The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Description

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lenses are hemispherical shells and are available as multifocal lens designs. The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is fabricated from Hioxifilcon D, which is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-, Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linkned with ethylene glycol dimethacrylate (EGDMA). It consists of 46% Hioxifilcon Datod 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, rransparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye.

AI/ML Overview

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is substantially equivalent to the predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens cleared under 510(k) K062854. The submission does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial with a test set, ground truth, or statistical analysis. Instead, it relies on substantial equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implicitly established by demonstrating that its characteristics are substantially equivalent to those of the predicate device (Benz-G 4X Lathed Lens, K062854). The relevant "performance criteria" are the physical, chemical, and intended use specifications, which are compared side-by-side.

Characteristic	Acceptance Criteria (Predicate Device K062854)	Reported Device Performance (New Device)
Intended Use	Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes that are myopic or hyperopic. Spherical lens for astigmatism ≤ 0.75 Diopters; Toric lens for astigmatism up to 10.0 Diopters. For daily wear, frequent/planned replacement.	Correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. Spherical lens for astigmatism ≤ 0.75 Diopters; Toric lens for astigmatism up to 10.0 Diopters. For daily wear, frequent/planned replacement. (Addition of presbyopic correction)
USAN Name	Hioxifilcon D	Hioxifilcon D
Classification Number	LPL	LPL
Classification Name	Soft (hydrophilic) contact lens, daily wear	Soft (hydrophilic) contact lens, daily wear
Material Classification	FDA Group 2 (> 50% H2O, non-ionic polymer)	FDA Group 2 (> 50% H2O, non-ionic polymer)
Production Method	Lathe-Cut	Lathe-Cut
Water Content	54% ± 2	54% ± 2
Specific Gravity	1.299 (dry)	1.299 (dry)
Expansion	1.35	1.35
Refractive Index	1.408 hydrated	1.408 hydrated
Light Transmission	Greater than 95% T	Greater than 95% T
Tint	Blue Phthalocyanato (2) - (copper)	Blue Phthalocyanato (2) - (copper)
Oxygen Permeability	18 x 10-11 Fatt Dk units (Fatt method) / 23 x 10-11 Fatt Dk units (ANSI Z80:2004 polarographic method)	18 x 10-11 Fatt Dk units (Fatt method) / 23 x 10-11 Fatt Dk units (ANSI Z80:2004 polarographic method)
Optical Zone	Optic Zone: 7.971	Optic Zone: 8.0 (OZ1: 1.8 - 6.2, OZ2: 6.2 - 1.8) (Difference in design due to multifocal nature)
Breaking Force	57 gms	57 gms
Tensile Strength	25 g/sq.mm	25 g/sq.mm
Modulus	21 g/sq.mm	21 g/sq.mm
Elongation	186%	186%

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses." Therefore, there was no separate test set of subjects/data used for clinical evaluation of the new device. The data provenance would be inherent in the predicate device's original clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical study with a test set was conducted for the new device. The ground truth for the predicate device would have been established at the time of its clearance (K062854).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study with a test set was conducted for the new device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable for a new clinical study. The basis of equivalence is the identical physical and chemical properties and manufacturing process to the predicate device, with an expanded intended use to include presbyopia.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted.

9. How the ground truth for the training set was established

Not applicable, as no new clinical study was conducted.

Study Proving Acceptance Criteria:

The study proving the acceptance criteria for the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses is based on a side-by-side comparison testing with its predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens (K062854).

The document explicitly states:

"Side by side comparison testing was conducted on the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854, and Multifocal Lenses manufactured by Benz Research & Development from Hioxifilcon D material."
"This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854."
"The Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses have the identical manufacturing process (lathe-cut versus lathed-cut) as the marketed lens Benz-G 4X (Hioxifilcon D) Lathed."

The conclusion drawn from this comparison is that the new device is substantially equivalent to the predicate device in terms of:

Intended use (with the addition of presbyopia correction)
Materials
Toxicological properties
Physicochemical properties

The primary difference, an additional optical zone for multifocal correction, is presented as an enhancement to visual acuity correction rather than a fundamental change requiring new extensive clinical testing, given the identical base material and manufacturing process. The FDA's August 9, 2010 letter confirms this determination of substantial equivalence.

Summary

{0}------------------------------------------------

KIO1122

BENZ RESEARCH & DEVELOPMENT 510(k) Premarket Notification

510(k) SUMMARY OF SAFETY AND EFFECTIVENES

AUG - 9 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Applicant Information:

Date Prepared:	April 14, 2010
Name:	Benz Research & Development6447 Parkland DriveSarasota, FL 34243
Contact Person:	Giovanny Espinosa / Patrick H. Benz, Ph.D.Assoc. Regulatory Affairs / PresidentBenz Research & Development
Phone number:	941-758-8256
Fax number:	941-758-1191
Device Information:
Device Classification:	Class II
Classification number:	LPL
Classification Name:	Lens, Soft Contact, Daily Wear
Trade Name:	Benz-G 4X (Hioxifilcon D) Multifocal Lenses

Purpose of the 510(k) Submission:

Benz Research & Development is requesting clearance from the FDA to manufacture and market Benz-G 4X (Hioxifilcon D) Multifocal Lathed Lenses.

Predicate Devices:

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is substantially equivalent to the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854.

{1}------------------------------------------------

Device Description:

Intended Use (Indications):

The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10 0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.0 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear. with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

{2}------------------------------------------------

Comparison to Predicate Device:

Side by side comparison testing was conducted on the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854, and Multifocal Lenses manufactured by Benz Research & Development from Hioxifilcon D material.

	Predicate Device	New Device
	Benz-G 4X Lathed LensK062854	Benz-G 4X Multifocal Lens
Intended Use:	Intended for daily wear for thecorrection of visual acuity inaphakic and non-aphakic personswith non-diseased eyes that aremyopic or hyperopic. Thespherical lens may be worn bypersons who exhibit astigmatismof 0.75 Diopters or less that doesnot interfere with visual acuity.The toric lens may be worn bypersons who exhibit astigmatismof up to 10.0 Diopters. Lenses areintended for frequent and/orplanned replacement wear asprescribed by the eye carepractitioner.	Intended for daily wear for thecorrection of visual acuity inaphakic and non-aphakic personswith non-diseased eyes that aremyopic, hyperopic, possessastigmatism of 10.0 diopters orless and are presbyopic. Thespherical lens may be worn bypersons who exhibit astigmatismof 0.75 Diopters or less that doesnot interfere with visual acuity.The toric lens may be worn bypersons who exhibit astigmatismof up to 10.0 Diopters.Lenses are intended for frequentand/or planned replacement wearas prescribed by the eye carepractitioner.
USAN Name:	Hioxifilcon D	Hioxifilcon D
Classification Number:	LPL	LPL
Classification Name:	Soft (hydrophilic) contact lens,daily wear	Soft (hydrophilic) contact lens.daily wear
Material Classification:	FDA Group 2(> 50% H2O, non-ionic polymer)	FDA Group 2(> 50% H2O, non-ionic polymer)
Production Method:	Lathe-Cut	Lathe-Cut
Water content:	54% ± 2	54% ± 2
Specific Gravity	1.299 (dry)	1.299 (dry)
Expansion:	1.35	1.35
Refractive Index:	1.408 hydrated	1.408 hydrated
Light Transmission:	Greater than 95% T	Greater than 95% T
Tint	Blue Phthalocyanato (2) -(copper)	Blue Phthalocyanato (2) -(copper)
Oxygen Permeability	18 x 10-11 Fatt Dk units (Fattmethod)23 x 10-11 Fatt Dk units(cm2/sec)(ml O2/ml x mm Hg)ANSI Z80:2004 polarographicmethod corrected for boundary-layer end edge effects	18 x 10-11 Fatt Dk units (Fattmethod)23 x 10-11 Fatt Dk units(cm2/sec)(ml O2/ml x mm Hg)ANSI Z80:2004 polarographicmethod corrected for boundary-layer end edge effects

{3}------------------------------------------------

Optical Zone	Optic Zone: 7.971	Optic Zone: 8.0
		OZ1: 1.8 - 6.2OZ2: 6.2 - 1.8
Tensile Properties:
Breaking Force	57 gms	57 gms
Tensile Strength	25 g/sq.mm	25 g/sq.mm
Modulus	21 g/sq.mm	21 g/sq.mm
Elongation	186%	186%

. . . . .

, :

. . . . . . . . . . :

{4}------------------------------------------------

Clinical Data:

It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses.

This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854.

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses have the identical manufacturing process (lathe-cut versus lathed-cut) as the marketed lens Benz-G 4X (Hioxifilcon D) Lathed.

Conclusion:

The information provided in this premarket submission establishes that the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses is substantially equivalent in terms of intended use, materials, toxicological and physiochemical properties to the predicate device, Benz-G 4X (Hioxifileon D) Lathed Lens. This change is to correct the visual acuity in aphakic and nonaphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. This visual acuity correction is achieved with the addition of another optical zone.

	Predicate Device	New Device
	Benz-G 4X Lathed LensK062854	Benz-G 4X Multifocal Lens
Optical Zone	Optic Zone: 7.971	Optic Zone: 8.0OZ1: 1.8 - 6.2OZ2: 6.2 - 1.8

In addition, the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses are manufactured at Benz Research & Development according to the identical manufactured are manufactured a following previously cleared hydrophilic contact lenses:

Benz-G 4X (Hioxifilcon D) K062854

This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854.

Benz-G 4X (Hioxifilcon D) Multifocal lathed lens therefore meets the requirements of substantial equivalence and is as safe and effective as the predicate device.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Benz Research & Development c/o Mr. Giovanny Espinosa Associate Regulatory Affairs 6447 Parkland Drive Sarasota, FL 34243

AUG - 9 2010

Re: K101122

Trade/Device Name: bemz-G 4X (Hioxifilcon D) Multifocal Lathed Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 28, 2010 Received: June 30, 2010

Dear Mr. Espinosa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{6}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Mark
Dir
Div

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{7}------------------------------------------------

Indications for Use

AUG - 9 2010

510(k) Number (if known): K101122

Device Name: Benz-G 4X (Hioxifilcon D) Multifocal Lathed Contact Lenses

Indications For Use: The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lula N. Brown

Page 1 of

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101122

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.