Inflation and deflation time• Device tracking, delivery, and retrieval• Torque strength• Kink resistance• Joint strength testing• Rated burst pressure• Simulated useThe following standards were used in testing:• ISO 11135:2018, Sterilization of health-care products - Ethyleneoxide - Requirements for the development, validation and routinecontrol of a sterilization process for medical devices• ISO 10993-1:2018, Biological evaluation of medical devices• ISO 10555:2018, Intravascular catheters – Sterile and single useintravascular catheters.

Conclusion:

The INFINITY Angioplasty Balloon Catheter™ intended use, indicationfor use, materials, and fundamental scientific technology is similar to thepredicate device. Performance bench testing and pre-clinical testingdemonstrate that the differences between the subject device and thepredicate device do not raise new risks of safety and effectiveness.

INFINITY Angioplasty Balloon Company, LLC

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Premarket Notification for the INFINITY Angioplasty Balloon Catheter™

Regulation Number and Section

§ 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).