(52 days)
No
The summary describes a contact lens and its material properties, manufacturing process, and intended use. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No.
The device is indicated for the correction of refractive error and management of irregular corneal conditions, which are corrective and management functions, not therapeutic.
No
The device is a contact lens intended for correcting refractive errors and managing irregular corneal conditions. It does not perform any diagnostic function.
No
The device described is a rigid gas permeable contact lens, which 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 clearly states that the device is a contact lens 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 description details the material, manufacturing process, and physical characteristics of a contact lens. It does not describe any components or functions related to testing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition
The device is a medical device, specifically a contact lens, used for vision correction and management of certain eye conditions. Its function is to physically alter the light entering the eye or reshape the cornea, not to provide diagnostic information based on in vitro testing.
N/A
Intended Use / Indications for Use
Acuity 200™ with Tangible® Hydra PEG® (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 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 with Tangible® Hydra-PEG® (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
Acuity 200™ with Tangible® Hydra PEG® (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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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.
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for spheres .
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameters of 7.0 to 21.0 mm
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.
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)
No clinical studies were deemed necessary for the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens as Acuity 200™ fluoroxyfocon A was cleared via K201194 where clinical studies were described. Expanded indications for irregular corneas were described in K203571.
Non-clinical Studies:
Biocompatibility Testing:
Biocompatibility evaluation was conducted on the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens in accordance with ISO 10993-1:2018 "Biological Evaluation of Medical Devices". The following tests were performed:
- Cytotoxicity - Agar Diffusion
- Systemic Toxicity
- Ocular Irritation
Performance Testing:
To establish the performance of Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, the follow tests were performed:
- Lens/solution compatibility
- Manufacturing verification
- Contact angle Measurement
- Accelerated Wet Shelf-Life testing
- Lens stability testing
Key Results:
The non-clinical data demonstrates the safety of the device and that the device should perform as intended. The Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens performs substantially equivalent to the predicate devices currently marketed for the indication of correcting ametropia.
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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 30, 2021
Acuity Polymers, Inc. James A. Bonafini, Jr. President & COO 1667 Lake Ave. Suite 303 Rochester, NY 14615
Re: K213538
Trade/Device Name: Acuity 200™ Tangible® Hydra PEG® (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: November 5, 2021 Received: November 8, 2021
Dear James Bonafini:
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. 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
1
801); medical device 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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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, 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) K213538
Device Name
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
Acuity 200™ with Tangible® Hydra PEG® (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 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 with Tangible® Hydra-PEG® (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) | ||||
|---|---|---|---|---|
|× Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
The assigned 510(k) number is K213538
SUBMITTER
| Date Prepared: | November 5, 2021 |
|---|---|
| Name and Address: | Acuity Polymers, Inc. |
| 1667 Lake Avenue, Suite 354 | |
| Rochester, NY 14615 | |
| (585) 458-8409 | |
| Contact Persons: | James A. Bonafini, Jr. President |
| Telephone: (585) 458-8409 | |
| E-Mail: Jim.bonafini@acuitypolymers.com | |
| DEVICE | |
| Common Name: Daily Wear Contact Lens | |
| Proprietary Name: | Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
| Device Classification: | Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II |
| (21 CFR 886.5916) | |
| Device Product Code: | HQD |
| PREDICATE DEVICES | |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
| (K201194) | |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
| (K203571) | |
| Optimum GP with HPT (roflufocon C, D, and E Daily Wear Contact | |
| Lenses (K161100) |
DEVICE DESCRIPTION
Acuity 200™ with Tangible® Hydra PEG® (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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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)
4
properties while not affecting the mechanical or optical properties of the underlying material.
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for spheres .
- with base curves of 4.0 mm to 11.50 mm ●
- with base curve chord of 6.0 mm to 6.5 mm ●
- with diameters of 7.0 to 21.0 mm
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material. The device herein described is substantially equivalent to Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194), Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571) and the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (K161100)
INDICATIONS FOR USE
Acuity 200™ with Tangible® Hydra PEG® (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 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
PERFORMANCE DATA
Non-clinical Studies
Biocompatibility Testing
Biocompatibility evaluation was conducted on the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens in accordance with ISO 10993-1:2018 "Biological Evaluation of Medical Devices". The following tests were performed:
-
- Cytotoxicity - Agar Diffusion
-
- Systemic Toxicity
-
- Ocular Irritation
5
Performance Testing
To establish the performance of Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, the follow tests were performed:
-
- Lens/solution compatibility
-
- Manufacturing verification
-
- Contact angle Measurement
-
- Accelerated Wet Shelf-Life testing
-
- Lens stability testing
Comparison of Characteristics with the Predicate Device
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens manufactured by Acuity Polymers, Inc. have been found to show biocompatibility, for a surface device, limited contact. In addition to biocompatibility, the chemical, mechanical and optical characteristics of the new device have been shown to be substantially equivalent to the predicate devices.
| | NEW DEVICE | PREDICATE DEVICE
K201194, K203571 | PREDICATE DEVICE |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lens
Characteristics | Acuity 200™ with
Tangible® Hydra PEG®
(fluoroxyfocon A) Rigid Gas
Permeable Contact Lens | Acuity 200™ (fluoroxyfocon
A) Rigid Gas Permeable
Contact Lens | Optimum GP with HPT
(roflufocon C, D, and E Daily
Wear Contact Lenses (K161100) |
| Manufacturer | Acuity Polymers, Inc | Acuity Polymers, Inc | Contamac Ltd. |
| Material | fluoroxyfocon A | fluoroxyfocon A | roflufocn C, D, E |
| Production
method | Lathe Cut | Lathe Cut | Lathe Cut |
| UV Blocking | Yes | Yes | Yes |
| Base Curves
(varies with
vault) | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm | 5.0 mm to 8.0 mm |
| Base Curve
Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm |
| Design | Standard geometry with anterior
aspheric surface | Standard geometry with anterior
aspheric surface | Standard & reverse geometry with
anterior aspheric surface |
| Diameters: | 7.0-21.0 mm | 7.0-21.0 mm | 7.0-22.0 mm |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D | -20.00D to +20.00D |
| Astigmatism
range corrected | Up to 9.00 D | Up to 9.00 D | up to 10.00 D |
| Add Powers (for
multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D | up to +4.00 D |
| Indications
for Use | The Acuity 200™ with
Tangible® Hydra PEG®
(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 | 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 | Indicated for the daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia and/or presbyopia. The lens
may also be prescribed for the
management or irregular corneal |
6
| | 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 with Tangible®
Hydra-PEG® (fluoroxyfocon A)
Rigid Gas Permeable Contact Lens
may be cleaned and disinfected
using a chemical (not heat) lens care
system. | 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. | conditions such as keratoconus and
post graft fitting. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Refractive Index | 1.430 | 1.430 | 1.4406 (roflufocon C) |
| Oxygen
Permeability | 200 | 200 | 65 |
| Specific Gravity | 1.18 | 1.18 | 1.27 |
| Hardness (Shore
D) | 78 | 78 | NA |
| Modulus (MPa) | 1194 | 1194 | NA |
| Tint | Visibility Tints - various
D&C Green #6, D&C Violet #2,
Solvent Yellow 18, D&C Red
#17 | Visibility Tints - various
D&C Green #6, D&C Violet #2,
Solvent Yellow 18, D&C Red #17 | Visibility Tints - various
D&C Green #6, D&C Red #17,
Solvent Yellow #18 |
| Water Content |