The HEXA100 (hexafocon 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 nondiseased eyes with myopia or hyperopia.

The HEXA100 (hexafocon 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 non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The HEXA100 (hexafocon 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 HEXA100 (hexafocon 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.

The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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.

Device Description

The HEXA100 (hexafocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm.

The HEXA100 (hexafocon 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 HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 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 10 Hydra-PEG, the underlying material (hexafocon 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 30mm in thickness.

The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon 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%.

The HEXA100 (hexafocon 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: 5.0mm to 8.0mm
Spherical Powers: -20.00 Diopters to +20.00 Diopters
Toric Powers: up to -10.00 Diopters
Add Powers: up to +4.00 Diopters

The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:
● Chord Diameter: 6.5 to 11.5 mm
● Center Thickness: 0.10 to 0.70 mm

Base Curve (BC): 6.5 to 11.0 mm
● Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
● Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
Spherical Powers: -10.00 to +3.00 D

AI/ML Overview

Acceptance Criteria and Device Performance for HEXA100 (hexafocon A) Daily Wear Contact Lens

This submission establishes substantial equivalence for the HEXA100 (hexafocon A) Daily Wear Contact Lens by comparing its performance to predicate devices. The acceptance criteria are essentially demonstrated equivalence to these established devices through physical, chemical, and biological testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates performance equivalent or superior to predicate devices across various physical and chemical properties and biocompatibility. The acceptance criteria for the HEXA100 (hexafocon A) Daily Wear Contact Lens are implicitly set by the performance characteristics of its predicate devices and internal validation for safety and stability.

Property	Acceptance Criteria (Based on Predicate Devices and Safety Standards)	HEXA100 (hexafocon A) Reported Performance (Uncoated)	HEXA100 (hexafocon A) Reported Performance (Hydra-PEG Coated)
Biocompatibility & Toxicology	Non-toxic, non-irritating (GLP-compliant)	Not toxic, not irritating	Not toxic, not irritating
Physicochemical, Mechanical, Optical Properties	Substantially equivalent to predicate devices	Substantially equivalent to predicates	Substantially equivalent to predicates
Bioburden Levels	<100 cfu/lens initially and after 30 days storage	Below acceptance criteria	Below acceptance criteria
Physical Parameter Stability	Stable after 30 days storage in Unique pH	Stable after 30 days storage	Stable after 30 days storage
Compatibility with Care Solutions	Physically compatible with currently marketed solutions	Physically compatible	Physically compatible
Material (USAN name)	hexafocon A (Boston XO)	hexafocon A	hexafocon A
Water Content (%)	<1%	<1%	<1%
Specific Gravity (g/cm³)	1.265 (Boston XO)	1.266	1.266
Oxygen Permeability (Dk)	108 x 10⁻¹¹ (Boston XO)	113 x 10⁻¹¹	118 x 10⁻¹¹
Wettability (Sessile Drop Contact Angle)	96.4° (Boston XO) / Roflufocon C, D, E specific values (Optimum GP with HPT, OPTIMUM GP OK)	96.4°	49.1° (significant improvement)
UV Absorber/Blocker Availability	Yes, optional (similar to predicates)	Yes, Optional	Yes, Optional
Includes Hydra-PEG Surface Coating	Yes (similar to predicate Optimum GP with HPT)	No (for uncoated)	Yes, Optional
Refractive Index (dry)	Not explicitly stated for predicates, but consistency expected	1.4136	1.4134
Light Transmission (@380-780nm)	Not explicitly stated for predicates, but >90% generally expected	>91%	>94%
UVA Transmission (@316-380nm)	<16% (demonstrates UV blocking)	<16%	<16%
UVB Transmission (@280-315nm)	<2% (demonstrates UV blocking)	<2%	<2%

2. Sample Size for Test Set and Data Provenance

The provided document does not explicitly state a sample size for a "test set" in the context of clinical trials as it relies heavily on non-clinical testing and established clinical safety of the material and coating.

Non-clinical Testing: Conducted "in vitro and in vivo" for toxicology and biocompatibility. All toxicology tests were conducted in accordance with GLP regulations.
Wettability Data (Sessile Drop Contact Angle): The table indicates "n=30" for the average sessile drop contact angle measurements.
Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It also does not specify whether the data is retrospective or prospective, although GLP (Good Laboratory Practice) regulations generally imply prospective and controlled studies for toxicology.

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

The concept of "experts" establishing ground truth as typically understood in AI/imaging studies (e.g., radiologists) is not applicable here. This submission focuses on the material's physical, chemical, and biological properties, and its substantial equivalence to predicate contact lenses. The "ground truth" for these tests is established by scientific methodologies and accepted standards (e.g., ISO for Dk, GLP for toxicology).

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are not applicable here. These methods are typically used in clinical studies where human interpretation of medical images or patient outcomes requires consensus among multiple experts. The testing performed for this device involved laboratory measurements and analyses of material properties and biological responses, not subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not performed, nor is it applicable for this device. Such studies are typically conducted for AI-assisted diagnostic devices where the interaction between human readers (e.g., radiologists) and AI algorithms is being evaluated for improved diagnostic accuracy or efficiency. The HEXA100 contact lens is a passive medical device, not an AI diagnostic tool.

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

A standalone algorithm-only performance study was not performed, nor is it applicable. This device is a contact lens, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Scientific and Engineering Standards: Measurements of physical properties (e.g., refractive index, specific gravity, oxygen permeability) and chemical properties.
Biological Standards: Results from in vitro and in vivo biocompatibility and toxicology tests, often governed by ISO standards (e.g., ISO 10993 for biological evaluation of medical devices).
Predicate Device Performance: The established safety and effectiveness profiles of legally marketed predicate devices serve as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

A "training set" is not applicable for this device. This is not a machine learning or AI device that requires a training set. The manufacturing process of contact lenses (lathe-cut, custom manufactured) and the material properties are characterized through traditional scientific and engineering methods.

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

As there is no training set, this question is not applicable.

Summary

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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.

510(k) number:

K171077

Applicant information:

Date Prepared:	June 27th, 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, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	HQD; MUW

Classification Name: Daily Wear Rigid Gas Permeable Contact Lens (21 CFR 886.5916)

Trade Name: HEXA100 (hexafocon A) Daily Wear Contact Lens

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

Predicate Devices:

The HEXA100 (hexafocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"Boston XO (hexafocon A) Daily Wear Contact Lens" -primary predicate By Bausch & Lomb, Inc.

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510(k) number: K071043

"OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E)" by Contamac Ltd. 510(k) number; K160859

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

Device Description:

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

	HEXA 100 - Hexafocon A
	Uncoated*	Tangible™ Hydra-PEGCoated*
Average Sessile Drop Contact Angle(degrees) n=30	96.4°	49.1°
Standard Deviation	2.79	5.81
% Standard Deviation	2.90	11.82

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

The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or

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"wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon 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%.

The physical properties of the HEXA100 (hexafocon A) Daily Wear Contact Lenses are as follows:

	HEXA100 (hexafocon A)	HEXA100 (hexafocon A) withTangible™ Hydra-PEG
Refractive Index (dry)	1.4136	1.4134
Light Transmission (@380-780nm)	>91%	>94%
UVA Transmission (@316-380nm)	<16%	<16%
UVB Transmission (@280-315nm)	<2%	<2%
Specific Gravity (g/cm³)	1.266	1.266
Oxygen Permeability(Dk)ISO/FATT Method	113 x 10-11 11(cm /sec) (ml O /ml x mm Hg @35°C)	118 x 10-11 "(cm /sec) (ml O /ml x mm Hg @35°C)
Visitint lenses contain one or more of thefollowing color additives conforming to:21 CFR Part 73 & 74, Subpart D	D&C Green No. 6, C.I. SolventYellow No. 18, D&C Violet No. 2 andD&C Red No. 17	D&C Green No. 6, C.I. SolventYellow No. 18, D&C Violet No. 2and D&C Red No. 17

The HEXA100 (hexafocon 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:
Base Curve:

●

Spherical Powers:
Toric Powers:
Add Powers:
Varies 5.0mm to 8.0mm
-20.00 Diopters to +20.00 Diopters
up to -10.00 Diopters
up to +4.00 Diopters

The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:

6.5 to 11.5 mm ● Chord Diameter:
Center Thickness: 0.10 to 0.70 mm ●
- Base Curve (BC): 6.5 to 11.0 mm
0.10 to 2.0 mm (flatter or steeper than BC) ● Secondary Curves:
0.10 to 2.0 mm (flatter or steeper than BC) Peripheral Curves: ●
Spherical Powers: -10.00 to +3.00 D

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Intended Use:

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 HEXA100 (hexafocon 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 non-clinical testing on the HEXA100 (hexafocon A) Daily Wear Contact Lens demonstrate that:
- The finished lenses (uncoated and coated with Tangible " Hydra-PEG) are ● not toxic and not irritating,
- The physicochemical, mechanical, and optical properties of the Tangible™ . Hydra-PEG coated and uncoated 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,

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Physical parameters are stable following 30 days of storage in Menicon ● Unique pH at ambient temperatures, and
The Tangible "10 HydraPEG coated Hexafocon A lenses are physically ● compatible with currently marketed care solutions.

Clinical Testing The clinical safety and effectiveness has been previously established for contact lenses manufactured from (hexafocon A) and contact lenses coated with Tangible™ 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 HEXA100 (hexafocon 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:

The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the Boston XO (hexafocon A) Daily Wear Contact Lens (cleared under K071043) in terms of the following:

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

The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) (cleared under K160859) in terms of the following:

indications for use (daily wear orthokeratology)
orthokeratology lens design ●

The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the Optimum

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GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens (cleared under K161100) in terms of the following:

may incorporate the Tangible™ Hydra-PEG surface coating .
The following matrix illustrates the production method, lens function and material characteristics of the HEXA100 (hexafocon A) Daily Wear Contact Lens as well as the predicate devices.

Substantial Equivalence Matrix

HEXA100 (hexafocon A)New Device	Boston XO(hexafocon A)Predicate Device	Optimum GP withHPT(roflufocon C, D, E)Predicate Device	OPTIMUM GP OK(Orthokeratology)(roflufocon D & E)Predicate Device
Intended Use	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 such askeratoconus and post graft fitting.Indicated for daily wear in anorthokeratology fitting program forthe temporary reduction of myopiaof up to 5.00 diopters in non-diseased eyes. To maintain theorthokeratology effect of myopiareduction, lens wear must becontinued on a prescribed wearingschedule.	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopiaand/or presbyopia.The lens may also beprescribed formanagement ofirregular cornealconditions such askeratoconus and postgraft fitting.	Indicated for daily wear forthe correction of visualacuity in aphakic and notaphakic persons with non-diseased eyes with myopiaor hyperopia and/orpresbyopia. The lens mayalso be prescribed formanagement of irregularcorneal conditions such askeratoconus and post graftfitting.	Indicated for daily wear inan orthokeratology fittingprogram for the temporaryreduction of myopia of upto 5.00 diopters in non-diseased eyes. To maintainthe orthokeratology effectof myopia reduction, lenswear must be continued ona prescribed wearingschedule.
Functionality	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina	The contact lensesact as a refractivemedium that focuslight rays fromnear and distantobjects on theretina	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina
Indications	Daily Wear	Daily Wear	Daily Wear	Daily Wear
ProductionMethod	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	hexafocon A	hexafocon A	roflufocon C, D, E	roflufocon D, E
Water Content(%)	<1%	<1%	<1%	<1%
Specific Gravity	1.266	1.265	Roflufocon C: 1.178Roflufocon D: 1.166Roflufocon E: 1.155	Roflufocon D: 1.166Roflufocon E: 1.155
OxygenPermeability(cm /sec) (ml O /ml x mmHg @ 35°C)	Uncoated: 113 x 10-11Hydra-PEG Coated: 118 x10-11	108 x 10-11	Roflufocon C: 65x10-11Roflufocon D: 100x10-11Roflufocon E: 125x10-11	Roflufocon D: 100x10-11Roflufocon E: 125x10-11
Wettability(sessile dropcontact angle)	Hydra-PEG Coated: 49.1°Uncoated: 96.4°	96.4°	Roflufocon C: 40.28°Roflufocon D: 40.40°Roflufocon E: 36.90°(measured by captivebubble)	Roflufocon D: 93.28°Roflufocon E: 93.64°(measured by captivebubble)
UVAbsorber/BlockerAvailable	Yes, Optional	Yes	Yes, Optional	Yes, Optional
Includes Hydra-PEGSurface Coating	Yes. Optional	No	Yes	No

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

August 1, 2017

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

Re: K171077

Trade/Device Name: HEXA100 (hexafocon A) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD; MUW Dated: June 28, 2017 Received: June 29, 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. Iisting 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.

{9}------------------------------------------------

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 devicerelated 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 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,

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

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.