LogoFDA 510(k) Search
K Number
K961103
Device Name
BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
Manufacturer
BENZ RESEARCH AND DEVELOPMENT CORP.
Date Cleared
1996-08-23

(156 days)

Product Code
LPL
Regulation Number
886.5925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity. BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-The spherical lenses are being applied for diseased eyes. from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.
Device Description
BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical shell. The non-ionic material, hioxifilcon A is an ultra high molecular weight homo-polymer of 2-hydroxyethyl methrylate (2-HEMA). This material is made from extremely high purity monomer using state of the art polymer synthesis technique. It consists of 62% hioxifilcon A and 38% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching. The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-IPL, approved DEC. 1, 1995.
More Information

P830012/S04, K952620

P830012/S04, K952620

No
The summary describes a standard soft contact lens made from a specific material. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The focus is on the material properties, manufacturing process, and clinical performance for vision correction.

No
The device is indicated for correcting visual acuity, which is a refractive correction, not a therapeutic treatment.

No

Explanation: The device described is a contact lens, which is used for correcting visual acuity by focusing light rays on the retina. It is a therapy device, not a diagnostic device.

No

The device description clearly states it is a physical contact lens made of polymacon material, not software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that this device is a contact lens. Contact lenses are placed on the eye (the cornea) to correct vision. They do not analyze biological specimens taken from the body.
  • Intended Use: The intended use is for the "correction of visual acuity," which is a physical function of the eye, not a diagnostic test performed on a sample.

The information provided describes a medical device, specifically a contact lens, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-The spherical lenses are being applied for diseased eyes. from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

Product codes

Not Found

Device Description

BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical The non-ionic material, hioxifilcon A is an ultra shell. high molecular weight homo-polymer of 2-hydroxyethyl methrylate (2-HEMA). This material is made from extremely high purity monomer using state of the art polymer synthesis It consists of 62% hioxifilcon A and 38% water by technique. weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching.

The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-IPL, approved DEC. 1, 1995.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical:

  1. Toxicology: BENZ RESEARCH AND DEVELOPMENT, INC. ran all preclinical studies for the clear lenses in 1990 and for the blue visibility tinted product in 1995. Conclusion: Clear Approved 1990. Test results on Blue Visibility tinted product are within the same acceptable limits.
  2. Microbiology: All microbiology work done by Unilens Corp. USA. in 1995 using a validated process. Conclusion: Clear approved in 1990.
  3. Lens compatibility studies: Run by BENZ Research and Development. Conclusion: Within Normal Limits.
  4. Lens Stability: Shelf life will be run by each lens manufacturing unit.
  5. Preservative Uptake: Tests were run on the original BENZ 38 material for P830012/S04 approved June 5, 1990. Results are within normal limits.

Clinical:
Clinical Study was done on the original BENZ 38 Clear material for P830012/S04 which was approved June 5, 1990. Study results fell within normal limits.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

P830012/S04, K952620

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

510(k) NOTIFICATION FOR BENZ 38 (polymacon) MAF

ALG 23 x

SUMMARY of SAFETY AND EFFECTIVENESS

  • T . General Information:
    Address :

  • A. Generic (USAN) Name: polymacon

  • B. Device Trade Name: BENZ 38 Clear and Visibility Tinted optical buttons and BENZ 38 Lenses Clear and Visibility Tinted C. Sponsor's Name and

Benz Research and Development, Inc. 6447 Parkland Drive Sarasota, FL 34243 (813) 758-8256

  • D. 510(k) Number: TO BE ASSIGNED
  • E. Date Notice of approval sent to Sponsor:
  • G. Additional Lens manufacturers who will be asking for FDA approval to manufacture and distribute soft (hydrophilic) contact lenses made from BENZ 38 will file a separate 510(k) notification. The first will be:

UNILENS CORP. . USA 10431 - 72nd Street North Largo. Florida 34543 (813) 544-2531

II. Indications

BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-The spherical lenses are being applied for diseased eyes. from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

III. Device Description

BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical The non-ionic material, hioxifilcon A is an ultra shell. high molecular weight homo-polymer of 2-hydroxyethyl methrylate (2-HEMA). This material is made from extremely

1

510(k) NOTIFICATION FOR BENZ 38 (polymacon) MAR. 19, 1996

high purity monomer using state of the art polymer synthesis It consists of 62% hioxifilcon A and 38% water by technique. weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching.

The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-IPL, approved DEC. 1, 1995.

  • IV. Alternative Practices or Procedures
    Alternative practices or procedures are in the use of available prescription products with the same indication.

  • V. Technical Summaries

    • A. Nonclinical
        1. Toxicology

BENZ RESEARCH AND DEVELOPMENT, INC. ran all preclinical studies for the clear lenses in 1990 and for the blue visibility tinted product in 1995 (submitted with this notification.

Conclusion: Clear Approved 1990. Test results on Blue Visibility tinted product are within the same acceptable limits.

    1. Microbiologv
      We are submitting all microbiology work done by Unilens Corp. USA. in 1995 using a validated process.

Conclusion: Clear approved in 1990

    1. Lens compatibility studies run by BENZ Research and Development included with this Notification in "Lens Compatibility Studies"
      Conclusion: Within Normal Limits
    1. Lens Stability The Shelf life will be run by each lens manufacturing unit. Our lenses were sterilized at Unilens Corp. USA and we are asking for the same expiration date as they will. The results are listed under Shelf Life.
      204

2

have to make it's own protocol for this study and apply for an individual shelf life.

    1. Preservative Uptake Tests were run by on the original BENZ 38 material for P830012/S04 approved June 5, 1990.
      Results are within normal limits.

B. Clinical

Clinical Study was done on the original BENZ 38 Clear material for P830012/S04 which was approved June 5, 1990.

Study results fell within normal limits.

RENZ RESEARCH AND DEVELOPMENT, INC. will own the polymer BENZ 38 (polymacon) in clear and visibility tint and is applying to the FDA for permission to have this basic optical polymer approved.

In a separate notification UNILENS, Corp., USA will apply to the FDA to approve their facilities for the manufacture and distribution of soft (hydrophilic) contact lenses made from this polymer BENZ 38 (polymacon).

The equipment manufacturers of lathes, autoclaves, laminar flow units. polishing equipment may be different between those at BENZ Research and Development and the alternate site companies however the end contact lens products are for all intents equivalent.

The manufacturing materials. manufacturing methods, and quality control methods employed by both companies are equiva lent .

Benz Research and Development intends to add additional finishing laboratories in the future. These will be the subject of separate 510(k) notifications.

BENZ R&D was last FDA inspected on March 20, 1990

VI. RECOMMENDATION

This Notification is based on the previous FDA approval of P830012/S04 on June 5, 1990 and the approval of a similar polymer with the identical pigment for visibility tint in K952620 on Dec. 1, 1995.

A favorable recommendation from the FDA is anticipated for the manufacture and distribution of optical button of BENZ 38 (polymacon) clear and blue visibility tinted as well as the manufacture and distribution of soft (hydrophilic) lenses made from this polymer. Any additional information will be supplied by the individuals who's name and address first appear in this notification.