(29 days)
The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The Stryker Neurovascular InZone Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.
Here's an analysis of the provided text regarding the acceptance criteria and study for the InZone® Detachment System:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is a Special 510(k) for firmware modifications to an already cleared device (K103008). Therefore, the "acceptance criteria" discussed are primarily related to verifying the impact of these changes and demonstrating substantial equivalence, rather than establishing initial performance benchmarks for a new device.
The document lists "Physical and Performance Characteristics" that describe the device, but these are not explicitly presented as "acceptance criteria" with quantitative targets and reported performance. Instead, the "Verification Testing" section outlines the types of tests performed to confirm the modifications did not negatively impact the device or raise new safety/effectiveness questions.
| Characteristic / Acceptance Criterion (Implicit) | Reported Device Performance / Assessment |
|---|---|
| Firmware Functionality (General) | Software (firmware) test case model and bench top testing conducted. |
| Delivery Wire Detection | Assessed via software (firmware) test case model and bench top testing. (Goal: Reduce wire type detection time compared to predicate) |
| Maximum Detachment Time | Assessed via software (firmware) test case model and bench top testing. |
| Detachment Consistency | Assessed via software (firmware) test case model and bench top testing. |
| Detachment Attempts (Full Cycle vs. Less-than-Full Cycle) | Assessed via software (firmware) test case model and bench top testing. (Goal: Differentiate between these and increase first cycle detachment success for Target coils) |
| Labeling Changes | Assessed and verified. |
| Software Verification | Performed in accordance with Stryker Neurovascular Corporate SOP for Medical Device Software Development. |
| Risk Assessment | Conducted in accordance with ISO 14971:2009 using DFMEA. (Conclusion: No new questions of safety or effectiveness raised by modifications) |
| Impact on Sterility Assurance | Assessed, determined to have no impact. |
| Impact on Shelf Life | Assessed, determined to have no impact. |
| Impact on Packaging Validation | Assessed, determined to have no impact. |
| Substantial Equivalence | Device materials, design, and performance technology compared to predicate. Modifications do not alter intended use/indications or fundamental scientific technology. Verification testing (bench top and firmware test cases) and risk assessment concluded substantial equivalence to K103008, raising no new questions of safety and effectiveness. (Implicit acceptance: Device functions as intended for detachment without introducing new risks or compromising existing performance standards). |
2. Sample Size for the Test Set and Data Provenance
The document provides no specific sample sizes for "test sets" in the traditional sense of clinical or even large-scale performance testing using patient data. The verification testing described is primarily bench-top and firmware test case modeling.
- Sample Size: Not specified quantitatively. The text refers to "software (firmware) test case model" and "bench top testing." This typically implies a systematic set of tests covering various scenarios and parameters, but not a large statistical sample of physical units or clinical cases. For a firmware change, test cases would be numerous but not necessarily represent a "sample size" in the conventional sense.
- Data Provenance: Not applicable as it's not a clinical study. The testing is internal to Stryker Neurovascular ("bench top") and software-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study involving human interpretation of data where ground truth would be established by experts. The "ground truth" for firmware and bench testing would be the expected functional behavior and performance defined by the design specifications.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of an adjudication method as no expert-derived ground truth or human assessments were involved. The testing is objective and based on engineering verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe any MRMC comparative effectiveness study. It's a technical submission for firmware modifications to a detachment system, not an imaging-based AI diagnostic device requiring human reader assessment studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in essence. The verification testing conducted (software/firmware test case model and bench top testing) assesses the device's performance in a standalone manner. The device, which automates a detachment process based on embedded firmware, acts as an "algorithm only" system in this context. The study did not involve human-in-the-loop performance modification.
7. The Type of Ground Truth Used
The ground truth used for this type of verification testing is based on:
- Design Specifications: The intended behavior and performance parameters defined during the device's design and development.
- Predicate Device Performance: The established and cleared performance of the original InZone Detachment System (K103008). The firmware modifications aim to improve specific aspects (e.g., wire detection time, detachment success for Target coils) while maintaining overall safety and effectiveness.
- Industry Standards: Compliance with relevant standards like ISO 14971:2009 for risk management.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI algorithm in the context of data training. The "firmware" is a program with predefined logic and parameters, not something that "learns" from a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of firmware update.
§ 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).