(269 days)
The single use disposable injectors (Model R-INJ-04 and Model R-INJ-04/18) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.
There are two types of Rayner disposable single use soft tipped injectors (Model R-INJ-04 and Model R-INJ-04/18). They are the same except Model R-INJ-04 has a 2.0 mm diameter nozzle and Model R-INJ-04/18 has a 1.8 mm nozzle. The size is indicated on the barrel flap of the respective injectors by 1.8 or 2.0 embossed texts. The injectors are assembled from a nozzle, barrel, flap, guide bushes and plunger components which are made of polypropylene material. The plunger has a thermoplastic elastomer soft tip at one end. The injectors are supplied sterile.
The provided document describes the non-clinical performance data for the Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18), comparing them to a predicate device. This is a 510(k) submission, focused on demonstrating substantial equivalence, and therefore the study design is centered on confirming that the new devices perform as well as the predicate and meet established specifications.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (as per ISO 11997-3 and manufacturer specifications) | Reported Device Performance |
|---|---|---|
| Injector Biocompatibility | Materials are biocompatible and toxically safe for intended use. | All tests were passed on the predicate device's materials (same as the new devices), demonstrating biocompatibility and toxicological safety. |
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10^-6 for ethylene-oxide (ETO) sterilization. | Sterilization process was validated and achieved SAL 10^-6. |
| Visual, Mechanical, & Optical Testing of Injected Lens (Pre & Post Injection) | No significant impact on optical and mechanical performance or cosmetic features of the lenses. No optic damage/tear, haptic damage, folding lines, deposits, or debris. MTF, power within specifications. | Satisfactory results for all visual, mechanical, and optical tests on lenses injected using the new devices. Criteria met as per ISO 11997-3, including MTF, power. |
| Visual & Mechanical Testing of Disposable Rayner Injectors | Nozzle-tip detachment, proper dimensions, surface finish, cosmetic quality, compression force, aperture opening, injection force within specifications. | Criteria met as per ISO 11997-3, including cosmetic defects, compression force, surface finish, dimensions, nozzle-tip detachment, aperture opening test, and injection force testing. |
| Packaging Performance & Stability Studies | Sterility maintained, no dye penetration, burst strength maintained. | Sterility test, dye penetration, and burst test were conducted and met criteria (implied by "satisfactory results" and "criteria were met"). |
Study Description:
The study conducted was a series of non-clinical performance tests designed to demonstrate that the Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18) are safe, effective, and perform as well as (or better than) the predicate device. The focus was on comparing the technical characteristics and test results of the new devices with a previously cleared predicate device (K091507).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each individual test (e.g., number of injectors or lenses tested for mechanical integrity, optical performance, etc.). It generally states that "tests were completed" and "pre and post injection tests have been completed."
- Data Provenance: The data is non-clinical performance data, generated from laboratory testing of the devices. The document does not specify the country of origin for the testing, but the manufacturer is based in the UK. The studies are prospective in the sense that they were designed and executed to evaluate the new devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve human experts establishing ground truth in the way a clinical study would (e.g., expert radiologists reviewing images). The acceptance criteria (ground truth) for mechanical, visual, and optical performance are established by pre-determined specifications based on international standards (ISO 11997-3) and internal engineering/quality requirements. The "experts" involved would be the engineers, technicians, and quality control personnel who perform and analyze these tests, ensuring adherence to the established protocols and standards. Their qualifications would be in engineering, materials science, optics, and quality assurance, but specific details are not provided.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical, specification-based testing. Performance is measured against objective, quantitative, or qualitative (e.g., "no visible damage") criteria as defined by standards and internal procedures, not through expert adjudication of subjective findings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This is a non-clinical 510(k) submission, which focuses on device performance and substantial equivalence rather than comparative clinical effectiveness with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a medical injector, not an algorithm or AI system. The performance evaluated is the physical function and characteristics of the injector and its impact on the intraocular lens.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on engineering specifications, international standards (specifically ISO 11997-3), and predefined performance criteria. For example, biocompatibility is based on passing specific biological tests, sterility on achieving a defined SAL, and optical/mechanical performance on meeting specified tolerances for MTF, power, dimensions, and visual integrity.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.