The PVS Basic™2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic" 2 (migafocon A) and Epic 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D.

Device Description

The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6. The lenses have the following dimensions and characteristics: Material: migafocon A, Indication: Daily Wear, Water Content: < 1%, Oxygen Permeability*: 74 x 10-11 Dk at 35° C., Oxygen Permeability**: 52 x 10-11 Dk at 35° C, Luminous Transmittance (blue) : 87%, Wetting Angle (receding angle): 16, Hardness (Shore D): 82.6, Refractive Index**: 1.454 (nD at 25° C), Specific Gravity: 1.10, Color: Blue. Lens Parameters: Chord Diameter: 7.0 to 10.5 mm, Center Thickness: 0.05 to 0.70 mm, Base Curve: 6.50 to 9.00 mm, Power: -20.00 to +12.00 Diopters, Bifocal Add Power: + 0.25 to +4.00 Diopters, Concentric Bifocal Add Diameter: 2.0 to 4.0 mm, Monocentric Bifocal Add Diameter: 4.0 to 9.0 mm, Monocentric Bifocal Prism: 0 to 2.5 Diopters.

AI/ML Overview

This document describes the 510(k) summary for the PVS Basic™ 2 and Epic® 2 rigid gas permeable contact lenses. It focuses on demonstrating substantial equivalence to a predicate device, PVS Basics™ (paflufocon E) contact lenses, rather than a clinical study with an acceptance criteria for a new AI/medical device.

Here's the information extracted, re-framed to best fit the categories provided, acknowledging that this is a contact lens submission and not an AI or diagnostic device:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for contact lenses demonstrating substantial equivalence, the "acceptance criteria" are the physical, optical, and chemical properties of the predicate device. The "reported device performance" are the corresponding properties of the new device being submitted. All values for the new device are presented as meeting the implied equivalence to the predicate.

Parameter	Predicate Device (PVS Basics™ - paflufocon E)	New Device (PVS Basic™ 2 & Epic® 2 - migafocon A)	Comparison / "Acceptance Criteria Met"
Material	paflufocon E	migafocon A	Different material, but deemed equivalent in performance parameters
Indication	Daily Wear	Daily Wear	Equivalent
Water Content/Absorption	< 1%	< 1%	Equivalent
Oxygen Permeability (Revised Fatt Method)	67 x 10^-11	74 x 10^-11	Meets/Exceeds (Higher is generally better for oxygen permeability)
Oxygen Permeability (ISO/ANSI Method)	35 x 10^-11	52 x 10^-11	Meets/Exceeds (Higher is generally better for oxygen permeability)
Luminous Transmittance	87%	87%	Equivalent
Wetting Angle (receding angle)	16	16	Equivalent
Hardness (Shore D)	81.7	82.6	Very similar, deemed equivalent
Refractive Index, nD @ 25°C	1.454	1.454	Equivalent
Specific Gravity	1.10	1.10	Equivalent
Modulus (kgf/cm²)	14962	16334	Very similar, deemed equivalent
Flexural Strength Stress @ Break (kgf/cm²)	436	460	Very similar, deemed equivalent
Flexural Strain	3.6%	3.6%	Equivalent
Toughness (gf - mm)	354	366	Very similar, deemed equivalent
Color	Blue	Blue	Equivalent
UV Absorber	None	None	Equivalent

Additionally, the submission includes biocompatibility testing:

Cytotoxicity Study (ISO Agarose Overlay Method): Test article showed no evidence of causing cell lysis or toxicity. Met USP grade < 2 (mild reactivity).
Acute Systemic Toxicity Study (ISO, mouse): No mortality or systemic toxicity from extracts. Met test requirements.
Ocular Irritation Study (ISO, rabbit): SC and CSO test article extracts not considered irritants to ocular tissue.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for each physical/chemical test. The data provenance is not explicitly stated beyond implying these are standard laboratory tests conducted by the manufacturer, Paragon Vision Sciences. It's prospective in the sense that these tests were performed on the new device for the purpose of this submission.
For the biocompatibility studies:

Cytotoxicity: Not specified, but standard ISO agarose overlay method implies a cell culture approach.
Acute Systemic Toxicity: "in the mouse" - specific number of mice not given.
Ocular Irritation: "in the rabbit" - specific number of rabbits not given.

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)

This is not applicable as the submission focuses on physical, optical, chemical, and biocompatibility properties of a contact lens material, not diagnostic interpretation or clinical outcomes requiring human expert "ground truth" establishment in the context of an AI device. The "ground truth" for the equivalence claim is the established properties of the predicate device as measured by standardized methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of human interpretations.

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. This is not a diagnostic device or an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device. The "standalone" performance refers to the physical, chemical, and biocompatibility characteristics of the lens itself, which are measured directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the measured physical, optical, chemical, and biocompatibility properties of the contact lenses, determined using recognized ISO, ANSI, and ASTM standards/methods. The equivalence is established by direct comparison to the legally marketed predicate device's measured properties using the same or similar standard methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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APR 2 5 2002

APPENDIX H

K013310

510(k) Summary

Submitter

Company Name:
Address:
Phone:
Fax:
Registration:

Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226 Owner Operator # 9024618

Manufacturer Information

Company Name:	Paragon Vision Sciences
Address:	945 East Impala Ave., Mesa, AZ 85204
Phone:	480-892-7602
Fax:	480-892-3226
Registration:	Site Registration #2020433

Official Correspondent

Name:	William E. Meyers, Ph.D.
Address:	% Paragon Vision Sciences
Address:	945 East Impala Ave., Mesa AZ 85204
Phone:	480-507-7606
Fax:	480-892-3226
Reason for 510(k) Submission:	Material change

10/02/01

Reason for 510(k) Submission:

Date of Submission:

Device Identification:

Trade Name:	PVS Basic™ 2 and Epic® 2
Common Name:	Contact lens
Classification Name:	Rigid gas permeable contact lens for daily wear
Reference:	21 CFR 886.5916; rigid gas permeable contact lens, Class II - dailywear contact lens

Indications For Use:

The PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic™ 2 (migafooon A) and Epice 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D.

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The lenses have the following dimensions and characteristics.

Characteristics	PVS Basic™ 2 and Epic® 2
Material	migafocon A
Indication	Daily Wear
Water Content	< 1%
Oxygen Permeability*	74 x 10-11 Dk at 35° C.
Oxygen Permeability**	52 x 10-11 Dk at 35° C
Luminous Transmittance (blue) ***	87%
Wetting Angle (receding angle)****	16
Hardness (Shore D)	82.6
Refractive Index*****	1.454 (nD at 25° C)
Specific Gravity	1.10
Color	Blue

(cm2/sec) / (mL x mm Hg) Revised Method of I. Fatt ** (cm2/sec) / (mL x mm Hg) ISO/ANSI Method, ISO 9913-1 *** ANSI Z80.20 - 1998 and ISO 8699: 1994 **** After soaking in conditioning solution

**** ISO 9914: 1995

Lens Parameters

Chord Diameter	7.0 to 10.5 mm
Center Thickness	0.05 to 0.70 mm
Base Curve	6.50 to 9.00 mm
Power	-20.00 to +12.00 Diopters
Bifocal Add Power	+ 0.25 to +4.00 Diopters
Concentric Bifocal Add Diameter	2.0 to 4.0 mm
Monocentric Bifocal Add Diameter	4.0 to 9.0 mm
Monocentric Bifocal Prism	0 to 2.5 Diopters

The PVS Basic" 2 (migafocon A) and Epic® 2 (migatocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6.

Under the conditions of the cytotoxicity study using the ISO Agarose Overlay Method, the test article showed no evidence of causing cell lysis or toxicity. The test article met the USP since the grade was less than a grade 2 (mild reactivity). The negative control and the positive control performed as anticipated.

Under the conditions of the ISO acute systemic toxicity study in the mouse, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.

Under the conditions of the ISO ocular irritation study in the rabbit, the SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbit.

The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) Dk 74 contact lenses are substantially equivalent to the PVS Basics™Dk 67 rigid gas permeable contact lens marketed by Paragon Vision Sciences which is presently approved for daily wear 510(k), K984436. The physical, optical and chemical properties of PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) contact lenses are substantially equivalent to PVS Basics™ (paflufocon E) contact lenses. See table of next page.

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Similarities and Differences

Physical Characteristics

Parameters	PVS Basic™ 2 & Epic® 2	PVS Basics™
Material	migafocon A	paflufocon E
Indication	Daily Wear	Daily Wear
Water Content/Absorption1	< 1%	< 1%
Oxygen Permeability, Revised Fatt Method 2	74 x 10-11	67 x 10-11
Oxygen Permeability, ISO/ANSI Method 3	52 x 10-11	35 x 10-11
Luminous Transmittance @ +12 D, 7mmOZ, 7.8 BC, .45mm CT, harmonic meanthickness over 7mm = 0.329 mm 4	87%	87%
Wetting Angle (receding angle)5	16	16
Hardness (Shore D)	82.6	81.7
Refractive Index, nD @ 25°C 6	1.454	1.454
Specific Gravity	1.10	1.10
Modulus (kgf/cm²) 7	16334	14962
Flexural StrengthStress @ Break (kgf/cm²) 7	460	436
Flexural Strain 7	3.6%	3.6%
Toughness (gf - mm) 7	366	354
Color	Blue	Blue
UV Absorber	None	None

1 ANSI Z80.20 - 1998, Method 8.22

2 (cm²/sec) (mL x mm Hg) Revised Method of I. Fatt, [Dk (at 35°C)]

: ,

3 (cm2/sec) {mL x mm Hg) ISO/ANSI Method, ISO 9913-1, [Dk (at 35°C)]

4 ANSI Z80.20 - 1998 and ISO 8599: 1994

§ After soaking in conditioning solution

6 ISO 9914:1995

' ANSI Z80.20 — 1998; ASTM D790M - 92

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2002

Paragon Vision Sciences c/o William E. Meyers, Ph.D. 947 East Impala Mesa, AZ 85204

Re: K013310

Trade/Device Name: PVS Basic™ 2 and Epic® 2 Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: October 2, 2001 Received: October 4, 2001

Dear Mr. Meyers:

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.

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Page 2 - William E. Meyers, Ph.D.

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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Indications Statement

510(k) Number (if known):

K013310

Device Name: PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) Contact Lenses

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	x	OR Over-The Counter Use
------------------	---	-------------------------	--

Daniel W. Brown Ph.D.

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number	K013310

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.