The EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

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

Device Description

The EvePrintPRO (roflufocon D) Scleral GP Lens is a rigid gas permeable (RGP) lens designed from measurements of the ocular surface obtained by the EyePrint Impression Process. The vinyl polysiloxane (VPS) impression material used for the EyePrint Impression process is Panasil Initial Contact Light, with 510(k) clearance under K083701. The lenses are manufactured from the hydrophobic contact lens material (roflufocon D). When placed on the human cornea, the EvePrintPRO RGP lenses act as a refracting medium to focus light rays upon the retina.

The EyePrintPRO (roflufocon D) Scleral GP Lenses are available as lathe cut lenses manufactured from (roflufocon D) optical blanks, which incorporate a handling tint using the following FDA listed color additives: D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18.

In the EyePrintPRO (roflufocon D) Scleral GP Lenses with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2,2'-Dihydroxy-4,4'dimethoxybenzophenone.

The UV blocking for EyePrintPRO (roflufocon D) Scleral GP Lenses averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380nm.

AI/ML Overview

The provided document describes the EyePrintPRO (roflufocon D) Scleral GP Lenses and presents information regarding its substantial equivalence to a predicate device, as well as some safety studies. However, it does not contain a comprehensive description of acceptance criteria for a device's performance that is then proven by a study. Instead, it presents limited safety evaluation criteria and their results.

Here's an analysis based on the available information, addressing what can be found and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, only one specific acceptance criterion and its corresponding result are clearly stated under the "Bioburden" section:

Acceptance Criteria	Reported Device Performance
Less than 100 CFU per lens	Less than 1 CFU per lens (for rigid gas permeable lenses manufactured at AVT)

For the "Clinical Evaluation of EyePrint Impression Process," the criteria are less quantitative:

Acceptance Criteria for NITBUT, Ocular Surface Redness, and Corneal Staining: No significant changes from baseline.
Reported Device Performance: No significant changes from baseline were observed.

2. Sample Size Used for the Test Set and Data Provenance

Bioburden Testing: The sample size for this test is not explicitly stated, only "rigid gas permeable lenses manufactured at the Advanced Vision Technologies facility." The provenance is internal (Advanced Vision Technologies).
Clinical Evaluation of EyePrint Impression Process: The sample size was n = 8. The document does not specify the country of origin, but given the FDA submission, it is likely that the study was conducted in the US. It appears to be a prospective study as it involved evaluating subjects before and after a specific process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bioburden testing or the clinical evaluation. These are typically objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication methods used for the test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done, as this device (scleral GP lenses) is not typically evaluated in that manner. The information presented focuses on the physical properties and safety of the lens and the impression process, not on diagnostic accuracy involving multiple readers.

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

N/A. This device is a physical medical device (contact lens) and not an AI algorithm. Therefore, the concept of a "standalone" algorithmic performance does not apply.

7. The Type of Ground Truth Used

Bioburden Testing: The ground truth is established through microbiological culture methods, which provide a quantitative measure of colony-forming units.
Clinical Evaluation of EyePrint Impression Process: The ground truth for NITBUT, ocular surface redness, and corneal staining would be objective clinical measurements and observations taken by eye care professionals.

8. The Sample Size for the Training Set

N/A. This device is a physical medical device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

N/A. As stated above, there is no training set for this type of device.

Summary of Missing Information:

The request asks for details typically found in submissions for AI/ML-enabled diagnostic devices. The EyePrintPRO (roflufocon D) Scleral GP Lenses are a physical medical device (contact lenses). Therefore, many of the requested categories, such as MRMC studies, standalone algorithm performance, training sets, and ground truth establishment for AI models, are not applicable to this document. The document focuses on demonstrating the substantial equivalence of the new device to a predicate device based on material properties, manufacturing process, and safety data, as required for a 510(k) submission for this type of product.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

April 27, 2016

Advanced Vision Technologies % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068

Re: K152724

Trade/Device Name: EyePrintPRO (roflufocon D) Scleral GP Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 15, 2016 Received: March 18, 2016

Dear Mr. Andre:

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

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forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

Enclosure

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Indications for Use

510(k) Number (if known) K152724

Device Name EyePrintPRO (roflufocon D) Scleral GP Lenses

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:	K152724
Applicant information:
Date Prepared:	April 25th, 2016
Name:	Advanced Vision Technologies969 South Kipling ParkwayLakewood, CO 80226United States
Contact Person:	Keith ParkerVice President
Phone number:	(888) 393-5374
Consultant:	Bret J AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068United States
Phone number:	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	HQD
Classification Name:	Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
Trade Name:	EyePrintPRO (roflufocon D) Scleral GP Lenses

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Purpose for Submission:

~ Labeling Change ~

Equivalent Devices:

The EyePrintPRO (roflufocon D) Scleral GP Lenses are substantially equivalent to the following predicate devices:

Predicate devices:

. "OPTIMUM GP" -Primary Predicate By Contamac ltd. 510(k) number; K070628 & K033594

Device Description:

In the EyePrintPRO (roflufocon D) Scleral GP Lenses with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2,2'-Dihydroxy-4,4'dimethoxybenzophenone.

The UV blocking for EyePrintPRO (roflufocon D) Scleral GP Lenses averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380nm.

The physical and mechanical properties of the lens are:

Refractive Index	1.4333
Light Transmission (clear)	greater than 97%
Light Transmission (tinted)	greater than 90%
Wetting Angle	3°
Specific Gravity	1.166
Oxygen Permeability	100 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)
Flexural Strength (Mpa)	49.0
Modulus (Mpa)	76.7
Shore D Hardness	77.5

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Packaging:

The EyePrintPRO (roflufocon D) Scleral GP Lens may be shipped "dry" or "wet" in a contact lens case. The primary container for shipping the EyePrintPRO (roflufocon D) Scleral GP Lens is the #750/750U by Pelican Products, Inc./Paragon Vision Sciences, with clearance under 510(k) K030987. The lens is shipped (wet) non-sterile in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162. The solution contains lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

The EyePrintPRO (roflufocon D) Scleral GP Lenses are manufactured to the following specifications:

Chord Diameter	13.0 mm to 20.00 mm
Center Thickness	0.25 mm to 0.90 mm
Base Curve	6.0 mm to 10.0 mm
Power Range	-25.00D to +25.00D in 0.12 steps

Indications for Use:

The EvePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as: keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

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.

Description of Safety:

The safety profile for finished contact lenses manufactured from (roflufocon D) may be referenced in 510(k) K033594. Additional studies were conducted to evaluate the safety and effectiveness of the EyePrintPRO (roflufocon D) Scleral GP Lenses. A summary of the results are presented below:

Bioburden

Bioburden testing was performed on rigid gas permeable lenses manufactured at the Advanced Vision Technologies facility. Testing resulted in less than 1 colony forming units (CFU) per lens. The acceptance criteria is less than 100 CFU per lens.

Clinical Evaluation of EyePrint Impression Process

Non-invasive tear break up time (NITBUT), ocular surface redness, and corneal staining were evaluated (n = 8) before and after the EyePrint Impression Process. No significant changes from baseline were observed

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Conclusions Drawn from Studies

Studies presented demonstrate that the EyePrint Impression Process is safe for the ocular surface, and the EyePrintPRO (roflufocon D) Scleral GP Lenses are substantially equivalent and do not raise different questions of safety and effectiveness than the previously marketed OPTIMUM GP contact lenses (roflufocon D), 510(k) cleared under K070628 & K033594.

Substantial Equivalence:

The EyePrintPRO (roflufocon D) Scleral GP Lenses are identical to the predicate device in terms of contact lens material (roflufocon D). lathe cut manufacturing processes, and indications for use.

The EvePrintPRO (roflufocon D) Scleral GP Lenses are substantially equivalent and do not raise different questions of safety and effectiveness than the predicate device identified previously.

The following comparison table depicts characteristics of the EyePrintPRO (roflufocon D) contact lens, as well as the predicate device.

	AVTEyePrintPROSubject Device	Contamac ltd.Optimum GPPredicate Device
Functionality	Same as predicate device	After machining from the opticalblank, the contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina.
Indication for Use	Same as predicate device	Daily Wear, Rigid GasPermeable (RGP) ContactLenses
Production Method	Lathe-cut;EyePrint Impression Process forlens design specifications	Lathe-cut;Corneal Topographer orKeratometer readings for lensdesign specifications
USAN name	Same as predicate device	roflufocon D
FDA Group #	Same as predicate device	Group # 3 FluoroSilicone Acrylate
Oxygen Permeability	Same as predicate device	$100 x 10^{-11} (cm^2/sec)(mlO_2)/(ml x mmHg @ 35°C)$ (revised Fattmethod)
Water Content (%)	Same as predicate device	<1%

Substantial Equivalence Matrix

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.