(127 days)
Not Found
No
The summary describes a rigid gas permeable contact lens and its material properties and manufacturing process. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is indicated for the correction of refractive error, which is not considered a therapeutic function.
No
The device is a contact lens designed for the correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a rigid gas permeable contact lens manufactured from a physical material, indicating it is a hardware device.
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 taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Acuity 200™ contact lenses are placed on the eye to correct refractive errors. They do not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes. This is a therapeutic/corrective function, not a diagnostic one based on in vitro analysis.
Therefore, the Acuity 200™ contact lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear.
Product codes (comma separated list FDA assigned to the subject device)
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 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 the Acuity 100 (hexafocon A) Contact Lenses described in K162005.
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)
This study was an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days. Seventy-four (74) subjects were enrolled in the study-of which 50 subjects wore the test lenses. Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and 24 subjects wore the control lenses (Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens). Subjects were evaluated at four independent clinical sites across the United States. Subjects wore the Test or Control lenses for 90 days bilaterally according to the randomization method.
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.
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K162005)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
September 8, 2020
Acuity Polymers. Inc. James A. Bonafini, Jr. President & COO 1667 Lake Avenue, Suite 354 Rochester, NY 14615
Re: K201194
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: August 3. 2020 Received: August 5, 2020
Dear James A. Bonafini, Jr .:
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 (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 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 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, 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K201194
Device Name
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear.
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
510(k) SUMMARY
SUBMITTER
| Date Prepared: | April 30, 2020 | |
|---|---|---|
| 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 | ||
| Consultant: | Bret Andre | |
| EyeReg Consulting | ||
| 6119 Canter Ln. | ||
| West Linn, OR 97068 | ||
| Telephone: (503) 372-5226 | ||
| DEVICE | ||
| Common Name: | Daily Wear Contact Lens | |
| Proprietary Name: | Acuity 200™ (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 DEVICE | ||
| Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | ||
| (K162005). |
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.
4
The Acuity 200™ (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 the Acuity 100 (hexafocon A) Contact Lenses described in K162005.
INDICATIONS FOR USE
The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are 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 lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear.
PERFORMANCE DATA
Non-clinical Studies
Biocompatibility Testing
Biocompatibility evaluation was conducted on the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens in accordance to ISO 10993-1:2018 "Biological Evaluation of Medical Devices". The following tests were performed:
- Cytotoxicity Agar Diffusion 1.
-
- Systemic Toxicity
-
- Ocular Irritation
- Skin Sensitization 4.
Performance Testing
To establish the performance of Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses, the follow tests were performed:
-
- Lens/solution compatibility
-
- Manufacturing verification
-
- Extractable testing
-
- Contact angle
-
- Dry shelf life
-
- Lens stability testing
5
Comparison of Characteristics with the Predicate Device
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses 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 device.
| Lens Characteristics | NEW DEVICE | PREDICATE DEVICE |
|---|---|---|
| Lens | ||
| Characteristics | Acuity 200™ (fluoroxyfocon A) Rigid Gas | |
| Permeable Contact Lens | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact | |
| Lens K162005 | ||
| Manufacturer | Acuity Polymers, Inc | Acuity Polymers, Inc |
| Material | fluoroxyfocon A | hexafocon A |
| Production | ||
| method | Lathe Cut | Lathe Cut |
| UV Blocking | Yes | Yes |
| Base Curves | ||
| (varies with vault) | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm |
| Design | Standard geometry with anterior aspheric | |
| surface | Standard & reverse geometry with anterior aspheric | |
| surface | ||
| Diameters: | 7.0-21.0 mm | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D |
| Astigmatism range | ||
| corrected | Up to 9.00 D | Up to 9.00 D |
| Add Powers (for | ||
| multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Indications | ||
| for Use | The Acuity 200™ Rigid Gas Permeable | |
| Contact Lenses are 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 lens | ||
| may be prescribed in spherical and aspheric | ||
| powers ranging from -20.00 D to +20.00 D | ||
| for daily wear. | The Acuity 100 (hexafocon A) Rigid Gas Permeable | |
| Contact Lenses are 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 lens may be | ||
| prescribed in spherical and aspheric powers ranging from - | ||
| 20.00 D to +20.00 D for daily wear. 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. | ||
| Refractive Index | 1.430 | 1.415 |
| Oxygen | ||
| Permeability | 200 | 111 |
| Specific Gravity | 1.18 | 1.27 |
| Hardness (Shore | ||
| D) | 78 | 80 |
| Modulus (MPa)* | 1194 | 1414 |
| 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, D&C Yellow #18 | ||
| Water Content | ) than grade 2 for staining, edema, vascularization, hyperemia, infiltrates or any other complication. One (1) eye in the control arm reported a severity of grade 3 for bulbar redness. All other eyes treated with the control lens reported a severity of grade 2 or lower for other findings. |
The test and control lenses performed similarly with respect to subject reported symptoms, problems and complaints. Symptoms reported with the highest frequency were discomfort (control 39%, test 38%), dryness (control 42%, test 31%), and irritation (control 31%, test 31%). These results indicate no clinical difference between the incidence of symptoms reported in the test arm compared to the control arm. The adverse events that occurred in the study were similar in both arms, in terms of incidence and severity.
The test and control lenses performed equally well with regards to vision safety measures-keratometry changes, refractive changes, and best corrected visual acuityover the 90-day treatment period. Trend analysis shows no emerging trends for test and control lenses for the duration of the study.
CONCLUSIONS
The non-clinical data demonstrates the safety of the device and demonstrates that the device should perform as intended. Clinical studies were completed and demonstrate that the Acuity 2001 Rigid Gas Permeable Contact Lens performs substantially equivalent to the predicate device currently marketed for the indication of correcting ametropia.
The clinical study results establish no clinically relevant differences between the Acuitv 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (predicate device) with respect to biomicroscopy findings, symptoms or vision safety measures; this clinical investigation supports the claim of substantial equivalence between the two device types with regard to clinical safety and effectiveness.