Infinity Angioplasty Balloon Catheter

K192399 · Infinity Angioplasty Balloon Company, LLC · LIT · May 20, 2020 · Cardiovascular

Device Facts

• Record ID: K192399
• Device Name: Infinity Angioplasty Balloon Catheter
• Applicant: Infinity Angioplasty Balloon Company, LLC
• Product Code: LIT · Cardiovascular
• Decision Date: May 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Intravascular angioplasty balloon catheter; 6Fr system; 150cm shaft length. Features retractable sheath allowing variable balloon inflation lengths up to 250mm. Radiopaque marker bands denote 0mm, 100mm, 200mm, and 250mm lengths. Semi-compliant balloon; 5.0-5.5mm nominal diameter; 15atm rated burst pressure; 4-12atm clinical use range. Used in peripheral vasculature by physicians to dilate obstructive lesions. Physician controls balloon length via outer sheath placement. Output is mechanical dilation of vessel/fistula; benefits patient by restoring blood flow.

Clinical Evidence

No human clinical data. Evidence consists of performance bench testing and pre-clinical animal testing. Bench tests included balloon compliance, nominal diameter, length, fatigue, marker visibility, inflation/deflation time, tracking/delivery/retrieval, torque strength, kink resistance, joint strength, rated burst pressure, and simulated use.

Technological Characteristics

6Fr OTW catheter; 150cm shaft. Semi-compliant balloon; 5.0-5.5mm diameter. Retractable sheath for variable length (up to 250mm). 5 radiopaque marker bands. Sterilization: Ethylene Oxide (ISO 11135:2018). Biocompatibility: ISO 10993-1:2018. Mechanical standards: ISO 10555:2018.

Indications for Use

Indicated for Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for coronary or cerebrovascular arteries.

Regulatory Classification

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

• Boston Scientific Corporation Sterling Over-the-Wire PTA Balloon Dilation Catheter (K141112)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 20px;">☑</span> </div> |
|----------------------------------------------|------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size: 20px;">☐</span> </div> |

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| Submitter: | INFINITY Angioplasty Balloon Company, LLC | | INFINITY Angioplasty<br>Balloon Catheter<br>(Subject Device) | Boston Scientific<br>Corporation<br>Sterling™ Over-the-<br>Wire PTA Balloon<br>Dilation Catheter<br>(Predicate Device) | Comment |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Wittwer<br>Regulatory Affairs | 510(k) Number | K192399 | K141112 | |
| | Phone: [phone]<br>E-mail: [e-mail] | Manufacturer | INFINITY Angioplasty<br>Balloon Co., LLC | Boston Scientific<br>Corporation | |
| 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 INFINITY<br>Angioplasty Balloon<br>Catheter is indicated for<br>Percutaneous<br>Transluminal Angioplasty<br>(PTA) in the peripheral<br>vasculature, including<br>iliac, femoral,<br>popliteal, infra-popliteal<br>arteries, and for the<br>treatment of obstructive<br>lesions of native or<br>synthetic arteriovenous<br>dialysis fistulae. This<br>catheter is not for use in<br>coronary or<br>cerebrovascular arteries. | The Sterling OTW PTA<br>Balloon Dilatation<br>Catheter is indicated for<br>Percutaneous<br>Transluminal Angioplasty<br>(PTA) in the peripheral<br>vasculature, including<br>iliac, femoral,<br>popliteal, infra-popliteal.<br>and renal arteries, and for<br>the treatment of<br>obstructive lesions of<br>native or synthetic<br>arteriovenous dialysis<br>fistulae. This device is<br>also indicated for post-<br>dilatation<br>of balloon expandable and<br>self-expanding stents in<br>the peripheral vasculature. | Subject device has<br>narrower indication for<br>use than the predicate.<br>This difference limits use<br>of the device compared to<br>the predicate and does not<br>raise new questions of<br>safety or effectiveness. |
| Regulation | 21 CFR 870.1250 | Principle of operation | Inflation of semi-<br>compliant balloon for<br>dilation | Inflation of semi-<br>compliant balloon for<br>dilation | Same |
| Predicate Device(s): | The subject device is substantially equivalent to the following device:<br>● Boston Scientific Corporation Sterling Over-the-Wire PTA<br>Balloon Catheter (K141112) | Balloon Diameter (mm) | 5.0 | 2.0, 2.5, 3.0, 3.5, 4.0, 5.0,<br>6.0, 7.0, 8.0, 9.0, 10.0 | Same as one predicate<br>device size |
| Device Description: | The INFINITY Angioplasty Balloon Catheter is a intravascular<br>angioplasty balloon catheter with a retractable sheath allowing a<br>variable length inflatable balloon; up to 250mm. The over the wire<br>(OTW) catheter has a retractable sheath allowing the balloon to be<br>inflated at various lengths as determined by the physician. The balloon<br>lengths are graduated with radiopaque marker bands denoting 0mm,<br>100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a<br>6Fr catheter system with a shaft working length of 150cm.<br>The device uses a semi-compliant balloon with a rated burst pressure<br>of 15atm and an indicated clinical use range of 4atm - 12atm. The<br>balloon expands to a nominal diameter of 5.0 to 5.5mm. | Balloon Length (mm) | Variable<br>Marker bands located at<br>100mm, 200mm, and<br>250mm on balloon length | 20, 30, 40, 60, 80, 100,<br>200, 220 | Dimensional testing,<br>simulated use, rated burst<br>pressure, and in vivo<br>testing demonstrates the<br>difference does not create<br>additional risk to safety<br>and effectiveness of the<br>subject device |
| Indication for Use: | The INFINITY Angioplasty Balloon Catheter is indicated for<br>Percutaneous Transluminal Angioplasty (PTA) in the peripheral<br>vasculature, including iliac, femoral, popliteal, infra-popliteal arteries,<br>and for the treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This catheter is not for use in coronary<br>or cerebrovascular arteries. | Balloon Length Variability | Yes | No 1 fixed balloon length<br>per device size | Simulated use and in vivo<br>testing demonstrate the |

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| | Balloon length controlled<br>by outer sheath placement<br>relative distal tip of the<br>balloon. | | difference does not create<br>additional risk to safety<br>and effectiveness of the<br>subject device |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Outer Sheath | Yes | Yes | Same |
| Number of radiopaque<br>markerbands | 5<br>Proximal and distal ends<br>of balloon, 100mm and<br>200mm balloon length,<br>and distal tip of outer<br>sheath | 2<br>Proximal and distal ends<br>of balloon | Visibility, marker band to<br>balloon alignment, and in<br>vivo testing demonstrate<br>the difference does not<br>create additional risk to<br>safety and effectiveness<br>of the subject device |
| Location markers | Yes Markers designate<br>location of the sheath<br>relative to the catheter<br>shaft | Markers designate<br>locations on catheter tip to<br>the guiding catheter | Marker band to balloon<br>alignment, and simulated<br>use demonstrate the<br>difference does not create<br>additional risk to safety<br>and effectiveness of the<br>subject device |
| Catheter Shaft Lengths<br>(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 and<br>performance requirements, representative samples of the<br>device underwent performance bench testing and pre-clinical<br>animal testing. As a result of verification and validation<br>activities and risk assessment, testing ensures the device<br>design meets its functional and performance requirements. The<br>following tests were performed:<br>• Balloon compliance<br>• Balloon nominal diameter<br>• Balloon length<br>• Balloon Fatigue<br>• Marker band visibility<br>• Inflation and deflation time<br>• Device tracking, delivery, and retrieval<br>• Torque strength<br>• Kink resistance<br>• Joint strength testing<br>• Rated burst pressure<br>• Simulated use<br>The following standards were used in testing:<br>• ISO 11135:2018, Sterilization of health-care products - Ethylene<br>oxide - Requirements for the development, validation and routine<br>control of a sterilization process for medical devices<br>• ISO 10993-1:2018, Biological evaluation of medical devices<br>• ISO 10555:2018, Intravascular catheters – Sterile and single use<br>intravascular catheters. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The INFINITY Angioplasty Balloon Catheter™ intended use, indication<br>for use, materials, and fundamental scientific technology is similar to the<br>predicate device. Performance bench testing and pre-clinical testing<br>demonstrate that the differences between the subject device and the<br>predicate device do not raise new risks of safety and effectiveness. |

INFINITY Angioplasty Balloon Company, LLC

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