The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Device Description

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

AI/ML Overview

This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.

Characteristic	Oxfore®100 (hexafocon A) RGP Lens (New Device)	Boston XO™ (hexafocon A) RGP Lens (Predicate Device)	Implicit Acceptance Criteria (Achieved)
Material	hexafocon A	hexafocon A	Same material (hexafocon A)
Production method	Lathe Cut	Lathe Cut	Same production method
Actions/Operational Principles	When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity	When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity	Same fundamental mechanism of action
Product Code	HQD	HQD	Same FDA product code
Common Name	Contact Lens, Rigid Gas Permeable	Contact Lens, Rigid Gas Permeable	Same classification
Device Class	II	II	Same device class
CFR Reference	21 CFR 886.5916	21 CFR 886.5916	Same regulatory classification
FDA Group #	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate	Same FDA material group
Indications for Use	Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. Disinfected using chemical disinfection system only.	Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia), management of irregular corneal conditions (keratoconus, etc.), and therapeutic use for ocular surface disease. Disinfected using chemical disinfection system only.	Partially equivalent, with predicate having broader therapeutic indications not claimed by the new device. However, the core refractive correction indication is equivalent.
Refractive Index (RGP)	1.415	1.415	Identical
Oxygen Permeability (RGP Center)	100	100	Identical
Specific Gravity (RGP)	1.27	1.27	Identical
Hardness (Shore D)	81	81	Identical
Modulus (MPa)	1500	1500	Identical
Tint	Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18, D&C Red No. 17)	Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18)	Largely similar, with new device having one additional tint (D&C Red No. 17). This is considered a minor difference.
Water Content (Soft Skirt)	<1%	<1%	Identical (for RGP material, this is typically very low)
Lens Type	RGP	RGP	Same lens type

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical" testing and evaluation.

Conclusion: "Based on the data generated from the chemical/physical testing (See Side by Side Comparison) of Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lens, it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston XO™ (hexafocon A) Daily Wear Contact Lens."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The "testing" appears to refer primarily to characterization of the material itself (hexafocon A) rather than a large-scale clinical trial with patient-specific "test sets."
Data Provenance: Not explicitly stated, but the testing would have been conducted by Paragon Vision Sciences, Inc. or a contracted lab. This is a premarket notification, so the data is prospective in the sense that it was generated for this submission, but not necessarily a long-term clinical prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the evaluation is based on chemical/physical properties and biocompatibility, not expert interpretation of clinical outcomes or images. The "ground truth" for material properties is established through standardized laboratory methods.

4. Adjudication Method for the Test Set

Not applicable for chemical/physical testing.

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 device is a contact lens, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a contact lens.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical testing appears to be the established scientific and regulatory standards for contact lens materials, including:
- Specific values for physical properties (refractive index, oxygen permeability, specific gravity, hardness, modulus, water content).
- Biocompatibility requirements outlined in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009) for a surface device, limited contact.
- The characteristics of the legally marketed predicate device (Boston XO™).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device. "Training set" is not relevant here.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 5, 2023

Paragon Vision Sciences, Inc. Vimala Punsammy Global Regulatory Affairs Manager 2120 W. Guadalupe Rd. Gilbert, AZ 52233

Re: K221768

Trade/Device Name: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 30, 2023 Received: March 31, 2023

Dear Vimala Punsammy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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.

{1}------------------------------------------------

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation titled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J Angelo Green -S

Image /page/1/Picture/6 description: The image shows the logo of the Food and Drug Administration (FDA). The logo consists of the letters 'FDA' in a bold, sans-serif font. The color of the letters is a light blue or gray, and the background is white. The logo is simple and recognizable, representing the FDA's role in regulating and overseeing food and drug products.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221768

Device Name

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Paragon Vision Sciences, Inc.510(k) Premarket Notification	510(k) Summary
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	K221768

510(k) Summary

1. SUBMITTER

Date Prepared:	April 27, 2023
Name and Address:	Paragon Vision Sciences, Inc.2120 W. Guadalupe Rd.Gilbert, AZ 85233-2810(800) 825-8279

Contact Person:	Vimala Punsammy
	Regulatory Affairs Consultant
	Telephone: (646)-639-5458
	E-Mail: vpunsammy@coopervisionsec.com

2. DEVICE

Proprietary/Trade Name:	Oxfore® 100 (hexafocon A) Rigid Gas Permeable ContactLenses
Regulation Number:	21 CFR 886.5916 (Rigid Gas Permeable Contact Lenses)
Device Classification:	Class II
Device Product Code:	HQD

3. PREDICATE DEVICES

The Oxfore®100 (hexafocon A) RGP contact lenses for daily wear are substantially equivalent to the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404) in terms of the following:

Intended Use daily wear contact lenses ●
Actions
Classifications Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II (21 ● CFR 886.5916)
FDA material group - group #3 fluoro silicon acrylate
Production method lathe cut ●
USAN hexafocon A ●

{4}------------------------------------------------

Paragon Vision Sciences, Inc.510(k) Premarket Notification	510(k) Summary
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	K221768

4. DEVICE DESCRIPTION

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs:

Spherical
Aspherical ●
Toric ●
Mulifocal ●
Scleral ●
Semi-scleral ●

Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404.

These devices will not be marketed with multiple components or any required accessories.

5. INDICATION FOR USE

The Oxfore® 100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

6. SUBSTANTIAL EQUIVALENCE

Substantial equivalence is based on:

For design: The predicate lenses, the Boston XO™ RGP lenses for daily wear, have several designs including spherical, aspherical, toric and scleral.. The new lenses, the Oxfore® 100 RGP lenses for daily wear have the same substantially equivalent designs.

For material: The predicate lens materials are comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A). The new lens material also is comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A).

{5}------------------------------------------------

Paragon Vision Sciences, Inc.510(k) Premarket Notification	510(k) Summary
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	K221768

The new lenses in this submission therefore are substantially equivalent to the lenses cleared under K171404.

The table below shows a side-by side comparison of Oxfore®100 with the predicate device

	NEW LENS	PREDICATE LENS
Lens Characteristics	Oxfore®100 (hexafocon A) RGP Lens	Boston XOTM (hexafocn A) RGP Lens
Manufacturer	Paragon Vision Sciences, Inc.	Bausch + Lomb
Material	hexafocon A	hexafocon A
Production method	Lathe Cut	Lathe Cut
Actions/Operational Principles	When placed on the eye the Rigid GasPermeable Contact Lens acts as arefracting medium to focus light rays onthe retina to improve visual acuity	When placed on the eye the Rigid GasPermeable Contact Lens acts as arefracting medium to focus light rays on theretina to improve visual acuity
Product Code	HQD	HQD
Common Name	Contact Lens, Rigid Gas Permeable	Contact Lens, Rigid Gas Permeable
Device Class	II	II
CFR Reference	21 CFR886.5916	21 CFR886.5916
FDA Group #	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate
Indications for Use	The Oxfore®100 (hexafocon A) ContactLenses are indicated for daily wear for thecorrection of refractive ametropia(myopia, hyperopia, astigmatism andpresbyopia) in aphakic and non aphakicpersons with non-diseased eyes. Thelenses may be disinfected using a chemicaldisinfection system only.	The Boston XOTM (hexafocon A) ContactLenses are indicated for daily wear for thecorrection of refractive ametropia (myopia,hyperopia, astigmatism and presbyopia) inaphakic and non aphakic persons with non-diseased eyes. Also, the lenses may beprescribed in otherwise non-diseased eyesthat require a gas permeable contact lensfor the management of irregular cornealconditions such as keratoconus, pellucidmarginal degeneration, or followingpenetrating keratoplasty or refractive (e.g.LASIK surgery). The lenses may bedisinfected using a chemical disinfectionsystem only.Furthermore, eyes suffering from certainocular surface disorders may benefit fromthe physical protection, aqueous hydratedenvironment and the saline bath providedby scleral lens designs.The Boston XOTM (hexafocon A) ContactLenses (Scleral) for daily wear areindicated for therapeutic use for themanagement of irregular and distortedcorneal surfaces where the subject:1.cannot be adequately corrected withspectacle lenses2.requires a rigid gas permeable contactlens surface to improve vision
Paragon Vision Sciences, Inc.	510(k) Summary
510(k) Premarket Notification
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses		K221768

	3.is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularitiesCommon causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).The Boston XOT™ (hexafocon A) Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.The lenses may be disinfected using a chemical disinfection (not heat) system only.
Refractive Index (RGP)	1.415	1.415
Oxygen Permeability (RGP Center)	100	100
Specific Gravity (RGP)	1.27	1.27
Hardness (Shore D)	81	81
Modulus (MPa)	1500	1500
Tint	Visibility Tints – variousD&C Green No. 6, D&C Violet No. 2,D&C Yellow No. 18, D&C Red No. 17	Visibility Tints - variousD&C Green No. 6, D&C Violet No. 2,D&C Yellow No. 18
Water Content (Soft Skirt)	<1%	<1%
Lens Type	RGP	RGP
Paragon Vision Sciences, Inc.510(k) Premarket Notification	510(k) Summary
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	K221768

{6}------------------------------------------------

{7}------------------------------------------------

In the evaluation of RGP materials, various properties are measured to ascertain the material's ability to meet the intended application requirements. The properties which characterize the materials classification and use are refractive index, oxygen permeability, specific gravity, hardness, modulus and water content. Those properties are described in the above comparison table. These properties or characteristics are important to the function of the final lens and form the basis for the determination of use. These material values meet the minimum values required for use in the manufacture (lathing) of RGP lenses.

Based on the data generated from the chemical/physical testing (See Side by Side Comparison) of Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lens, it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston XO™ (hexafocon A) Daily Wear Contact Lens.

7. PERFORMANCE DATA

Clinical

Clinical studies for the Oxfore®100 (hexafocon A) material have been deemed as not necessary in support of clearance of this premarket notification as no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material.

Non-Clinical

The hexafocon A lens material manufactured by Paragon Vision Sciences, Inc. has been tested and found to meet the biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact. The chemical and optical characteristics of the new lens have been shown to be equivalent to the predicate lenses.

8. CONCLUSION

The Oxfore® 100 (hexafocon A) Rigid Gas Permeable Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeling for the proposed indications.

The risks related to Oxfore®100 (hexafocon A) are the same as those normally associated to wearing rigid gas permeable daily wear contact lenses. The benefits to the patients are the same as those for associated with similar RGP contact lenses.

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.