(175 days)
No
The summary describes rigid gas permeable contact lenses and their materials. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The intended use states that the lenses are for the "correction of visual acuity" and "management of irregular corneal conditions", which are not considered therapeutic treatments.
No
Explanation: The device is a contact lens used for correction of visual acuity and management of irregular corneal conditions, not for diagnosing conditions.
No
The device description clearly details the physical materials and composition of rigid gas permeable contact lenses, which are hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity and management of irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the materials and composition of contact lenses, which are physical devices applied to the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact 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 lenses may be disinfected only by using chemical disinfection
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.
The blue tinted onsifocon A lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
The safety and efficacy of the TYRO™ -97 (hofocon A) and ONSI™ -56 (onsifocon A) Rigid Gas Permeable Contact Lenses were demonstrated in 510(k) Premarket Notifications as follows: K052507 - SE Decision Date 02-NOV-05 and K033599 - SE Decision Date 16-SEP-04, respectively.
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
-K 102154.
JAN 2 1 2011
December 14, 2010
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
TYRO™ -97 (hofocon A) and ONSI™ -56 (onsifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear
1. SUBMITTER INFORMATION:
The Lagado Corporation 2890 South Tejon St Englewood, CO 80110
Contact:
John M. Szabocsik, Ph.D.
Official agent Szabocsik and Associates 203 N. Wabash, Ste 2208 Chicago, IL 60601 . (312) 553-0828 .
-
- December 13, 2010 DATE PREPARED:
3. DEVICE NAME:
rigid gas permeable (hydrophilic) contact lenses Classification Name:
TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric Proprietary Names: and Bifocal Contact Lens
ONSI™ -56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric. Toric and Bifocal Contact Lens
CLASSIFICATION: 4 .
Class II (Performance Standards) Classification: HQD 21 CFR 886.5916 (b) (1) Rigid Gas Permeable Contact Lens for Daily Wear
5. DESCRIPTION OF DEVICES:
The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
The physical properties of the hofocon A lenses are as follows:
Typical Property
Test Value
1
| Hardness | D/82 (Shore HardnessUnits) |
|---|---|
| Water Content | 95%T |
| Blue >70% T | |
| Green>70% T | Clear>95% T |
| Blue>70% T | |
| Green>70% T | |
| Grey>70% T | |
| Blue-violet>70% T | |
| Blue-UV>70%T(400-780nm) | >92% |
な
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Szabocsik and Associates c/o Dr. John M. Szabocsik 203 North Wabash Avenue Suite 2208 Chicago, Illinois 60601
JAN 2 1 201
Re: K102154
Trade/Device Name: TYRO-97 (hofocon A), ONSI™ - 56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens for Daily Wear Regulatory Class: Class II Product Code: HQD Dated: December 20, 2010 Received: December 23, 2010
Dear Dr. Szabocsik:
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.
5
Page 2 - Dr. John M. Szabocsik
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 liasting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11178001,1 profox the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFF), Paul 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 Small Manufacturers, International and Consumer Assistance 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,
Kesia Alexander
Image /page/5/Picture/7 description: The image shows the handwritten word "for" in cursive. The letter "f" has a large, elongated loop extending below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the ink is black. The background is plain white.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
December 14, 2010
Page 1 of 1
510(k) NUMBER (IF KNOWN)
DEVICE NAME TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear
INDICATIONS FOR USE
The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact 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 lenses may be disinfected only by using chemical disinfection
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X Over-The-Counter-Use (Per 21 CFR 801.109) OR (Optional Format 1-2-96)
Page 1 of 1
Jana Postell
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102154