(28 days)
The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.
The Scepter XC Occlusion Batheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.
The provided document describes a 510(k) premarket notification for the Scepter XC Occlusion Balloon Catheter, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this document.
Instead, the submission focuses on non-clinical performance testing to demonstrate that the new device performs comparably to the predicate and meets design specifications.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or not provided in a 510(k) summary of this nature:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of "Pre-clinical Testing" with "Pass" as the result for each test. This indicates that the device met the internal acceptance criteria for these engineering and performance tests, which are typically designed to ensure safety and functionality. However, the specific quantitative acceptance criteria for each test (e.g., "Tensile strength must be > X Newtons") are not explicitly stated in this summary, only the outcome "Pass."
| Pre-clinical Testing | Acceptance Criteria (Implicit - met design specs) | Reported Device Performance |
|---|---|---|
| Surface and physical attributes | Met internal design specifications | Pass |
| Tensile strength | Met internal design specifications | Pass |
| Leakage (liquid and air) | Met internal design specifications | Pass |
| Static and dynamic burst pressure | Met internal design specifications | Pass |
| Simulated use | Met internal design specifications | Pass |
| Compatibility with devices | Met internal design specifications | Pass |
| Kink resistance | Met internal design specifications | Pass |
| Catheter flexural fatigue | Met internal design specifications | Pass |
| Hydrophilic coating | Met internal design specifications | Pass |
| Hub testing | Met internal design specifications | Pass |
| Torque testing | Met internal design specifications | Pass |
| Balloon testing - burst, compliance, deflation time, fatigue | Met internal design specifications | Pass |
| Biocompatibility testing (ISO 10993-1) | Met ISO 10993-1 standards | Pass |
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance testing for this 510(k) submission. The "test set" here refers to physical devices undergoing pre-clinical engineering tests. The sample sizes for these specific tests are not provided in this summary.
- Data Provenance: The device is submitted by MicroVention, Inc., based in Tustin, California, U.S.A. The pre-clinical testing would have been conducted by or for MicroVention.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not applicable as this submission focuses on pre-clinical engineering and performance testing, not a clinical study involving expert interpretation of data or images to establish a diagnostic ground truth.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reason as point 3. Adjudication methods are relevant for clinical studies where multiple reviewers assess outcomes or diagnoses.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically conducted for diagnostic imaging devices to compare human reader performance with and without AI assistance, which is outside the scope of this device (an occlusion balloon catheter).
- Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable as no MRMC study or AI component is described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- No, this information is not applicable. The Scepter XC Occlusion Balloon Catheter is a physical medical device, not a diagnostic algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- For the pre-clinical tests, the "ground truth" equates to pre-defined engineering specifications and international standards (e.g., ISO 10993-1 for biocompatibility). The device either met these specifications ("Pass") or it did not. This is not clinical ground truth (like pathology or outcomes data).
8. The Sample Size for the Training Set:
- This information is not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not an AI or machine learning system that requires data for training.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable for the same reason as point 8.
In summary:
This 510(k) submission for the Scepter XC Occlusion Balloon Catheter primarily relies on demonstrating substantial equivalence to a predicate device (Scepter C Occlusion Balloon Catheter, K110741) through pre-clinical engineering and performance testing. The "acceptance criteria" were internal design specifications and relevant international standards for medical devices, which the new device "passed." The submission does not involve clinical studies with human participants, expert ground truth establishment, or AI algorithm performance evaluations, which are typically associated with the other questions.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).