The ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise nondiseased 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.

Eye care 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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoroitaconate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the ENFLU 18 (enflufocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for ENFLU 18 averages > 98% in the UVB range of 280nm - 315nm and >83% in the UVA range of 316 - 380mm.

The ENFLU 18 (enflufocon A) 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, D&C Violet No. 2 and D&C red No. 17.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "M Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (enflufocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses may be 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%.

AI/ML Overview

The provided document describes the ENFLU 18 (enflufocon A) Daily Wear Contact Lens, a rigid gas permeable (RGP) contact lens, and its substantial equivalence to predicate devices, thus demonstrating its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the ENFLU 18 device in the format of a pre-defined threshold vs. actual performance data. Instead, it demonstrates substantial equivalence by comparing the ENFLU 18's physical properties and performance characteristics to those of predicate devices. The "reported device performance" are the physical properties listed for ENFLU 18. The "acceptance criteria" are implied by the properties of the predicate devices for which the new device is deemed substantially equivalent.

Characteristic	Acceptance Criteria (Predicate Boston ES)	Acceptance Criteria (Predicate Optimum GP)	Reported Device Performance (ENFLU 18 Uncoated)	Reported Device Performance (ENFLU 18 Tangible™ Hydra-PEG Coated)
Material USAN Name	enflufocon A	roflufocon C, D, E	enflufocon A	enflufocon A
Water Content (%)	<1%	<1%	<1%	<1%
Specific Gravity (g/cm³)	1.220	Roflufocon C: 1.178, D: 1.166, E: 1.155	1.221	1.221
Oxygen Permeability (Dk)	22 x 10⁻¹¹	Roflufocon C: 65x10⁻¹¹, D: 100x10⁻¹¹, E: 125x10⁻¹¹	$21.03 \times 10^{-11}$	$23.96 \times 10^{-11}$
Wettability (Sessile Drop Contact Angle)	87.5°	Roflufocon C: 40.28°, D: 40.40°, E: 36.90°	86.5° (Average, n=30)	48.0° (Average, n=30)
Refractive Index (dry)	Not explicitly listed for predicate	Not explicitly listed for predicate	1.4436	1.4432
Light Transmission (@380-780nm)	Not explicitly listed for predicate	Not explicitly listed for predicate	>90%	>90%
UVA Transmission (@316-380nm)	Not explicitly listed for predicate (Yes UV Blocker)	Not explicitly listed for predicate (Yes UV Blocker)	<17%	<14%
UVB Transmission (@280-315nm)	Not explicitly listed for predicate (Yes UV Blocker)	Not explicitly listed for predicate (Yes UV Blocker)	<2%	<1%

2. Sample Size for the Test Set and Data Provenance

Sample Size for Wettability Testing: 30 lenses (n=30) were used for the sessile drop contact angle measurements for both uncoated and Tangible™ Hydra-PEG coated ENFLU 18 lenses.
Data Provenance: The document states that "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed". It also mentions that "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." This implies a controlled laboratory setting. The country of origin for the data is not explicitly stated. The study is described as "preclinical" and "in vitro and in vivo," indicating a mix of laboratory and potentially animal or human (for biocompatibility) testing. The document also states "The clinical safety and effectiveness has been previously established for contact lenses manufactured from (enflufocon A) and contact lenses treated with Tangible ™ Hydra-PEG," indicating that the clinical data for these materials are retrospective from prior research.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies mentioned are primarily technical and laboratory-based, focusing on material properties, toxicology, and biocompatibility, rather than diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are not based on subjective interpretation or a diagnostic assessment requiring adjudication. They focus on objective measurements of physical, chemical, and biological properties.

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

A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (contact lens) and its substantial equivalence submission. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed, nor is it applicable. The device is an RGP contact lens, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests described were:

Objective measurements: For physical properties like refractive index, light transmission, specific gravity, oxygen permeability, and wettability (sessile drop contact angle).
Established scientific protocols/standards: For toxicology, biocompatibility, and microbiological testing (e.g., GLP regulations, bioburden acceptance criteria).
Predicate device characteristics: The acceptance that the ENFLU 18 is substantially equivalent relies on its properties being comparable to those of the legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable as the document describes the testing of a medical device (contact lens), not the development of an artificial intelligence or machine learning model that requires a training set.

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

This information is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2017

CONTAMAC Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K171575

Trade/Device Name: ENFLU 18 (enflufocon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: September 11, 2017 Received: September 14, 2017

Dear Bret 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue

Silver Spring, MD 20993 www.fda.qov

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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,

Denise L. Hampton -S

for Malvina 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) K171575

Device Name

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

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)

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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:	K171575
Applicant information:
Date Prepared:	May 22nd, 2017
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)
Common Name:	Rigid Gas Permeable Contact Lens
Trade Name:	ENFLU 18 (enflufocon A) Daily Wear Contact Lens

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Purpose of 510(k) Submission: ~ New Device ~

Predicate Devices:

The ENFLU 18 (enflufocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"Boston ES (enflufocon A) Daily Wear Contact Lens" By Bausch & Lomb, Inc. 510(k) number; K943177 -primary predicate

"Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses" by Contamac Ltd. 510(k) number; K161100 -reference predicate

Device Description:

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	ENFLU 18 - Enflufocon A
	Uncoated*	Tangible TM Hydra-PEG Coated*
Average Sessile Drop Contact Angle(degrees) n=30	86.5	48.0
Standard Deviation	2.85	4.20
% Standard Deviation	3.30	8.75

*lenses were manufactured and soaked in borate buffered saline for 24 hours prior to contact angle measurement

The physical properties of the ENFLU 18 (enflufocon A) Daily Wear Contact Lens are as follows:

	ENFLU 18 (enflufocon A)	ENFLU 18 (enflufocon A) withTangible HydraPEG
Refractive Index (dry)	1.4436	1.4432
Light Transmission (@380-780nm)	>90%	>90%
UVA Transmission (@316-380nm)	<17%	<14%
UVB Transmission (@280-315nm)	<2%	<1%
Specific Gravity (g/cm³)	1.221	1.221
Oxygen Permeability(Dk)ISO/FATT Method	$21.03 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C)	$23.96 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C)
Visitint lenses contain one ormore of the following coloradditives conforming to:21 CFR Part 73 & 74, Subpart D	D&C Green No. 6, C.I. Solvent YellowNo. 18, D&C Violet No. 2 and D&C redNo. 17	D&C Green No. 6, C.I. Solvent YellowNo. 18, D&C Violet No. 2 and D&C redNo. 17

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

Chord Diameter: 7.0mm to 22.0mm ●
- Center Thickness: Varies
Base Curve:

●

Spherical Powers:
-20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

5.0mm to 8.0mm

o Toric Powers: Add Powers: up to +4.00 Diopters ●

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Intended Use:

The ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) 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 nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The ENFLU 18 (enflufocon A) 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 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 ENFLU 18 (enflufocon A) 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.

Eye care 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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens. 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 nonclinical testing on the ENFLU 18 (enflufocon A) Daily Wear Contact Lens demonstrate that:

The finished lenses are not toxic and not irritating, ●
The physicochemical, mechanical, and optical properties of the lenses are ● substantially equivalent to the predicate device.
. Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially (dry) and following 30 days of storage in Unique pH at ambient temperatures.
. Physical parameters are stable following 30 days of storage in Menicon Unique pH at ambient temperatures,
. The surface properties of the lens are stable following 24 days of accelerated aging in Menicon Unique pH.

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Clinical Testing The clinical safety and effectiveness has been previously established for contact lenses manufactured from (enflufocon A) and contact lenses treated with Tangible 114 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 ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens is substantially equivalent to the Boston ES (enflufocon A) Daily Wear Contact Lens (cleared under K943177) in terms of the following:

contact lens material (enflufocon A)
production method: lathe cut manufacturing process
functionality
indications for use (sphere, toric, multifocal, irregular cornea) o

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is substantially equivalent to the Optimum GP with HPT (roflufocon C, D. and E) Daily Wear Contact Lens (cleared under K161100) in terms of the following:

may optionally incorporate the Tangible™ Hydra-PEG surface coating ●
The following matrix illustrates the production method, lens function and material characteristics of the ENFLU 18 (enflufocon A) Daily Wear Contact Lens as well as the predicate devices.

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Substantial Equivalence Matrix

	ENFLU 18(enflufocon A)New Device	Boston ES (enflufocon A)Predicate Device	Optimum GP with HPT(roflufocon C, D, E)Predicate Device
Intended Use	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 inaphakic and not aphakic personswith non-diseased eyes with myopiaor hyperopia and/or presbyopia.The lens may also be prescribed formanagement of irregular cornealconditions such as keratoconus andpost graft fitting.	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia and/orpresbyopia. The lens may also beprescribed for management ofirregular corneal conditions suchas keratoconus and post graftfitting.
Functionality	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	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina
Indications	Daily Wear	Daily Wear	Daily Wear
Production Method	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	enflufocon A	enflufocon A	roflufocon C, D, E
Water Content (%)	<1%	<1%	<1%
Specific Gravity	1.221	1.220	Roflufocon C: 1.178Roflufocon D: 1.166Roflufocon E: 1.155
Oxygen Permeability(cm2/sec) (ml O2/ml x mm Hg @35°C)	Uncoated: 21 x 10-11Coated: 24 x 10-11	22 x 10-11	Roflufocon C: 65x10-11Roflufocon D: 100x10-11Roflufocon E: 125x10-11
Wettability(sessile drop contactangle)	Uncoated: 86.5°Coated: 48.0°	87.5°	Roflufocon C: 40.28°Roflufocon D: 40.40°Roflufocon E: 36.90°(measured by captive bubbleadvancing contact angle)
UV Absorber/BlockerAvailable	Yes, Optional	Yes	Yes, Optional
Includes Hydra-PEGSurface Coating	Yes, Optional	No	Yes

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.