(59 days)
The InZone™ Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Boston Scientific's InZone™ Detachment System is a sterile, handheld, single-patient use device designed for use with Boston Scientific 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.
The provided text describes Boston Scientific's InZone Detachment System, which is intended for use with detachable coils for embolization procedures. This document details a 510(k) premarket notification for modifications to an already cleared device, not an initial market clearance study. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel acceptance criteria through a comprehensive clinical study.
Given the nature of the submission (modifications to an existing device), the "acceptance criteria" primarily relate to the functional performance of the modified components and ensuring that the modifications do not negatively impact the safety and effectiveness of the device compared to the predicate. The "study" proving this largely consists of verification testing.
Here's an attempt to extract and present the information as requested, acknowledging the limitations of the provided document in the context of a typical standalone clinical study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a new device's clinical performance. Instead, the focus is on functional verification that the modified device still performs as intended and is substantially equivalent to its predicate. The "performance" reported is primarily the successful completion of these verification tests and the unchanged fundamental scientific technology.
| Acceptance Criteria (Implied from Verification Testing) | Reported Device Performance |
|---|---|
| Functional Operation at Start-up: The device powers on and initiates sequence correctly. | Verification testing of the modified InZone Detachment System included "Functional testing to assess proper operation of the InZone device at start-up". Implied successful performance. |
| Proper Detachment of Boston Scientific Detachable Coils: The device successfully facilitates the electrolytic detachment of coils. | Verification testing included "Functional testing... in the detachment of Boston Scientific Detachable Coils." Implied successful performance. |
| Software Integrity & Functionality: Firmware modifications operate correctly and adhere to software lifecycle processes. | "Software verification in accordance with Boston Scientific's Corporate SOP for Medical Device Software Development and in accordance with AAMI/ANSI/IEC 62304:2006." Implied successful performance. |
| Risk Assessment: Modifications do not introduce new or unacceptable risks. | "Risk assessment in accordance with EN ISO 14971:2009" and "design and use FMEAs... demonstrated the modifications raise no new questions of safety or effectiveness." |
| No Impact on Sterility Assurance: Sterilization method remains effective. | "Assessment of the modifications for impact upon: Sterility Assurance (no impact)." |
| No Impact on Shelf Life: Device shelf life remains unchanged. | "Assessment of the modifications for impact upon: Shelf Life (no impact)." |
| No Impact on Packaging Validation: Packaging integrity remains valid. | "Assessment of the modifications for impact upon: Packaging Validation (no impact)." |
| Continued Compliance to Standards: Device continues to meet relevant standards. | "Assessment of the modifications for impact upon: Compliance to standards." |
| Signal Detachment Changes (firmware update): Device correctly signals detachment in the revised manner. | Firmware modified to "change the way the InZone unit signals detachment." Implied successful verification during functional testing. |
| Grounding Indicator Changes (firmware update): Device correctly signals proper grounding for GDC and Matrix2 coils in the revised manner. | Firmware modified to "change the way the InZone device's grounding indicator signals proper grounding." Implied successful verification during functional testing. |
| Reduced Detachment Cycle Times (firmware update): Device achieves reduced detachment times. | Firmware modified to "reduce detachment cycle times." Implied successful verification during functional testing. |
| Smoother Coil Wire Placement: Modified cone/wire guide facilitates easier placement. | "the device's cone/wire guide component was modified to facilitate smoother placement of the InZone unit over detachable coil delivery wires." Implied successful verification during functional testing/design validation. |
| Substantial Equivalence: Overall device performance remains substantially equivalent to the predicate. | "Verification testing of the modified InZone Detachment System has demonstrated the device to be substantially equivalent to the predicate InZone Detachment System cleared under K093142." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The verification testing mentioned (functional testing, software verification) would have involved specific numbers of devices, components, and possibly simulated detachments. This is a technical (benchtop and software) verification, not a clinical trial.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from internal Boston Scientific verification testing, software analysis, and risk assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. Given that the study is primarily device verification (functional, software, risk assessment) rather than a clinical study requiring expert interpretation of patient data, formal "ground truth" established by external clinical experts would typically not be a primary component. Internal engineering and quality assurance personnel would be involved in assessing the verification test results against design specifications.
4. Adjudication Method for the Test Set
- Not applicable. This was not a study requiring adjudication of expert interpretations of medical images or patient outcomes.
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 describes a medical device (a coil detachment system that is a power supply), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. While it has firmware (an "algorithm"), its performance is always in conjunction with human use during a medical procedure, albeit as a tool rather than an interpretive system. A standalone "algorithm only" performance study, as understood in diagnostic AI, is not applicable.
7. The Type of Ground Truth Used
- For the verification testing described, the "ground truth" would be the engineering design specifications and expected functional performance parameters of the device. For example, successful detachment (yes/no), correct LED signal behavior, proper grounding detection, and adherence to software requirements. It does not involve "expert consensus, pathology, or outcomes data" in the clinical sense for this specific submission.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "firmware" is programmed based on engineering design, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set." The software/firmware's "ground truth" is defined by its design specifications and functional requirements established during the device's development process.
§ 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).