K Number

Device Name

(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT

Manufacturer

BENZ RESEARCH AND DEVELOPMENT CORP.

Date Cleared

1997-03-07

(115 days)

Product Code

LPL

Regulation Number

886.5925

Intended Use

BENZ-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfare with visual acuity. BENZ-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic The toric lenses are persons with with non-diseased eyes. available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction. The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

Device Description

BENZ-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical shell. The non-ionic The Toric has a Toric Base Curve. material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA). The copolymer consists of 52% BENZ-G 3X (hioxifilcon B) and 48% water by weight when immersed in normal saline solution buttered with sodium bicarbonate.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard contact lens made from a specific material, with no mention of any computational or data-driven features that would indicate the use of AI or ML.

Therapeutic

No.
A therapeutic device is used to treat or prevent a disease or condition. This device is indicated for the correction of visual acuity, which is a refractive correction, not a therapeutic treatment for a disease.

Diagnostic

The device is a contact lens intended for the correction of visual acuity, which is a therapeutic function, not a diagnostic one. It does not identify or diagnose a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly describes a physical contact lens made from a specific material (hioxifilcon B), which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVDs are used to examine specimens from the human body. The provided text describes contact lenses, which are medical devices placed on the surface of the eye to correct vision. They do not involve the examination of bodily fluids, tissues, or other specimens.
The intended use is for correcting visual acuity. This is a functional correction of a physical condition, not a diagnostic test to identify a disease or condition.

The description clearly indicates that these are contact lenses for vision correction, which falls under the category of ophthalmic devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BENZ-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic The toric lenses are persons with with non-diseased eyes. available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.

The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

Product codes

Not Found

Device Description

The lens BEN7-G 3X (hioxifilcon B) is made from BEN7-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light ravs on the retina.

RENZ-G 3X (hioxifilcon B) optical buttons with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes, cornea

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Pre Clinical:

Toxicology: Toxikon ran all pre-clinical studies necessary for review for Class TT daily wear soft (hydrophilic) contact lenses. Results were within normal limits.
Microbiology: Relevant studies have been run and are included with this 510(k) notification, including autoclave validation.
Tens.compatibility studies: run by BENZ Research and Development, Conclusion: Within Normal Timits.
Lens Stability: Shelf life studies have been started by Metro Optics of Austin, Tnc. and will be complete later in the year. The procedure is based on sample supplied by FDA in Guidance Document for 510)k) for Daily Wear Contact Tenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.
Preservative Uptake: Tests were run by ATCON and are included in this Notification in Sect 6.5. They fall within normal limits.

In house tests showing that heat has no injurious effect on the lenses made of this polymer. BENZ-G 3X studies are on file at BENZ R&D and are included with this supplement.

Key Metrics

Not Found

Predicate Device(s)

BENZ-G 55 (5X) (hioxifilcon A)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

SUPPLEMENT to K964528 BENZ-G 3X (hioxifileon B) JAN. 15. 1997

6.0 SUMMARY of SAFETY AND EFFECTIVENESS

MAR
10 1997

General Information: I .
A. Generic (USAN) Name: hioxifilcon B

B. Device Trade Name: BENZ-G 3X (hioxiTilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear in Clear and with a Blue Visibility Tint

ﻦ Sponsor's Name and BENZ Research and Development, Inc. Address: 6447 Parkland Drive Sarasota, FL 24243 (941) 758-8256

どが

x964528 D. 510(k) Number:

II. Indications

The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

III. Device Description

510(k) NOTTFICATION for BENZ-G 3X (hioxifilcon B) Jan. 15, 1997

6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

RENZ-G 3X (hioxifilcon B) optical buttons with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.

TV. Alternative Practices or Procedures

Alternative practices or procedures are in the use of available prescription products Soft and RGP Contact Lenses and spectacles for the same indication.

V. Technical Summaries

A_ Pre Clinical

1. Toxicology
  Toxikon ran all pre-clinical studies necessary for review for Class TT daily wear soft (hydrophilic) Results were within normal limits. contact lenses.

ుండ

1. Microbiology
  Relevant studies have been run and are included with This includes autoclave this 510(k) notification. validation.
1. Tiens.compatibility studies run by BENZ Research and Development included with this Notification in Section 6.3 "Tens Compatibility Studies"
  Conclusion: Within Normal Timits
1. Lens Stability The Shelf life studies have been started by Metro Optics of Austin, Tnc. and will be complete later in the year. The procedure is based on sample supplied by FDA in Guidance Document for 510)k) for Daily Wear Contact Tenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.
5 -Preservative Uptake Tests were run by ATCON and are included in this Notification in Sect 6.5 They fall within normal limits.

This application includes application for Heat and Chemical (Not Heat) disinfection as the polymer as the polymer is Non-ionic. In house tests showing that heat

6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

has no injurious effect on the lenses made of this polvmer. BENZ-G 3X studies are on file at BENZ R&D and are included with this supplement.

BENZ RESEARCH AND DEVELOPMENT, TNC. will own the polymer BENZ-G 3X (hioxifilcon B) optical blanks in clear and with blue visibility tint and make the polymer available to any contact lens laboratory that will apply to the FDA through 510(k) Notification and he approved to manufacture and distribute soft (hydrophilic) contact lenses made from BENZ-G 3X.

This summary of safety and effectiveness enclosed covers the hioxifilcon B lathe-cut lens made by RENZ. Research and Development. Tnc.

A favorable recommendation from the FDA for the BENZ-G 3X (hioxifilcon B) Spherical and Toric Contact Lenses made from HENZ-G 3X (hioxifileon B) in clear or with blue visibility Tint for daily wear use is anticipated. We feel that a review of notification will show that this polymer is close enough to the approved BENZ-G 55 (5X) (hioxifilcon A) (48% water as opposed to 58% water). The BENZ-G 55 (5X) was both safe and effective for its intended purpose of a daily wear contact lens.

Should additional information be desired, please contact Wally Stirling. South East Regulatory Associates, The. 770-475-1668 .