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510(k) Data Aggregation
(209 days)
Glaukos Corporation
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 |
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(126 days)
Glaukos
The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery.
The iPRIMET™ Viscodelivery System is a sterile, single-use ophthalmic surgical instrument for dispensing cohesive viscoelastic fluid (supplied separately, at point of use) during ophthalmic surgery. The iPRIMET™ Viscodelivery System is a delivery device for delivering viscoelastic fluid. The procedure is performed by a trained ophthalmic professional in a sterile surgical setting. The iPRIME device is filled by the user, at the point of use, with FDA approved commercially available cohesive viscoelastic fluid (e.g. HEALON® PRO, Amvisc® or PROVISC®; sold and supplied separately). The iPRIME device consists of a handpiece which includes a reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter manufactured from medical grade materials. The slide button allows the user to adjust the microcatheter length. The dispense trigger dispenses the viscoelastic fluid. The rotatable hub allows the user to adjust the angle of the cannula in order to dispense viscoelastic fluid into other areas within the anterior chamber. The iPRIMET™ Viscodelivery System serves as dispensary means to deliver cohesive viscoelastic fluid. The OVD device containing the viscoelastic fluid is connected to the iPRIME luer fitting and viscoelastic is pumped into the iPRIME device. After the device is fully primed and the microcatheter has been extended to the desired location, the user advances forward the dispense trigger delivering a small amount of viscoelastic fluid into the desired location within the anterior chamber of the eye.
The iPRIME™ Viscodelivery System was subjected to various non-clinical tests to demonstrate its performance and substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional & Performance | Joint Strength Testing | Able to perform according to intended use and predicate device characteristics | Met all acceptance criteria and performs as intended |
| Microcatheter and Cannula Extension/Retraction | Able to perform according to intended use and predicate device characteristics | Met all acceptance criteria and performs as intended | |
| Priming/Dispense Volume Testing | Able to perform according to intended use and predicate device characteristics | Met all acceptance criteria and performs as intended | |
| Corrosion Testing | Able to perform according to intended use and predicate device characteristics | Met all acceptance criteria and performs as intended | |
| Human Factors Engineering Evaluation | Able to perform according to intended use and predicate device characteristics | Met all acceptance criteria and performs as intended | |
| Biocompatibility | Cytotoxicity (ISO 10993-1: 2018) | Components contacting directly or indirectly with patient are biocompatible | Demonstrated biocompatibility |
| Sensitization (ISO 10993-1: 2018) | Components contacting directly or indirectly with patient are biocompatible | Demonstrated biocompatibility | |
| Intracutaneous Irritation (ISO 10993-1: 2018) | Components contacting directly or indirectly with patient are biocompatable | Demonstrated biocompatibility | |
| Systemic Toxicity (ISO 10993-1: 2018) | Components contacting directly or indirectly with patient are biocompatible | Demonstrated biocompatibility | |
| Package Integrity | Packaging Visual Inspection | Sterile barrier maintained throughout the three-month shelf life | Maintained sterile barrier |
| Packaging Peel Test | Sterile barrier maintained throughout the three-month shelf life | Maintained sterile barrier | |
| Packaging Bubble Test | Sterile barrier maintained throughout the three-month shelf life | Maintained sterile barrier | |
| Dispensed Volume | Viscoelastic Fluid (per activation) | 2.7 µL of cohesive viscoelastic fluid per activation of dispense trigger | 2.7 µL per activation (No total volume limit specified for the proposed device) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each non-clinical test. It only states that the device was "subjected to the following functional and performance tests." The data provenance is from non-clinical testing performed on the iPRIME™ Viscodelivery System by the manufacturer, Glaukos Corporation. This is not patient data, so concepts like country of origin or retrospective/prospective do not apply in the same way.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these non-clinical tests is based on objective measurements and established engineering and biological standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical tests involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data are not included in this submission and are not required. Substantial equivalence is based on technological comparison." Therefore, no MRMC comparative effectiveness study was performed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The iPRIME™ Viscodelivery System is a medical device, not an algorithm or AI software. Its performance is evaluated through non-clinical functional, performance, and biocompatibility testing.
7. Type of Ground Truth Used
The ground truth for the non-clinical tests used objective measurements and adherence to established standards and criteria for device functionality, material biocompatibility (ISO 10993-1: 2018), and package integrity. For the dispensed volume, the ground truth is the measured volume of viscoelastic fluid dispensed per activation.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a software algorithm, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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