(128 days)
The Smart Coil is indicated for the embolization of:
· Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion in an identical fashion to the Penumbra Coil System. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
The Penumbra Smart Coil is a medical device designed for the embolization of intracranial aneurysms, neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The provided document focuses on demonstrating the substantial equivalence of the Penumbra Smart Coil to predicate devices through a series of non-clinical tests.
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 presents several tables detailing acceptance criteria and results for various non-clinical tests. Due to the extensive nature of these tables, they are summarized below by category. Please refer to the original document for the full detailed tables.
| Test Category | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Biocompatibility | ||
| In vitro Cytotoxicity | Sample extracts must yield cell lysis grade ≤ 2 | Grade: 0 (Non-toxic) |
| Sensitization | Test Group shall yield Grade 10% weight loss in ≥3 animals). | No evidence of systemic toxicity (No deaths, no toxic signs, no weight loss >10% in any animals - Non-toxic) |
| Material Mediated Pyrogen | Sample extracts must not cause a total rise in body temperature of ≥ 0.5° C | Non-pyrogenic: no animals had a temperature rise ≥ 0.5°C |
| Sub-Chronic Toxicity | Parameters (death, body weight change, clinical signs, hematology, histopathology) will be reviewed for patterns of toxicity. | Negative for systemic toxicity (No deaths, no significant differences in body weights, no abnormal clinical signs, no patterns of toxicity in hematology or histopathology - Non-toxic) |
| Hemocompatibility (Thrombosis) | Device must be non-thrombogenic after 4 hours in vivo when compared to a predicate device. | Test device was not thrombogenic when compared to the predicate; exhibited acceptable interaction with blood (Non-hemolytic) |
| Hemocompatibility (Coagulation - PT & PTT) | Coagulation times must be similar to the predicate or negative control values using analysis of variance. | Test article coagulation times are statistically similar to the predicate (p-value=1.000 for PT, p-value=0.105 for PTT) |
| Hemocompatibility (Hemolysis) | Sample extracts must be nonhemolytic (≤2% hemolytic index). | Nonhemolytic (Hemolytic index ≤ 1.25%, Corrected hemolytic index ≤ 0.40%) |
| Hemocompatibility (Complement Activation) | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to or lower than the predicate. | C3a = similar at all time points; SC5b-9 = lower at 30, 60 minutes / similar at 90 minutes. |
| Genotoxicity (Ames, Mouse Lymphoma, Mouse Micronucleus) | Sample extracts must be non-mutagenic. | Non-mutagenic |
| Bench-top Testing | ||
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable product). | Pass |
| Simulated Use/Detachment Reliability | Units meet all inspection criteria for release of finished goods (clinically acceptable product). | Pass |
| Fatigue Testing | The Coil Implant shall retain its secondary shape after being cycled into/out of introducer sheath 5 times. | Pass |
| Torsion Resistance | The Coil Implant can be subjected to 8 turns minimum. | Pass |
| Corrosion Resistance | No visible corrosion after testing. | Pass |
| Friction Testing | Push/pull friction acceptable through a 0.0165 in. ID microcatheter. | Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient tensile strength. | Pass |
| Coil Dimensional Inspection (after simulated use testing) | Units withstood the simulated use testing. | Pass |
| Sterilization | Identical acceptance criteria and testing methods as the predicate device (in accordance with EN ISO 11135-1:2007). | Tested to be sterile. |
| Shelf Life | Minimum one year shelf life (using identical acceptance criteria and testing methods as the predicate device, in accordance with ASTM D4169:2009 and ASTM F2096:2004). | Tested to have a minimum one year shelf life. |
| MR Environment | Standards ASTM F2182-11, ASTM F2052-06, ASTM F2213-06, and ASTM F2119-07 (R 13) | Tested in the MR environment to advise the MR Conditional statement in the IFU. (Implies satisfactory performance for MR safety labeling) Specific performance values not in given text. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical testing (bench-top and in vitro/animal studies) for biocompatibility, physical/mechanical properties, sterilization, and shelf life.
- Sample Size: The exact sample sizes for each specific test are not explicitly stated in the summary. For example, for the systemic toxicity test, it mentions "Death in 2 or more animals" as an acceptance criterion, but not the total number of animals tested. The biocompatibility tests refer to "samples," "test articles," "animals," and "groups."
- Data Provenance: Not applicable in the context of clinical data for a device intended for human use. The studies are non-clinical (laboratory and animal studies). The document does not specify the country of origin for the non-clinical data, but it is submitted to the U.S. FDA by a U.S.-based company (Penumbra, Inc., Alameda, CA, USA). The studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices, which are US federal regulations.
- Retrospective/Prospective: These non-clinical studies are inherently prospective in their design, meaning they were planned and executed to evaluate the device's properties.
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 to the provided document. The studies described are non-clinical (biocompatibility, mechanical testing, etc.) and do not involve human subjects or expert clinical evaluation to establish a "ground truth" for diagnostic or treatment efficacy. The "ground truth" for these non-clinical tests would be the measured physical, chemical, or biological responses against predefined scientific or regulatory standards. For example, in histopathology for implant studies, a pathologist would interpret slides, but their role is to report observations against scientific criteria, not establish a "ground truth" for a clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process where multiple clinical readers (e.g., radiologists) review cases and a discrepancy resolution method is employed, often involving a super-reader. The studies described are non-clinical and do not involve human clinical readers or case 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
This question is not applicable. The Penumbra Smart Coil is a physical neurovascular embolization device, not an AI-powered diagnostic or assistive tool for human readers. The document describes non-clinical testing of the device's material properties, mechanical performance, and biological safety, not its impact on human reader performance in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Penumbra Smart Coil is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical studies are established by:
- Scientific and regulatory standards: e.g., EN ISO 10993 for biocompatibility, ASTM standards for material testing, EN ISO 11135-1 for sterilization.
- Measured physical/chemical properties: e.g., tensile strength, corrosion presence, hemolytic index.
- Biological responses in controlled in vitro or animal models: e.g., cell lysis grade, sensitization scores, animal physiological responses, histopathological findings.
- Comparison to predicate devices: For several tests (e.g., hemocompatibility, sterilization, shelf life), performance is compared to or demonstrated using methods identical to predicate devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of physical medical device testing for 510(k) clearance, as this is not a machine learning or AI device. The document describes pre-market non-clinical validation studies.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8. No "training set" exists for this type of device submission.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).