(173 days)
The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.
The HARBOR Occlusion Device is a self-expanding braided nitinol arterial embolization implant (Figure 1) supplied with components used for implantation (Figure 2). The Device has a radiopaque marker band attached to the proximal end of the implant. The implant is packaged collapsed within an Introducer sheath and attached to a Delivery System provided within a hoop dispenser.
The provided FDA 510(k) clearance letter and summary for the HARBOR Occlusion Device outlines the device's technical specifications and the testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance criteria in relation to human interpretation or outcomes. Therefore, several requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness) are not applicable to the information provided.
However, the document does detail the acceptance criteria (implicitly, "Pass" for each test) and the studies (bench and animal) that prove the device meets these criteria in the context of its substantial equivalence submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly "Pass" for each test listed, indicating that the device must perform acceptably in those areas to demonstrate substantial equivalence.
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Implant Biocompatibility (ISO 10993-1) | Medical Device Chemical Characterization and Extractables and Leachable for Compatibility of Materials (ISO 10993-18) | In accordance with ISO 10993 |
| Implant Hemolysis Test | In accordance with ISO 10993 | |
| Implant Complement Activation Test | In accordance with ISO 10993 | |
| Toxicological Risk Assessment (ISO 10993-17) | In accordance with ISO 10993 | |
| Cytotoxicity (L929 MEM Elution Cytotoxicity Assay) (ISO 10993-5) | In accordance with ISO 10993 | |
| Sensitization (Kligman Maximization Sensitization in Guinea pigs with two extracts) (ISO 10993-10) | In accordance with ISO 10993 | |
| Irritation (Irritation/Intracutaneous Injection Reactivity) (ISO 10993-23) | In accordance with ISO 10993 | |
| Pyrogenicity (Material Mediated Rabbit Pyrogen) (ISO 10993-11) | In accordance with ISO 10993 | |
| Biocompatibility Evaluation Report (ISO10993-1) | In accordance with ISO 10993 | |
| Delivery System & Introducer Sheath Biocompatibility (ISO 10993-1) | Cytotoxicity (L929 MEM Elution Cytotoxicity Assay) (ISO 10993-5) | In accordance with ISO 10993 |
| Sensitization (Kligman Maximization Sensitization in Guinea pigs with two extracts) (ISO 10993-10) | In accordance with ISO 10993 | |
| Irritation (Irritation/Intracutaneous Injection Reactivity) (ISO 10993-23) | In accordance with ISO 10993 | |
| Systemic Toxicity (Acute Systemic Injection with two extracts) (ISO 10993-11) | In accordance with ISO 10993 | |
| Pyrogenicity (Material Mediated Rabbit Pyrogen) (ISO 10993-11) | In accordance with ISO 10993 | |
| Hemocompatibility (ASTM Hemolysis Complete, Indirect Contact) (ISO 10993-4) | In accordance with ISO 10993 | |
| Preclinical Mechanical, Visual, and Bench Testing | Visual/Dimension Inspection | Pass |
| Simulated Use (Preparation/Flush, Introduction, Tracking, Advancement, Kink Resistance, Flexibility, Microcatheter Compatibility, Deployment, Retraction, Detachment, Migration Resistance, Overall Performance) | Pass | |
| Radial Force | Pass | |
| Implant Tensile Strength | Pass | |
| Joint Tensile Strength | Pass | |
| Nickel Ion Release | Pass | |
| Corrosion Resistance | Pass | |
| Magnetic Resonance (MR) Testing | Pass | |
| Radiopacity | Pass | |
| Occlusion Time | Pass | |
| Shelf-Life Study (Products/Packaging) | Pass | |
| Pyrogenicity | Pass | |
| Sterility | Pass | |
| Packaging Validation | Validation per ASTM D4169, ASTM D4332, ASTM F88/F88M, ASTM F2096 | Pass |
| Sterilization Validation | Achieved SAL of 10^-6 | Pass |
| GLP Animal Study | Ease of delivery (friction and tortuosity) | Pass |
| Acute Complications | Pass | |
| Recanalization of the vessels/durability of occlusion | Pass | |
| Local and systemic foreign body reactions | Pass | |
| Device migration | Pass | |
| Effectiveness | Pass |
2. Sample size used for the test set and the data provenance
Test Set Sample Size:
- Bench Tests: Not explicitly stated for each test, but implied to be sufficient for meeting ISO and ASTM standards.
- Animal Study: Not explicitly stated, but the study was described as "GLP Animal Study."
Data Provenance: Not explicitly stated. The document refers to "pre-clinical testing" and "GLP animal study," which are typically conducted in a controlled laboratory environment but the country of origin is not specified. The studies are prospective in nature, as they were conducted specifically for this device's submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes the technical and biological performance of a medical device (an occlusion device) rather than an AI/CADe system or a diagnostic imaging device that would typically involve expert readers for establishing ground truth on image interpretation. The "acceptance criteria" here relate to the device's physical and biological functioning.
4. Adjudication method for the test set
Not applicable. As above, this is not a study assessing observer performance or diagnostic accuracy.
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. This document does not describe an AI-enabled device or an MRMC study. It pertains to a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests is established by:
- Engineering specifications and standards: For bench testing (e.g., specific tensile strength values, radial force, dimensions, nickel ion release limits).
- Biological responses: For biocompatibility tests (e.g., absence of cytotoxicity, irritation, sensitization, pyrogenicity, hemolysis, complement activation as per ISO 10993 standards).
- Physiological and pathological observations in an animal model: For the GLP animal study (e.g., direct observation of delivery, acute complications, vessel recanalization, foreign body reactions, device migration, and effectiveness of occlusion).
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm or system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).