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510(k) Data Aggregation
(126 days)
iPrime Viscodelivery System
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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