(98 days)
The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravasular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
The Branchor Balloon Guide Catheter has the same design, materials and accessories as the predicate device (K203723). The change to the subject device includes performance testing and labeling to allow use with a power injector.
This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon quide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of this balloon quide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the quidewire and other devices through the section.
This is a 510(k) Pre-Market Notification submission for a medical device, which focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML device, and therefore the concepts of "acceptance criteria for an AI device," "experts used to establish ground truth," "adjudication methods," "MRMC studies," "standalone performance," or "training set" are not applicable in the context of this document.
The document describes non-clinical bench testing for the Branchor Balloon Guide Catheter to support its use with power injectors. The acceptance criteria and the study are as follows:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission for a non-AI device, the "acceptance criteria" here refer to the performance standards met during non-clinical bench testing. The document states that the device "met all acceptance criteria" without explicitly listing numerical thresholds for each test. However, it reports a general "Pass" for each test.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Burst Pressure under static condition | Device does not burst under specified pressure conditions | Pass |
| Power Injection | Device maintains integrity and functionality during power injection | Pass |
| Flow Rate | Device allows for adequate flow rate | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench test (Burst Pressure, Power Injection, Flow Rate). It refers to "non-aged and aged devices" being tested, implying multiple units were used.
- Data Provenance: The tests were "non-clinical bench testing," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is ASAHI INTECC CO., LTD from Japan, with ASAHI INTECC USA, Inc. as the primary contact. The tests are prospective in nature, as they assess the performance of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical bench study for a medical device, not a study involving ground truth established by human experts.
4. Adjudication method for the test set:
Not applicable. There is no adjudication method as this is not a study assessing interpretations or diagnoses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a non-AI medical device; therefore, MRMC studies and human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, "ground truth" is established by direct physical measurements and observations of the device's mechanical and functional performance under specified test conditions in a laboratory setting, rather than clinical outcomes or expert consensus. For example:
- Burst Pressure: Ground truth is the physical bursting pressure measured.
- Power Injection: Ground truth is the device's ability to withstand the forces and pressures of power injection without failure and maintain patency for flow.
- Flow Rate: Ground truth is the measured flow rate through the device.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device and does not involve a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).