(141 days)
Not Found
No
The device description and intended use are for rigid gas permeable contact lenses, which are physical devices for vision correction. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is indicated for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) and management of irregular corneal conditions, which are corrective or management functions rather than therapeutic.
No
Explanation: The device is a rigid gas permeable contact lens used for vision correction, not for diagnosing medical conditions. Its intended use is to correct refractive errors and manage irregular corneal conditions.
No
The device description clearly states it is a "Rigid Gas Permeable Contact Lenses" made of a specific material (hexafocon A) and describes physical parameters like power range, base curves, and diameter. This indicates a physical medical device, not a software-only one.
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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Acuity 100™ lenses are contact lenses intended for correcting refractive error and managing irregular corneal conditions. They are worn on the eye, not used to test samples from the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to disease detection or monitoring through laboratory tests.
Therefore, based on the provided information, the Acuity 100™ Rigid Gas Permeable Contact Lenses are a medical device, but they fall under the category of ophthalmic devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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 spheric 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 lons for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.
Product codes
HQD
Device Description
The Acuity 100™ (hexafocon 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 sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (hexafocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, 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
Prescription Use (Part 21 CFR 801 Subpart D)
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: The hexafocon A lens material manufactured by Acuity Polymers, 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 mechanical and optical characteristics of the new lens have been shown to be equivalent to the predicate lenses.
Clinical Studies: Clinical studies for the Acuity 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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2016
Acuity Polymers, Inc. James Bonafini President & COO 1667 Lake Avenue, Suite 354 Rochester, NY 14615
Re: K162005
Trade/Device Name: Acuity 100 (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: October 31, 2016 Received: November 1, 2016
Dear Mr. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162005
Device Name
Acuity 100TM (hexafocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
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 nondiseased eyes. The lens may be prescribed in spheric 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 lons for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens 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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| ACUITY POLYMERS, INC.
510(k) Premarket Notification
Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses | | 510(k) Summary
RGP Contact Lens |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------|
| Section 10.1: 510(k) SUMMARY | | |
| 1. Date Prepared | July 11, 2016 | |
| 2. Applicant's Name:
and Address: | Acuity Polymers, Inc.
1667 Lake Avenue, Suite 354
Rochester, NY 14615
(585) 458-8409 | |
| 3. Contact Person: | James A. Bonafini, Jr. President
Telephone: (585) 458-8409
E-Mail: jim.bonafini@acuitypolymers.com | |
| 4. Identification of Device:
Common Name:
Proprietary Name: | Daily Wear Contact Lens
Acuity 100™ (hexafocon A) RGP | |
| Device Classification: | Lenses, Rigid Gas Permeable, Daily Wear Contact Lens
Class II (21 CFR 886.5916) | |
| Device Product Code: | HQD | |
-
- Premarket Notification Number not available 6. Establishment Registration Number: 3012228452 7. Owner Operator Number: 10051193
-
- Description of the New Device
The Acuity 100™ (hexafocon 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 sphere 0
- with base curves of 4.0 mm to 11.50 mm 0
- 0 with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm 0
The lens material (hexafocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO Material and Contact Lenses (hexafocon A) described in K071043.
4
| ACUITY POLYMERS, INC.
| 510(k) Premarket Notification | 510(k) Summary |
|---|---|
| Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
These devices will not be marketed with multiple components or any required accessories.
9. Intended Use
The Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens 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. The lens may be disinfected using a chemical disinfection system only.
10. Predicate Devices:
The Acuity 100™ (hexafocon A) RGP contact lenses for daily wear are substantially equivalent to the Boston XO (hexafocon A) Daily Wear Contact Lens (K071043). This lens was selected because it is made from an identical material and has optics designed to address the same Indications for Use.
11. Substantial Equivalence
Substantial equivalence is based on:
For design: The predicate lenses, the Boston XO RGP lenses for daily wear, have a standard or reverse lens geometry with an anterior aspheric optic surface. The new lenses, the Acuity 100TM RGP lenses for daily wear have the same substantially equivalent standard or reverse geometry with an anterior optic surface design.
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).
The new lenses in this submission therefore are substantially equivalent to the lenses cleared under K071043.
12. Non-Clinical Studies
The hexafocon A lens material manufactured by Acuity Polymers, 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 mechanical and optical characteristics of the new lens have been shown to be equivalent to the predicate lenses.
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| ACUITY POLYMERS, INC.
| 510(k) Premarket Notification | 510(k) Summary |
|---|---|
| Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
13. Clinical Studies
Clinical studies for the Acuity 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.
14. Packaging
The primary lens container for shipping is a "Flat Pack Card" which is composed of a double well lens case and card labeling. The lenses are shipped dry and are not be sterilized by Acuity Polymers, Inc. prior to shipment to customers.
15. Relationship to Special Controls (Guidance)
This submission requires reliance upon a guidance document to describe the change and its relevance to current guidance. The FDA Daily Wear Contact Lens Guidance Document, May 1994, is the relevant document to which this submission is based. Clinical performance data is not necessary since the material and optical design of the new lenses is substantially equivalent to the material and optical design of the predicate lenses in K071043. Both the new lenses and the predicate lens feature identical aspheric anterior optics.
16. Manufacturing & Packaging:
Finished Product Manufacturing, Inspection, Packaging and Distribution: Acuity Polymers, Inc. (Est. Regis: #3012228452) 1667 Lake Avenue, Suite 303 Rochester, NY 14615 (585) 458-8409
17. Action Taken to Comply with FDA Special Controls:
The submission is for a daily wear contact lens. Class II subject to Special Controls. The Special Control is the FDA Daily Wear Contact Lens Guidance Document, May 1994 to which this submission is applied. All testing listed in this 510(k) submission is in accordance with that document.
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| ACUITY POLYMERS, INC.
| 510(k) Premarket Notification | 510(k) Summary |
|---|---|
| Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
10.2: Side-by-Side Comparison
| NEW LENS | PREDICATE LENS | |
|---|---|---|
| Lens Characteristics | Acuity 100™ (hexafocon A) RGP Lens | Boston XO (hexafocon A) RGP Lens |
| Manufacturer | Acuity Polymers, Inc | Bausch + Lomb |
| Material | hexafocon 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 & reverse 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 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. | Boston XO 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. | ||
| Refractive Index | 1.415 ±0.002 | 1.415 |
| Oxygen Permeability | 111 ±22 | 100 |
| Specific Gravity | 1.27 ±0.02 | 1.27 |
| Hardness (Shore D) | 80 ±2 | 81 |
| Modulus (MPa) | 1496 ±200 | 1500 |
| Tint | Visibility Tints - various | |
| D&C Green #6, D&C Violet #2, D&C | ||
| Yellow #18 | Visibility Tints - various | |
| D&C Green #6, D&C Violet #2, D&C | ||
| Yellow #18 | ||
| Water Content |