(63 days)
The Comforthone™ Keratoconus Aspheric (patlufocon C) 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.
The Comfort Kone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens material (patfufocon C). The material is a thermoset copolymer derived from fluorosilicone acrylate When placed on the human cornea, the ComfortKone" Keratoconus Aspheric rigid gas monomer. permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The ComfortKone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acury to the keratoconus patient. The ComfortKone" lens design begins with a spherical 4,0 mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then 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. The design finishes with two junctionless peripheral aspheric curves to maintain alignment.
The provided document is a 510(k) premarket notification for a contact lens, the ComfortKone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel technology. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for an AI/device with measurable performance metrics like sensitivity, specificity, or reader improvement.
Instead, the document demonstrates equivalence by comparing the new device's characteristics (production method, lens function, material properties) to those of a predicate device.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
-
Cannot be provided in the requested format. The document does not specify "acceptance criteria" for performance metrics like sensitivity, specificity, etc., nor does it report "device performance" in that context. Instead, it compares specific characteristics of the new device to a predicate device to establish substantial equivalence.
The closest we can get to showing "criteria" and "performance" here is by reproducing the "Substantial Equivalence Matrix" from the document, which serves as the fundamental comparison for acceptance:
| Characteristic | ComfortKone Keratoconus Aspheric (New Device) | Predicate Device: ROSE K LENS Keratoconus Aspheric | Acceptance (based on equivalence) |
|---|---|---|---|
| 1.) PRODUCTION METHOD | Lathe-Cut | Lathe-Cut | Met |
| 2.) LENS FUNCTION | Keratoconus management. Refractive medium...compensating for refractive error, including (astigmatism) | Keratoconus management. Refractive medium...compensating for refractive error, including (astigmatism) | Met |
| 3.) RGP MATERIAL | Rigid Gas Permeable (RGP) Fluroperm 30 | Rigid Gas Permeable (RGP) Boston ES | Met (with noted polymer difference) |
| a. Water Content | < 1% | < 1% | Met |
| b. Polymer | (paflufocon C) | (enflufocon A) | Considered equivalent |
| c. Oxygen Permeability | 30 | 31 | Met (very close) |
| d. Refractive Index | 1.475 | 1.443 | Met (within acceptable range for equivalence) |
| e. Specific Gravity | 1.14 | 1.22 | Met (within acceptable range for equivalence) |
| f. Wetting Angle | 12.8 deg. | 52.0 deg. | Met (within acceptable range for equivalence) |
| g. Light Transmission (clear lens) | > 93 % | > 84 % | Met |
The acceptance criterion applied here is the demonstration of "substantial equivalence" of these characteristics to the predicate device, which implies that the new device does not raise new questions of safety or effectiveness. The document explicitly states: "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."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document is a 510(k) premarket notification for a contact lens seeking substantial equivalence. It does not describe a clinical study with a "test set" of patients or data in the way an AI/software device would. The "data" here refers to the physical and chemical properties of the lens material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. There is no "ground truth" establishment by experts on a test set of data as this is a physical medical device (contact lens) seeking substantial equivalence based on material properties and design, not an AI or diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. As there is no test set or human interpretation involved, there is no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This is not an AI-assisted device. Therefore, no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a physical contact lens, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the established physical and chemical properties of the new contact lens material and design, and the established safety and effectiveness profile of the predicate device. The document relies on:
- Laboratory measurements of the new device's material properties (e.g., refractive index, light transmission, oxygen permeability, wetting angle, specific gravity, hardness).
- The known performance and safety history of the predicate device (Rose K Lens, K945955).
- Pre-clinical toxicology and manufacturing/chemistry data.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device that requires a training set. The "development" of the device likely involved material science and engineering, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, this question does not apply.
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3/31/99
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: | K990264 |
|---|---|
| Applicant information: | |
| Date Prepared: | January 25th, 1999 |
| Name: | Metro Optics, Inc. |
| Address | 15802 Vision Drive |
| Pflugerville, TX 78660 | |
| P.O. Box 14847 | |
| Austin, Texas 78761 | |
| Contact Person: | Mr. Steve Webb |
| Vice President | |
| Phone Number: | (512) 251-2382 |
| Fax: | (512) 251-6554 |
| Official Correspondent: | Med-Vice Consulting, Inc. |
| Regulatory Consultant: | Mr. Martin Dalsing |
| 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: | HQD |
| Trade Name: | ComfortKone TM Keratoconus Aspheric (paflufocon C)Rigid Gas Permeable (RGP) Daily Wear Contact Lens(Clear and Tinted, Lathe-cut from Lens Blank) |
| Classification Name: | Lenses, Contact (other material), Daily Wear |
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Equivalent Devices:
The Comfort Kone™ Keratoconus Aspheric (patiufocon C) 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:
Rose K Lens ર ! 0(k) # K945955 Manufactured under license by: 510(k) Author:
Lens Dynamics, Inc. Rose K International Limited
Device Description:
The Comfort Kone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens material (patfufocon C). The material is a thermoset copolymer derived from fluorosilicone acrylate When placed on the human cornea, the ComfortKone" Keratoconus Aspheric rigid gas monomer. permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The ComfortKone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acury to the keratoconus patient. The ComfortKone" lens design begins with a spherical 4,0 mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then 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. The design finishes with two junctionless peripheral aspheric curves to maintain alignment.
The physical properties of the lens are
| Refractive Index | 1.475 (Nd at 25°C) |
|---|---|
| Light Transmission (clear) | 93 % |
| Light Transmission (blue) | 91 % |
| Light Transmission (gray) | 91 % |
| Light Transmission (green) | 92 % |
| Wetting Angle (receding angle) | 12.8° |
| Specific Gravity | 1.14 |
| Hardness (shore D) | 84 |
| Water Content | < 1% |
| Color Pigment Names | D & C Green No. 6, Perox Yellow No. 9, D & C Violet No. 2 |
| 21 CFR § 74.3206, § 73.3122, § 74.3602 | |
| Oxygen Permeability | 30 X 10-11 (cm2/sec) (ml O 2/ml x mm Hg @ 35°C), |
| revised Irving Fatt method. |
The Comfort Keratoconus Aspheric (patlufocon C) Rigid Gas Permesble (RGP) Daily Wear Contact Leas
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Intended Use:
The Comforthone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Leas 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.
Substantial Equivalence:
The new device will be manufactured according to specified process controls and a Quality Management System certified to CGMP guidelines. The new device will undergo manufacturing, packaging and other process procedures similar to RGP 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 Rose K Lens (RGP), 510(k) #K945955. 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 Kone™ Keratoconus Aspheric (patlufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens are substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, wetting angle and light transmission are as well substantially equivalent to the predicate device.
... 8
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Metro Optics 510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix
,
:
1 - 1 - 1 - 1
. T
1 - 1 - 1 - 1 - 1 -
| Characteristic | ComfortKoneKeratoconus Aspheric | Predicate Device:ROSE K LENSKeratoconus Aspheric | |
|---|---|---|---|
| 1.) | PRODUCTIONMETHOD | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Keratoconus management.Refractive medium that focuseslight rays from near and distantobjects on the retina, whilecompensating for refractive error,including (astigmatism) | Keratoconus management.Refractive medium that focuseslight rays from near and distantobjects on the retina, whilecompensating for refractive error,including (astigmatism) |
| 3.) | RGP MATERIAL | Rigid Gas Permeable (RGP)Fluroperm 30 | Rigid Gas Permeable (RGP)Boston ES |
| a. | Water Content | < 1% | < 1% |
| b. | Polymer | (paflufocon C) | (enflufocon A) |
| c. | Oxygen Permeability | 30 | 31 |
| d. | Refractive Index | 1.475 | 1.443 |
| e. | Specific Gravity | 1.14 | 1.22 |
| f. | Wetting Angle | 12.8 deg. | 52.0 deg. |
| g. | Light Transmission(clear lens) | > 93 % | > 84 % |
The ComfortKone™ Keratocoms Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Costact Lens
:
.
.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines. The image is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Mr. Martin Dalsing Official FDA Correspondent for Metro Optics, Inc. Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K990264
Trade Name: ComfortKone™, Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable Contact Lens for Daily Wear (Clear and Tinted)
Regulatory Class: II Product Code: 86 HQD Dated: March 23, 1999 Received: March 26, 1999
Dear Mr. Dalsing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 -- Mr. Martin Dalsing
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
. '
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
્રોંક
Device Name:
Comforthonem Keratoconus Aspheric, (paflufocon C) Rigid Gas Permeable (RGP), Daily Wear Contact Leus (Clear and Tinted, Lathe-cut from Lens Blank)
INDICATIONS FOR USE:
The Comforthone™ Keratoconus Aspheric (patlufocon C) 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.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Or
Over-The-Counter Use
(Optional Format 1-2-96)
Smteeto
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number k 990264
§ 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.