(141 days)
The Modified Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
The Modified Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip with filaments. A radiopaque distal coil facilitates fluoroscopic visualization.
The provided text is for a 510(k) Pre-Market Notification for a medical device called the "Modified Concentric Retriever." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through a full clinical trial with detailed acceptance criteria and performance metrics against such criteria.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement for ground truth, and comparative effectiveness studies are not available or applicable in the provided document. The 510(k) is a regulatory submission for a Class II device, which typically relies on bench testing and comparison to a legally marketed predicate device.
Here's an analysis of what can be gleaned from the document, acknowledging the limitations for your specific questions:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Retrieval of foreign bodies misplaced during interventional radiological procedures in neuro, peripheral, and coronary vascular systems. | "The Modified Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems." (Matches intended use of predicate) |
| Function: Perform similarly to the predicate Concentric Retriever. | "The Modified Concentric Retriever was tested in a similar manner as the predicate Concentric Retriever (K003410, K030476)." "All components, subassemblies, and/or full devices met the required specifications for the completed tests." "The Modified Concentric Retriever is substantially equivalent to the predicate product, the Concentric Retriever, in terms of indications for use, function, methods of manufacturing, and materials used." (Implies functional equivalence) |
| Materials: Made of materials suitable for this use and used in previously cleared products. | "All materials used in the manufacture of the Modified Concentric Retriever are suitable for this use and have been used in numerous previously cleared products." (Meets material suitability) |
| Manufacturing Quality: Designed under a quality system in compliance with 21CFR§820.30. | "The Modified Concentric Retriever was designed under the Concentric Quality System which is in compliance with 21CFR§820.30." (Meets quality system compliance) |
Study that proves the device meets the acceptance criteria:
The document describes a "Testing Summary" stating: "The Modified Concentric Retriever was tested in a similar manner as the predicate Concentric Retriever (K003410, K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests."
This implies a series of bench tests (e.g., mechanical strength, dimensional accuracy, material compatibility, functional deployment/retrieval in a simulated environment) were conducted to demonstrate that the modified device performs similarly to the predicate and meets its own internal specifications. No clinical study is mentioned.
Regarding the specific questions, much of the information is not provided due to the nature of a 510(k) for this type of device:
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The "Testing Summary" refers to "all components, subassemblies, and/or full devices," implying a certain number of units were tested, but no concrete sample size is given.
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. Given it's bench testing, it would be conducted in a laboratory setting, likely at the manufacturer's facility in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For bench testing of a device like a catheter, "ground truth" as it relates to clinical outcomes or expert consensus on diagnosis/treatment is not established by medical experts for the device's performance. The "ground truth" would be the engineering specifications and performance against industry standards or the predicate device's known performance characteristics.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials to resolve discrepancies in human readings or diagnoses. This device's testing involves engineering and performance metrics, not human interpretation of clinical data.
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:
- Not applicable. This device is a physical medical instrument (a retriever catheter) and does not involve AI or human "readers" interpreting images or data. Therefore, an MRMC study and AI-related effectiveness are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- For this 510(k), the "ground truth" for the device's performance is based on engineering specifications, design requirements, and the established performance characteristics of the predicate device. This is demonstrated through bench testing (e.g., mechanical integrity tests, simulated use tests) to ensure the Modified Concentric Retriever meets its intended function and safety profile when compared to its predicate.
8. The sample size for the training set:
- Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).