Viatrac 14 Plus Peripheral Dilatation Catheter

K221057 · Abbott Vascular · LIT · May 5, 2022 · Cardiovascular

Device Facts

• Record ID: K221057
• Device Name: Viatrac 14 Plus Peripheral Dilatation Catheter
• Applicant: Abbott Vascular
• Product Code: LIT · Cardiovascular
• Decision Date: May 5, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries, and carotid arteries) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Story

Peripheral dilatation catheter; integrated shaft system with distal balloon; dual-lumen design (one for balloon inflation with contrast medium, one for guidewire advancement). Radiopaque markers aid positioning in stenosis; proximal markers indicate catheter position relative to guiding catheters. Used by physicians in clinical settings to dilate peripheral vascular stenoses or obstructive lesions in dialysis fistulae; also used for stent post-dilatation. Device provides controlled expansion at specific pressures to restore vessel patency; benefits patient by improving blood flow.

Clinical Evidence

Bench testing only. Biocompatibility assessment per ISO 10993 (cytotoxicity, sensitization, hemocompatibility, pyrogenicity) and functional testing (catheter bend integrity, inner member lumen collapse, tensile integrity, tip tensile) demonstrated performance equivalent to the predicate.

Technological Characteristics

Percutaneous balloon dilatation catheter; integrated shaft with single/dual lumen tubing. Features radiopaque markers for positioning. Materials evaluated per ISO 10993. No changes to design, performance, or sterilization compared to predicate.

Indications for Use

Indicated for patients requiring dilation of stenotic lesions in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal, carotid arteries) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also indicated for post-dilatation of peripheral stents.

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

• Viatrac 14 Plus Peripheral Dilatation Catheter (K072798)

Submission Summary (Full Text)

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May 5, 2022

Abbott Vascular Jiyoung Dang Associate Director Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054

Re: K221057

Trade/Device Name: Viatrac 14 Plus Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 6, 2022 Received: April 11, 2022

Dear Jiyoung Dang:

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 801); medical

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device reporting (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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) K221057

Device Name Viatrac 14 Plus Peripheral Dilatation Catheter

#### Indications for Use (Describe)

The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arties) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

The 510(k) Summary is prepared in accordance with 21 CFR Part 807.92

| Submitter's Name: | Abbott Vascular |
|----------------------|-----------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95054 |
| Telephone:<br>Fax: | 408-845-3000<br>408-845-3743 |
| Contact Person: | Jiyoung M. Dang, Ph.D.<br>Associate Director Regulatory Affairs |
| Date Prepared: | May 5, 2022 |
| Device Trade Name: | Viatrac 14 Plus Peripheral Dilatation Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Regulatory Class: | Class II |
| Product Code | LIT |
| Predicate Device: | K072798<br>Viatrac 14 Plus Peripheral Dilatation Catheter |

### Summary of Substantial Equivalence:

The subject device Viatrac 14 Plus Peripheral Dilatation Catheter is comprised of an inner member material that is produced using a similar resin material source change, as compared to the predicate Viatrac 14 Plus Peripheral Dilatation Catheter. The change in resin material source does not alter the Viatrac 14 Plus Peripheral Dilatation Catheter's technological characteristic, device design, or manufacturing process. There is no change to the intended use or indication for use. Therefore, the subject device Viatrac 14 Plus Peripheral Dilatation Catheter can be concluded to be substantially equivalent to the predicate Viatrac 14 Plus Peripheral Dilatation Catheter.

#### Device Description:

The Viatrac 14 Plus Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of the single lumen and dual lumen tubing. One lumen is used for the inflation of the balloon with a contrast medium. The second lumen in the distal shaft permits the use of a guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated.

The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length at a specific pressure.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both

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indicate the relative position of the catheter to the end of a brachial, femoral, or renal guiding catheter. An additional marker is located at the guidewire exit notch and aids in locating the guidewire exit notch.

#### Intended Use:

The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries, and carotid arteries) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

### Technological Characteristics:

There have been no changes to the technological characteristics such as device design, performance properties, sterilization, and packaging. The difference in resin material source does not alter the device technological characteristics, therefore the subject device can be considered substantially equivalent to the predicate device.

### Performance Data:

The substantial equivalence of the Viatrac 14 Plus Peripheral Dilatation Catheter has been demonstrated through:

- . Biocompatibility assessment in accordance with ISO 10993 series of standards for biological evaluation of medical devices consisting of the following:
- O Cytotoxicity
- Sensitization O
- Hemocompatibility (hemolysis, complement activation, thrombogenicity) O
- Pyrogenicity O
- . Functional testing consisting of:
- Catheter bend integrity o
- Inner member lumen collapse O
- Catheter tensile integrity O
- o Tip tensile

#### Conclusions:

The Viactrac 14 Plus Peripheral Dilataion Catheter has the same intended use and operating principle and technology as the predicate device. The only difference between the subject device and predicate device is a change in the resin material used in the inner material. Biocompatibility and functional testing were performed. The results of these tests demonstrate that the subject device performs as intended and does not raise new questions of safety and effectiveness.