(27 days)
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Target Coils are indicated for endovascular embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature
Stryker Neurovascular's (Boston Scientific) Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Stryker Neurovascular's InZone™ Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy.coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops. The coils are designed to be delivered and deployed under fluoroscopic guidance. Once placement in the anatomy. is appropriate, the coil is detached from the delivery wire through the use of the battery-operated power supply. This is accomplished by means of an electrolytic reaction where the anode is the delivery wire and the cathode (or ground) is the return electrode. The body's electrolytes serve as an electrolytic carrier between the two electrodes. The cross section of the stainless steel delivery wire and coil junction is designed in such a manner that when current is applied to the wire, the current causes the exposed stainless steel at the junction to dissolve due to electrolysis, which subsequently disconnects the wire from the coil material. The design of coils allows the electrolytic dissolution to occur only in the detachment zone. Once circuitry in the power supply detects coil detachment, the power supply emits audible beeps signaling detachment and the flow of current is halted. Using fluoroscopy, the physician verifies that the coil has detached and removes the delivery wire without disturbing the newly placed coil. In order to achieve optimum occlusion, it is usually necessary to deploy multiple coils at a single embolization site. The coil properties, namely, the secondary coil shape and stiffness, in concert with each other, impact conformability and optimal packing of the coils in the aneurysm sac. These properties help the coil conform to the contours of the space within which it is deployed. It is important that the coil is able to do this without disrupting the rest of the coil mass. In addition, the coil stretch resistance incorporates an element to help it resist stretching or unraveling under the typical forces exerted upon it during deployment and retraction. Stryker Neurovascular's (Boston Scientific) InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The provided document is a 510(k) summary for a medical device (Target Detachable Coils) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, much of the requested information regarding acceptance criteria, study design for AI models, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies is not applicable or not present in this type of submission.
However, I can extract the relevant information from the document as it pertains to the device's verification testing and regulatory acceptance:
1. Table of acceptance criteria and the reported device performance
The document describes "Verification Testing" for the Target Detachable Coils, primarily to demonstrate that modifications do not alter safety or effectiveness, and that the device remains substantially equivalent to predicate devices. The acceptance criteria are implicitly met by successful completion of these tests, which were previously approved for predicate devices (K102672 and K112385).
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance (Implicit from Successful Testing) |
|---|---|
| Maintain Main Junction Tensile Strength | Met (Functional testing completed) |
| Maintain Delivery Wire Tensile Strength | Met (Functional testing completed) |
| Maintain Coil Detachment Time | Met (Functional testing completed) |
| MR Compatibility: Magnetically induced displacement (ASTM F2052) | Met (Testing completed, DFU revised for comprehensive MR Conditional statement) |
| MR Compatibility: Magnetically induced torque (ASTM 2213) | Met (Testing completed) |
| MR Compatibility: Magnetically induced heating effect (in 1.5 T and 3 T MR systems - ASTM F2182) | Met (Testing completed) |
| MR Compatibility: MR induced image artifact (ASTM F2119) | Met (Testing completed) |
| Post-implant MR artifact data | Provided (Pre-clinical testing completed) |
| Assessment in coiled aneurysm models | Comparable to control coils (Pre-clinical testing completed) |
| Biocompatibility: MEM Elution Cytotoxicity (EN ISO 10993-5:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Hemolysis (EN ISO 10993-4:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Direct Contact | Met (Confirmatory testing completed) |
| Biocompatibility: USP Physico-Chemical | Met (Confirmatory testing completed) |
| Biocompatibility: Sensitization, Guinea Pig Maximization (EN ISO 10993-10:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Intracutaneous Reactivity (EN ISO 10993-10:2010) | Met (Confirmatory testing completed) |
| Biocompatibility: Acute Systemic Injection (EN ISO 10993-11:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Rabbit Pyrogen, Materials Medicated (EN ISO 10993-11:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Partial Thromboplastin Time (EN ISO 10993-4:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: In Vitro Hemocompatibility (EN ISO 10993-4:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Complement Activation (EN ISO 10993-4:2009) | Met (Confirmatory testing completed) |
| Biocompatibility: Latex Testing (ASTM D6499-07) | Met (Confirmatory testing completed) |
| Assess new grade stainless-steel | Assessed by Corporate Toxicology group |
| Coil / Catheter Compatibility | Met (Functional testing completed) |
| Product Removal from the Flushing Dispenser Coil | Met (Functional testing completed) |
| Packaging Verification to protect finished device | Met (Testing completed) |
| Shelf Life Testing for protection after climatic conditioning/distribution simulation | Met (Testing completed) |
| Design Validation: Physician assessment of new introducer sheath/retention clip to protect device | Acceptable (Physician evaluation completed) |
| Design Validation: Physician assessment of acceptable introducer sheath friction | Acceptable (Physician evaluation completed) |
| Design Validation: Physician assessment of proper hydration within new introducer sheath | Acceptable (Physician evaluation completed) |
| Design Validation: Physician assessment of easy removal from dispenser coil | Acceptable (Physician evaluation completed) |
| Physician evaluation of revised DFU for clarity, legibility, ease of reading | Clear, legible, easy to read (Physician evaluation completed) |
| Risk assessment of modifications (design and use FMEAs) | No new questions of safety or effectiveness raised (EN ISO 14971 +A1:2003) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each test set. The provenance of the data is generally from laboratory testing and pre-clinical animal models (for MR artifact), as well as physician evaluations. This is a 510(k) submission for a physical medical device, not an AI/ML software. Therefore, the concept of "test set" in the context of an AI model does not apply directly. The testing described is primarily in vitro and pre-clinical.
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)
For the "Design Validation testing," the document states "a physician assessed the new introducer sheath and new retention clip." It does not specify the number of physicians or their specific qualifications (e.g., number of years of experience, specialty). It refers to "Boston Scientific's Corporate Toxicology group" for assessing the new grade stainless steel, but no specific number or detailed qualifications. Given this is a physical device, the "ground truth" for functional and biocompatibility tests is based on established engineering and biological standards, not expert consensus as in image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. The testing involves physical and chemical property verification, and physician assessment, but not a process that would typically require adjudication as seen in clinical trials or AI model validation where multiple readers provide interpretations.
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 such MRMC comparative effectiveness study was done or is applicable. This submission is for a physical medical device (detachable coils), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification testing described is primarily based on:
- Established engineering standards (e.g., ASTM standards for MR compatibility, tensile strength measurements).
- Biocompatibility standards (e.g., EN ISO 10993 series).
- Pre-clinical animal model observations (for post-implant MR artifact and assessment in coiled aneurysm models).
- Physician qualitative assessment for usability and protection of the device.
8. The sample size for the training set
Not applicable. This is for a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this 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).