(57 days)
No
The summary describes a contact lens with a specific physical design (aspheric curves) for managing keratoconus. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a contact lens intended for vision correction and management of keratoconus, but it does not directly treat or cure a disease or condition in a therapeutic manner. It acts as a refracting medium to focus light for vision correction.
No
The device, a contact lens, is intended for vision correction in individuals with keratoconus and refractive ametropia. It acts as a refracting medium to focus light and manage the condition rather than diagnosing it.
No
The device description clearly states it is a rigid gas permeable contact lens fabricated from specific materials, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Keratoconus management" and "correction of refractive ametropia." This describes a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description explains how the lens acts as a "refracting medium to focus light rays upon the retina" and how its design helps with fitting and visual acuity in keratoconus patients. This is a description of a medical device that physically interacts with the eye to improve vision.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease state based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not perform such a function.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HOD
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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:
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.
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
2
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.
3
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial Equivalence Matrix
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and the comments of
:
| | Characteristic | New Device
ComfortKone
Keratoconus Aspheric
(hybufocon A, filofocon A,
pemufocon A) | Predicate Device
ComfortKone
Keratoconus 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 requiring
Keratoconus management. The lens
may be prescribed for the correction of
refractive ametropia (myopia, hyperopia,
and astigmatism) in aphakic and not
aphakic persons with non-diseased
eyes. | Daily wear for persons requiring
Keratoconus management. The lens
may be prescribed for the correction of
refractive ametropia (myopia, hyperopia,
and astigmatism) in aphakic and not
aphakic persons with non-diseased
eyes. |
| 3.) | PRODUCTION
METHOD | Lathe-Cut | Lathe-Cut |
| 4.) | RGP MATERIAL
common name | HyBrid FS
Hydro2
Accucon | Fluroperm 30 |
| a. | Water Content | (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
11:11:11:1
: |
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4
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.
5
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
6
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:
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.
(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)
Of
Over-The-Counter Use
(Optional Format 1-2-96)
Myra Smith
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number KO24169