(270 days)
No
The device description and performance studies focus on the mechanical and material properties of the microsnare kit, with no mention of AI or ML algorithms for image processing, decision support, or any other function.
No.
The device is intended for the retrieval and manipulation of foreign bodies, which is a diagnostic or interventional procedure rather than a therapeutic function that aims to treat a disease or condition.
No
The device is intended for the retrieval and manipulation of foreign bodies, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists physical components (Microsnare, Microsnare Catheter, Introducer, Torque Handle) and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical device (microsnare, catheter, introducer, torque handle) used for mechanical manipulation within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform such testing on specimens.
The Halo™ Single-Loop Microsnare Kit is an invasive medical device used for interventional procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
MMX, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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
- 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
Conclusion: The results of all testing demonstrate that the Halo™ Single-Loop Microsnare Kits are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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)
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.
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: | May 19, 2020 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Ana Jimenez-Hughes |
| Sr. Regulatory Affairs Specialist | |
| Phone: | |
| 903-676-4276 | |
| Fax: | |
| 903-677-9396 | |
| Email: | |
| ana.hughes@argonmedical.com | |
| Device Trade | |
| Name: | Halo™ Single-Loop Microsnare 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: K970668 Amplatz Goose Neck Microsnare |
| Reference: K142265 ONE Snare Endovascular Microsnare System | |
| Description of the | |
| Device: | 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. | |
| Indication for Use: | 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. |
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 | PRIMARY
PREDICATE DEVICE | REFERENCE
PREDICATE DEVICE |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Halo™ Single-Loop
Microsnare Kit | Amplatz Goose Neck
Microsnare | ONE Snare Endovascular
Microsnare System |
| Manufacturer | Argon Medical Devices | ev3 Inc. | Merit Medical Systems,
Inc. |
| 510(k) | TBD | K970668 | K142265 |
| Class | II | SAME | SAME |
| Classification Name | Device, Percutaneous
Retrieval | Catheter, Percutaneous | SAME |
| Regulation | 21 CFR 870.5150 | 21 CFR 870.1250 | SAME |
| Technical Characteristics Comparison | | | |
| Device Description | Each Halo Single-Loop
Microsnare kit consists of
(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
microsnare's super-
elastic construction. The
microsnare catheter is
constructed of flexible
tubing and contains a
radiopaque marker band. | The Amplatz "GOOSE
NECK" Microsnare is a
percutaneous retrieval
and manipulation
device with a uniquely
shaped retriever loop.
The "GOOSE NECK"
Microsnare component
consists of a core wire,
with the "beak-like"
retriever loop mounted
at a right angle to the
axis of shaft at its distal
tip. The device is
primarily comprised of a
nickel-titanium alloy
allowing virtual kink-
resistance performance
during navigation and
retrieval of a foreign
object. | ONE Snare
Endovascular
Microsnare System
contains: (1) Snare, (1)
Snare Catheter, (1)
Insertion Tool and (1)
Torque Device. The
snare is constructed of
nitinol cable and a
gold-plated tungsten
loop. The pre-formed
snare loop can be
introduced through
catheters without risk
of snare deformation
because of the snare's
super-elastic
construction. The
snare catheter is
constructed of
polyether block amide
and contains a
platinum/iridium
radiopaque marker
band. |
5
| Catheter, French Size | 3F | 2.3-3F | 2.3-3F |
|---|---|---|---|
| Catheter, working length | |||
| (cm) | 150 & 175 | SAME | SAME |
| Catheter, composition | Pebax tubing with | ||
| Platinum Iridium Marker | |||
| Band | HDPE | ||
| Barium Sulfate | |||
| Platinum/Iridium | |||
| Marker Band | |||
| LDPE | |||
| TPXRT 18X B resin | Polyether block amide | ||
| (Pebax) | |||
| Catheter Tip Flexibility | Equivalent per | ||
| Characterization Testing | Equivalent per | ||
| Characterization Testing | Not available | ||
| Snare Loop Diameter (mm) | 2, 4 & 7 | SAME | SAME |
| Snare Length (cm) | 175 & 200 | SAME | SAME |
| Snare Tip Flexibility | Equivalent per | ||
| Characterization Testing | Equivalent per | ||
| Characterization Testing | Not available | ||
| Snare composition | Gold plated Tungsten coil | ||
| Nitinol Loop | |||
| Nitinol shaft | |||
| PTFE heat shrink | Gold plated Tungsten | ||
| coil | |||
| Nitinol Loop | |||
| Nitinol shaft | |||
| PTFE heat shrink | Gold plated tungsten | ||
| coil | |||
| Nitinol Loop | |||
| Nitinol 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.