(24 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, specifically retrieval kits for inferior vena cava (IVC) filters. The submission focuses on a modification to an existing device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a modification to an existing device, the "acceptance criteria" are not explicitly stated as numerical targets in a table. Instead, the acceptance criteria are implicit in meeting the performance standards of the predicate device and ensuring the modification doesn't negatively impact safety or effectiveness. The reported device performance is that all tests met their respective acceptance criteria.
| Acceptance Criteria (Implicit from Predicate & Safety) | Reported Device Performance |
|---|---|
| Material Properties (Outer Sheath Modification): | |
| Outer Sheath - Visual | Met acceptance criteria |
| Outer Sheath - Dimensional | Met acceptance criteria |
| Outer Sheath - Tensile Strength | Met acceptance criteria |
| Outer Sheath - Liquid Leakage | Met acceptance criteria |
| Outer Sheath - Simulated Use | Met acceptance criteria |
| Outer Sheath - Delamination | Met acceptance criteria |
| Biocompatibility (for modified material): | |
| Cytotoxicity (ISO 10993-5) | Met acceptance criteria |
| Sensitization (ISO 10993-10) | Met acceptance criteria |
| Irritation or Intracutaneous Reactivity (ISO 10993-23) | Met acceptance criteria |
| Material Mediated Pyrogen (ISO 10993-11) | Met acceptance criteria |
| Acute Systemic Toxicity (ISO 10993-11) | Met acceptance criteria |
| Hemocompatibility (ISO 10993-4): | Met acceptance criteria |
| - ASTM Hemolysis, Direct and Extract | Met acceptance criteria |
| - Complement Activation, SC5b-9 | Met acceptance criteria |
| - Partial Thromboplastin (PTT) | Met acceptance criteria |
| - Platelet and Leukocyte Count | Met acceptance criteria |
| - In vitro Blood Loop | Met acceptance criteria |
| Leveraged Non-Clinical Testing (from predicate K191758): | |
| Visual/Dimensional (Inner Sheath, Dilator, Delivery Catheter, Single-Loop Snare & Triple-Loop Snare) | Met acceptance criteria |
| Leak Test (Inner Sheath, Dilator and Delivery Catheter) | Met acceptance criteria |
| Burst Test | Met acceptance criteria |
| Pull Test/Tensile Strength (Inner Sheath, Dilator, Delivery Catheter, Single-Loop Snare & Triple-Loop Snare) | Met acceptance criteria |
| Corrosion Resistance (Single-Loop Snare & Triple-Loop Snare) | Met acceptance criteria |
| Torque Response (Snare Assembly) | Met acceptance criteria |
| Radiopacity | Met acceptance criteria |
| Luer Testing | Met acceptance criteria |
| Contrast Medium Injection | Met acceptance criteria |
| High Pressure Stopcock Testing | Met acceptance criteria |
| Flexural Modulus and Tip Flexibility Testing | Met acceptance criteria |
| Radial Force Testing | Met acceptance criteria |
| Design Validation Testing and Summative Usability Testing | Met acceptance criteria |
The document explicitly states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical test. It only lists the types of tests performed. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing. The tests are non-clinical (bench testing, biocompatibility) rather than human subject studies, so the terms "retrospective or prospective" are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The tests performed are non-clinical (mechanical, materials, biocompatibility) and do not involve expert interpretation or ground truth establishment in the way clinical studies with AI algorithms would. The "ground truth" for these tests is based on objective measurements against established engineering and biocompatibility standards (e.g., ISO and ASTM standards).
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (retrieval kit) with a material modification, not an AI-powered diagnostic or interpretive device. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This is not an AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Engineering specifications and standards: For mechanical and dimensional tests (e.g., tensile strength, leak test, burst test, radiopacity, Luer testing, flexural modulus, radial force).
- Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, hemocompatibility).
- Simulated use conditions: For tests like simulated use and design validation.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI device and therefore has no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not an AI device and therefore has no "training set" or associated ground truth establishment process.
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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 RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
|---|---|
| Contact: | Ana Jimenez-HughesSenior Regulatory Affairs SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com |
| Device Trade Name: | Single-Loop Snare Retrieval KitTriple-Loop Snare Retrieval Kit |
| Device Common Name: | Device, Percutaneous Retrieval |
| Device Classification: | Device, Percutaneous RetrievalProduct code, MMX21 CFR 870.5150Class IIReview 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 x93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fullyexpanded) with Torque Handle. | |
| The snares have radiopaque loops and are preloaded in the snare catheter. The snarecatheter, inner sheath, and outer sheath have a radiopaque marker band at the distaltip for enhanced fluoroscopic visualization. |
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| Indication forUse: | Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended forthe percutaneous removal of retrievable inferior vena cava (IVC) filters that are nolonger medically required, via jugular approach. |
|---|---|
| DeviceModification: | The device modification included in this submission is limited to the change of innerlayer material of the 11F (ID) Outer Sheath. |
| SubstantialEquivalence: | There is no change of intended use or fundamental scientific technology betweenthe proposed modified and predicate device. The proposed modified device hasthe same indication for use as the predicate, K191758.Non-Clinical TestingIn accordance with the Design Failure Modes and Effects Analysis, supplementalverification testing was identified to support the substantial equivalence of themodified Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit. Testingincluded: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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§ 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).