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

Device Description

The TYRO ™ -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
Distance Power: +12.00D to -20.00D
Add Power 1.00D to 4.00D

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

This device is a contact lens, and as such, the "acceptance criteria" are related to the physical properties of the lens material and its safety and efficacy for daily wear. The "study" refers to the clinical trials conducted to demonstrate this.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Device)	Reported Device Performance (TYRO™-97)
Water Content: <1%	<0.2%
Oxygen Permeability: 26x10-11 Fatt Units (1990)	97.98 ANSI units (Note: Different units, but likely a higher value indicating better oxygen permeability, which is generally desired for contact lenses)
Refractive Index: 1.44	1.440
Hardness: D/89 (Shore)	D/82 (Shore)
Specific Gravity: 1.25	1.087
Residual Monomers: Implied acceptable levels	No leachable monomers detected
Wetting Angle: 23.0±2° (CLMA method)	23.3° (sessile drop technique)
Mechanical (flexural) Strength: Not explicitly stated for predicate in comparison table, but a property evaluated.	3952psi
Light Transmittance (clear): 93%	>95% T
Light Transmittance (blue): 87%	>70% T
Light Transmittance (green): Not explicitly stated for predicate in comparison table.	>70% T
Light Transmittance (Blue-UV): Not explicitly stated for predicate.	>70% T (400-780nm), 0% T (200-380nm)
Non-toxic as per cytotoxicity, systemic toxicity, and acute ocular irritation tests.	Non-toxic in all tests (Agar Overlay Cytotoxicity, Systemic toxicity, Acute Ocular irritation).
Safety of daily wear for correction of visual acuity in not-aphakic persons with non-diseased eyes (myopic, hyperopic, presbyopic, and corneal astigmatism).	Clinically demonstrated safety for daily wear for the stated indications.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document mentions "clinical trials" but does not give a specific number of participants or eyes.
- Data Provenance: Not explicitly stated. The document refers to "clinical trials" and implies that the data was collected in accordance with a "Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994)," which would suggest a prospective study methodology. No country of origin is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of contact lens clinical trials for safety and efficacy. "Ground truth" for contact lenses typically refers to the objective measurements of the lens properties and the clinical outcomes (e.g., visual acuity, adverse events, comfort) observed in subjects by eye care professionals. The clinical study would have involved ophthalmologists or optometrists assessing these outcomes, but they are not establishing a "ground truth" in the same way experts would for image interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in studies involving expert interpretation of medical images. Clinical trials for contact lenses would involve clinical examinations and assessments by the study investigators.
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. This is a contact lens, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens. Physical and chemical properties are tested standalone, but clinical performance always involves human subjects.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the material properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., specific gravity, hardness, light transmittance).
- For clinical efficacy and safety, the "ground truth" is based on outcomes data from the clinical trial, including measurements of visual acuity, adverse events, comfort, and signs of ocular health observed by qualified eye care professionals during the study.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. (See #7)

Summary

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510(k) SUMMARY FOR FREEDOM OF INFORMATION

K052507

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 Corporation2890 South Tejon StEnglewood, CO 80110
Contact:	John M. Szabocsik, Ph.D.Official agentSzabocsik and Associates203 N. Wabash, Ste 1200Chicago, 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. SubstantialEquivalence	This product is substantially equivalent to other currently marketedrigid lenses, such as Oxycon (wilofocon A) Rigid Gas PermeableContact Lenses
6. DeviceDescription	The TYRO TM -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric,Toric and Bifocal Contact Lenses for Daily Wear are available inspherical, aspherical and toric designs in the clear untinted or blue, greenand gray tinted varieties with and without UV-blocker. Each is a shell ofthe 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

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Aspheric Lens
Eccentricity	-1.5 to 1.5Oblate 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

+12.00D

1.00D

-20.00D

4.00D

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

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: 上海

8. Comparison to predicate devices: see following table

SUBSTANTIAL EQUIVALENCE

	OXYCON (wilofoconA)	TYROTM-97 (hofoconA)
Water Content	<1%	<0.2%
Oxygen Permeability	26x10-11Fatt Units(1990)	97.98ANSI units
Refractive Index	1.44	1.440
Hardness	D/89 (Shore)	D/82 (Shore)
Specific Gravity	1.25	1.087
Residual Monomers		no leachable monomersdetected
Wetting Angle	23.0±2(CLMA method)	23.3°(sessile drop technique)
Mechanical (flexural)Strength		3952psi
Light Transmittanceclearbluegreen	93%87%	>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,

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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.

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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.

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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, 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

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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 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

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.