(29 days)
No
The summary describes rigid gas permeable contact lenses and their materials, indications, and manufacturing process. There is no mention of AI or ML technology being used in the device itself or its function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the lenses are "also indicated for therapeutic use in eyes with ocular surface disease... limbal stem cell deficiency... disorders of the skin... neurotrophic keratitis... and corneal exposure".
No
The device is a contact lens designed for correction of refractive errors and therapeutic use in ocular surface diseases, not for diagnosing conditions.
No
The device description clearly states that the device is a physical contact lens made from specific materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a contact lens. Its function is to be worn on the eye for the correction of refractive error and for therapeutic purposes related to ocular surface conditions. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states the device is for correcting vision and managing ocular surface conditions by being placed on the eye.
Therefore, this device falls under the category of a medical device, specifically a contact lens, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, 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), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eve 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 reservor and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.
Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.50mm | ± 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) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D) |
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D) ± 0.37 (2 to = 4D) ± 0.50 (over 4D) |
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surface defect |
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) and Acuity 200TM with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lens:
| 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 x 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 |
The following table depicts the physical properties of the Acuity 100™ and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens:
| Hexafocon A Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.415 |
| Modulus (MPa) | 1496 |
| Hardness (Shore D) | 80 |
| Specific Gravity | 1.27 |
| Oxygen Permeability (Dk) | 111 x 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 |
The following table depicts the shipping method, storage solution for wet shipping, and shipping case used for each lens model:
| MODEL | Acuity 200 (fluoroxyfocon A) | Acuity 100 (hexafocon A) | Acuity 200 (fluoroxyfocon A) with Tangible Hydra-PEG | Acuity 100 (hexafocon A) with Tangible Hydra-PEG |
|---|---|---|---|---|
| Ship Method | Dry | Dry | Dry or Wet* | Dry or Wet* |
| Storage Solution | N/A | N/A | Menicon Unique pH Multi-purpose Solution (K130805) & Boston Simplus® Multi-Action Solution (K024289) | Menicon Unique pH Multi-purpose Solution (K130805) & Boston Simplus® Multi-Action Solution (K024289) |
| Shipping Case | Deep Well Lens Case (K171539) | Deep Well Lens Case (K171539) | Deep Well Lens Case (K171539) | Deep Well Lens Case (K171539) |
- Lenses coated with Tangible Hydra-PEG are stored wet.
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
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)
Non-Clinical Studies
Non-clinical testing to demonstrate the safety and effectiveness of the Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses have been addressed through previously cleared 510(k) premarket notifications as described in the following table:
| Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity 100TM (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity 200™ with Tangible® Hydra- PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity 100™ with Tangible® Hydra- PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | |
|---|---|---|---|---|
| Manufacturing Design Verification | K201194 | K162005 | K213538 | K230965 |
| Physicochemical and Mechanical Property Testing | K201194 | K162005 | K213538 | K230965 |
| Extraction Studies | K201194 | K162005 | K213538 | K230965 |
| Bioburden Testing | K201194 | K162005 | K213538 | K230965 |
| Solution Compatibility | K201194 | K162005 | K213538 | K230965 |
| Shelf-Life Studies | K201194 | K162005 | K213538 | K230965 |
| Biocompatibility | K201194 | K162005 | K213538 | K230965 |
Clinical Studies
Clinical performance of the ocular surface disease indication was addressed for fluoroxyfocon A and hexafocon A scleral contact lenses in 510(k) K233325.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K233325, K201194, K162005, K213538, K230965, K180616
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
April 3, 2024
Bret Andre, Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068
Re: K240618
Trade/Device Name: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon 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: February 26, 2024 Received: March 6, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Page 2
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-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
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
3
Indications for Use
510(k) Number (if known) K240618
Device Name
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity 100™ (hexatocon A) Rigid Gas Permeable Contact Lens, Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise nondiseased 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), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eve 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 reservor and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
| 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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SPECIAL 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: K240618
I. SUBMITTER
| Date Prepared: | March 30, 2024 |
|---|---|
| Name: | Acuity Polymers, Inc. |
| Address: | 1667 Lake Avenue, Suite 354 |
| Rochester, NY 14615 | |
| United States | |
| Contact Person: | James A. Bonafini, Jr |
| President | |
| Phone number: | (585) 458-8409 |
| Consultant: | Bret Andre |
| Andre Vision and Device Research | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Acuity 200 TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens;
Acuity 100 TM (hexafocon A) Rigid Gas Permeable Contact Lens;
Acuity 200 TM with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas
Permeable Contact Lens;
Acuity 100 TM with Tangible® Hydra-PEG® (hexafocon 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 |
| Reason for Submission | Indications for Use Change |
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III. PREDICATE DEVICE
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are substantially equivalent to the following predicate devices:
- . "Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)" By Visionary Optics LLC 510(k) number: K233325 Product Code: HQD
- l "Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K201194 Product Code: HQD
- . "Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K162005 Product Code: HQD
- I Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens By Acuity Polymers, Inc. 510(k) number; K213538
- Product Code: HQD
- "Acuity 100™ (hexafocon A) with Tangible® Hydra-PEG®, TYRO™-97 (hofocon A) . with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K230965 Product Code: HQD
- . "OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA 100 (hexafocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number; K180616 Product Code: HQD
DEVICE DESCRIPTION IV.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.
Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the
6
mechanical or optical properties of the underlying material.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.50mm | $\pm$ 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | $\pm$ 0.02 mm |
| Diameter | 7.0mm to 21.0mm | $\pm$ 0.10mm |
| Spherical Power | -20.00D to +20.00D | $\pm$ 0.12 (0 to = 5D) |