(58 days)
The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Any use for procedures other than those indicated in the instructions is not recommended.
The Bridge Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure
The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. This guidewire lumen is used to pass the catheter over a guidewire.
Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.
This document describes the Bridge Occlusion Balloon, a device intended for temporary vessel occlusion of the superior vena cava (SVC). The purpose of the document is to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally focused on device specifications and performance attributes, rather than specific quantitative metrics with thresholds. This is typical for equivalence claims where the device aims to match the performance of a legally marketed predicate and where the performance itself is described in functional terms.
| Performance Characteristic | Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|---|
| Design Verification & Validation Tests | ||
| Crossing Profile | Acceptable for intended use | Met specifications |
| Balloon Working Length | Within specified range | Met specifications |
| Guidewire Compatibility | Compatible with specified guidewire | Met specifications |
| Catheter Effective Length | Within specified range | Met specifications |
| Surface Appearance | Free from defects | Met specifications |
| Distal Tip Configuration | Conforms to design | Met specifications |
| Luer Compatibility | Compatible with Luer fittings | Met specifications |
| Performance Tests | ||
| Deployment & Retraction | Smooth and reliable operation | Met specifications |
| Inflation & Deflation Time | Within specified time limits | Met specifications |
| Balloon Bond Strength | Adequate for intended use | Met specifications |
| Inflated Balloon Size Stability | Stable at intended pressure | Met specifications |
| Tip Bond Strength | Adequate for intended use | Met specifications |
| Hub Bond Strength | Adequate for intended use | Met specifications |
| Flexibility & Kink | Sufficient flexibility, kink-resistant | Met specifications |
| Leak Testing | No leaks detected | Met specifications |
| Balloon Burst Volume | Capable of sustained inflation | Met specifications |
| Device Fatique | Resists fatigue under intended use | Met specifications |
| Sterilization | Sterile per ISO 11135 | Validated (Half Cycle) |
| Biocompatibility | Biocompatible for intended contact | Met specifications |
| Cytotoxicity | Non-cytotoxic | Met specifications |
| Sensitization | Non-sensitizing | Met specifications |
| Intracutaneous Reactivity | Non-reactive | Met specifications |
| Acute Systemic Toxicity | Non-toxic | Met specifications |
| C3a Complement Activation | Acceptable levels | Met specifications |
| SC5b-9 Complement Activation | Acceptable levels | Met specifications |
| Direct Hemolysis | Non-hemolytic | Met specifications |
| Indirect Hemolysis | Non-hemolytic | Met specifications |
| Partial Thromboplastin Time | Acceptable levels | Met specifications |
| Material Mediated Pyrogenicity | Non-pyrogenic | Met specifications |
| Preclinical (Animal Study) | Achieves SVC occlusion | Demonstrated SVC occlusion |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many balloons were tested for burst volume, how many animals were used in the preclinical study). However, it lists various "Design Verification and Validation Testing" categories, along with "Performance Testing," "Sterilization," and "Biocompatibility" tests.
- Preclinical Testing: Mentioned as "preclinical GLP testing." The specific number of animals is not provided.
- Data Provenance: The preclinical study was a prospective study conducted to demonstrate the device's intended use in SVC occlusion. The location of these studies is not specified, but they were conducted by the device manufacturer for regulatory submission in the USA.
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 in the context of this device and study. The studies described are engineering, materials, and animal studies, not studies involving human interpretation or subjective assessment by experts to establish a "ground truth" as it would be for AI/imaging devices. The "ground truth" for these tests are the objective measurement results and observations of physical performance and biological response.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are primarily objective measurements and observations, not requiring expert adjudication in the manner medical imaging studies might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (balloon catheter), not an AI algorithm for diagnostic interpretation that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the various tests:
- Engineering and Performance Tests: Ground truth is based on the design specifications and measurable physical/chemical properties (e.g., dimensions, material properties, inflation/deflation times, bond strengths, leak detection).
- Biocompatibility Tests: Ground truth is established by standardized biological assays and observation of biological reactions (e.g., cell viability for cytotoxicity, skin reaction for sensitization, blood component analysis for hemolysis).
- Preclinical Animal Study: The ground truth for this segment relates to the objective demonstration of SVC occlusion within the animal model, observed through physiological measurements or imaging.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to the described studies for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).