Merit ASAPLP Aspiration Catheter

K132155 · Merit Medical Systems, Inc. · QEZ · Nov 7, 2013 · Cardiovascular

Device Facts

• Record ID: K132155
• Device Name: Merit ASAPLP Aspiration Catheter
• Applicant: Merit Medical Systems, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Merit ASAPLP Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

Device Story

Dual lumen rapid exchange aspiration catheter; compatible with 0.014” guide wires. Used for removal of fresh, soft emboli/thrombi from arterial vessels. Features include radiopaque marker band, hydrophilic coating on distal region, and included stiffening stylet. Operated by clinicians in clinical settings. Device inserted over guide wire; aspiration applied to remove thrombus. Benefits include smaller outer diameter and round aspiration lumen compared to predicate, facilitating navigation and aspiration performance. Output is physical removal of embolic material.

Clinical Evidence

Bench testing only. No clinical data. Testing included surface condition, corrosion resistance, force at break, leak testing, dimensions, radiodetectability, kink/stiffness, aspiration/flow performance, coating lubricity, marker band retention, guide wire friction, and simulated use in anatomical/tortuous path models. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility).

Technological Characteristics

Dual lumen rapid exchange catheter; 145cm working length; 0.055" max OD; 0.014" guide wire compatibility. Features hydrophilic coating, radiopaque marker band, and stiffening stylet. Sterilized via ethylene oxide (ISO 11135-1). Complies with ISO 10555-1, ISO 594-1/2, EN 13868, and ASTM F640-12/F756-08.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial vessels. Contraindicated for use in cerebral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• ASAP Aspiration Catheter (K100569)

Submission Summary (Full Text)

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July 27, 2020

Merit Medical Systems, Inc. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, Utah 84095

Re: K132155

Trade/Device Name: Merit ASAPLP Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Susan Christensen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 7, 2013. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], [e-mail].

Sincerely.

Gregory W.
O'connell -S
Digitally signed by
Gregory W. O'connell -S
Date: 2020.07.27 08:18:30
-04'00'

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 7, 2013

Merit Medical Systems, Inc. % Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, UT 84095 US

Re: K132155

> Trade/Device Name: Merit ASAPLP™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: October 9, 2013 Received: October 10, 2013

Dear Ms. Christensen:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

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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K132155 Indications for Use Page 1 of 1

## Section 4

## Indications for Use

K132155 510(k) Number (if known):

Device Name: Merit ASAPLP™ Aspiration Catheter

Indications for Use:

The Merit ASAPLP Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system.

Not for use in cerebral vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hilleman

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## Section 5

## 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>Susan Christensen<br>July 11, 2013<br>1721504 | |
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| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Merit ASAPLP™ Aspiration Catheter<br>Embolectomy Catheter<br>Embolectomy Catheter | |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | ASAP® Aspiration Catheter<br>Embolectomy Catheter<br>K100569<br>Merit Medical Systems, Inc. | |
| Classification | Class II<br>21 CFR § 870.5150<br>FDA Product Code: DXE<br>Review Panel: Cardiovascular | | |
| Intended Use | The Merit ASAPLP Aspiration Catheter is intended for the removal of<br>fresh, soft emboli and thrombi from vessels of the arterial system.<br>Not for use in cerebral vasculature. | | |
| Device<br>Description | The ASAPLP Aspiration Catheter is a dual lumen rapid exchange<br>catheter, compatible with 0.014”/0.36mm guide wires. It is packaged<br>with related accessories including a stiffening stylet. The catheter<br>has a maximum outer diameter of 0.055"/0.140cm and a working<br>length of 145cm. The catheter has a radiopaque marker band<br>located approximately 2mm proximal to the distal tip. The catheter<br>has three (3) non-radiopaque positioning marks located<br>approximately 90cm, 100cm and 110cm proximal of the distal tip.<br>The distal region has a hydrophilic coating. The rapid exchange<br>lumen is 20cm in length. | | |
| Comparison to<br>Predicate<br>Device | The technological characteristics of the subject Merit ASAPLP<br>Aspiration Catheter are substantially equivalent to those of the<br>predicate device. The Merit ASAPLP Aspiration Catheter has a<br>smaller outer diameter than the predicate ASAP Aspiration Catheter.<br>In addition, the design of the Merit ASAPLP Aspiration Catheter is<br>slightly different and includes a round aspiration lumen instead of "U"<br>channel aspiration lumen with several material changes. Also, the<br>length of the Rapid Exchange Lumen is increased, and a stiffening<br>stylet is added which can be used during insertion of the catheter. | | |
| Safety &<br>Performance<br>Tests | No applicable mandatory performance standards or special controls<br>have been established under Section 514 of the Food, Drug and<br>Cosmetic Act for these devices. However, a battery of tests was<br>performed according to protocols based on the requirements of<br>industry standards and the device risk analysis and the device met<br>the acceptance criteria necessary to demonstrate the safety and<br>efficacy of the device.<br>Where appropriate, the tests were based on the requirements of the<br>following documents:<br>ISO 10555-1: 1995. Sterile, single-use intravascular catheters -<br>●<br>Part 1: General requirements<br>ISO 594-1:1986, Conical Fittings with a 6% (Luer) taper for<br>●<br>syringes, needles, and certain other medical equipment - Part 1:<br>General Requirements<br>ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for<br>●<br>syringes, needles, and certain other medical equipment - Part 2:<br>Lock fittings<br>EN 13868: 2002, Test methods for kinking of single lumen<br>0<br>catheters and medical tubing<br>ISO 11135-1: 2007, Sterilization of health care products -<br>●<br>Ethylene oxide - Part 1: Requirements for development,<br>validation and routine control of a sterilization process for<br>medical devices<br>ASTM F640-12, Standard Test Methods for Determining<br>●<br>Radiopacity for Medical Use<br>ASTM F756-08, Standard Practice for Assessment of Hemolvtic<br>●<br>Properties of Materials<br>ISO 10993-1: 2009, Biological Evaluation of Medical Devices<br>●<br>Part-1: Evaluation and Testing within a risk management<br>process<br>ISO 10993-3: 2003, Biological Evaluation of Medical Devices<br>●<br>Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive<br>Toxicity<br>ISO 10993-4: 2002, Biological Evaluation of Medical Devices<br>●<br>Part-4: Selection of Tests for Interactions with Blood, as<br>amended 2006<br>ISO 10993-5: 2009, Biological Evaluation of Medical Devices<br>● | | |
| | | | |

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| Safety &<br>Performance<br>Tests<br>(Continued) | Part-5 Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical Devices<br>Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-10: 2010, Biological Evaluation of Medical Devices<br>Part-10 Tests for Irritation and Skin Sensitization ISO 10993-11: 2006, Biological Evaluation of Medical Devices<br>Part-11 Tests for Systemic Toxicity USP 35-151: 2012, United States Pharmacopeia 35, National<br>Formulary 30, 2012 <151> Pyrogen Test The following is a list of all significant testing performed on the<br>ASAPLP. All testing was successfully completed.<br><br>Surface Condition / Visual<br>Corrosion Resistance<br>Force at Break<br>Catheter Liquid Leak under Pressure<br>Catheter Air Aspiration Leak<br>Dimensions<br>Luer Gauging Test<br>Luer Liquid Leak Test<br>Luer Air Aspiration Leak Test<br>Luer Separation Force Test<br>Luer Unscrewing Torque Test<br>Luer Ease of Assembly Test<br>Luer Resistance to Overriding Test<br>Luer Stress Cracking Test<br>Radio-Detectability<br>Kink<br>Stiffness<br>Aspiration<br>Flow<br>Coating Lubricity and Coverage<br>Marker Band Retention<br>Guide Wire Friction Test<br>Simulated Use Test in Anatomical Model<br>Simulated Aspiration and Use Test in Tortuous Path Model<br><br><b>Biocompatibility Tests</b><br>Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Rabbit Pyrogen Test<br>Genotoxicity<br>Hemocompatibility<br>Physicochemical Tests |
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| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, and safety and<br>performance testing, the subject Merit ASAPLP Aspiration Catheter<br>meets the requirements that are considered essential for its intended<br>use and is substantially equivalent to the predicate device, the ASAP<br>Aspiration Catheter (K100569), manufactured by Merit Medical<br>Systems, Inc. |
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