Advocate PTA Catheter

K173621 · Merit Medical Systems, Inc. · LIT · Dec 13, 2017 · Cardiovascular

Device Facts

• Record ID: K173621
• Device Name: Advocate PTA Catheter
• Applicant: Merit Medical Systems, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal, and renal arteries.

Device Story

Advocate PTA Catheter is a percutaneous transluminal angioplasty device used for balloon dilation of peripheral arteries (iliac, femoral, popliteal, infra-popliteal, renal). Device features dual-lumen design: guidewire lumen (0.014", 0.018", or 0.035") and inflation lumen. Radiopaque marker bands facilitate visualization during placement and inflation. Operated by clinicians in clinical settings; inserted via 4Fr-7Fr introducers. Device is identical to Pirouette predicate line; manufactured by same contract manufacturer. No clinical or performance testing required due to identical technological characteristics.

Clinical Evidence

No clinical data. Bench testing not required as the device is identical to the predicate devices.

Technological Characteristics

Dual-lumen percutaneous catheter; guidewire lumen (0.014", 0.018", 0.035"); inflation lumen; balloon diameters 2.0-12.0mm; lengths 20-300mm; radiopaque marker bands for visualization; compatible with 4Fr-7Fr introducers.

Indications for Use

Indicated for patients requiring balloon dilation of iliac, femoral, popliteal, infra-popliteal, and renal 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

• Pirouette 014 (K162316)
• Pirouette 018 (K151153)
• Pirouette 035 (K161427)

Submission Summary (Full Text)

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December 13, 2017

Merit Medical Systems, Inc. Mr. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K173621

Trade/Device Name: Advocate PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 20, 2017 Received: November 22, 2017

Dear Mr. O'Sullivan:

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. 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 device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K173621

Device Name Advocate PTA Catheter

Indications for Use (Describe)

The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

| | Submitter Name: | Merit Medical Systems, Inc. |
|-----------------------|----------------------|-----------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | ([phone] (Ext. 3061) |
| | Fax Number: | ([phone] |
| | Contact Person: | Mark Mullaney |
| | Registration Number: | 1721504 |
| General<br>Provisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| | Address: | Parkmore Business Park<br>Parkmore, Galway, Ireland |
| | Telephone Number: | ([phone] (Ext. 3223) |
| | Fax Number: | ([phone] |
| | Contact Person: | Michael O'Sullivan |
| | Date of Preparation: | 20 November 2017 |
| | Registration Number: | 9616662 |
| Subject<br>Device | Trade Name: | Advocate PTA Catheter |
| | Common/Usual Name: | Percutaneous Catheter |
| | Classification Name: | Catheter, Angioplasty, Peripheral,<br>Transluminal |

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| Predicate<br>Device | Premarket Notification Predicate #1:<br>Trade Name: Pirouette 014<br>Classification Name: 21 CFR 870.1250 Percutaneous Catheter<br>Premarket Notification: K162316<br>Manufacturer: Arravasc Limited |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Premarket Notification Predicate #2:<br>Trade Name: Pirouette 018<br>Classification Name: 21 CFR 870.1250 Percutaneous Catheter<br>Premarket Notification: K151153<br>Manufacturer: Arravasc Limited |
| | Premarket Notification Predicate #3:<br>Trade Name: Pirouette 035<br>Classification Name: 21 CFR 870.1250 Percutaneous Catheter<br>Premarket Notification: K161427<br>Manufacturer: Arravasc Limited |
| Classification | Class II<br>21 CFR § 870.1250<br>Product code: LIT<br>Division of Cardiovascular Devices |
| Intended Use | The Advocate PTA Catheter is intended for balloon dilation of<br>the iliac, femoral, popliteal, infra-popliteal, and renal arteries. |
| Device<br>Description | The Advocate PTA Catheter consists of two lumens, a compatible<br>guidewire lumen (0.014", 0.018" or 0.035") extending from guide<br>wire port in the manifold to the catheter distal tip, and an inflation<br>lumen extending from the proximal inflation port in the manifold to<br>the balloon interior. There are various size balloons in the product<br>matrix, ranging from 2.0-12.0mm in diameter and 20-300mm in<br>length. The catheter has two radiopaque marker bands that facilitate<br>visibility and location during the placement and inflation of the<br>balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr<br>haemostatic or non haemostatic introducer, depending on the model<br>selected. |
| Comparison<br>to Predicate | There are no technological differences between the subject and<br>predicate devices. They device is manufactured under contract by<br>the same Manufacturer who makes the identical device under the<br>Pirouette name. |
| | The only difference between the two devices in in the naming and<br>labelling of the product, with the Merit product named and labelled<br>as the "Advocate PTA Catheter". |
| Safety &<br>Performance<br>Tests | No Safety or Performance testing is required to establish the safety<br>and efficacy of the subject device |
| Summary of<br>Substantial<br>Equivalence | Based on the comparisons noted, the subject Merit Advocate PTA<br>Catheter meets the requirements that are considered essential for<br>its intended use and is substantively equivalent to the three<br>Predicate Devices, the Pirouette 014, 018 and 035 [K162316,<br>K151153, K161427], manufactured by Arravasc Limited. |

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