(148 days)
The Acuity 58™ (en:flufocon B) 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 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.
The Acuity 58™ (enflufocon B) 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 (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.
Here's an attempt to extract the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Acuity 58™ enflufocon B) |
|---|---|---|
| Material | enflufocon B | enflufocon B (identical) |
| Production Method | Lathe Cut | Lathe Cut (identical) |
| UV Blocking | Yes | Yes (identical) |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm (identical) |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm (identical) |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface (identical) |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm (identical) |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D (identical) |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D (identical) |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D (identical) |
| Indications for Use | Effectively identical scope (myopia, hyperopia, presbyopia, astigmatism in aphakic/non-aphakic non-diseased eyes, irregular corneal conditions) | Effectively identical scope as predicate |
| Refractive Index | 1.429 | 1.429 (identical) |
| Oxygen Permeability | 58 | 58 (identical) |
| Specific Gravity | 1.23 | 1.24 (very close) |
| Hardness | 114 (Rockwell R) | 81 (Shore D) (Note: Different scales, not directly comparable without conversion. The document states "materials values meet minimum values required for use.") |
| Modulus | 1500 MPa | 1568 MPa (very close) |
| Tint | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) (identical) |
| Water Content | <1% | <1% (identical) |
| Lens Type | RGP | RGP (identical) |
| Biocompatibility | Meet requirements of FDA Daily Wear Contact Lens Guidance Document (May 1994) and ISO 10993-1 (2009) for a surface device, limited contact. | Tested and found to meet these requirements. |
| Chemical/Mechanical/Optical Characteristics | Comparable to predicate lenses. | Shown to be equivalent to predicate lenses. |
2. Sample Size Used for the Test Set and the Data Provenance
The submission states that no clinical studies were deemed necessary (Page 5, Section 13) because "no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." Therefore, there isn't a specific "test set" in the context of a clinical trial with human subjects. The evaluation for substantial equivalence was based on non-clinical (bench) testing of the material and physical characteristics.
The data provenance for these non-clinical tests is not specified in terms of country of origin or retrospective/prospective nature, as they are laboratory tests performed by the manufacturer, Acuity Polymers, Inc., located in Rochester, NY, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As no clinical studies were performed, there was no "ground truth" derived from expert assessment of patient outcomes or conditions. The "ground truth" for material properties would be established by standard laboratory testing methodologies.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a rigid gas permeable contact lens, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (contact lens), not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth was established by adherence to regulatory standards and guidance documents: FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.
For the chemical, mechanical, and optical characteristics, the "ground truth" for comparison was the properties of the predicate device material (Boston EO Material, enflufocon B). The new device's properties were compared against these established values to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2017
Acuity Polymers, Inc. James A. Bonafini, Jr. President & COO 1667 Lake Avenue, Suite 354 Rochester, NY 14615
Re: K170007
Trade/Device Name: Acuity 58" (enflufocon B) 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: May 8, 2017 Received: May 9, 2017
Dear James 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. 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.
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Page 2 - James A. Bonafini, Jr.
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 devicerelated 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.
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 yours.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Fonn Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170007
Device Name Acuity 58TM (enflufocon B) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
The Acuity 58™ (en:flufocon B) 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 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.
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8114) | Page 1 of 1 | PSC Publishing Services (301) <143-67<40 EF |
|---|---|---|
| ---------------------- | ------------- | --------------------------------------------- |
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| ACUITY POLYMERS, INC.510(k) Premarket Notification | K170007510(k) Summary |
|---|---|
| Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
510(k) SUMMARY
| 1. Date Prepared: | December 29, 2016 | ||
|---|---|---|---|
| 2. Applicant's Nameand 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: | Daily Wear Contact Lens | ||
| Proprietary Name: | Acuity 58TM (enflufocon B) RGP | ||
| Device Classification: | Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II (21CFR 886.5916) | ||
| Device Product Code: | HQD | ||
| 5. Premarket Notification Number: | K170007 | ||
| 6. Establishment Registration Number: | 3012228452 | ||
| 7. Owner Operator Number: | 10051193 |
8. Description of the New Device:
The Acuity 58™ (enflufocon B) 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 (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
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| ACUITY POLYMERS, INC. | K170007 |
|---|---|
| 510(k) Premarket Notification | 510(k) Summary |
| Acuity 58™ (enflufocon B) 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 58™ (enflufocon B) Gas Permeable Contact Lens are indicated for daily wear for the correction of refractive error (myopia, hresbyopia 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 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 58TM (enflufocon B) RGP contact lenses for daily wear are substantially equivalent to the Boston EO (enflufocon B) Daily Wear Contact Lens (K980741). 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 EO RGP lenses for daily wear, have a standard or reverse lens geometry with an anterior aspheric optic surface. The Acuity 58™ 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 fluoroitaconate copolymer (enflufocon B). The new lens material also is comprised of a siloxanyl fluoroitaconate copolymer (enflufocon B).
The new lenses in this submission therefore are substantially equivalent to the lenses cleared under K980741.
12. Non-Clinical Studies:
The enflufocon B 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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13. Clinical Studies:
Clinical studies for the Acuity 58™ (enflufocon B) 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. The lenses will 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 K980741. 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 354 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 | K170007510(k) Summary |
|---|---|
| Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
Side-by-Side Comparison
| NEW LENS | PREDICATE LENS | |
|---|---|---|
| Lens Characteristics | Acuity 58TM (enflufocon B) RGP Lens | Boston EO (enflufocon B) RGP Lens |
| Manufacturer | Acuity Polymers, Inc | Bausch + Lomb |
| Material | enflufocon B | enflufocon B |
| 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 anterioraspheric surface | Standard & reverse geometry with anterioraspheric 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 58TM (enflufocon B ) RigidGas Permeable Contact Lenses areindicated for daily wear for the correctionof refractive error (myopia, hyperopia,presbyopia and/or astigmatism) in aphakicand non-aphakic persons with non-diseased eyes. The lens may be prescribedin spherical and aspheric powers rangingfrom -20.00 D to +20.00 D for daily wear.The lenses may be prescribed for dailywear in otherwise non-diseased eyes thatrequire a rigid contact lens for themanagement of irregular cornealconditions such as keratoconus, pellucidmarginal degeneration, or followingpenetrating keratoplasty or refractive (e.g.,LASIK) surgery. | The BOSTON EO® (enflufocon B) RigidGas Permeable Contact Lenses areindicated for the daily wear correction ofrefractive ametropia (myopia, hyperopia,astigmatism, and presbyopia) in aphakicand not-aphakic persons with non- diseasedeyes. Also, the lenses may be prescribed inotherwise non-diseased eyes that require arigid contact lens for the management ofirregular corneal conditions such askeratoconus, pellucid marginaldegeneration, or following penetratingkeratoplasty or refractive (e.g. LASIK)surgery. The lenses may be disinfectedusing a chemical disinfection system only. |
| Refractive Index (RGP) | 1.429 | 1.429 |
| Oxygen Permeability (RGPCenter) | 58 | 58 |
| Specific Gravity (RGP) | 1.24 | 1.23 |
| Hardness (Shore D) | 81 | 114 (Rockwell R) |
| Modulus (MPa) | 1568 | 1500 |
| Tint | Visibility Tints – variousD&C Green #6, D&C Violet #2, SolventYellow 18 | Visibility Tints – variousD&C Green #6, D&C Violet #2, SolventYellow 18 |
| Water Content | <1% | <1% |
| Lens Type | RGP | RGP |
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| ACUITY POLYMERS, INC. | K170007 |
|---|---|
| 510(k) Premarket Notification | 510(k) Summary |
| Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses | RGP Contact Lens |
Conclusions
In the evaluation of RGP materials, various properties are measured to ascertain the material's ability to meet the intended application requirements. The properties which characterize the materials classification and use are refractive index, oxygen permeability, specific gravity, hardness, modulus and water content. Those properties are described in the above comparison table. These properties or characteristics are important to the function of the final lens and form the basis for the determination of use. These material values meet the minimum values required for use in the manufacture (lathing) of RGP lenses.
Based on the data generated from the chemical/physical testing (See Side by Side Comparison) of Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens, it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston EOTM (enflufocon B) Daily Wear Contact Lens.
§ 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.