(61 days)
The Symphony Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
The Symphony 16F 82cm Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
The Symphony™ Thrombectomy System is comprised of several devices:
- 24F Symphony Catheter
- 24F Symphony Standard Dilator
- 24F Symphony Advance™ Long Dilator
- 24F Symphony ProHelix™
- 16F Symphony Catheter
- 16F Symphony Dilator
- 16F Symphony ProHelix™
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
The Symphony™ 16F 82cm Thrombectomy System is comprised of several devices:
- 16F 82cm Symphony Catheter
- 16F 82cm Symphony Length Matched Dilator
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.
The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus. The Symphony Catheter is used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.
The provided 510(k) clearance letter details the substantial equivalence of the Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System to a predicate device. However, the document does not describe a study involving "acceptance criteria" and "reported device performance" in the context of an AI/human reader study or a standalone algorithm study looking at diagnostic performance metrics.
Instead, the document focuses on the technical and physical performance characteristics of a medical device (a thrombectomy system) designed for the non-surgical removal of emboli and thrombi. The "acceptance criteria" mentioned in the document refer to engineering and material performance specifications rather than diagnostic accuracy, sensitivity, or specificity.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes assessed through a study with a test set of data (e.g., sensitivity, specificity, accuracy for an AI system). The "acceptance criteria" listed are for bench and laboratory tests (e.g., Kink/Bend Verification, Tensile and Torque Strength Verification).
- Sample size used for the test set and data provenance: There is no mention of a "test set" in the context of diagnostic data. The "testing" refers to physical device performance.
- Number of experts used to establish ground truth and their qualifications: Ground truth in this context would typically refer to a diagnosis or an outcome for a dataset. The document refers to engineering verification of device function.
- Adjudication method for the test set: Not applicable based on the content.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is for a physical medical device, not a diagnostic AI tool.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for these tests are engineering specifications.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How ground truth for the training set was established: Not applicable.
Summary of "Acceptance Criteria" and "Study" as described in the provided 510(k) (focused on device function, not diagnostic performance):
The "studies" conducted were a series of bench and laboratory (in-vitro) tests to demonstrate the physical and functional performance of the device and its substantial equivalence to a predicate device.
Table: Acceptance Criteria and Reported Device Performance (from the document's perspective)
| Category of Test | Acceptance Criteria (Implied/General) | Reported Device Performance (from "Performance Data Supporting Substantial Equivalence" section) |
|---|---|---|
| Material/Physical Integrity | Device meets pre-specified engineering and material specifications. | Met all acceptance criteria. Performance data demonstrate that the subject devices function as intended and the changes do not raise any new questions of safety and/or effectiveness. |
| Visual and Dimensional Verification | Device conforms to design specifications. | Performed. |
| Kink / Bend Verification | Device resists kinking/bending beyond specified limits. | Performed. |
| Actuation Force Verification | Actuation force is within acceptable range. | Performed. |
| Tensile and Torque Strength Verification | Device withstands specified tensile and torque forces. | Performed. |
| Bond Strength Verification | Bonds within the device are strong enough. | Performed. |
| Positive Pressure / Fluid Leak Verification | Device does not leak under positive pressure. | Performed. |
| Negative Pressure / Fluid Leak Verification | Device does not leak under negative pressure (aspiration). | Performed. |
| Drop Testing Verification | Device withstands drops without damage or functional impairment. | Performed. |
| Component Fatigue Testing Verification | Components do not fail under specified fatigue cycles. | Performed. |
| Kink Characterization | Characterized. | Performed. |
| Torque Characterization | Characterized. | Performed. |
| Biocompatibility | Device materials are biocompatible (non-cytotoxic, non-hemolytic, etc.). | Passed. No evidence of cytotoxicity. Samples non-cytotoxic and non-hemolytic. All testing conducted in compliance with GLP regulations. |
| Sterilization | Device achieves sterility assurance level (SAL) of 1x10⁻⁶. | Validated per ISO 11135 overkill method. |
| Shelf Life & Packaging | Device and packaging maintain integrity and sterility for specified shelf life. | Established based on accelerated aging testing (ASTM F1980). Verified. Supported by aging testing. |
Additional Information Extracted from the Document:
- Sample size for the test set and the data provenance: Not applicable in the context of diagnostic data. The "tests" mentioned are engineering and material tests, likely involving a number of units of the device. There is no mention of patient data (retrospective/prospective, country of origin).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests are established engineering and material standards and specifications. Expertise would be in engineering and testing methodologies, not clinical diagnosis.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
- The type of ground truth used: Engineering specifications and ISO/ASTM standards for material and device performance.
- The sample size for the training set: Not applicable; this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In essence, the provided document is a 510(k) clearance for a physical medical device (a thrombectomy system), not a diagnostic algorithm or AI product. Therefore, the "acceptance criteria" and "studies" refer to the physical and functional performance of the device itself, rather than its performance in interpreting medical data or assisting human readers.
§ 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).