(103 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.
Stryker Neurovascular's 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 InZone Detachment System, focusing on acceptance criteria and the supporting study:
The provided document (K212455) is a 510(k) summary for modifications to the InZone Detachment System. It does not describe a study involving human readers or AI. Instead, it focuses on bench testing and software verification to demonstrate substantial equivalence to a predicate device after firmware modifications. The device is a medical instrument used for detaching coils in neurovascular procedures, not an AI or imaging diagnostic tool. Therefore, many of the requested points related to AI, ground truth establishment, expert consensus, and MRMC studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly treats the successful completion of the listed verification tests as meeting acceptance criteria, demonstrating the modified device functions as intended and is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Firmware Functionality: | Verification testing of the modified InZone Detachment System consisted of the following: |
| • Software (firmware) test case model as well as bench top testing to assess: | |
| a) detachment cycle time | |
| b) maximum detachment time | |
| c) detachment consistency | |
| d) detection consistency | |
| e) max voltage output | |
| f) max current output | |
| g) low battery detection | |
| h) fault detection at power up | |
| i) over voltage and over current detection | |
| j) data storage and retrieval capability | |
| k) delivery wire compatibility and detection | |
| l) button activation | |
| m) audio and visual signals | |
| • Software verification in accordance with EN 62304 and Stryker Neurovascular Design and Development Planning SOP. | |
| (The document states these tests were successfully completed, indicating the performance met the criteria.) | |
| Risk Management: | • Risk assessment in accordance with ISO 14971 and Stryker Neurovascular Risk Management Planning SOP. |
| • Design failure modes and effects analysis (DFMEA) was conducted. | |
| (Result: "Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.") | |
| Impact on Other Device Aspects: | • Assessment of the modifications for impact upon: |
| Electrical Safety (no impact) | |
| Electromagnetic Compatibility (no impact) | |
| Sterility Assurance (no impact) | |
| Shelf Life (no impact) | |
| Packaging Verification (no impact) | |
| Packaging Shelf Life (no impact) | |
| Substantial Equivalence: | • "Verification testing of the modified InZone Detachment System has demonstrated the device to be substantially equivalent to the predicate InZone Detachment System cleared under K160096." |
| Minimum Number of Detachments: | • The device should be capable of a "Minimum of 20 detachments." |
| (Although not explicitly stated as a test result, this is a listed characteristic, implying it was verified.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily bench-top testing of the device's firmware and physical characteristics. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in the clinical sense. The "test cases" for software and bench-top testing would refer to specific scenarios and conditions the device was put through. The number of iterations or specific samples for each bench test (e.g., how many coils were detached for detachment consistency) is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. This device is an instrument, not an AI diagnostic tool requiring expert interpretation of medical data for ground truth. Ground truth for the device's functionality would be established by engineering specifications, proper electrical readings, and functional verification, typically performed by engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in the context of expert review. The device's performance is objectively measured against engineering specifications.
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 study was performed. The device is a tool used by interventionalists, and the study focuses on its functional performance, not its impact on human reader effectiveness for diagnosis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the "algorithm" being its firmware). The "Verification Testing" detailed in the table above is a standalone assessment of the device's performance. It evaluates the device's ability to perform its functions (detachment, detection, safety features) without human intervention beyond initiating the process.
7. The Type of Ground Truth Used
The ground truth used for the verification testing (standalone performance) is based on engineering specifications and expected functional outcomes. For example:
- Detachment cycle time: Should fall within a defined range.
- Max voltage/current output: Must not exceed specified limits.
- Low battery detection: Must accurately signal when battery is low.
- Fault detection: Must correctly identify and signal specified faults.
- Delivery wire compatibility and detection: Must correctly identify and interface with different coil types.
These ground truths are derived from existing design requirements, safety standards (e.g., ISO 14971, EN 62304), and the established performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI system that undergoes "training" with data in the conventional machine learning sense. Its firmware is programmed based on design specifications and engineering principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's design and programming comes from established medical device standards, functional requirements for electrolytic detachment, and the performance characteristics of the previously cleared predicate device.
§ 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).