(121 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a snare kit, with no mention of AI or ML capabilities.
No
The device is intended to retrieve and manipulate foreign objects, which is an interventional or diagnostic function, not a therapeutic one where it treats a disease or condition.
No
Explanation: The device description and intended use clearly state that the Halo™ Single-Loop Snare Kit is used for retrieving and manipulating foreign objects within the cardiovascular system or hollow viscous. It is an interventional or therapeutic tool, not one designed to diagnose conditions or identify diseases.
No
The device description explicitly lists physical components (Snare, Snare Catheter, Introducer, Torque Handle) and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, the Halo™ Single-Loop Snare Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use "in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects." This describes a procedure performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a physical device (snare, catheter, introducer, torque handle) designed for mechanical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Halo™ Single-Loop Snare Kit is a surgical/interventional tool.
N/A
Intended Use / Indications for Use
The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle.
The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular system or hollow viscous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for 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 Snare Kit substantial equivalence.
Performance Testing, including:
● Tensile strength
● Liquid leakage
● Air leakage
● Corrosion Resistance
● System Tip Flexibility
● Tip Flexibility – Snare & 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)
- ASTM Hemolysis Direct and Indirect Contact O
- Complement Activation, SC5b-9 O
- O Platelet and Leucocyte Counts
- O Partial Thromboplastin Time (PTT)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
| Date Prepared: | January 31, 2020 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Ana Jimenez-Hughes |
| Sr. Regulatory Specialist | |
| Phone: 903-676-4276 | |
| Fax: 903-677-9396 | |
| Email: ana.hughes@argonmedical.com | |
| Device Trade Name: | Halo™ Single-Loop Snare Kit |
| Device Common Name: | Percutaneous Retrieval Device |
| Device Classification: | Device, Percutaneous Retrieval |
| Product code, MMX | |
| 21 CFR 870.5150 | |
| Class II | |
| Review Panel: Cardiovascular Devices | |
| Predicate Device(s): | Primary: K972511 Amplatz Goose Neck Snare Kit/Catheter |
| Reference: K122088 Merit ONE Snare™ Endovascular Snare System | |
| Description of the | |
| Device: | Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, |
| (1) Introducer and (1) Torque Handle. | |
| The snare is constructed of a flexible and radiopaque loop. The pre- | |
| formed snare loop can be introduced through the snare catheter | |
| without risk of snare deformation because of the snare's super- | |
| elastic construction. The snare catheter is constructed of flexible | |
| tubing and contains a radiopaque marker band. | |
| Indication for Use: | The Halo™ Single-Loop Snare Kit is intended for use in the |
| cardiovascular system or hollow viscous to retrieve and manipulate | |
| foreign objects. | |
| Technological | |
| Characteristics: | A comparison of the technological characteristics of the subject |
| device and the predicate devices shows the Halo™ Single-Loop Snare | |
| Kit to be substantially equivalent to the current marketed predicate | |
| devices. |
Equivalence is based upon the product performance, design and
intended use. The Halo™ Single-Loop Snare Kit and the predicate
devices have similar materials of construction, dimensional
specifications, designs and sterilization process. |
| Performance Tests
(Non-Clinical): | No performance standards have been established under section
514, performance standards, of the Food, Drug and Cosmetic Act for
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 Snare Kit substantial
equivalence. |
| | Performance Testing, including:
● Tensile strength
● Liquid leakage
● Air leakage
● Corrosion Resistance
● System Tip Flexibility
● Tip Flexibility – Snare & 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 |
510(k) Summary
4
5
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.