(24 days)
Not Found
No
The summary describes a purely mechanical device for retrieving IVC filters and makes no mention of AI or ML capabilities, image processing for analysis, or data sets for training/testing.
Yes
The device is described as a "Retrieval Kit" intended for the "percutaneous removal of retrievable inferior vena cava (IVC) filters," which is a direct therapeutic intervention to remove a medical device from a patient's body.
No
The device is described as a "Snare Retrieval Kit" intended for the percutaneous removal of IVC filters, indicating a therapeutic or interventional purpose rather than a diagnostic one. Its function is to retrieve objects, not to diagnose a condition.
No
The device description explicitly lists multiple physical components (sheaths, dilator, valve, stopcock, catheter, snares) and describes their material properties and physical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "percutaneous removal of retrievable inferior vena cava (IVC) filters". This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components are physical tools designed for mechanical retrieval (sheaths, dilator, snare catheter, snare).
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not interact with or analyze biological samples in this way.
- Anatomical Site: The device is used within the inferior vena cava, which is an anatomical structure within the body, not a biological sample.
In summary, this device is a surgical/interventional tool used for a therapeutic procedure, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.
Product codes
MMX
Device Description
The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior vena cava (IVC), jugular approach
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
In accordance with the Design Failure Modes and Effects Analysis, supplemental verification testing was identified to support the substantial equivalence of the modified Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit. Testing included:
Outer Sheath - Visual
Outer Sheath - Dimensional
Outer Sheath - Tensile Strength
Outer Sheath - Liquid Leakage Simulated Use
Outer Sheath - Delamination
Biocompatibility:
Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10)
Irritation or Intracutaneous Reactivity (ISO 10993-23)
Material Mediated Pyrogen (ISO 10993-11)
Acute Systemic Toxicity (ISO 10993-11)
Hemocompatibility (ISO10993-4)
ASTM Hemolysis, Direct and Extract
Complement Activation, SC5b-9
Partial Thromboplastin (PTT)
Platelet and Leukocyte Count
In vitro Blood Loop
The following testing was leveraged from K191758:
Visual/Dimensional (Inner Sheath, Dilator, Delivery Catheter Single-Loop Snare & Triple Loop Snare)
Leak Test (Inner Sheath, Dilator and Delivery Catheter)
Burst Test
Pull Test/Tensile Strength (Inner Sheath, Dilator, Delivery Catheter Single-Loop Snare & Triple Loop Snare)
Corrosion Resistance (Single-Loop Snare & Triple Loop Snare)
Torque Response (Snare Assembly)
Radiopacity
Luer Testing
Contrast Medium Injection
High Pressure Stopcock Testing
Flexural Modulus and Tip Flexibility Testing
Radial Force Testing
Design Validation Testing and Summative Usability Testing
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
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.
Not Found
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 7, 2023
Argon Medical Devices, Inc. Ana Jimenez-Hughes Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K232443
Trade/Device Name: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: August 9, 2023 Received: August 14, 2023
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
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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 W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2023.09.07
11:13:13-04'00'
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) K232443
Device Name Single-Loop Snare Retrieval Kit Triple-Loop Snare Retrieval Kit
Indications for Use (Describe)
Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared: August 9, 2023
| Company: | Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, Texas 75751 USA
Facility Registration number: 1625425 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ana Jimenez-Hughes
Senior Regulatory Affairs Specialist
Phone: 903-676-4276
Fax: 903-677-9396
Email: ana.hughes@argonmedical.com |
| Device Trade Name: | Single-Loop Snare Retrieval Kit
Triple-Loop Snare Retrieval Kit |
| Device Common Name: | Device, Percutaneous Retrieval |
| Device Classification: | Device, Percutaneous Retrieval
Product code, MMX
21 CFR 870.5150
Class II
Review Panel: Cardiovascular Devices |
| Predicate Device(s): | Primary: K191758 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
| Description of the Device: | The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. |
| | The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath,
[C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F]
7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x
93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully
expanded) with Torque Handle. |
| | The snares have radiopaque loops and are preloaded in the snare catheter. The snare
catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal
tip for enhanced fluoroscopic visualization. |
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| Indication for
Use: | Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for
the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no
longer medically required, via jugular approach. |
|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Modification: | The device modification included in this submission is limited to the change of inner
layer material of the 11F (ID) Outer Sheath. |
| Substantial
Equivalence: | There is no change of intended use or fundamental scientific technology between
the proposed modified and predicate device. The proposed modified device has
the same indication for use as the predicate, K191758.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, supplemental
verification testing was identified to support the substantial equivalence of the
modified Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit. Testing
included:
Outer Sheath - Visual Outer Sheath - Dimensional Outer Sheath - Tensile Strength Outer Sheath - Liquid Leakage Simulated Use Outer Sheath - Delamination Biocompatibility: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or Intracutaneous Reactivity (ISO 10993-23) Material Mediated Pyrogen (ISO 10993-11) Acute Systemic Toxicity (ISO 10993-11) Hemocompatibility (ISO10993-4) ASTM Hemolysis, Direct and Extract Complement Activation, SC5b-9 Partial Thromboplastin (PTT) Platelet and Leukocyte Count In vitro Blood Loop |
| | The following testing was leveraged from K191758:
Visual/Dimensional (Inner Sheath, Dilator, Delivery Catheter Single-Loop Snare & Triple Loop Snare) Leak Test (Inner Sheath, Dilator and Delivery Catheter) |
| • | Burst Test |
| • | Pull Test/Tensile Strength (Inner Sheath, Dilator, Delivery Catheter Single-Loop Snare & Triple Loop Snare) |
| • | Corrosion Resistance (Single-Loop Snare & Triple Loop Snare) |
| • | Torque Response (Snare Assembly) |
| • | Radiopacity |
| • | Luer Testing |
| • | Contrast Medium Injection |
| • | High Pressure Stopcock Testing |
| • | Flexural Modulus and Tip Flexibility Testing |
| • | Radial Force Testing |
| • | Design Validation Testing and Summative Usability Testing |
| Animal testing was not required for the determination of substantial equivalence. | |
| Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications. | |
| Conclusion: | The proposed device modifications to the Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval kit do not change its intended use or principles of operation. Based on the Indication for Use, design, and performance testing, the Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit meet the requirements for its intended use and is substantially equivalent to the predicate device. |
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