Halo™ Single-Loop Snare Kit

K200268 · Argon Medical Devices, Inc. · MMX · Jun 3, 2020 · Cardiovascular

Device Facts

• Record ID: K200268
• Device Name: Halo™ Single-Loop Snare Kit
• Applicant: Argon Medical Devices, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Jun 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Device Story

Halo™ Single-Loop Snare Kit is a percutaneous retrieval device used to retrieve and manipulate foreign objects within the cardiovascular system or hollow viscous. The kit includes a snare, snare catheter, introducer, and torque handle. The snare features a flexible, radiopaque, super-elastic loop designed to resist deformation during introduction through the catheter. The catheter includes a radiopaque marker band for visualization. Operated by a physician, the device is inserted percutaneously; the snare is deployed to capture the target object, which is then manipulated or retrieved. The device benefits patients by providing a minimally invasive method for removing misplaced or foreign objects, reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including tensile strength, liquid/air leakage, corrosion resistance, tip/system flexibility, snare flexing/fracture, catheter kink/flexural modulus, marker band pull, torque strength, simulative use, radiopacity, particulate, and luer testing. Biocompatibility testing was conducted per ISO 10993 standards, including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (hemolysis, complement activation, platelet/leucocyte counts, and PTT).

Technological Characteristics

Device consists of a super-elastic, radiopaque snare loop, a flexible catheter with a radiopaque marker band, an introducer, and a torque handle. Materials are consistent with predicate devices. Testing performed per ISO 10993 for biocompatibility and various mechanical standards for performance. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects in patients requiring percutaneous retrieval.

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

• Amplatz Goose Neck Snare Kit/Catheter (K972511)

Reference Devices

• Merit ONE Snare™ Endovascular Snare System (K122088)

Submission Summary (Full Text)

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June 3, 2020

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

Re: K200268

Trade/Device Name: Halo™ Single-Loop Snare Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: April 22, 2020 Received: April 24, 2020

## Dear Ms. 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 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 post-marketing 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 medical devices and radiation-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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# Indications for Use

510(k) Number (if known) K200268

Device Name Halo™ Single-Loop Snare Kit

Indications for Use (Describe)

The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

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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| Date Prepared: | January 31, 2020 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Argon Medical Devices, Inc.<br>1445 Flat Creek Road<br>Athens, Texas 75751 USA<br>Facility Registration number: 1625425 |
| Contact: | Ana Jimenez-Hughes<br>Sr. Regulatory Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade Name: | Halo™ Single-Loop Snare Kit |
| Device Common Name: | Percutaneous Retrieval Device |
| Device Classification: | Device, Percutaneous Retrieval<br>Product code, MMX<br>21 CFR 870.5150<br>Class II<br>Review Panel: Cardiovascular Devices |
| Predicate Device(s): | Primary: K972511 Amplatz Goose Neck Snare Kit/Catheter<br>Reference: K122088 Merit ONE Snare™ Endovascular Snare System |
| Description of the<br>Device: | Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter,<br>(1) Introducer and (1) Torque Handle. |
| | The snare is constructed of a flexible and radiopaque loop. The pre-<br>formed snare loop can be introduced through the snare catheter<br>without risk of snare deformation because of the snare's super-<br>elastic construction. The snare catheter is constructed of flexible<br>tubing and contains a radiopaque marker band. |
| Indication for Use: | The Halo™ Single-Loop Snare Kit is intended for use in the<br>cardiovascular system or hollow viscous to retrieve and manipulate<br>foreign objects. |
| Technological<br>Characteristics: | A comparison of the technological characteristics of the subject<br>device and the predicate devices shows the Halo™ Single-Loop Snare<br>Kit to be substantially equivalent to the current marketed predicate<br>devices.<br><br>Equivalence is based upon the product performance, design and<br>intended use. The Halo™ Single-Loop Snare Kit and the predicate<br>devices have similar materials of construction, dimensional<br>specifications, designs and sterilization process. |
| Performance Tests<br>(Non-Clinical): | No performance standards have been established under section<br>514, performance standards, of the Food, Drug and Cosmetic Act for<br>these devices. A series of testing was conducted in accordance with<br>protocols based on requirements outlined in guidances and industry<br>standards and the below were shown to meet the acceptance<br>criteria that were determined to demonstrate substantial<br>equivalence.<br><br>The following tests were performed under the specified testing<br>parameters to support the Halo™ Single-Loop Snare Kit substantial<br>equivalence. |
| | Performance Testing, including:<br>● Tensile strength<br>● Liquid leakage<br>● Air leakage<br>● Corrosion Resistance<br>● System Tip Flexibility<br>● Tip Flexibility – Snare & Catheter<br>● Snare Flexing & Fracture Test<br>● Catheter Flexural Modulus<br>● Catheter Kink Test<br>● Marker Band Pull Test<br>● Torque Strength Test<br>● Simulative Use<br>● Radiopacity<br>● Particulate<br>● Luer Testing<br>● Shipping Test |

# 510(k) Summary

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### 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)
- ASTM Hemolysis Direct and Indirect Contact O
- Complement Activation, SC5b-9 O
- O Platelet and Leucocyte Counts
- O Partial Thromboplastin Time (PTT)

Substantial Based on the Indication for Use, design, and safety and performance Equivalence: testing, the Halo™ Single-Loop Snare 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 Snare Kits are substantially equivalent to the predicate devices.