(51 days)
The Concerto™ Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
The Concerto™ Detachable Coil System consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Concerto™ coil configurations include bare platinum coils. The Concerto™ Detachable Coil System consists of three components: 1- Implantable Coil, 2- Implant Delivery Pusher, 3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
While the document explicitly states that the Concerto™ Detachable Coil System is substantially equivalent to the Axium™ Detachable Coil System because "the same methods and materials in construction, packaging and sterilization are used", and therefore "no performance data were generated in support of this submission."
This means there is no acceptance criteria or study data provided in this document to fulfill the request. The submission relies solely on the substantial equivalence to a predicate device (Axium™ Detachable Coil System) that presumably had supporting performance data.
Therefore, for the sake of completeness using the provided text, I will address the points by stating that such information is not present.
Here's the information based on the provided text, noting where details are unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| No performance data were generated for the Concerto™ Detachable Coil System in this submission. The device leverages substantial equivalence to the Axium™ Detachable Coil System. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No performance data was generated for this device submission.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No performance data was generated for this device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No performance data was generated for this device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission states, "no performance data were generated in support of this submission."
- Effect Size of Human Readers with AI vs. Without AI: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone performance study was not done. The submission states, "no performance data were generated in support of this submission."
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No performance data was generated for this device submission.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. No new performance data or algorithm training was detailed for this submission.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. No new performance data or algorithm training was detailed for this submission.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).