(30 days)
Boston Scientific's InZone™ Detachment System is intended for use with all versions of BSC 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 preloaded with two AAAA (1.5 VDC) batteries.
Boston Scientific's IZDSTM Connecting Cable is a 180 cm cable intended for use with the InZone Detachment System in the detachment of Boston Scientific's GDC® Detachable Coils and Matrix2® Detachable Coils. The cable completes the connection between the InZone unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.
The provided 510(k) summary for the Boston Scientific InZone™ Detachment System and IZDS™ Connecting Cable (K092666) does not contain a typical "study" that would prove device performance against numerical acceptance criteria. Instead, it relies on a demonstration of substantial equivalence to a previously cleared predicate device (K021494).
Here's an analysis based on the provided text, addressing your specific points:
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use/Indications for Use | The new device must have the same intended use and indications for use as the predicate device. | "Boston Scientific's InZone™ Detachment System has the same intended use and indications for use as the current legally marketed predicate device." (K021494) and "Intended use and indications for use are the same as for the predicate device." |
| Fundamental Scientific Technology | The modifications (materials, firmware, packaging, IFU) must not alter the fundamental scientific technology of the predicate device. | "Although the InZone Detachment System incorporates modifications in materials, firmware, packaging, and instructions for use, the modifications do not alter the fundamental scientific technology of the predicate device." and "The modifications that have been made that have resulted in the IZDS Connecting Cable do not alter the fundamental scientific technology of the predicate connecting cable." |
| Safety and Effectiveness | Modifications must not raise new questions of safety or effectiveness. | "Risk assessment of the modifications... has been conducted... Boston Scientific has determined the modifications to the predicate device raise no new questions of safety or effectiveness." and "successful verification testing raise no new questions of safety and effectiveness." |
| Materials and Components | Materials and components should be similar to the predicate, and verification testing should demonstrate substantial equivalence. | "The materials and components of the InZone unit consist of polymers, screws, resistors, capacitors and other electronic components. Components are similar to those used in the construction of the predicate device. Verification testing has demonstrated the InZone device to be substantially equivalent to the current legally marketed predicate device." |
| Firmware | Firmware should be similar to the predicate, and a level of concern assessment should be consistent. Verification testing should demonstrate substantial equivalence. | "The firmware of the InZone™ Detachment System is similar to that used in the operation and control of the predicate device. A level of concern assessment has determined the InZone firmware to be the same level of concern as for the predicate device. Verification testing has demonstrated the InZone device to be substantially equivalent to the current legally marketed predicate device." |
| Packaging | Packaging modifications for size and sterility must be validated. Verification testing should demonstrate substantial equivalence. | "Packaging modifications have been made to accommodate the different size of the InZone unit as well as the fact that the device is to be provided as a sterile unit. Verification testing, including validation of the sterilization process, has demonstrated the InZone device to be substantially equivalent to the current legally marketed predicate device." |
| Electrical Safety | Device must meet applicable electrical safety standards. | "Verification testing of the InZone Detachment System and IZDS Connecting Cable, including electrical safety testing in accordance with applicable parts of the EN 60601-series of standards, has demonstrated the devices to be substantially equivalent to the predicate device." |
| Risk Assessment | Risks associated with modifications should be identified and assessed. | "Risk assessment of the modifications, in the form of design and use failure modes and effects analysis (design and use FMEAs), has been conducted in accordance with EN ISO 14971 +A1:2003." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly mention a "test set" in the context of clinical data or comparative performance against specific metrics. The testing referred to is primarily verification testing (e.g., electrical safety, material compatibility, firmware function, sterilization validation). These are engineering and quality assurance tests, not typically clinical trials with 'test sets' of patient data. Therefore, details like sample size for clinical data or data provenance are not applicable or provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the submission focuses on substantial equivalence through verification testing and risk assessment rather than a clinical study requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring expert adjudication is described.
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 MRMC comparative effectiveness study was conducted or described. This device is an electro-mechanical system for detaching coils, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm, but a hardware system used by a clinician during a medical procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the verification testing, the "ground truth" would be established engineering specifications, safety standards (e.g., EN 60601), and the performance characteristics of the predicate device. It's not clinical "ground truth" in the sense of gold-standard diagnoses or patient outcomes.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 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).