The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

Device Description

The ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. design finishes with two junctioniess peripheral aspheric curves to maintain alignment.

AI/ML Overview

The provided document is a 510(k) summary for a contact lens, specifically for the addition of three new RGP materials to a previously cleared design and indication for use. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI-enabled diagnostic devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on material properties, manufacturing methods, and intended use. The "acceptance criteria" here are effectively the demonstration of comparable physical characteristics and safety profile to the predicate device.

Therefore, many of the requested sections (sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of regulatory submission as it's not a de novo device or a performance study for a new diagnostic algorithm.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the ComfortKone™ Keratoconus Aspheric Contact Lens (with new materials hybufocon A, filofocon A, and pemufocon A) focuses on demonstrating substantial equivalence to a previously cleared predicate device (ComfortKone™ Keratoconus Aspheric (paflufocon C), K990264). The "acceptance criteria" are implied by the comparative evaluation of various characteristics between the new device and the predicate device. The study to "prove" meeting these criteria is a direct comparison of physical and chemical properties and intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Predicate Device Performance)	New Device Reported Performance (hybufocon A, filofocon A, pemufocon A)	Conclusion
INDICATION	Daily wear, RGP contact lens	Daily wear, RGP contact lens	Substantially Equivalent
INTENDED USE	Daily wear for keratoconus management and correction of refractive ametropia in non-diseased eyes.	Daily wear for keratoconus management and correction of refractive ametropia in non-diseased eyes.	Substantially Equivalent
PRODUCTION METHOD	Lathe-Cut	Lathe-Cut	Substantially Equivalent
RGP Material Common Name	Fluroperm 30 (paflufocon C)	HyBrid FS, Hydro2, Accucon	This is the primary difference; the new materials are being added, and their properties are compared for equivalence.
Water Content	< 1%	(hybufocon A) <1%(filofocon A) < 1%(pemufocon A) < 1%	Substantially Equivalent
Polymer/USAN	Fluroperm 30 (paflufocon C)	HyBrid FS (hybufocon A)Hydro2 (filofocon A)Accucon (pemufocon A)	New polymers, but evaluated for substantial equivalence in overall device performance.
Specific Gravity	1.14	(hybufocon A) 1.18(filofocon A) 1.14(pemufocon A) 1.16	Considered substantially equivalent, falling within a similar range for RGP materials.
Oxygen Permeability (Dk)	30	(hybufocon A) = 23(filofocon A) = 50(pemufocon A) = 25	Considered substantially equivalent. While there are variations, they are within the expected range for RGP lenses and do not raise new questions of safety or effectiveness, especially given the "daily wear" indication. Referencing rights from button manufacturers imply these Dk values are already accepted for other contact lenses.
Wetting Angle	12.8	(hybufocon A) = immeasurable (filofocon A) = <5 (pemufocon A) = <25 *	Considered substantially equivalent or superior in some cases (lower wetting angle generally means better wettability).
Light Transmittance	>93%	(hybufocon A) = >93%(filofocon A) = >93%(pemufocon A) = >93%	Substantially Equivalent
Refractive Index	1.47	(hybufocon A) = 1.44(filofocon A) = 1.45(pemufocon A) = 1.45	Considered substantially equivalent.

Note: The acceptance criteria are essentially the properties of the predicate device that the new device's properties are compared against for substantial equivalence.

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

This document describes a comparison of material properties, not a clinical "test set" in the sense of patient data. The properties are inherent to the materials themselves. The "study" involves characterizing these materials and comparing them to the predicate. The document doesn't specify sample sizes for material testing, but it's implied that standard material characterization methods were used. There is no information about country of origin for data or whether it's retrospective/prospective in a clinical trial sense. The referenced 510(k) numbers for the raw materials (K021977, K000485, K944223) indicate that the physical properties of these materials were previously characterized and accepted independently.

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

Not applicable. Ground truth for a clinical "test set" is not relevant here as this is a material and design modification submission. The "ground truth" for the material properties would be established through laboratory testing and characterization.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical "test set" or diagnostic reading being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission is for contact lens material additions, not a diagnostic imaging device with human-in-the-loop performance evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used for this submission is the established physical and chemical properties of the new materials, as well as the design parameters of the ComfortKone™ lens, all compared to the previously cleared predicate device. This is based on laboratory characterization of materials and established manufacturing processes, not expert consensus, pathology, or outcomes data in a clinical sense for this specific submission. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is stated to be equivalent to the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary

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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. FEB 1 2 2003

The assigned 510(k) number is:

KD24164

Applicant information:

Date Prepared:

February 4, 2003

Name: Address Metro Optics, Inc. 15802 Vision Drive Pflugerville, TX 78660

Contact Person: Phone Number: . Fax:

Mr. Steve Webb Vice President (512) 251-2382 (512) 251-6554

Official Correspondent:	Med-Vice Consulting, Inc.
Regulatory Consultant:	Ms. Deanna Werber
	623 Glacier Drive
	Grand Junction, CO 81503
Phone Number:	(970) 243-5490
Fax Number:	(970) 243-5501

Device Information:

Regulatory Classification: Class II

Product Code: HOD

Trade Name:

ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pernufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank)

Purpose for 510(k)

Addition of three RGP materials to a previously cleared design and indication for use. (K990264)

Classification Name:

Lenses, Contact (other material), Daily Wear

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Equivalent Devices:

The Comfort Keratoconus Aspheric (hybufocon A. filofocon A. pernufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device manufacturer: Metro Optics of Austin, Inc. 1.) 15802 Vision Drive Pflugerville, TX 78660 510(k) 990264

Device name: ComfortKone™, Keratoconus, Daily Wear

510(k) #: K990264

Device Description:

Metro Optics of Austin, Inc., has been granted referencing rights from the button manufacturers. The physical properties of the lenses can be referenced in the corresponding 510(k)'s.

Contamac HyBrid FS (hybufocon A) reference 510(k) K021977 Innovision Hydro2 (filofocon A) reference 510(k) K000485 Innovision Accucon (pemufocon A) reference 510(k) K944223

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Intended Use:

The Comfort Kone™ Keratoconus Aspheric (hybufocon A, filofocon A, persufocon A) Rigid Gas The Connortone - Romact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratocomus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in appakic and not-arbakic persons. The lens may be disinfected with a chemical disinfection system.

Substantial Equivalence:

The new device will be manufactured according to specified process controls and a Quality Management System certified to OSR guidelines. The new device will undergo manufacturing, packaging and other bysich berther to QGP devices currently marketed and distributed by Metro Optics, Inc. in the USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Metro Optics, Inc. ComfortKone™, Keratoconus, Daily Wear SION #K990264. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates that the production method, lens function and material of the Comfort Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens are substantially equivalent to the predicate device. In addition, the indication, intended use, production method, water content, polymer, Dk value, specific gravity, are as well substantially equivalent to the predicate device.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial Equivalence Matrix

: 上一

: 上

: 1

1 : 1 : 1 :

and the comments of

	Characteristic	New DeviceComfortKoneKeratoconus Aspheric(hybufocon A, filofocon A,pemufocon A)	Predicate DeviceComfortKoneKeratoconus Aspheric(paflufocon C)
1.)	INDICATION	Daily wear, Rigid Gas Permeable(RGP) contact lens	Daily wear, Rigid Gas Permeable(RGP) contact lens
2.)	INTENDED USE	Daily wear for persons requiringKeratoconus management. The lensmay be prescribed for the correction ofrefractive ametropia (myopia, hyperopia,and astigmatism) in aphakic and notaphakic persons with non-diseasedeyes.	Daily wear for persons requiringKeratoconus management. The lensmay be prescribed for the correction ofrefractive ametropia (myopia, hyperopia,and astigmatism) in aphakic and notaphakic persons with non-diseasedeyes.
3.)	PRODUCTIONMETHOD	Lathe-Cut	Lathe-Cut
4.)	RGP MATERIALcommon name	HyBrid FSHydro2Accucon	Fluroperm 30
a.	Water Content	(hybufocon A) <1%(filofocon A) < 1%(pemufocon A) < 1%	< 1%
b.	Polymer/USAN	HyBrid FS (hybufocon A)Hydro2 (filofocon A)Accucon (pemufocon A)	Fluroperm 30 (paflufocon C)
c.	Specific Gravity	(hybufocon A) 1.18(filofocon A) 1.14(pemufocon A) 1.16	(paflufocon C) 1.14
d.	Oxygen Permeability	(hybufocon A) = 23(filofocon A) = 50(pemufocon A) = 25	30
e.	Wetting Angle	(hybufocon A) = immeasurable (filofocon A) = <5 (pemufocon A) = <25 *	12.8
f.	Light Transmittance	(hybufocon A) = >93%(filofocon A) = >93%(pemufocon A) = >93%	>93%
g.	Refractive Index	(hybufocon A) = 1.44(filofocon A) = 1.45(pemufocon A) = 1.45	1.47

** receding angle mathod in the course igle medioxi

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

Metro Optics, Inc. c/o Ms. Deanna Werber MedVice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K024164

ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: December 9, 2002 Received: December 17, 2002

Dear Ms. Werber:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. halyi Rosenthal

A. Ralph Rosenthal, 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 STATEMENT

Device Name:

Comfort Kone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Timed, Lathe-cut from Lens Blank)

INDICATIONS FOR USE:

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

Prescription Use
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use

(Optional Format 1-2-96)

Myra Smith

(Division Sign-Off) Division of Ophthalmic Devices

510(k) Number KO24169

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.