(24 days)
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The lenses may be disinfected using chemical disinfection systems.
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution.
When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
Acceptance Criteria and Device Performance for BENZ Methafilcon A Contact Lenses
This document describes the acceptance criteria and the study that demonstrates the safety and effectiveness of BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses.
1. Acceptance Criteria and Reported Device Performance
The submission relies on demonstrating substantial equivalence to previously approved methafilcon A products. The acceptance criteria are implicitly based on meeting "normal limits" or being "within accepted limits" for various tests, consistent with established standards for Class II contact lenses and similar methafilcon A products already on the market.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pre-Clinical Testing | Within normal limits for Class II contact lens materials | All results obtained were within normal limits, hence this material is acceptable for Class II contact lenses. |
| Primary Ocular Irritation | Normal limits | Within normal limits |
| Systemic Injection | Normal limits | Within normal limits |
| Agar Diffusion | Normal limits | Within normal limits |
| Physical Testing | Within normal limits for lens material properties | All results obtained were within normal limits. |
| Burst Test | Within normal limits for material properties | Entire batch of the material is within normal limits. |
| 12 Lens Parameter Test | All measured parameters within normal limits | The lenses made from BENZ methafilcon A optical blanks were within normal limits. |
| Finished Lens Testing | Manufactured in accordance with referenced 510(k) K950294 (Flexlens 55) | All lenses to be produced from BENZ methafilcon A will be manufactured in accordance with the methods, equipment, and manufacturing controls as stated in K950294. |
| Microbiology | Conforming to standards in K950294 | Reference to K950294 (Flexlens 55) |
| Solutions Compatibility | Conforming to standards in K950294 | Reference to K950294 (Flexlens 55) |
| Shelf Life/Stability | Conforming to standards in K950294 | Reference to K950294 (Flexlens 55) |
| Preservative Uptake/Release | Conforming to standards in K950294 | Reference to K950294 (Flexlens 55) |
| Overall Safety & Effectiveness | No more likely or severe adverse effects than other methafilcon A or soft contact lens materials; Safe and effective for intended purpose | Adverse effects not any more likely or severe; safe and effective for intended purpose as a daily wear contact lens. |
2. Sample Sizes and Data Provenance
-
Test Set (for physical testing):
- "12 Lens Parameter Test": 200 lenses made from BENZ methafilcon A optical blanks.
- "Burst Test": An entire batch of material (specific number not provided).
- Data Provenance: The tests were run by a "recognized independent testing facility" and an "independent laboratory." No country of origin is explicitly stated, but the submission is to the FDA, implying conformity with U.S. regulatory standards. The data is retrospective, as the tests were completed prior to the 510(k) submission.
-
Training Set: Not applicable in this context. The majority of the submission relies on physical and material testing, and reference to an already approved device (K950294) for finished lens performance and manufacturing controls, rather than machine learning models requiring training data.
3. Number and Qualifications of Experts for Ground Truth
- Not applicable for the reported pre-clinical and physical testing. The tests performed (e.g., irritation, injection, agar diffusion, burst test, lens parameter measurements) are objective laboratory measurements against defined standards, not human expert interpretation of subjective data.
- For the "Finished Lens Testing" section, the submission refers to the previously approved 510(k) K950294 for Flexlens 55 (methafilcon A) Soft Contact Lenses. It is implied that the original approval of K950294 would have involved appropriate expert evaluation during its review process; however, this submission does not detail those specifics.
4. Adjudication Method for the Test Set
- Not applicable. The tests are objective measurements with predefined "normal limits" or "within limits" criteria, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant to the evaluation of contact lens material and physical properties as presented in this 510(k) notification. MRMC studies are typically used to assess the improvement in diagnostic accuracy or efficiency when human readers use AI-assisted tools for image interpretation.
6. Standalone (Algorithm Only) Performance Study
- No. This submission is for a medical device (contact lenses) and its material properties, not an algorithm or AI software. Therefore, an algorithm-only performance study is not applicable.
7. Type of Ground Truth Used
- Objective Laboratory Measurements and Established Standards:
- Pre-Clinical Testing: Ground truth is established by "normal limits" for primary ocular irritation, systemic injection, and agar diffusion, which are standard toxicological and biocompatibility assessments.
- Physical Testing: Ground truth is established by "normal limits" for physical properties determined through tests like the Burst Test and 12 Lens Parameter Test, likely against internal specifications or industry standards for contact lens manufacturing.
- Finished Lens Testing: Ground truth is established by the methods, equipment, and manufacturing controls, along with the performance data (Microbiology, Solutions Compatibility, Shelf Life/Stability, Preservative Uptake/Release) detailed in the referenced and previously approved 510(k) K950294.
8. Sample Size for the Training Set
- Not applicable. This submission does not involve a machine learning model, and therefore, no training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no corresponding ground truth establishment method for it.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.