(48 days)
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.
The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:
- . 087 Balloon Guide Catheter
- 1cc Inflation Syringe ●
- 8Fr Peel Away Introducer ●
- Hub Extension
- Three Way Stopcock ●
The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
The provided document is a 510(k) Premarket Notification from the FDA for the 087 Balloon Guide Catheter System. This document outlines the regulatory review of a medical device, focusing on demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on your request:
1. A table of acceptance criteria and the reported device performance
The document presents a "Nonclinical Performance Testing Summary" which serves as the primary evidence for meeting acceptance criteria. Each "Study Name" implicitly defines an acceptance criterion (e.g., "Conditioning, Distribution, and Shelf Life Aging Verification" implies a criterion for packaging strength and integrity). The reported device performance for all tests is simply "Pass" with the statement "All samples met the pre-determined acceptance criteria."
| Acceptance Criteria (Derived from Study Description) | Reported Device Performance |
|---|---|
| Product meets packaging strength and packaging integrity after accelerated aging (6-month shelf life equivalent) | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets packaging visual inspection requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies visual surface requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets dimensional specifications | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets inflation volume vs. balloon diameter specifications | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon is capable of withstanding an injection volume of 1.0CC | Pass (All samples met the pre-determined acceptance criteria) |
| Stiffness of the distal end of the product is similar to other marketed devices | Pass (All samples met the pre-determined acceptance criteria) |
| Product is capable of 720 degrees of rotation about the central lumen axis without failure | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies peak tensile requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Flow rate is comparable to the predicate device | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets the requirements for small-bore connectors (ISO 80369-7) | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies corrosion resistance requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Radiopaque characteristics of the device meet requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Extension Liquid Leakage Under Pressure meets requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Extension Hub Aspiration Air Leakage meets requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Quantity and size of particles generated during simulated use are acceptable | Pass (All samples met the pre-determined acceptance criteria) |
| Liquid Leakage Under Pressure meets requirements (ISO 10555-1) | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Aspiration Air Leakage meets requirements (ISO 10555-1) | Pass (All samples met the pre-determined acceptance criteria) |
| No degradation of the Balloon after 20 inflation cycles | Pass (All samples met the pre-determined acceptance criteria) |
| Product does not lose structural integrity when used in a tortuous path model | Pass (All samples met the pre-determined acceptance criteria) |
| Product has acceptable kink resistance | Pass (All samples met the pre-determined acceptance criteria) |
| Device performance under simulated use conditions (including stent retrievers) compared to predicate device is acceptable | Pass (All samples met the pre-determined acceptance criteria) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence." The entire submission relies on non-clinical performance bench test data.
- Sample Size: The document does not specify the numerical sample size for any of the individual bench tests. It consistently reports "All samples met the pre-determined acceptance criteria," implying that a specific sample size was tested for each criterion, but the exact number is not provided.
- Data Provenance: The data is from non-clinical bench testing. There is no information about the country of origin of the data as these are laboratory tests. It is inherently retrospective in the sense that the testing was performed and then reported for this submission.
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 to this submission. The "ground truth" for the non-clinical performance bench tests is established by technical standards and pre-determined acceptance criteria (e.g., ASTM, ISO standards, or internal specifications). There's no indication that human experts were used to establish ground truth for these device performance metrics.
4. Adjudication method for the test set
This is not applicable. Since the ground truth for the bench tests is based on objective measurements against pre-defined numerical or qualitative criteria (e.g., "Pass/Fail" based on whether a specification is met), there is no need for expert adjudication.
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
There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (catheter), not an AI/software device that assists human readers with interpretation. Therefore, questions regarding AI assistance and effect size are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance bench tests is based on established engineering and material science standards (e.g., ISO and ASTM standards) and pre-determined internal acceptance criteria. For example:
- ASTM F88 for Seal Strength
- ASTM F2096 for Detecting Gross Leaks
- ISO 10555-1 for General requirements of intravascular catheters
- ISO 10555-4 for Balloon Dilatation Catheters
- ISO 80369-7 for Small-bore connectors
- AAMI TIR42 and **USP ** for particulates
- DIN EN 13868 for kink resistance
- FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 (for particulates)
These standards define the methodologies and acceptable limits for various physical and functional characteristics of catheters.
8. The sample size for the training set
This is not applicable. The device is a physical catheter, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).