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.

Device Description

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.

AI/ML Overview

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.

Summary

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980418

510(k) Notification BENZ Methafilcon A

January 30, 1998

SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS FEB 2 7 1998

Soft (hydrophilic) contact lenses for Daily Wear manufactured from methafilcon A material are generally recognized as safe and effective. Such lenses have been successfully marketed in the U.S. since the early 1980's by several manufacturers of both optical blanks and finished lenses. To date, there are more than twelve approved methafilcon A products (PMA's & 510(k)'s) on the U.S. market.

To demonstrate the methafilcon A material manufactured by BENZ R&D and the finished lenses manufactured from BENZ methafilcon A is safe and effective for its intended use, we offer the following statements :

1. PURPOSE OF THIS NOTIFICATION

BENZ's primary interest is in the distribution of optical blanks. They will manufacture and test a limited number of finished lenses for Quality Assurance and customer support purposes. The methafilcon A blanks will only be sold to finishing laboratories with the appropriate regulatory approvals for the distribution of methafilcon A contact lenses.

2. DEVICE DESCRIPTION

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.

When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.

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510(k) Notification BENZ Methafilcon A

January 30, 1998

SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)

3. ALTERNATIVE PRACTICES AND PROCEDURES

Alternative practices and procedures for the same indications are in use and generally consist of other prescription products such In use and generally Combines made from other materials, or spectacles.

4. TECHNICAL SUMMARY

A. PRE-CLINICAL TESTING

The following pre-clinical tests were run by a recognized independent testing facility:

i. Primary Ocular Irritation ii. Systemic Injection iii. Agar Diffusion

All results obtained were within normal limits hence this material All results obtainsd were within his for Class II contact lenses.

B. PHYSICAL TESTING

The following tests were run to demonstrate the physical properties of the lens material are within normal limits:

i. Burst Test

This test was performed by an independent laboratory and inis test was performed by an entires of the material is within normal limits.

ii. 12 Lens Parameter Test 2 Lens Farameter 200lenses made from BENZ methafilcon A optical blanks. The fenses made from being accidentes when measured were within normal limits.

C. FINISHED LENS TESTING

All lenses to be produced form BENZ methafilcon A will be manufactured in accordance with the methods, equipments, and mandlactard in anted in the referenced 510(k) Notification K950294 Flexlens 55 (methafilcon A) Soft Contact Lenses.

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January 30, 1998 510(k) Notification BENZ Methafilcon A

SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)

Please refer to K950294 for the following information for all BENZ methafilcon A lenses:

i. Microbiology ii. Solutions Compatibility iii. Shelf Life/Stability iv. Preservative Uptake/Release

12000

A letter of authorization to reference this 510(k) is included with this Notification.

Flexlens last FDA inspection was March 7, 1996 and there are no outstanding GMP deficiencies.

CONCLUDING STATEMENTS

Any adverse effects to the patient would not be any more likely or any more severe with lenses made from BENZ methafilcon A than with lenses made from any other methafilcon A or any other soft contact lens material.

From the above referenced test data, it can be deduced that the BENZ methafilcon A material is safe and effective for its intended purpose as a daily wear contact lens.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Clark Consultant to BENZ c/o South East Regulatory Associates, Inc. 1070 Thornwood Lane Dacula, GA 30019

FEB 2 7 1998

K980418 Re:

Trade Name: BENZ methafilcon A Spherical and Toric Soft (hydrophilic) contact lenses (clear, lathe cut) for Daily Wear

Regulatory Class: II Product Code: 86 LPL Dated: January 30, 1998 Received: February 3, 1998

Dear Mr. Clark:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The symbol is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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Page 2 - Mr. Michael A. Clark

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

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.

****************************************************************************************************************************************************************************** (Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown, Ph.D.
Division Sign-Off

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980418

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.