Overview:
On March 4, 2020, US FDA published a new draft guidance to allow manufacturers of eligible daily wear soft (hydrophilic) contact lenses to use new performance criteria pathway to support substantial equivalence instead of a direct comparison of the performance of their device to that of a predicate device during 510(K) submission.
Eligibility Criteria
The soft (hydrophilic) daily wear contact lenses are Class II devices, are regulated under 21 CFR 886.5925, with the product code LPL and are subject to 510(K) submission.
The soft (hydrophilic) daily wear contact lenses that fall within the scope of this guidance are prescription devices intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye for the optical correction of ametropia (myopia or hyperopia with or without astigmatism). The lenses are designed to be frequent replacement or daily disposable lenses.
Additionally, the proposed guidance applies only to Soft (hydrophilic) daily wear contact, spherical or toric lenses that are made from polymacon, etafilcon A or hioxifilcon D polymeric materials.
Safety and Performance Criteria
For eligible soft (hydrophilic) daily wear contact lenses, manufacturers will be able to include in their 510(K) submission, a summary of the performance tests summarized here below to demonstrate substantial equivalent instead of comparing their device to predicates.
Physical and Optical Testing
Test Name | Standards | Performance criteria |
Spectral Transmittance | – ISO 18369-3 – ANSI Z80.20 – ISO18369-4 | – (polymacon): 93% ± 5% – (etafilcon A): 94% ± 5% – (hioxifilcon D): 96% ± 5% |
Ultra Violet (UV)Transmittance (% | – (polymacon): τUVB < 0.05τV; τUVA < 0.50 τV – (etafilcon A): τUVB < 0.05τV; τUVA < 0.50 τV – (hioxifilcon D): τUVB < 0.05τV; τUVA < 0.50 τV | |
Refractive Index | – (etafilcon A): 1.402 ± 0.005 – (hioxifilcon D): 1.407 ± 0.005 | |
Oxygen Permeability (Dk or [cm2/s][ml O2/ml x mmHg]) | – (polymacon): 10.76 x 10-11 ± 20% – (etafilcon A): 22.43 x 10-11 ± 20% – (hioxifilcon D): 20.84 x 10-11 ± 20% | |
Extractables (< 1% with water and hexane) | – (polymacon): <1% extractables, hexane and water – (etafilcon A): <1% extractables, hexane and water – (hioxifilcon D): <1% extractables, hexane and water | |
Water Content (%) | – Contact Lenses – Standard Terminology, Tolerances, Measurements and Physicochemical Properties | – (polymacon): 38 ± 2% – (etafilcon A): 58 ± 2% – (hioxifilcon D): 54 ± 2% |
Specific Gravity | – Any standard methodology accepted | – (polymacon): 1.124 ± 0.037 – (etafilcon A): 1.062 ± 0.041 – (hioxifilcon D): 1.214 ± 0.094 |
Mechanical Testing
Test Name | Standards | Performance criteria |
Modulus (MPa or N/mm2) | – ASTM D882 – ANSI Z80.20
| – (polymacon): 0.62 ± 0.25 MPa – (etafilcon A): 0.42 ± 0.09 MPa – (hioxifilcon D): 0.36 ± 0.10 MPa |
Tensile Strength (MPa or N/mm2) | – (polymacon): 0.63 ± 0.11 MPa – (etafilcon A): range of 0.07 to 0.41 MPa – (hioxifilcon D): 0.65 ± 0.26 MPa | |
Elongation at Break (%) | – (polymacon): 240 ± 108% – (etafilcon A): range of 50 to 340% – (hioxifilcon D): 249 ± 69% |
Packaging Solution
Test Name | Standards | Performance criteria |
Packaging Solution pH | Any standard methodology accepted
| (all materials): 7.2 – 7.4 |
Packaging Solution Osmolality (osmol/kg) | (all materials): 280-320 osmol/kg |
Sterilization
Test Name | Standards | Performance criteria |
Sterilization | – ISO 17665-1 – ISO 11607-1 – ISO 11607-2 | Validation testing should demonstrate the cleanliness and sterility of the device to a sterility assurance level of 10-6. |
Biocompatibility
Test Name | Standards | Performance criteria |
Biocompatibility endpoints | ISO 10993-1 | All direct or indirect tissue contacting components of the device and device-specific instruments should be determined to have an acceptable biological response. |
More Like this:
- FDA guidance. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Pre-market Submissions
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