(148 days)
The 091 Balloon Guide Catheter is infacilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a balloon at the distal end. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A compliant balloon is flush mounted on the catheter to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A peel-away introducer, dilator, and one-way luer valve accessory are included within the packaging. A similar dilator was cleared as part of the reference device under K172468. The 091 Balloon Guide Catheter is supplied sterile, non- pyrogenic, and is intended for single use only.
The provided text is a 510(k) Summary for a medical device called the "091 Balloon Guide Catheter". It describes the device, its indications for use, and how its substantial equivalence to a predicate device was established through various performance tests.
However, the questions posed (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC studies, etc.) are typically associated with the evaluation of AI/ML-enabled medical devices where performance is measured in terms of diagnostic accuracy, sensitivity, specificity, or other clinically relevant metrics based on analyzing data (images, signals, etc.).
The "091 Balloon Guide Catheter" is a physical medical device, not an AI/ML diagnostic or therapeutic device. The "performance data" section (Table 6.2) refers to engineering verification and validation tests for physical properties such as tensile strength, burst pressure, particulate matter, and dimensions, not AI model performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies for an AI model does not apply to this medical device submission.
Here's why and what can be extracted from the document:
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1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): For a physical device, the acceptance criteria are implicit in the "Pass" results listed in Table 6.2. For instance, "The catheter must meet tensile strength specifications" is the acceptance criterion, and "Pass" is the reported performance. The specific numerical thresholds for these specifications are not disclosed in this summary but would be in the full design verification and validation reports.
- Reported Device Performance:
Test performed Test Summary Reported Performance Catheter Tensile Strength The catheter must meet tensile strength specifications. Pass Catheter Burst The catheter must meet catheter burst specification. Pass Particulate The catheters were tested in comparison to the predicate device for all particle sizes including the large particles to establish substantial equivalence to the predicate device. Pass Dilator Working Length The dilator must meet working length specification. Pass Dilator Inner Diameter (ID) The dilator must meet inner diameter (ID) specification. Pass Dilator Outer Diameter (OD) The dilator must meet outer diameter (OD) specification. Pass Dilator Hub Compatibility The hub luer shall meet the applicable criteria for each test as defined by ISO 594-1 and ISO 594-2. Pass Dilator Radiopacity The dilator shall be visible under fluoroscopic imaging. Pass Dilator Tensile Strength The dilator must meet tensile strength specifications. Pass Dilator Visual Inspection Samples were visually inspected under 2.5X magnification to ensure acceptance criteria were met. Pass Label Content The label and directions for use (DFU) must meet content specifications. Pass Usability - Simulated Use Testing Simulated use testing was conducted utilizing all accessory devices expected to be used during a clinical procedure. Pass
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2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML model's test set for diagnostic performance. For physical device testing, samples are typically drawn from manufacturing lots, but the specific number of units tested for each parameter is not disclosed in this summary. The data provenance is testing conducted by the manufacturer. All tests listed are bench tests, not clinical studies, so "country of origin for data" or "retrospective/prospective" don't apply in the sense of patient data.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established by engineering measurements and standards, not expert clinical interpretation of data.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for image/data interpretation.
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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 for AI/ML diagnostic tools.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for performance testing is defined by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. For example, the ground truth for "Dilator Hub Compatibility" is adherence to ISO 594-1 and ISO 594-2.
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8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
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9. How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to a traditional physical medical device (catheter) and its regulatory clearance based on engineering performance tests and substantial equivalence to a predicate device, not an AI/ML-enabled device. Therefore, the detailed questions about AI model testing methodologies do not apply.
§ 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).