Advocate PTA Catheter

K192907 · Merit Medical Systems, Inc. · LIT · Nov 26, 2019 · Cardiovascular

Device Facts

• Record ID: K192907
• Device Name: Advocate PTA Catheter
• Applicant: Merit Medical Systems, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Nov 26, 2019
• 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 use to treat vascular stenoses, abnormal narrowing of a blood vessels, in various clinical settings during endovascular procedures for adult patient populations

Device Story

Advocate PTA Catheter; percutaneous transluminal angioplasty device. Dual-lumen design: guidewire lumen (0.014", 0.018", or 0.035") and inflation lumen. Balloon diameters 2.0-12.0mm; lengths 15-300mm. Two radiopaque marker bands for fluoroscopic visualization. Used in endovascular procedures; inserted via 4Fr-7Fr introducer. Operated by physicians in clinical settings. Balloon inflation dilates stenotic vessels or dialysis fistulae; improves blood flow. Device performance validated via deliverability, trackability, and pushability testing.

Clinical Evidence

Bench testing only. Validation testing performed for deliverability, trackability, and pushability to support expanded indications for use. No clinical data provided.

Technological Characteristics

Dual-lumen percutaneous catheter; balloon diameters 2.0-12.0mm, lengths 15-300mm. Radiopaque marker bands for visualization. Compatible with 0.014", 0.018", or 0.035" guidewires. Requires 4Fr-7Fr introducer. Non-powered, mechanical device.

Indications for Use

Indicated for balloon dilation of iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae in adult patients.

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

• Advocate PTA Catheter (K173621)
• Pirouette 018HP (K172033)

Submission Summary (Full Text)

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November 26, 2019

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

Re: K192907

Trade/Device Name: Advocate PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 10, 2019 Received: October 15, 2019

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. 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

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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) 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 (OS) 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 ([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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192907

Device Name Advocate PTA Catheter

Indications for Use (Describe)

The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)

#

| General<br>Provisions | 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 |
| | 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: | 3 October 2019 |
| | Registration Number: | 9616662 |
| | 510(k) Number: | K192907 |
| Subject<br>Device | Trade Name: | Advocate PTA Catheter |
| | Common/Usual Name: | Percutaneous Catheter |
| | Classification Name: | Catheter, Angioplasty, Peripheral,<br>Transluminal |
| | Premarket Notification Predicate: | |
| | Trade Name: | Advocate PTA Catheter |
| | Classification Name: | 21 CFR 870.1250 Percutaneous Catheter |
| | Premarket Notification: | K173621 |
| | Manufacturer: | Merit Medical |
| Predicate<br>Device | Premarket Notification Reference Predicate: | |
| | Trade Name: | Pirouette 018HP |
| | Classification Name: | 21 CFR 870.1250 Percutaneous Catheter |
| | Premarket Notification: | K172033 |
| | Manufacturer: | Arravasc |

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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)

| Classification | Class II<br>21 CFR § 870.1250<br>Product code: LIT<br>Division of Cardiovascular Devices |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Advocate PTA Catheter is intended for balloon dilation of the<br>iliac, femoral, popliteal, infra-popliteal, renal arteries and for the<br>treatment of obstructive lesions of native or synthetic arteriovenous<br>dialysis fistulae. |
| Intended Use | The Advocate PTA catheter is intended for use to treat vascular<br>stenoses, abnormal narrowing of a blood vessels, in various<br>clinical settings during endovascular procedures for adult patient<br>populations |
| 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 15-300mm 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. |

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Merit Medical Systems, Inc. Merit Advocate PTA Catheter Traditional Premarket Notification 510(k)

> There are no technological differences between the subject and predicate devices. The changes to the device for this submission are as follows

- Indications for Use Change to: The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Comparison . Removal of the 1.25mm and 1.5mm Balloon diameters from to Predicate the list of applied 0.014 devices
- Change of Manufacturing location from Subcontractor at . Arravasc in Galway to Merit Medical in Galway, using the same processes as already qualified for the device.

The only difference between the two devices are the indications for use, the Manufacturing location and the removal of Devices with balloon diameters of 1.25mm and 1.5mm.

The existing Safety or Performance testing was not performed for the manufacturing location move as the process used is the same as already qualified by Arravasc Ltd when they acted as a subcontractor manufacturing location for the device. The processes were transferred into Merit Galway as is and were used to manufacture the devices that make up this submission. The process is the same as previously qualified under K173621.

## Safety & Performance Tests

However, extra Validation testing was done on the device to qualify the expanded indications for use, that this change is introducing.

The following is a list of testing that was successfully completed:

- Deliverability AVF Trackability ●
- Deliverability Pushability .

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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)