(322 days)
No
The summary describes rigid gas permeable contact lenses and their material properties. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia), which are optical corrections, not treatments for a disease or condition.
No
Explanation: The device, the Oxfore®100 Rigid Gas Permeable Contact Lenses, is indicated for the correction of refractive ametropia. It is a corrective device, not a diagnostic one.
No
The device description clearly states it is a physical contact lens made from a specific material (hexafocon A) and is lathe cut into various designs. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text clearly describes the Oxfore®100 as contact lenses intended for correcting refractive errors in the eye. They are worn on the surface of the eye.
- Intended Use: The intended use is for the "correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes." This is a therapeutic and corrective use, not a diagnostic test performed on a sample.
The description focuses on the physical properties of the contact lens material and design, not on analyzing biological samples.
N/A
Intended Use / Indications 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.
Product codes
HQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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)
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.
| 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) |
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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 Contact
Lenses |
|-------------------------|-----------------------------------------------------------------|
| 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 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 | ||
| Product Code | HQD | HQD |
| Common Name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable |
| Device Class | II | II |
| CFR Reference | 21 CFR | |
| 886.5916 | 21 CFR | |
| 886.5916 | ||
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate |
| Indications for Use | The Oxfore®100 (hexafocon A) Contact | |
| Lenses are indicated for daily wear for the | ||
| correction of refractive ametropia | ||
| (myopia, hyperopia, astigmatism and | ||
| presbyopia) in aphakic and non aphakic | ||
| persons with non-diseased eyes. The | ||
| lenses may be disinfected using a chemical | ||
| disinfection system only. | The Boston XOTM (hexafocon A) Contact | |
| Lenses are indicated for daily wear for the | ||
| correction of refractive ametropia (myopia, | ||
| hyperopia, astigmatism and presbyopia) in | ||
| aphakic and non aphakic persons with non- | ||
| diseased eyes. 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 using a chemical disinfection | ||
| system only. | ||
| Furthermore, eyes suffering from certain | ||
| ocular surface disorders may benefit from | ||
| the physical protection, aqueous hydrated | ||
| environment and the saline bath provided | ||
| by scleral lens designs. | ||
| The Boston XOTM (hexafocon A) Contact | ||
| Lenses (Scleral) for daily wear are | ||
| indicated for therapeutic use for the | ||
| management of irregular and distorted | ||
| corneal surfaces where the subject: | ||
| 1.cannot be adequately corrected with | ||
| spectacle lenses | ||
| 2.requires a rigid gas permeable contact | ||
| lens 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 irregularities | ||
| Common 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 – 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 | ||
| Water Content (Soft Skirt) |