(123 days)
Not Found
No
The summary describes a rigid gas permeable contact lens and its physical properties and intended use. There is no mention of AI, ML, or any software component that would suggest the use of such technologies. The performance study is a retrospective review of patient charts, not an evaluation of an AI/ML algorithm.
Yes.
The device is indicated for the management of irregular corneal conditions such as keratoconus and pellucid marginal degeneration, which are therapeutic applications.
No
Explanation: The device is a rigid gas permeable contact lens indicated for the correction of refractive error and management of irregular corneal conditions, not for diagnosing conditions.
No
The device description clearly states it is a "Rigid Gas Permeable Contact Lens" manufactured from a physical material with specific parameters and physical properties. This is a physical medical device, not software.
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 refractive error and management of irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a physical device placed on the eye for vision correction and management of corneal shape. It does not perform any in vitro testing of biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease or condition by testing samples outside the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
HQD
Device Description
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
Parameter: Base Curve, Range: 4.00mm to 11.5mm, Tolerance: ± 0.05 mm
Parameter: Center Thickness, Range: 0.08mm to 0.75mm, Tolerance: ± 0.02 mm
Parameter: Diameter, Range: 7.0mm to 21.0mm, Tolerance: ±0.10mm
Parameter: Spherical Power, Range: -20.00D to +20.00D, Tolerance: ± 0.12 (0 to = 5D), ± 0.18 (5 to = 10.0D), ± 0.25 (10 to = 15D), ± 0.37 (15 to = 20D), ± 0.50 (over 20D)
Parameter: Cylindrical Power, Range: Up to 9.00D, Tolerance: ± 0.25 (0 to = 2D), ± 0.37 (2 to = 4D), ± 0.50 (over 4D)
Parameter: Multifocal Power, Range: +1.00D to 4.00D, Tolerance: ± 0.25D
Parameter: Surface Appearance, Tolerance: Lenses should be clear with no surface defect
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
Refractive Index: 1.430
Modulus (MPa): 1194
Hardness (Shore D): 78
Specific Gravity: 1.18
Oxygen Permeability (Dk): $200 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C)
Color Additives: Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17
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
Prescription Use
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: Four (4) independent practitioners retrospectively reviewed medical charts of 41 patients (66 total eyes) presenting with irregular corneal conditions that were managed using contact lenses manufactured from Acuity 200 (fluoroxyfocon A) material. For all patients, the irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses. The successful fitting of 66 eyes over a total of 13,760 days without any serious adverse reaction reported demonstrate the Acuity 200 (fluoroxyfocon A ) contact lenses are safe and effective for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue rectangle with the letters "FDA" in white. To the right of the rectangle, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
April 9, 2021
Acuity Polymers, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068
Re: K203571
Trade/Device Name: Acuity 200™ (fluoroxyfocon 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: March 1, 2021 Received: March 8, 2021
Dear Bret Andre:
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.
1
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): medical device reporting (reporting of medical device-related 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-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 entitled, "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-devices/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/medical-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
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203571
Device Name
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
I. SUBMITTER
| Date Prepared: | April 7th, 2021 |
|---|---|
| Name: | |
| Address: | Acuity Polymers, Inc. |
| 1667 Lake Avenue, Suite 354 | |
| Rochester, NY 14615 | |
| United States | |
| Contact Person: | |
| Phone number: | James A. Bonafini, Jr |
| President | |
| (585) 458-8409 | |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
|---|---|
| Common | |
| Name: | Daily wear rigid gas permeable contact lens |
| Classification | |
| Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory | |
| Class: | Class II |
| Product Code: | HQD |
| New Indications for Use |
4
III. PREDICATE DEVICE
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is substantially equivalent to the following predicate devices:
- "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" ■ By Acuity Polymers, Inc. 510(k) number; K201194
- 트 "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461
- I "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)" By Art Optical Contact Lens, Inc. 510(k) number; K172314
IV. DEVICE DESCRIPTION
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) |