(50 days)
Oxycon (wilofocon A)
No
The 510(k) summary describes a rigid gas permeable contact lens with various physical parameters and material composition. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies are clinical trials evaluating the safety of the lens material.
No.
The contact lenses are indicated for the correction of visual acuity, which improves an existing condition but does not treat a disease or restore a damaged function in a therapeutic sense.
No
The device description indicates that the TYRO™-97 lenses are used for the correction of visual acuity (e.g., myopia, hyperopia, presbyopia, astigmatism), which falls under treatment or correction, not diagnosis. The device description does not mention any function for identifying or detecting a medical condition.
No
The device description clearly details physical contact lenses made of a specific polymer material with defined dimensions and tints, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in the eye. This is a direct interaction with the patient's body for a therapeutic purpose (correcting vision).
- Device Description: The device is a contact lens, which is a physical object placed on the surface of the eye.
- Lack of In Vitro Testing: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are designed for such testing.
- Clinical Trial: The safety was confirmed through a clinical trial involving daily wear on patients, which is typical for medical devices that interact directly with the body.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The TYROTM-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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 presbyoptic and which may exhibit corneal astigmatism.
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 TM -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear are available in spherical, aspherical and toric designs in the clear untinted or blue, green and gray tinted varieties with and without UV-blocker. Each is a shell of the following dimensions.
Spherical Contact Lens:
Horizontal Lens Size: 6.5 mm to 11.50mm
Base Curve: 6.50mm to 9.50mm
Distance Powers: +12.00D to -20.00D
Center Thickness:
for low minus 0.05mm to 0.30mm
for plus 0.10mm to 0.70mm
Aspheric Lens
Eccentricity -1.5 to 1.5 Oblate to prolate
Peripheral Curves 0.1 to 1.0mm
Toric Lens
Axis 1 to 180 degrees in 1 degree step
Cylinder power 0.50 to 4.00D
Translating Bifocal Contact Lens:
Horizontal Lens Size: 8.00mm to 10.50mm
Base Curve: 6.50mm to 8.50mm
The 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 CI Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. 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 of the TYRO-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses has been confirmed through a clivical, trial for daily wear contact lens materials according to the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994).
The data of the clinical trials demonstrate the safety of the TYRO-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses.
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.
Oxycon (wilofocon A)
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
510(k) SUMMARY FOR FREEDOM OF INFORMATION
NOV - 2 2005
. .
. · TYRO™-97 (hofocon A) RIGID GAS PERMEABLE . SPHERICAL, ASPHERIC, TORÍC AND BIFOCAL CONTACT LENS FOR DAILY WEAR ·
| 1. Submitted by: | 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 1200
Chicago, IL 60601
(312) 553-0828 |
| 2. Date prepared: | September 8, 2005 |
| 3. Device:
Common Name | TYRO TM -97 (hofocon A) Rigid Gas Permeable Spherical,
Aspheric, Toric and Bifocal Contact Lenses for Daily Wear |
| Trade Name | TYRO TM -97 (hofocon A) Rigid Gas Permeable Spherical,
Aspheric, Toric and Bifocal Contact Lenses for Daily Wear |
| 4. Classification | Class II (Performance Standards)
21 CFR 886.5916 (b) (1)
Rigid Gas Permeable Contact Lens for Daily Wear |
| 5. Substantial
Equivalence | This product is substantially equivalent to other currently marketed
rigid lenses, such as Oxycon (wilofocon A) Rigid Gas Permeable
Contact Lenses |
| 6. Device
Description | The TYRO TM -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric,
Toric and Bifocal Contact Lenses for Daily Wear are available in
spherical, aspherical and toric designs in the clear untinted or blue, green
and gray tinted varieties with and without UV-blocker. Each is a shell of
the following dimensions. |
Spherical Contact Lens:
| Horizontal Lens Size: | 6.5 mm to 11.50mm |
|---|---|
| Base Curve: | 6.50mm to 9.50mm |
| Distance Powers: | +12.00D to -20.00D |
| Center Thickness: | |
| for low minus | 0.05mm to 0.30mm |
| for plus | 0.10mm to 0.70mm |
1
| Aspheric Lens | |
|---|---|
| Eccentricity | -1.5 to 1.5 |
| Oblate to prolate | |
| Peripheral Curves | 0.1 to 1.0mm |
| Toric Lens | |
| Axis | 1 to 180 degrees in 1 degree step |
| Cylinder power | 0.50 to 4.00D |
| Translating Bifocal Contact Lens: | |
| Horizontal Lens Size: | 8.00mm to 10.50mm |
| Base Curve: | 6.50mm to 8.50mm |
The 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 CI Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
+12.00D
1.00D
-20.00D
4.00D
to
to
- Intended use:
The TYROTM-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is 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.
The lenses may be disinfected only by using chemical disinfection
Distance Power:
Add Power
2
: 上海
8. Comparison to predicate devices: see following table
SUBSTANTIAL EQUIVALENCE
| | OXYCON (wilofocon
A) | TYROTM-97 (hofocon
A) |
|-----------------------------------------------|------------------------------|----------------------------------------|
| Water Content | 95% T
70% T
70% T |
| Blue-UV | | >70% T (400-780nm)
0% T (200-380nm) |
Introduction
:
The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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.
Contained in the submission are comparisons of the product to the predicate device, information on the chemistry and manufacturing, results of toxicological tests and the report of clinical trials.
Chemistry and Manufacturing I.
The 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,
7
3
and CI Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
Material and lenses are manufactured in the same manner as the predicate device, and details are contained in K990895.
-
II. Toxicology
The toxicological testing is summarized below. -
Agar Overlay Cytotoxicity: A.
-
B. Systemic toxicity:
-
C. Acute Ocular irritation:
The lens material was shown to be non-toxic in all tests.
- III. Microbiology
The material has a water content less than 1%, and is therefore exempt from the microbiological requirements for hydrophobic contact lenses.
IV. Clinical Studies
The safety of the TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses has been confirmed through a clivical, trial for daily wear contact lens materials according to the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994).
OVERALL CONCLUSION OF THE CLINICAL STUDY:
The data of the clinical trials demonstrate the safety of the TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses.
4
Public Health Service
Image /page/4/Picture/2 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol consisting of three overlapping profiles, which are meant to represent the health and well-being of individuals.
NOV - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Lagado Corporation c/o John M. Szabocsik, PhD Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601
Re: K052507
Trade/Device Name: TYRO-97 (hofocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 8, 2005 Received: September 13, 2005
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. Insting 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, permitts varied 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) 827-8910. 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/industry/support/index.html.
Sincerely yours.
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
September 8, 2005 :
510(k) NUMBER (IF KNOWN) KO 5 2 5 0 7
DEVICE NAME
TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens for Daily Wear
INDICATIONS FOR USE
The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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 presbyoptic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
Prescription Use X (Part 21CFR 801 Subpart D)
OR Over-The-Counter-Use (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Myrabnith
10-1-44
Page 1 of 1
516 Number K052507
K.