(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.
§ 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).