(134 days)
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.
The provided document is a 510(k) summary for the Concerto Versa™ Detachable Coil. This document pertains to a medical device (an embolization coil) and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, many of the requested categories, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set," and "Ground truth for training set," are not applicable to this submission.
The document primarily focuses on demonstrating the substantial equivalence of the new device (Concerto Versa™ Detachable Coil) to a legally marketed predicate device (Concerto Detachable Coil System) through a series of bench tests and leveraging existing data from the predicate. The "acceptance criteria" are implicitly the passing results of these non-clinical tests.
Here's the information that can be extracted and how it relates to the request:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally "Pass" for each test, indicating that the device met the specified performance requirements. The document does not provide specific numerical criteria for each test beyond stating they "meet specification."
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Friction in Catheter | Meet specification | Pass |
| Coil Force Transfer Ratio | Meet specification | Pass |
| Pusher Length | Meet specification | Pass |
| Coil Visual Inspection | No damage, kinks, 1st loop full | Pass |
| Friction in Sheath | Meet specification | Pass |
| Fatigue | Re-sheathed/deployed 6+ times without breaking/detaching | Pass |
| PP Tensile | Meet specification | Pass |
| Kink resistance | Track through 0.027" catheter without kinking | Pass |
| Detachment | Must detach when attempted | Pass |
| Tip Buckling | Meet min/max specifications | Pass |
| Tinius Olsen | Meet specification | Pass |
| Loop Deformation | Meet specification | Pass |
| Anchor Flow Rate | Meet specification | Pass |
| 1st Loop OD Measurement | Meet specification based on size | Pass |
| Flow Occlusion | Meet specification in vessel model | Pass |
| Primary Wind OD Measurement | Meet specification | Pass |
| Coil Length | Meet specification based on model | Pass |
| Pusher Elongation | Meet specification | Pass |
| Pusher Skive Tensile | Meet specification | Pass |
| Primary wind weld tensile strength | Meet specification | Pass |
| Couple Tube Tensile | Meet specification | Pass |
| Shield Coil Tensile | Meet specification | Pass |
| Detachment (time) | Less than 5s | Pass |
| Detachment (back-up method) | Manually detachable by back-up method | Pass |
| Fiber Amount Counting | Meet specification based on model | Pass |
| Fiber Pull Out Force | Meet specification | Pass |
| Distribution Simulation | Maintain integrity with packaging through shipping | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of coils or test replicates used for each bench test conducted on the Concerto Versa™ Detachable Coil. It states that "A subset of design verification testing was conducted."
- Data Provenance: The tests were "non-clinical bench testing." The document mentions "clinically relevant tortuosity model of the splenic and gastroduodenal arteries" which implies in-vitro testing. It also states that "GLP acute animal data was also leveraged from the predicate device," indicating some previous animal study data was used, but not for the subject device's new testing.
- Retrospective or Prospective: The testing performed for this submission would be considered prospective for the subject device, as it was specifically done for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a medical device submission based on physical and mechanical performance testing, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication process is described as it's not a diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not an MRMC comparative effectiveness study. It is a 510(k) submission for a non-diagnostic medical device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm. The performance evaluation is based on mechanical and physical characteristics.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests is the defined engineering and material specifications for the device. For example, a coil's length must meet a certain specification, or its detachment time must be below a certain threshold. There's no "ground truth" derived from patient outcomes or expert consensus in the typical sense for a diagnostic device. Biocompatibility was evaluated against ISO 10993 standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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).