K Number
K121324
Device Name
AVT NATURASOFT
Date Cleared
2012-08-23

(113 days)

Product Code
Regulation Number
886.5925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The AVT NATURASOFT, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters. The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters. The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eyecare practitioners are to prescribe the lenses for quarterly frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Device Description
The AVT NATURASOFT Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material. (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
More Information

Not Found

No
The summary describes a standard contact lens made from a specific material and its intended uses. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.

No.
The contact lenses are indicated for the correction of visual acuity and management of irregular corneal conditions, which are not considered therapeutic interventions based on typical medical device classifications.

No

The device is a contact lens intended for vision correction, not for diagnosis of any condition. It corrects visual acuity and manages irregular corneal conditions; it does not identify or diagnose diseases.

No

The device description clearly states it is a physical contact lens made from efrofilcon A, a silicone hydrogel material. It describes the physical properties and manufacturing process of the lens itself, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Function: The AVT NATURASOFT contact lenses are described as devices for the correction of visual acuity and the management of irregular corneal conditions. They are worn on the surface of the eye.
  • Lack of Testing on Samples: The description does not mention the device being used to test any samples taken from the body. Its function is directly related to the eye itself.
  • Clinical Performance: The text mentions "clinical performance" and "in vivo preclinical toxicology and biocompatibility tests," which are typical for medical devices that interact directly with the body, not for IVDs which analyze samples.

Therefore, the AVT NATURASOFT contact lenses fall under the category of medical devices, but not specifically In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The AVT NATURASOFT, toric (efrofileon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Product codes

LPL

Device Description

The AVT NATURASOFT Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material. (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The Physical properties of the lens are:
Refractive Index: 1.38
Light Transmission: greater than 97%
Surface Character: hydrophilic
Water Content: 74 %
Specific Gravity: 1.048 (hydrated)
Oxygen Permeability: 59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method).

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal toric and irregular cornea configurations with the following features and properties.
• Chord Diameter: 12.0 mm to 16.00 mm
• Center Thickness: 0.01 mm to 0.50 mm
• Base Curve: 8.0 mm to 9.5 mm
• Power Range: -20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric): -0.25D to -12.00D
• Cylinder Power (Multifocal Toric): -0.25D to -4.00D
• Add Power (Multifocal): +0.50D to +4.00D

The lens is supplied sterile in vials containing a 0.9% saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eye / cornea

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Eyecare practitioners

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)

Non-clinical Testing
A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the AVT NATURASOFT (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.
Test results of the non-clinical testing on the AVT NATURASOFT (efrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:

  • Lenses supplied in glass vials are sterile for the indicated shelf-life.
  • The packaging material and extracts are not toxic and not irritating, and ●
  • Lens physical and material properties are consistent with currently marketed . lenses.

Clinical Data
The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k).

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

Not Found

Predicate Device(s)

K100221, K052560, K983637

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) SUMMARY OF SAFETY AND EFFECTIVENESS

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:K121324
-----------------------------------------

Applicant information:

Date Prepared:April 25, 2012
Name:Advanced Vision Technologies
Address14828 West 6th Avenue, Suite 15B
Golden, CO 80401
Contact Person:Mr. Keith Parker
President
Phone number:(303) 384 1111
Consultant:Martin Dalsing
Medvice Consulting, Inc.
806 Kimball Avenue
Grand Junction, CO 81501
Phone number(970) 243-5490

Device Information:

Device Classification:Class II
Classification Number:LPL
Classification Name:Lenses, Soft Contact, Daily Wear
Trade Name:AVT NaturaSoft, Definitive Silicone Hydrogel Daily Wear
Soft Contact Lens (efrofilcon A)

AVT NaturaSoft, Custom Rx Silicone Hydrogel Daily Wear Contact Lens

K121324

1

Advanced Vision Technologies

K121324

510(k) Premarket Notification

Equivalent Devices:

The AVT NATURASOFT, Definitive Silicone Hydrogel Daily Wear Soft Contact Lenses (efrofileon A) are substantially equivalent to the following predicate devices:

Predicate devices:

"IntelliWave", Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221

"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number; K052560

"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637

Device Description:

The AVT NATURASOFT Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material. (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

2

510(k) Premarket Notification

The Physical properties of the lens are:

Refractive Index1.38
Light Transmissiongreater than 97%
Surface Characterhydrophilic
Water Content74 %
Specific Gravity1.048 (hydrated)
Oxygen Permeability59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method).

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal toric and irregular cornea configurations with the following features and properties.

• Chord Diameter12.0 mm to 16.00 mm
• Center Thickness0.01 mm to 0.50 mm
• Base Curve8.0 mm to 9.5 mm
• Power Range-20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric)-0.25D to -12.00D
• Cylinder Power (Multifocal Toric)-0.25D to -4.00D
• Add Power (Multifocal)+0.50D to +4.00D

The lens is supplied sterile in vials containing a 0.9% saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Intended Use:

The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The AVT NATURASOFT, toric (efrofileon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

3

Advanced Vision Technologies

510(k) Premarket Notification

The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Testing:

Non-clinical Testing

Non-clinical Testing A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the AVT NATURASOFT (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

Test results of the non-clinical testing on the AVT NATURASOFT (efrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:

  • Lenses supplied in glass vials are sterile for the indicated shelf-life.
  • The packaging material and extracts are not toxic and not irritating, and ●
  • Lens physical and material properties are consistent with currently marketed . lenses.

Clinical Data

The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k).

The AVT NATURASOFT, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221.

The AVT NATURASOFT, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathecut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221.

AVT NaturaSoft, Custom Rx Silicone Hydrogel Daily Wear Contact Lens

4

Advanced Vision Technologies

510(k) Premarket Notification

Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the AVT NATURASOFT, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the AVT NATURASOFT, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

AVT NaturaSoft, Custom Rx Silicone Hydrogel Daily Wear Contact Lens

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 stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Advanced Vision Technologies c/o Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Drive, Suite # B7 Grand Junction, CO 81505

AUG 2 3 2012

Re: K121324

AVT NaturaSoft, Definitive Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Lenses, Soft Contact, Daily Wear (Silicone Hydrogel) Regulatory Class: Class II Product Code: LPL Dated: August 10, 2012 Received: August 14, 2012

Dear Mr. Dalsing:

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.

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

6

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/CDRH/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 yours,
Kesia Alexander

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

Enclosure

7

INDICATIONS FOR USE STATEMENT

510(k): K121324

AVT NATURASOFT, Definitive Silicone Hydrogel Daily Wear Soft Contact Device Name: Lens (efrofilcon A)

INDICATIONS FOR USE:

The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The AVT NATURASOFT, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

Eyecare practitioners are to prescribe the lenses for quarterly frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K121324 510(k) Number_