(153 days)
- The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
- The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.
The ORBIT GALAXY™ Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and a stretch resistant embolic coil. The delivery tube and coil introducer of the ORBIT GALAXY™ Detachable Coil System are identical to the delivery tube and coil introducer of the TRUFILL DCS ORBIT™ Detachable Coil System. The delivery tube is the body of the device and functions as a guidewire and a mini infusion catheter. The coil introducer is designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The coil is the implantable segment of the device. It is comprised of a platinum alloy wire and integrates a stretch resistant polymer monofilament through the inner diameter of the coil.
The TRUFILL® DCS Syringe II (sold separately) is required to properly purge and detach the coil. The coil is detached from the delivery tube by a proprietary hydraulic release mechanism.
The ORBIT GALAXY™ Detachable Coil System is packaged inside a protective dispenser tube. The product is held in place by means of a hub-to-dispenser tube clip. The entire system is packaged inside a sealed protective pouch. A luer valve is provided with the system if the user prefers to remove the syringe from the hub of the delivery tube after purging and prior to detaching the coil. The luer valve is attached to the packaging dispenser with a clip.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a medical device, the ORBIT GALAXY™ Detachable Coil System, seeking 510(k) clearance. For this type of device, acceptance criteria are primarily demonstrated through equivalence to a predicate device and a series of bench, in-vivo, and in-vitro tests rather than a single, overarching performance metric like accuracy or sensitivity often seen in AI/diagnostic devices. The key "acceptance criteria" here relate to meeting the same specifications and safety profiles as the predicate.
| Test Category / Criterion | Acceptance Criteria (typically "Met same specifications as predicate" or "Met the acceptance criteria for the proposed device") | Reported Device Performance |
|---|---|---|
| Bench Tests: | ||
| Embolic Coil Length Verification | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Diameter Verification | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Shape Visual Inspection | Met same specifications as predicate | Met same specifications as predicate |
| Headpiece Length Verification | Met same specifications as predicate | Met same specifications as predicate |
| Coil Softness | Met same specifications as predicate | Met same specifications as predicate |
| Stretch Resistance Strength | Met the acceptance criteria for the proposed device | Met the acceptance criteria for the proposed device |
| Headpiece Attachment Strength | Met same specifications as predicate | Met same specifications as predicate |
| Atraumatic Bead Visual Inspection | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Placement Stability – In-vitro High Flow | Implied: Demonstrate stability. (Note: Xtrasoft coils are finishing coils for intracranial aneurysms only) | Xtrasoft coils are finishing coils indicated for embolizing intracranial aneurysms only. (This is a statement of intended function/limitation, not a direct performance result for stability test, but implies it meets the intended purpose for these coils). |
| Embolic Coil Attachment Strength | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Detachment Pressure | Met same specifications as predicate | Met same specifications as predicate |
| Luer Valve Burst Test | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Radiopacity | Met same specifications as predicate | Met same specifications as predicate |
| Embolic Coil Protrusion | Met same specifications as predicate | Met same specifications as predicate |
| Coil Conformability | Met same specifications as predicate | Met same specifications as predicate |
| Coil Placement Stability | Met same specifications as predicate | Met same specifications as predicate |
| Packing of Embolic Coils | Met same specifications as predicate | Met same specifications as predicate |
| Retrievability of Embolic Coils | Met same specifications as predicate | Met same specifications as predicate |
| Deliverability through a Microcatheter | Met same specifications as predicate | Met same specifications as predicate |
| Pushability | Met same specifications as predicate | Met same specifications as predicate |
| Ability to Purge Product with Accessory Valve | Met same specifications as predicate | Met same specifications as predicate |
| Biocompatibility Tests: | Meet ISO 10993 Part 1 and G95-1 requirements | All tests indicated "Non-cytotoxic," "Non-sensitizing," "Non-irritant," "Non-toxic," "Non-pyrogenic," "Non-mutagenic," "Non-clastogenic," "Non-hemolytic," "Pass" for platelet/leukocyte count, "Non-activator of complement activation pathways," "well tolerated," and "Passed" for aqueous extraction. |
| In-vivo and In-vitro Simulated Use Tests: | Adequately address user needs and evaluate coil performance for aneurysm treatment. | Performed in a porcine model and in an in-vitro aneurysm model. Specific performance metrics are not detailed but the summary implies they were successful. |
2. Sample Sizes and Data Provenance:
- Bench Tests: The document lists "Coils Tested" for each bench test, including "Xtrasoft," "Fill," and "Frame." It doesn't specify the number of coils tested for each type for each criterion.
- In-vivo Simulated Use Test: Conducted in an "in-vivo porcine model." The number of animals is not specified.
- In-vitro Simulated Use Test: Conducted in an "in-vitro aneurysm model." The number of models or tests is not specified.
- Biocompatibility Tests: Sample sizes are not explicitly stated for individual tests (e.g., number of guinea pigs, mice, or rabbit implants), but the conclusion is that the requirements were met.
- Data Provenance: The document does not specify country of origin for the data. All studies are described as "in-vitro laboratory bench top testing," "in-vivo and in-vitro simulated use test," and "biocompatibility testing," implying prospective studies conducted for this submission.
3. Number of Experts and Qualifications:
The document does not mention the involvement of experts to establish ground truth or review data in the context of diagnostic performance, as this device is an embolization coil and not a diagnostic AI device. The evaluation is based on engineering specifications, biocompatibility standards, and simulated use.
4. Adjudication Method:
Not applicable. This is not a diagnostic device involving expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as this is an embolization coil, not an AI-assisted diagnostic tool for human readers. There is no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's acceptance is based on:
- Pre-defined engineering specifications and manufacturing tolerances.
- Compliance with established biocompatibility standards (ISO 10993 Part 1, G95-1).
- Demonstration of performance in simulated use environments (in-vitro aneurysm models, in-vivo porcine models) against expected functional outcomes.
- Substantial equivalence to a legally marketed predicate device (TRUFILL® DCS ORBIT™ Detachable Coil System) as the primary benchmark.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 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).