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510(k) Data Aggregation
(64 days)
Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
Lantern Delivery Microcatheter is a single lumen intravascular catheter designed to aid physician in accessing distal vasculature. When used in conjunction with a guide catheter and guide wire, Lantern provides access to the target site. Once in place it provides a reinforcing conduit for other intravascular devices.
This document describes the Lantern™ Delivery Microcatheter and its substantial equivalence to a predicate device. The information provided focuses on the non-clinical data, specifically biocompatibility and bench-top testing, to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|
| In vitro Cytotoxicity (MEM Elution) | Sample extracts must yield cell lysis grade $\le$ 2 | Grade: 1 (slight) - Met |
| Sensitization (Magnusson-Kligman Method) | Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided Control Grade < 1) | Non-sensitizing - Met |
| Irritation (Intracutaneous Reactivity) | The difference in the mean test article and mean control score must be grade 1.0 or lower | Non-irritant - Met |
| Systemic Toxicity (Acute) (Acute Systemic Injection) | Sample extracts must not cause significant biological reaction greater than control. That is: Death in 2 or more animals Toxic signs (i.e. convulsions, prostration) Weight loss > 10% in 3 or more animals | Non-toxic - Met |
| Material Mediated Rabbit Pyrogen | Sample extracts must not cause a total rise in body temperature of $\ge$ 0.5° C | Non-pyrogenic - Met |
| Hemolysis – Indirect Contact | Sample extracts must be nonhemolytic ($\le$ 2% hemolytic index) | Non-hemolytic - Met |
| Complement Activation | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate control and statistically lower than the positive control for all exposure times | No greater biological response than corresponding control - Met |
| Thrombosis (Dog Thrombogenicity) | Device must be non-thrombogenic after 4 hours in vivo when compared to control device | Non-thrombogenic - Met |
| Bench-top Testing (various tests) | All predetermined requirements (specific criteria not detailed for each individual test in the document) | All established acceptance criteria were met. All testing met specification. - Met |
| Pyrogenicity (LAL validation) | < 2.15 EU/device | < 2.15 EU/device - Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily references biocompatibility testing performed on the predicate device to substantiate the biocompatibility of the Lantern™ Delivery Microcatheter. For bench-top testing, devices "assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle" were used.
- Sample Size: Not explicitly stated for each test beyond "devices" or "three lots of the longest effective length modified predicate" for LAL validation.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted "pursuant to 21 CFR, Part 58, Good Laboratory Practices."
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 device is a physical invasive medical device (microcatheter) and the testing described is primarily non-clinical (biocompatibility and bench-top engineering tests). There is no indication that "experts" were used to establish ground truth in the context of interpreting medical images or clinical outcomes for a test set, as this is not a diagnostic AI device. The "ground truth" for these tests comes from established laboratory standards and measurement techniques.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring reader adjudication for ground truth.
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 not an AI/diagnostic device, and no MRMC comparative effectiveness study involving human readers or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests (biocompatibility, bench-top mechanical testing, sterilization, shelf life) is based on:
- Established scientific and regulatory standards: e.g., EN ISO 10993-1 guidelines for biocompatibility, 21 CFR, Part 58 Good Laboratory Practices, EN ISO 10555-1:2013 for intravascular catheters, EN ISO 11135-1:2014 for sterilization.
- Direct measurements and observations: In-vitro and in-vivo test results against predefined thresholds.
- Comparison to a predicate device: For many tests, the new device needed to perform equivalently or better than the predicate.
8. The sample size for the training set
Not applicable. There is no AI component or "training set" in the context of this device. The development of the device would involve engineering design and iterative testing, but not a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this device.
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