Search Results
Found 1 results
510(k) Data Aggregation
(354 days)
BIOSENSORS EMBOLECTOMY CATHETER
The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.
Biosensors International (BI) has developed an embolectomy catheter that is equivalent in design and performance to embolectomy catheters currently marketed by Baxter. BSI's embolectorny catheters are configured as single lumen, balloon-tipped catheters.
The catheters vary in length and diameter to accommodate various thrombotic obstruction and vessel lumen sizes. They are supplied in 3, 4, 5, 6, and 7 French diameters, with inflated balloon diameters of 6, 9, 11, 13, and 14 mm, respectively.
The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.)
The proximal end of the flexible catheters terminate in a rigid, winged adapter with female luer lock port to permit attachment to a stylet for stiffening the catheter during insertion, or sterile syringe during balloon inflation. The distal end of the catheters terminate in a latex-coated tip immediately distal to the latex balloons. The latex balloons lie flat against the catheters during insertion through the vasculature and lesion, and are inflated with sterile isotonic saline or other appropriate sterile solution during embolectomy procedures.
The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.
The Biosensors Embolectomy Catheter received 510(k) clearance based on its substantial equivalence to the Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. The device's performance was assessed through a series of tests to demonstrate it met the acceptance criteria implied by its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Materials are biocompatible for short-term blood exposure. | Identical to those used for other Biosensors catheters exposed to circulating blood for a short period. |
| Burst Strength of Balloon: Maintains integrity under inflation. | Test data collected (specific values not provided, but deemed satisfactory). |
| Pull Strength of Balloon: Maintains attachment to catheter. | Test data collected (specific values not provided, but deemed satisfactory). |
| Balloon Inflation Volume Accuracy: Inflates to expected volume. | Test data collected (specific values not provided, but deemed satisfactory). |
| Tensile Strength of Catheter: Withstands forces during use. | Test data collected (specific values not provided, but deemed satisfactory). |
| Leak Test Data: Catheter and balloon system prevents fluid leakage. | Test data collected (specific values not provided, but deemed satisfactory). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (burst strength, pull strength, etc.). The study appears to be a retrospective comparison based on laboratory testing of the Biosensors Embolectomy Catheter against the characteristics of the predicate device. There is no indication of country of origin for the data provided, as it is a premarket notification for a US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For a medical device like an embolectomy catheter, the "ground truth" for performance evaluations typically comes from engineering testing against established standards and benchmarks of predicate devices, rather than expert consensus on a test set of clinical images or cases.
4. Adjudication Method for the Test Set:
This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting data or making diagnoses, often for image-based diagnostic devices. This premarket notification focuses on the physical and material performance of the catheter.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study involves human readers and is not relevant for the assessment of a physical medical device like an embolectomy catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone performance assessment was conducted in the sense that the device's physical and material properties were tested in a laboratory setting. This is an "algorithm only" equivalent in that the device's performance characteristics were evaluated as an isolated entity. The device's performance in terms of burst strength, pull strength, inflation volume accuracy, tensile strength, and leak resistance were evaluated independently.
7. Type of Ground Truth Used:
The "ground truth" for this study was based on engineering and performance specifications established for similar medical devices, specifically the predicate Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. It relies on the understanding that if the new device performs equivalently to a legally marketed predicate device on these objective measures, it is deemed safe and effective.
8. Sample Size for the Training Set:
This information is not applicable as this is a physical medical device, not an AI/algorithm-driven device requiring a training set in the conventional machine learning sense. The "training" for such a device would be the design and manufacturing process, optimized through engineering principles.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8. The "ground truth" relevant to the device's development would be established through industry standards, regulatory requirements, and the functional specifications of existing, successful embolectomy catheters.
Ask a specific question about this device
Page 1 of 1