The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Device Description

Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.

AI/ML Overview

The Halo™ Single-Loop Microsnare Kit underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. No clinical studies were conducted, thus, information regarding human readers or effect sizes with AI assistance is not available.

1. A table of acceptance criteria and the reported device performance:

The document indicates that acceptance criteria were determined to demonstrate substantial equivalence, and the device was shown to meet these acceptance criteria. However, specific numerical acceptance criteria and reported performance values for each test are not provided in the given text. Instead, the document lists the types of performance tests conducted.

Acceptance Criteria Category	Reported Device Performance
Performance Testing
Tensile strength	Met acceptance criteria
Liquid leakage	Met acceptance criteria
Air leakage	Met acceptance criteria
Corrosion Resistance	Met acceptance criteria
System Tip Flexibility	Met acceptance criteria
Tip Flexibility Microsnare & Microsnare Catheter	Met acceptance criteria
Snare Flexing & Fracture Test	Met acceptance criteria
Catheter Flexural Modulus	Met acceptance criteria
Catheter Kink Test	Met acceptance criteria
Marker Band Pull Test	Met acceptance criteria
Torque Strength Test	Met acceptance criteria
Simulative Use	Met acceptance criteria
Radiopacity	Met acceptance criteria
Particulate	Met acceptance criteria
Luer Testing	Met acceptance criteria
Shipping Test	Met acceptance criteria
Biocompatibility Testing
Cytotoxicity (ISO 10993-5)	Met acceptance criteria
Sensitization (ISO 10993-10)	Met acceptance criteria
Intracutaneous Irritation (ISO 10993-10)	Met acceptance criteria
Acute Systemic Toxicity (ISO 10993-11)	Met acceptance criteria
Material Mediated Pyrogen (ISO 10993-11)	Met acceptance criteria
Hemocompatibility (ISO10993-4)	Met acceptance criteria
o ASTM Hemolysis – Direct and Indirect Contact	Met acceptance criteria
o Complement Activation, SC5b-9	Met acceptance criteria
o Platelet and Leucocyte Counts	Met acceptance criteria
o Partial Thromboplastin Time (PTT)	Met acceptance criteria

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for each non-clinical test. The data provenance is non-clinical, meaning it comes from laboratory or bench testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies involving expert assessment of medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the studies were non-clinical performance and biocompatibility tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was conducted. The device is a medical instrument (microsnare kit), not an AI-powered diagnostic tool. The document focuses on demonstrating the physical and biological characteristics of the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable since the device is a medical instrument, not an algorithm. The performance tests evaluate the physical characteristics and biocompatibility of the device itself.

7. The type of ground truth used:

For performance testing, the "ground truth" would be established engineering specifications, industry standards, and regulatory requirements against which the device's physical and mechanical properties are measured. For biocompatibility testing, the "ground truth" is established biological responses as defined by ISO standards.

8. The sample size for the training set:

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 5, 2021

Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751

Re: K200963

Trade/Device Name: Halo Single-Loop Microsnare Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX, DQY Dated: November 30, 2020 Received: December 2, 2020

Dear Ana Jimenez-Hughes:

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

{1}------------------------------------------------

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 (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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200963

Device Name Halo™ Single-Loop Microsnare Kit

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date Prepared:	May 19, 2020
Company:	Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425
Contact:	Ana Jimenez-HughesSr. Regulatory Affairs SpecialistPhone:903-676-4276Fax:903-677-9396Email:ana.hughes@argonmedical.com
Device TradeName:	Halo™ Single-Loop Microsnare Kit
Device CommonName:	Percutaneous Retrieval Device
DeviceClassification:	Device, Percutaneous RetrievalProduct code, MMX21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices
PredicateDevice(s):	Primary: K970668 Amplatz Goose Neck MicrosnareReference: K142265 ONE Snare Endovascular Microsnare System
Description of theDevice:	Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) MicrosnareCatheter, (1) Introducer and (1) Torque Handle.The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheterwithout risk of microsnare deformation because of the snare's super-elasticconstruction. The microsnare catheter is constructed of flexible tubing andcontains a radiopaque marker band.
Indication for Use:	The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval andmanipulation of atraumatic foreign bodies located in the coronary andperipheral cardiovascular system and the extra-cranial neurovascularanatomy.

{4}------------------------------------------------

A comparison of the technological characteristics of the subject device and the Technological Characteristics: predicate devices shows the Halo™ Single-Loop Microsnare Kit to be substantially equivalent to the current marketed predicate devices.

The proposed Halo™ Single-Loop Microsnare Kit is similar in materials of construction, dimensional specifications, design and sterilization process to the primary predicate device, the Amplatz Goose Neck Microsnare (K970668) and the reference predicate, the ONE Snare Endovascular Microsnare System (K142265). The Halo™ Single-Loop Microsnare Kit consist of (1) microsnare made of gold plated Tungsten coil and nitinol loop; (1) microsnare catheter made of Pebax tubing/Platinum Iridium marker band, (1) peel-away introducer and (1) torque handle.

The Halo™ Single-Loop Microsnare Kit has the same principle of operation and indications for use as the predicate devices. The system is advanced through a sheath proximal to the target under imaging. The system is then manipulated to grab and reposition or grab and remove a foreign body. The intended use of the proposed device and the predicate device is the same: for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

	SUBJECT DEVICE	PRIMARYPREDICATE DEVICE	REFERENCEPREDICATE DEVICE
	Halo™ Single-LoopMicrosnare Kit	Amplatz Goose NeckMicrosnare	ONE Snare EndovascularMicrosnare System
Manufacturer	Argon Medical Devices	ev3 Inc.	Merit Medical Systems,Inc.
510(k)	TBD	K970668	K142265
Class	II	SAME	SAME
Classification Name	Device, PercutaneousRetrieval	Catheter, Percutaneous	SAME
Regulation	21 CFR 870.5150	21 CFR 870.1250	SAME
Technical Characteristics Comparison
Device Description	Each Halo Single-LoopMicrosnare kit consists of(1) microsnare, (1)microsnare catheter, (1)introducer and (1) torquehandle. The microsnareis constructed of aflexible and radiopaqueloop. The pre-formedmicrosnare loop can beintroduced through themicrosnare catheterwithout risk ofmicrosnare deformationbecause of themicrosnare's super-elastic construction. Themicrosnare catheter isconstructed of flexibletubing and contains aradiopaque marker band.	The Amplatz "GOOSENECK" Microsnare is apercutaneous retrievaland manipulationdevice with a uniquelyshaped retriever loop.The "GOOSE NECK"Microsnare componentconsists of a core wire,with the "beak-like"retriever loop mountedat a right angle to theaxis of shaft at its distaltip. The device isprimarily comprised of anickel-titanium alloyallowing virtual kink-resistance performanceduring navigation andretrieval of a foreignobject.	ONE SnareEndovascularMicrosnare Systemcontains: (1) Snare, (1)Snare Catheter, (1)Insertion Tool and (1)Torque Device. Thesnare is constructed ofnitinol cable and agold-plated tungstenloop. The pre-formedsnare loop can beintroduced throughcatheters without riskof snare deformationbecause of the snare'ssuper-elasticconstruction. Thesnare catheter isconstructed ofpolyether block amideand contains aplatinum/iridiumradiopaque markerband.

{5}------------------------------------------------

Catheter, French Size	3F	2.3-3F	2.3-3F
Catheter, working length(cm)	150 & 175	SAME	SAME
Catheter, composition	Pebax tubing withPlatinum Iridium MarkerBand	HDPEBarium SulfatePlatinum/IridiumMarker BandLDPETPXRT 18X B resin	Polyether block amide(Pebax)
Catheter Tip Flexibility	Equivalent perCharacterization Testing	Equivalent perCharacterization Testing	Not available
Snare Loop Diameter (mm)	2, 4 & 7	SAME	SAME
Snare Length (cm)	175 & 200	SAME	SAME
Snare Tip Flexibility	Equivalent perCharacterization Testing	Equivalent perCharacterization Testing	Not available
Snare composition	Gold plated Tungsten coilNitinol LoopNitinol shaftPTFE heat shrink	Gold plated TungstencoilNitinol LoopNitinol shaftPTFE heat shrink	Gold plated tungstencoilNitinol LoopNitinol shaft
Torque Handle	YES	SAME	SAME
Introducer Style	Peel-Away Introducer	Introducer	SAME
Single Use	YES	SAME	SAME
Supplied Sterile	YES	SAME	SAME
Sterilization	100% EtO	SAME	SAME

The Halo™ Single-Loop Microsnare Kit was subject to applicable testing to demonstrate equivalence, based upon the product performance, design and intended use.

Performance No performance standards have been established under section 514, Tests performance standards, of the Food, Drug and Cosmetic Act for (Non-Clinical): these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

The following tests were performed under the specified testing parameters to support the Halo™ Single-Loop Microsnare Kit substantial equivalence.

Performance Testing, including:

Tensile strength ●
Liquid leakage
Air leakage
Corrosion Resistance
System Tip Flexibility

{6}------------------------------------------------

Tip Flexibility Microsnare & Microsnare Catheter ●
Snare Flexing & Fracture Test
Catheter Flexural Modulus
Catheter Kink Test
Marker Band Pull Test
Torque Strength Test
Simulative Use
Radiopacity
Particulate
Luer Testing
Shipping Test

Biocompatibility Testing, including:

Cytotoxicity (ISO 10993-5)
· Sensitization (ISO 10993-10)
· Intracutaneous Irritation (ISO 10993-10)
· Acute Systemic Toxicity (ISO 10993-11)
· Material Mediated Pyrogen (ISO 10993-11)
· Hemocompatibility (ISO10993-4)
- O ASTM Hemolysis – Direct and Indirect Contact
- Complement Activation, SC5b-9 O
- Platelet and Leucocyte Counts O
- Partial Thromboplastin Time (PTT) O

Substantial Based on the Indication for Use, design, and safety and performance testing, Equivalence: the Halo™ Single-Loop Microsnare Kit meets the requirements for its intended use and is substantially equivalent to the predicate devices. Conclusion: The results of all testing demonstrate that the Halo™ Single-Loop Microsnare Kits are substantially equivalent to the predicate devices.

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).