(160 days)
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Benchmark™ Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. Benchmark Intracranial Access System is composed of a Delivery Catheter (guide catheter) used to support other diagnostic or therapeutic devices and a corresponding Select Catheter (microcatheter). Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.
The provided document K142321 is a 510(k) Pre-market Notification for the Penumbra, Inc. Benchmark™ Intracranial Access System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel clinical effectiveness through a comparative effectiveness study. As such, the information requested regarding acceptance criteria and studies would primarily relate to non-clinical performance and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Please refer to the tables below, which are directly extracted and compiled from Section 7.10.1 Biocompatibility Testing and 7.10.2 Bench-top Testing of the document.
Biocompatibility Testing
| Test | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield cell lysis grade 2 or lower | Grade 0-1: None to Slight | Pass |
| Sensitization | Test Group shall yield Grade 10% weight loss in 3 or more test animals, Mortality of 2 or more test animals, Abnormal behavior in 2 or more test animals | No evidence of systemic toxicity from sample extracts: No weight loss, No death, All test animals appeared normal | Pass |
| Rabbit Pyrogen Study | Sample Extracts must not cause a total rise in body temperature of >= 0.5°C | Non-pyrogenic: No evidence of material-mediated pyrogenicity; no single animal had a total body temperature rise of >= 0.5°C | Pass |
| In Vitro Hemolysis [Extract Method] | Sample extracts must be non-hemolytic (= 10 µm, = 25 µm, = 75 µm, 0 particles >= 125 µm | 100% Must meet Specification | 10 µm - 100% Pass, 25 µm - 100% Pass, 75 µm - 100% Pass, 125 µm - 100% Pass |
| Hub/Catheter Air Aspiration | N=30 | When negative pressure is pulled, no air may leak into hub | 100% Must meet Specification |
| Pressure Test | N=30 | 45 psi for 30 sec MIN | 100% Must meet Specification |
| Benchmark Delivery Catheter / Sheath compatibility (Friction Force) | N=30 | Maximum value per specification | 100% Must meet Specification |
| Benchmark Delivery Catheter / Benchmark Select Catheter compatibility (Friction Force) | N=30 | Maximum value per specification | 100% Must meet Specification |
| Catheter Shaft Tensile Strength (includes all joints) | N=30 | Minimum value per specification | 100% Must meet Specification |
| Hub to Shaft & Hub to Hypotube Bond Strength | N=30 | Minimum value per specification | 100% Must meet Specification |
| Elongation to Failure – Catheter | N=30 | % Elongation >= 5% | 100% Must meet Specification |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For Biocompatibility studies, sample sizes vary by test as detailed in the Biocompatibility table above (e.g., cell culture for cytotoxicity, animal models for sensitization, irritation, systemic toxicity, pyrogen, and some hemocompatibility tests).
- For Bench-top testing, sample sizes are N=10 or N=30 for most tests, as specified in the Bench-top table above.
- No human clinical test set is described or required for this 510(k) submission.
- Data Provenance: The document does not specify the country of origin for the data. All studies are described as "non-clinical" or "bench-top testing." Biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. These are prospective non-clinical laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This 510(k) submission is for a medical device (catheter system) and relies on non-clinical (biocompatibility and bench-top engineering/performance) testing, not on interpretation of medical images or clinical outcomes that would require expert human review for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess data (e.g., medical images) to establish a consensus ground truth. The presented studies are non-clinical engineering and biological tests with objective acceptance criteria.
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
No. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and would not be relevant for this type of medical device (intracranial access system). This submission is for hardware, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device; it's a physical medical device. Performance is evaluated through standard engineering and biological tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical studies is defined by objective, pre-determined acceptance criteria based on established engineering standards and biological safety guidelines (e.g., ISO 10993). Examples include specific thresholds for cell lysis grade, weight loss, temperature rise, particle counts, tensile strength, and pressure resistance.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The studies described are validation tests for device performance and safety.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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).