(209 days)
The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.
Here's a breakdown of the acceptance criteria and study information for the iStent infinite Trabecular Micro-Bypass System, as presented in the provided FDA 510(k) summary, structured to answer your questions:
1. A table of acceptance criteria and the reported device performance
Please note that for the clinical effectiveness endpoints, explicit "acceptance criteria" are not stated as pass/fail thresholds in the provided text. Instead, the study reports the observed performance, and the FDA determined this performance supports substantial equivalence. For bench testing, direct pass/fail results against implicit or explicit criteria are mentioned.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | ||
| Effectiveness: | (Reported at 12 months for ITT Population/Worst Postoperative IOP & Last Available Medication Classes): | |
| Proportion of responders (>= 20% MDIOP reduction from baseline on same or fewer medications) | (Implicit criteria for substantial equivalence, not explicitly stated as a numerical threshold in the document, but assessed against predicate data for efficacy.) | 72.1% (44/61 participants) with a 95% CI of (59.2%, 82.9%). Other imputation methods yielded similar results (e.g., 73.4% with multiple imputation). |
| Change from baseline in MDIOP | (Implicit criteria for substantial equivalence, not explicitly stated as a numerical threshold in the document, but assessed against predicate data for efficacy.) | -5.5 ± 5.24 mm Hg (mean ± SD) with a 95% CI of (-6.9, -4.2). |
| Safety: | (Implicit criteria that adverse event rates and types should be comparable to or better than predicate devices and acceptable for the intended use.) | No intraoperative adverse events. |
| Most common AEs included ocular surface disease (11.5%), substantial IOP increase vs. baseline (8.2%), and loss of BSCVA >= 2 lines (11.5%). | ||
| Stent obstruction occurred in 3.3%. Stent migration in 1.6%. Secondary surgical intervention in 4.9%. | ||
| No reports of: corneal decompensation, choroidal effusion/hemorrhage, hypotony maculopathy, deep stents not visible, stent explantation, stent dislocation (overall), or stent repositioning. | ||
| Bench Testing | ||
| Surface & Edge Quality | Stent had smooth edges and was free from surface defects. | Pass: SEM photos demonstrated smooth edges and no surface defects. |
| Dimensions | Production meets tolerances to appropriate statistical levels. | Pass: Validated that stent production meets tolerances. |
| Physical Stability | Dimensional measurements remain the same before and after incubation; surface finish maintained quality; coating intact after incubation. | Pass: Dimensional measurements and visual inspection confirmed stability after 14 days incubation. Coating remained intact. |
| Pressure/Flow Characteristics | Negligible flow resistance. | Pass: Numerical modeling and CFD showed negligible flow resistance. |
| Structural Integrity | Safety factors at lowest and highest implant velocities support structural integrity (e.g., 41x and 14x respectively). | Pass: FEA modeling showed safety factors of 41x and 14x, confirming structural integrity. |
| Insertion Testing | All specified requirements met (stent delivery, singulation, implantation, trocar penetration). | Pass: All tested injectors successfully passed predetermined acceptance criteria for stent delivery. |
| Stability of Coating | Coating stability demonstrated for shelf life. | Pass: Demonstrated for the shelf life period. |
| MRI Compatibility | MR Conditional. | Pass: Device is MR Conditional under specified conditions. |
| Corrosion Resistance | Acceptable corrosion resistance to pitting and crevice corrosion. | Pass: Test lab concluded acceptable corrosion resistance per ASTM F2129-15. |
| Sterilization SAL | 10^-6 sterility assurance level (SAL). | Pass: Gamma ray validation (25 kGy) substantiated 10^-6 SAL. |
| Bacterial Endotoxin | Meets recommendations for single-use intraocular ophthalmic devices. | Pass: LAL testing performed as recommended. |
| Packaging & Shelf Life | Functional performance of stent/injector, and packaging integrity maintained after simulated distribution and aging for 1 year. | Pass: Meets functional requirements and sterile barrier remains intact after simulated distribution and aging for 1 year. |
| Biocompatibility (Stent) | Non-toxic, non-mutagenic, non-irritating, non-sensitizing, no significant reaction after implantation, non-pyrogenic. | Pass for all tests: Cytotoxicity (Cell growth inhibition |
§ 886.3920 Aqueous shunt.
(a)
Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Aqueous Shunts—510(k) Submissions.”