The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

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 Description

The Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (ASAP® Aspiration Catheter and ASAPLP™ Aspiration Catheter). The document does not describe a study that proves the device meets specific performance acceptance criteria for an AI/ML or diagnostic application.

Instead, this 510(k) notification focuses on demonstrating substantial equivalence to a predicate device. The "Performance Data" section primarily addresses biocompatibility and bench testing related to the physical integrity and safety of the catheter, rather than clinical or diagnostic performance criteria as you might see for an AI/driven device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, human reader improvement with AI, ground truth, or training/test set data because this type of information is not present in the provided text.

The document states:

"No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." (Page 5)
Performance testing was "conducted based on the risk analysis and based on the requirements of the following international standards" related to biocompatibility and physical characteristics (ISO 10555-1, ISO 80369-7, ISO 10993 series, USP 43-NF 37). (Page 5-6)
"The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." However, the specific quantitative acceptance criteria for "safety and efficacy" related to the device's function (e.g., thrombus removal capabilities) are not detailed, nor is there a study described as you might see for a diagnostic AI. (Page 6)

The document is a regulatory submission for a physical medical device (catheter) based on substantial equivalence, not a performance study of a diagnostic or AI-powered device.

Summary

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November 3, 2021

Merit Medical Systems, Inc. Kirk McIntosh Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, Utah 84095

Re: K212199

Trade/Device Name: ASAP® Aspiration Catheter, ASAPLP™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: October 4, 2021 Received: October 5, 2021

Dear Kirk Mcintosh:

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K212199

Device Name ASAP® Aspiration Catheter (ASAP100); ASAPLPTM Aspiration Catheter (ASAPLP)

Indications for Use (Describe)

The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

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.

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 ASAP® and ASAPLP™ 510(k) Summary K212199

GeneralProvisions	Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-3695Kirk McIntoshJuly 13, 20211721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	ASAP® and ASAPLP™ Aspiration CathetersEmbolectomy CatheterEmbolectomy Catheter2QEZ870.5150Cardiovascular
PrimaryPredicate	Trade Name:Classification Name:Premarket Notification:Manufacturer:	ASAP® Aspiration CatheterEmbolectomy CatheterK100569Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall
SecondaryPredicate	Trade Name:Classification Name:Premarket Notification:Manufacturer:	ASAPLP™ Aspiration CatheterEmbolectomy CatheterK132155Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall

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fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit ASAPLP™ Aspiration Catheter is intended for the removal of Indications for Use fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
Note: There is no change in the Indications for Use statement from the predicate to the subject devices.

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Comparison toPredicateDevice	The subject devices are substantially equivalent to the predicatedevices based on an identical Indications for Use statement, the samebasic performance and safety profile, principle of operation,fundamental design principles, and manufacturing technology.The primary reason for submitting this Special 510(k) is the change tothe Luer hub material formulation for both the ASAP and ASAPLPcatheter configurations and update to the new ISO 80369-7 Luerstandard.There are no changes to the associated accessories.
PerformanceData	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject ASAP® and ASAPLP™ Aspiration Catheters wasconducted based on the risk analysis and based on the requirements ofthe following international standards:ISO 10555-1:2013 Intravascular catheters - Sterile and single-usecatheters – Part 1: General requirements ISO 80369-7:2021 Small Bore Connectors for liquids and gases inhealthcare applications – Part 7: Connectors for intravascular orhypodermic applications ISO 10993-1:2018, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andFDA guidance Use of International Standard ISO 10993-1,"Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process” (2020). ISO 10993-4: 2017, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood ISO 10993-5:2009 (Amd, 2017), Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2013, Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitization ISO 10993-11:2017, Biological evaluation of medical devices –Part 11: Tests for systemic toxicity United States Pharmacopeia (USP) 43-National Formulary (NF)37: 2019 <151> Pyrogen Test.
Safety &PerformanceTests cont.	The following performance data were provided in support of thesubstantial equivalence determination.Biocompatibility testing
and testing within a risk management process and the FDA guidance
document, Use of International Standard ISO 10993-1, “Biological
evaluation of medical devices – Part 1: Evaluation and testing within a
risk management process” (2020). The battery of testing included the
following tests:

The biocompatibility evaluation for the ASAP® and ASAPLP™
Aspiration Catheters was conducted in accordance with ISO 10993-1 (2018), Biological Evaluation of Medical Devices- Part 1: Evaluation

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Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
. Hemolysis

The ASAP® and ASAPLP™ Aspiration Catheters are considered tissue contacting for a duration of less than 24 hours.

Performance Testing-Bench

Force at break ●
. ISO 80369-7 Dimensional and functional testing

The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.

Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject ASAP® and ASAPLP™ Aspiration Catheters meet the requirements that are considered essential for their intended use and are substantially equivalent to their predicate devices, the ASAP® and ASAPLP™ Aspiration Catheters, K100569 and K132155, manufactured by Merit Medical Systems, Inc.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).