(111 days)
The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.
The Penumbra Catheter 025 is a variable stiffness, coil reinforced catheter with a maximum distal outer diameter of 0.040" and a maximum proximal outer diameter of 0.045". It is available with an inner diameter of 0.025". The Penumbra Catheter 025 has a PTFE-lined lumen, is coil re-enforced, flexible, and hydrophilically coated. The Penumbra Catheter 025 is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve, tip shaping mandrel and introducer sheath. The Penumbra Catheter 025 will be available in various tip configurations including straight, 45°, 90° and J, to allow physician ease of device tracking to the target site. The Penumbra Catheter 025 is sterile, non-pyrogenic and intended for single use only.
The Penumbra Catheter 025 is a medical device and is not an AI/ML device. Therefore, the questions related to AI/ML development (e.g., training set, ground truth experts, effect on human readers) are not applicable.
The acceptance criteria and the study proving the device meets these criteria are detailed in the "Summary of Non-clinical Data" section, which includes Biocompatibility and Design Verification (Bench-Top Testing). The studies conducted for this device were for 510(k) clearance, establishing substantial equivalence to predicate devices, rather than a clinical trial demonstrating efficacy against a specific medical condition.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance." Instead, it lists the tests performed and states that "All tests performed passed successfully." For biocompatibility, specific results are given qualitative descriptions.
| Test Category | Specific Test | Method | Acceptance Criteria (Implied) & Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | L929 MEM Elution Test | Non-cytotoxic / Slight cell lysis or reactivity (Acceptable) |
| Sensitization | Kligman Maximization | Non-sensitizing | |
| Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test | Non-irritant | |
| Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test | Non-toxic | |
| Hemocompatibility - Complement Activation | Complement Activation Test | No greater biological response than corresponding control | |
| Hemocompatibility - Hemolysis | Hemolysis Test | Non-hemolytic | |
| Hemocompatibility - In vivo thrombogenicity | In vivo thrombogenicity Test | Non-thrombogenic | |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test | Non-pyrogenic | |
| Design Verification | Dimensional / Visual Inspection | Not specified (Standard QC) | Passed successfully |
| Trackability | Not specified (Bench-top simulation) | Passed successfully | |
| Friction | Not specified (Bench-top test) | Passed successfully | |
| Torsion | Not specified (Bench-top test) | Passed successfully | |
| Joint Tensile Strength | Not specified (Bench-top test) | Passed successfully | |
| Catheter Burst | Not specified (Bench-top test) | Passed successfully | |
| Catheter Flow Rate | Not specified (Bench-top test) | Passed successfully | |
| Catheter Elongation | Not specified (Bench-top test) | Passed successfully | |
| Kink Resistance | Not specified (Bench-top test) | Passed successfully | |
| Corrosion | Not specified (Bench-top test) | Passed successfully | |
| GLP Simulated Use | Not specified (Bench-top simulation) | Passed successfully |
In summary, the statement "In summary, non-clinical testing found the Penumbra Catheter 025 to be non-cytotoxic, non-mutagenic, non-reactive (short and long-term implantation), non-sensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic)" acts as the overarching reported performance for biocompatibility. For design verification, "All tests performed passed successfully" serves as the reported performance, implying the device met the established acceptance criteria for each test.
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: The document states that "statistical sampling methods as required by the Penumbra Design Control procedures" were used, but it does not specify the exact sample sizes for each test (e.g., how many catheters were tested for burst strength or kink resistance). For biocompatibility, standard animal models or cell cultures are typically used, but specific numbers are not provided.
- Data Provenance: The studies were non-clinical (bench-top and in vitro/in vivo biocompatibility tests, likely animal studies for some bio-tests). No information is provided regarding the country of origin of the data, but the manufacturer is based in Alameda, CA, USA, and the submission is to the US FDA, implying testing was conducted to US regulatory standards. These are prospective tests designed specifically for the device's 510(k) submission.
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)
This question is not applicable. The Penumbra Catheter 025 is a physical medical device, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert medical interpretation or diagnosis is not relevant for this type of device. The "ground truth" for this device would be established by the objective results of the physical and chemical tests (e.g., did it burst at X pressure, did it cause a cytotoxic reaction).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth for AI/ML algorithms where expert consensus on interpretations is required. For this device, the tests have objective pass/fail 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
This question is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML-driven diagnostic tools, not for a physical medical catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This refers to AI/ML algorithm performance, which is not relevant to the Penumbra Catheter 025.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by objective physical, mechanical, and chemical test results. For example:
- Biocompatibility: Laboratory standard assays (e.g., L929 MEM Elution for cytotoxicity, ISO Acute Systemic Injection Test for toxicity), which have defined biological responses or lack thereof as "ground truth."
- Design Verification: Engineering specifications and performance metrics (e.g., a catheter burst at or above a certain pressure, trackability within defined parameters). The "ground truth" is measured and compared against established engineering and safety standards, often derived from predicate devices or industry guidelines.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a physical medical device. Training sets are used in AI/ML model development.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set."
§ 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).