BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

K153066 · Boston Foundation For Sight · HQD · Feb 9, 2016 · Ophthalmic

Device Facts

• Record ID: K153066
• Device Name: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
• Applicant: Boston Foundation For Sight
• Product Code: HQD · Ophthalmic
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

BostonSight IC Corneal & Scleral Lenses are rigid gas permeable (RGP) contact lenses used for vision correction and management of irregular corneal conditions. Lenses are lathe-cut from hydrophobic RGP materials (roflufocon D, roflufocon E, oprifocon A, or hexafocon B). Scleral lens design vaults over cornea, resting on conjunctiva overlying sclera. Prescribed by eyecare practitioners for daily wear; requires chemical cleaning and disinfection. Shipped dry or wet in polypropylene cases. Provides refractive correction for patients with keratoconus, pellucid marginal degeneration, or post-surgical corneal irregularities. Benefits include improved visual acuity through rigid lens optics in irregular corneal states.

Clinical Evidence

Bench testing only. Manufacturing verification confirmed lenses meet ANSI Z80.20 tolerances. Bioburden testing confirmed <1 CFU per lens, meeting acceptance criteria of <100 CFU per lens. Safety profiles rely on predicate device data for biocompatibility, shelf life, and solution compatibility.

Technological Characteristics

Lathe-cut RGP lenses; materials: roflufocon D, roflufocon E, oprifocon A, hexafocon B. Fluoro-silicone acrylate (Group 3). Water content <1%. UV blocking available. Chord diameter 8.0-26.0 mm; center thickness 0.05-0.60 mm; base curve 5.0-9.0 mm; power -25.00 to +35.00 D. Chemical disinfection required.

Indications for Use

Indicated for correction of refractive error in aphakic and non-aphakic persons. Prescribed for management of irregular corneal conditions including keratoconus, pellucid marginal degeneration, or post-penetrating keratoplasty or refractive (e.g., LASIK) surgery in otherwise non-diseased eyes.

Regulatory Classification

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.

Predicate Devices

• OPTIMUM EXTRA (roflufocon D) and OPTIMUM EXTREME (roflufocon E) (K033594)
• Boston EQUALENS II (oprifocon A) (K022128)
• Boston XO2 (hexafocon B) (K071266)

Reference Devices

• Bausch & Lomb Frequent Replacement Contact Lens Case (K896685)
• Boston Advance Comfort Formula Conditioning Solution (K974466)
• Boston SIMPLUS Multi-Action solution (K024289)
• OPTIMUM by Lobob Cleaning and Disinfecting Storage solution (K014162)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2016

Boston Foundation for Sight c/o Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K153066

Trade/Device Name: BostonSight IC Corneal Lens; BostonSight IC Scleral Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: December 29, 2015 Received: December 31, 2015

Dear Mr. 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 (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

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(21 CFR Part 807); labeling (21 CFR: Part 801); medical device 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or 301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

510(k) Number (if known)

K153066

Device Name BostonSight IC Corneal Lens BostonSight IC Scleral Lens

#### Indications for Use (Describe)

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: K153066 Applicant information: Date Prepared: 11/11/2015 Name: Boston Foundation for Sight Address 464 Hillside Avenue, Suite 205 Needham, MA 02494 Contact Person: Eugene A. Bonte President & CEO Phone number: 781-726-7503 Correspondent/Consultant: EyeReg Consulting, Inc. Bret Andre Phone number [phone] Fax number [phone]

## Device Information:

| Device Classification: | Class II |
|------------------------|------------------------------------------------------------|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | BostonSight IC Corneal Lens<br>BostonSight IC Scleral Lens |

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# Purpose of Submission:

~ New Device ~

# Equivalent Devices:

The BostonSight IC Corneal & Scleral Lenses for daily wear are substantially equivalent to the following predicate device(s)

## Predicate device:

| Predicate device<br>manufacturer | Device name | 510(k) number |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Contamac Ltd. | OPTIMUM EXTRA (Oxygen Permeable) Daily Wear<br>Contact Lenses (roflufocon D)<br>OPTIMUM EXTREME (Oxygen Permeable) Daily<br>Wear Contact Lenses (roflufocon E) | K033594 |
| Bausch & Lomb, Inc. | Boston EQUALENS II (oprifocon A)<br>Rigid Gas Permeable Contact Lenses | K022128 |
| Bausch & Lomb, Inc. | Boston XO2 (hexafocon B) Daily Wear Contact<br>Lens | K071266 |

# Device Description:

The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic rigid gas permeable (RGP) lens materials:

- roflufocon D supplied by Contamac Ltd.
- · roflufocon E supplied by Contamac Ltd.
- · oprifocon A supplied by Bausch and Lomb, Inc.
- · hexafocon B supplied by Bausch and Lomb. Inc.

The description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.

The BostonSight IC Corneal & Scleral Lenses for daily wear may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or following refractive (e.g. LASIK) surgery.

The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.

The BostonSight IC Corneal & Scleral Lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight IC Corneal & Scleral Lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.

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When shipped "wet". The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.

The physical properties of the BostonSight IC Corneal & Scleral Lenses manufactured from the various materials are as follows:

| | roflufocon D | roflufocon E | oprifocon A | hexafocon B |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.4230 | 1.4240 |
| Light Transmission<br>(clear) | >97% | >97% | >95% | >95% |
| Light Transmission<br>(tinted) | >90% | >90% | >90% | >83% |
| Specific Gravity | 1.166 | 1.155 | 1.24 | 1.19 |
| Oxygen<br>Permeability<br>(Dk) | $100 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $125 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $85 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $141 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) |
| ISO/FATT Method | | | | |
| Visitint lenses<br>contain one or more<br>of the following<br>color additives<br>conforming to:<br>21 CFR Part 73 &<br>74, Subpart D | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent<br>Yellow 18 | D&C Green No.6<br>and D&C Yellow<br>No.10 | D&C Green No.<br>6; C.I. Solvent<br>Yellow No. 18;<br>D&C Violet No.<br>2; D&C Red No.<br>17; C.I. Solvent<br>Yellow No.18 |
| UV Light Blocking<br>(UVB - 280nm –<br>315nm; UVA 316nm<br>– 380nm) | >98% UVB<br>>95% UVA | >98% UVB<br>>95% UVA | >95% UVB<br>>97% UVA | >95% UVB<br>>97% UVA |
| Dynamic Receding<br>Contact Angle | 3° | 6° | 56° | 40° |

Lens parameters:

- 米 Chord Diameter:
- 米 Center Thickness:
- 米 Base Curve:
- 米 Spherical Powers:

8.0 mm to 26.0 mm 0.05mm to 0.60 mm 5.0 mm to 9.0 mm -25.00 Diopters to +35.00 Diopters

# Indication for Use:

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the

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lens may be cleaned and disinfected using a chemical (not heat) lens care system.

## Description of Safety:

The safety profiles for finished lenses manufactured from the roflufocon D, roflufocon A, and hexafocon B rigid gas permeable (RGP) materials are demonstrated in K033594, K071266, and K022128 respectively-which address the following areas:

- · Biocompatibility
- · Shelf Life (Wet Shipping)
- · Solution Compatibility
- Clinical Evaluation

Additionally, the following testing was performed:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Boston Foundation for Sight to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Boston Foundation for Sight demonstrated that the colony forming units (CFU) per lens was less than 1. which is within the established acceptance criteria of less than 100 CFU per lens.

## ~ Conclusions Drawn from Testing ~

Testing presented in this submission demonstrate no significant differences from the predicate devicessupporting the substantial equivalence claim of these BostonSight IC Corneal & Scleral Lenses to the already marketed roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP contact lenses.

## Substantial Equivalence:

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are substantially equivalent to the predicate devices and do not raise different questions of safety and effectiveness than the predicate devices identified previously.

~ Discussion of Similarities and Differences ~

The BostonSight IC Corneal & Scleral Lenses are identical to the predicate devices in terms of material (USAN), indications, lens design, and production method. There are no significant differences to report between the BostonSight IC Corneal & Scleral Lenses and the predicate devices.

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The following table depicts the pre-clinical characteristics of the BostonSight IC Corneal & Scleral Lenses, as well as the predicate device.

| | BostonSight IC<br>Corneal & Scleral<br>Lenses | OPTIMUM GP<br>(OPTIMUM EXTRA &<br>OPTIMUM EXTREME) | BOSTON Equalens<br>II | BOSTON XO2 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| Indication for Use | The BostonSight IC<br>Corneal & Scleral<br>Lenses for Daily Wear<br>are indicated for the<br>correction of refractive<br>error in aphakic and not<br>aphakic persons. The<br>lenses may be prescribed<br>in otherwise non-diseased<br>eyes that require a rigid<br>gas permeable lens for the<br>management of irregular<br>corneal conditions such as<br>keratoconus, pellucid<br>marginal degeneration or<br>following penetrating<br>keratoplasty or refractive<br>(e.g. LASIK) surgery. | The OPTIMUM GP<br>(roflufocon D & E)<br>Daily Wear Contact Lens<br>may be prescribed<br>in otherwise non-diseased<br>eyes that require<br>a rigid gas permeable lens<br>for the management<br>of irregular corneal<br>conditions such as;<br>keratoconus, pellucid<br>marginal degeneration<br>of following penetrating<br>keratoplasty or following<br>refractive (e.g. LASIK)<br>surgery. | The BOSTON<br>Equalens II may be<br>prescribed in otherwise<br>non-diseased eyes that<br>require a rigid contact<br>lens for the<br>management of<br>irregular corneal<br>conditions such as<br>keratoconus, pellucid<br>marginal degeneration<br>or following<br>penetrating<br>keratoplasty or<br>refractive (e.g. LASIK)<br>surgery. | The Boston XO2<br>(hexafocon B) RGP<br>contact lenses may be<br>prescribed in otherwise<br>non-diseased eyes that<br>require a rigid contact<br>lens for management of<br>irregular corneal<br>conditions such as<br>keratoconus, pellucid<br>marginal degeneration, or<br>following penetrating<br>keratoplasty or refractive<br>(e.g. LASIK) surgery. |
| Device and<br>Classification | Class II<br>Daily wear, Rigid<br>Gas Permeable RGP<br>Contact Lens<br>HQD | Class II<br>Daily wear, Rigid Gas<br>Permeable RGP<br>Contact Lens<br>HQD | Class II<br>Daily wear, Rigid<br>Gas Permeable<br>RGP Contact Lens<br>HQD | Class II<br>Daily wear, Rigid<br>Gas Permeable RGP<br>Contact Lens<br>HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| Water Content | <1% | <1% | <1% | <1% |
| UV Absorber/Blocker<br>available | YES | YES | YES | YES |