The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only

The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens 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 Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (roflufocon C, D, and E) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

In the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380mm.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

7.0mm to 22.0mm Chord Diameter: ●
Center Thickness: Varies
Base Curve:
Spherical Powers:
Toric Powers:
Add Powers: ●

5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

up to +4.00 Diopters

AI/ML Overview

The document describes the K161100 submission for the "Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses." The purpose of this 510(k) submission is to introduce new technology to existing contact lenses by including Hydra-PEG Technology (HPT) to improve wettability.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion and performance metric highlighted is improved wettability, specifically measured by the captive bubble dynamic contact angle. The document compares the new HPT-coated lenses to the uncoated predicate lenses.

Acceptance Criterion (Improved Wettability)	Uncoated (Predicate) Optimum GP (Average Captive Bubble Dynamic Contact Angle, degrees)	HPT Coated (New Device) Optimum GP with HPT (Average Captive Bubble Dynamic Contact Angle, degrees)	Improvement (Reduction in Contact Angle)
Roflufocon C	95.30	40.28	55.02
Roflufocon D	93.28	40.40	52.88
Roflufocon E	93.64	36.90	56.74

Interpretation: The HPT-coated lenses demonstrate a significant reduction in the average captive bubble dynamic contact angle across all three roflufocon materials (C, D, and E), indicating improved wettability as intended.

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

Test Set Sample Size for Wettability: For the wettability measurement (contact angle), the sample size was n=3 for each material (roflufocon C, D, and E), for both uncoated and HPT-coated lenses.
Data Provenance: The document does not explicitly state the country of origin for the wettability data. It is an in-vitro study, comparing the physical properties of the lenses. The general statement "Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols" suggests a controlled laboratory environment. The provided information does not indicate if it's retrospective or prospective, but due to its nature as a controlled lab test, it would be considered prospective for the specific test.

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

The wettability test (captive bubble dynamic contact angle) is an objective physical measurement performed in a laboratory, not a subjective assessment requiring human experts to establish "ground truth" in the way clinical diagnosis or image interpretation would. Therefore, the concept of "experts" as described in the prompt is not applicable to this specific performance criterion.

4. Adjudication Method for the Test Set

Since the wettability test is a direct physical measurement, it does not involve human adjudication for establishing ground truth. The measurement is taken by instrumentation, and the results are quantitative. Therefore, no adjudication method (e.g., 2+1, 3+1) was used or is relevant for this specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this device. The submission focuses on the chemical and physical properties of the contact lens material and its surface coating, not on diagnostic performance or human-in-the-loop clinical effectiveness related to AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is a medical device (contact lens), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance measured is that of the physical device itself.

7. Type of Ground Truth Used

For the wettability performance, the "ground truth" is established by direct physical measurement using standardized laboratory methods (specifically, the captive bubble dynamic contact angle). This is an objective measurement of a material property rather than a subjective clinical assessment or pathology result.

8. Sample Size for the Training Set

This submission addresses a medical device (contact lens) and its material properties, not an AI or machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The testing performed is to characterize the physical properties of the device.

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

As stated above, this is not an AI/ML development, so the concept of a "training set" and its "ground truth" establishment is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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

August 10, 2016

Contamac Ltd. % Mr. Bret Andre Principal Consultant Evereg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K161100

Trade/Device Name: Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: June 23, 2016 Received: June 27, 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. Isting 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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161100

Device Name

Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses

Indications for Use (Describe)

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

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:	K161100
Applicant information:
Date Prepared:	June 23rd, 2016
Name:	Contamac Ltd.
Address	Carlton HouseShire HillSaffron WaldenEssex CB11 3AU
Contact Person:	Robert McGregorManaging Director
Phone number:	44-1799 542 000
Consultant:	Bret AndreEyeReg Consulting, Inc6119 Canter Ln.West Linn, OR 97068
Phone number	(503) 372-5226

Device Information:

Device Classification:	Class II
Product Code:	HQD
Classification Name:	Daily Wear Rigid Gas Permeable Contact Lens(21 CFR 886.5916)
Trade Name:	Optimum GP with HPT (roflufocon C, D, and E) DailyWear Contact Lenses

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Purpose of 510(k) Submission:

~ New Technology ~

The Optimum GP Daily Wear Contact Lenses—cleared under 510(k) K033594 and K070628-are modified to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, HPT treated contact lenses demonstrate a measureable improvement in the contact angle in comparison with the untreated lenses. The application of HPT to the surface of Optimum GP with HPT Daily Wear Contact Lenses does not change the design or indications for use in comparison with the untreated lenses, the predicate device (K033594 and K070628).

Predicate Devices:

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"Optimum GP (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses" By Contamac Ltd. 510(k) number; K033594 and K070628 -primary predicate

"IntelliWave4 with HPT (safrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K152046 -reference predicate

Device Description:

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	roflufocon C		roflufocon D		roflufocon E
	Uncoated	HPT Coated	Uncoated	HPT Coated	Uncoated	HPT Coated
Average CaptiveBubble DynamicContact Angle(degrees) n=3	95.30	40.28	93.28	40.40	93.64	36.90
Standard Deviation	0.55	6.44	2.13	5.05	3.47	8.04
% Standard Deviation	0.58	15.98	2.28	12.51	3.71	21.78

	(roflufocon c)	(roflufocon d)	(roflufocon e)
Refractive Index	1.4406	1.4333	1.4332
Light Transmission(clear)	>97%	>97%	>97%
Light Transmission(tinted)	>90%	>90%	>90%
Specific Gravity	1.178	1.166	1.155
Oxygen Permeability(Dk)ISO/FATT Method	$65 \times 10^{-11}$(cm2/sec) (ml O₂/ml xmm Hg @ 35 °C)	$100 \times 10^{-11}$(cm2/sec) (ml O₂/ml x mm Hg@ 35°C)	$125 \times 10^{-11}$(cm2/sec) (ml O₂/ml x mm Hg@ 35°C)
Visitint lenses containone or more of thefollowing coloradditives conformingto:21 CFR Part 73 & 74,Subpart D	D & C GreenNo. 6, FD & CRed No. 17,CI SolventYellow 18	D & C Green No. 6,FD & C Red No. 17,CI Solvent Yellow 18	D & C Green No. 6,FD & C Red No. 17,CI Solvent Yellow 18

The physical properties of the Optimum GP with HPT Contact Lens are as follows:

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7.0mm to 22.0mm Chord Diameter: ●
Center Thickness: Varies
Base Curve:
Spherical Powers:
Toric Powers:
Add Powers: ●

5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

up to +4.00 Diopters

Intended Use:

The Optimum GP with HPT (roflufocon C. D. and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only

The Optimum GP with HPT (roflufocon C. D. and E) Irregular Cornea Daily Wear Contact Lens 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.

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens 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 Optimum GP with HPT Daily Wear Contact Lens demonstrate that:

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The finished lenses are not toxic and not irritating,
. Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially and following 30 days of storage in Unique pH at ambient temperatures,
. The physical properties of the lens are stable following 30 days of storage in Unique pH at ambient temperatures, and
The surface properties of the lens are stable following 30 days of ● accelerated aging in buffered saline solution.
The clinical safety and effectiveness has been previously established for Clinical Testing contact lenses manufactured from (roflufocon C, D, and E) and contact lenses treated with Hydra-PEG.

Conclusions Drawn from Studies

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following 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 Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.

Substantial Equivalence:

Comparison to Predicate Device(s):

The Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens is substantially equivalent to the Optimum GP (roflufocon A, B, C, D, and E) Daily Wear Contact Lens (cleared under K033594 and K070628) in terms of the following:

contact lens material (roflufocon C, D, and E)
lathe cut manufacturing process
indications for use

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is substantially equivalent to the IntelliWave4 with HPT (cleared under K152046) in terms of the following:

Hydra-PEG surface coating

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The following matrix illustrates the production method, lens function and material characteristics of the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens, as well as the predicate devices.

	Optimum GP with HPT(roflufocon C, D, E)New Device	Optimum GP(roflufocon A, B, C, D, E)(uncoated)Predicate Device	Art OpticalIntelliWave4 with HPT,Silicone Hydrogel(safrofilcon A)Predicate Device
Intended Use	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia or hyperopiaand/or presbyopia. The lens may alsobe prescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or presbyopia. Thelens may also be prescribed formanagement of irregular cornealconditions such as keratoconus andpost graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or presbyopia. Thelens may also be prescribed formanagement of irregular cornealconditions such as keratoconus andpost graft fitting.
Functionality	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina
Indications	Daily Wear	Daily Wear	Daily Wear
Production Method	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	roflufocon C, D, E	roflufocon A, B, C, D, E	safrofilcon A
Water Content (%)	<1%	<1%	65±2%
Wettability(captive bubbleadvancing contact angle)	Roflufocon C: 40.28°Roflufocon D: 40.40°Roflufocon E: 36.90°	Roflufocon C: 95.30°Roflufocon D: 93.28°Roflufocon E: 93.64°	46°
UV Absorber/BlockerAvailable	YES	YES	YES
Includes Hydra-PEGSurface Coating	Yes	No	Yes

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.