BostonSight PD Prosthetic Device

K161461 · Bostonsight · HQD · Jul 25, 2016 · Ophthalmic

Device Facts

• Record ID: K161461
• Device Name: BostonSight PD Prosthetic Device
• Applicant: Bostonsight
• Product Code: HQD · Ophthalmic
• Decision Date: Jul 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that: 1. precludes satisfactory spectacle lens correction 2. demonstrates significant improved rigid contact lens corrected vision 3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens. Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma. The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error. The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

Device Story

BostonSight PD is a daily-wear, lathe-cut, rigid gas permeable (RGP) prosthetic contact lens. Device vaults over cornea, resting on scleral conjunctiva; creates tear reservoir between lens and cornea. Reservoir masks optical distortions; protects ocular surface from adverse environments (e.g., dysfunctional eyelids). Prescribed by eye care professionals for patients with corneal distortion or ocular surface disease. Lens provides physical protection and potential refractive correction. Patient self-administers daily; requires chemical (non-heat) cleaning/disinfection. Benefits include improved vision, ocular surface protection, and symptom relief for chronic conditions.

Clinical Evidence

No new clinical data provided. Safety and effectiveness supported by reference to predicate devices (K153066) and previously cleared RGP contact lenses (K033594, K022128, K071266) utilizing the same fluoro-silicone acrylate materials.

Technological Characteristics

Lathe-cut RGP lens; materials: roflufocon D, roflufocon E, oprifocon A, hexafocon B (Group 3 Fluoro Silicone Acrylate). Water content <1%. Diameter 18.0-26.0 mm. UV blocking >95-98%. Chemical disinfection only.

Indications for Use

Indicated for patients with distorted corneal surfaces (degeneration, dystrophy, post-surgical scarring, infection, trauma) or ocular surface disease (dry eye, limbal stem cell deficiency, skin disorders, neurotrophic keratitis, corneal exposure) requiring expanded tear reservoir and environmental protection. Suitable for patients unable to wear traditional corneal lenses or achieve satisfactory spectacle correction.

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

• BostonSight IC Corneal & Scleral Lens (K153066)
• Boston Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear (P860022/S40)

Reference Devices

• OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lenses (K033594)
• Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses (K022128)
• Boston XO2 (hexafocon B) Daily Wear Contact Lens (K071266)

Submission Summary (Full Text)

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

July 25, 2016

BostonSight % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068

Re: K161461

Trade/Device Name: BostonSight PD Prosthetic Device Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: May 20, 2016 Received: May 26, 2016

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.

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

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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

510(k) Number (if known) K161461

Device Name BostonSight PD Prosthetic Device

Indications for Use (Describe)

The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:

- 1. precludes satisfactory spectacle lens correction
- 2. demonstrates significant improved rigid contact lens corrected vision

3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens

Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.

The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.

The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 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: K161461 Applicant information: July 22nd, 2016 Date Prepared: Name: BostonSight Address 464 Hillside Avenue, Suite 205 Needham, MA 02494 Contact Person: Gene P. Guselli President and CEO Phone number: 781-726-7337 EyeReg Consulting, Inc. Consultant/Correspondent: 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 PD Prosthetic Device |

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# Predicate Devices:

The BostonSight PD Prosthetic Device is substantially equivalent to the following predicate device(s)

- "BostonSight IC Corneal & Scleral Lens" . - Primary Predicate Manufactured by Boston Foundation for Sight 510(k) number; K153066
- "Boston" Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear" . – Reference Predicate Manufactured by Boston Foundation for Sight PMA number: P860022/S40

# Device Description:

The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:

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

The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.

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

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| | 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% |
| Water Content | <1% | <1% | <1% | <1% |
| Dynamic Contact<br>Angle (Receding) | 3° | 6° | 56° | 40° |
| Specific Gravity | 1.166 | 1.155 | 1.24 | 1.19 |
| Modulus | 697 MPa | 77 MPa | 1300 MPa | 1160 MPa |
| Shore D Hardness | 75 | 77 | 81 | 78 |
| Oxygen<br>Permeability<br>(Dk)<br>ISO/FATT Method | $100 x 10^{-11}$<br>(cm2/sec) (ml O2/ml x<br>mm Hg @ 35°C) | $125 x 10^{-11}$<br>(cm2/sec) (ml O2/ml x<br>mm Hg @ 35°C) | $85 x 10^{-11}$ (cm2/sec)<br>(ml O2/ml x mm Hg @<br>35°C) | $141 x 10^{-11}$<br>(cm2/sec) (ml O2/ml x<br>mm Hg @ 35°C) |
| 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 |

The physical properties of the BostonSight PD Prosthetic Device manufactured from the various materials are as follows:

The parameters for the BostonSight PD Prosthetic Device are as follows:

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

18.0 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 Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of a distorted corneal surface that:

- 1. precludes satisfactory spectacle lens correction
- 2. demonstrates significant improved rigid contact lens corrected vision
- 3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens

Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g, lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.

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The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.

The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

# Description of Safety:

- ~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the predicate device, BostonSight IC Corneal & Scleral Lens (K153066).

~ Clinical Studies ~

Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the following:

- OPTIMUM GP(roflufocon D, roflufocon E) Daily Wear Contact Lenses K033594 ●
- . Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses - K022128
- . Boston XO2 (hexafocon B) Daily Wear Contact Lens - K071266

# Substantial Equivalence:

The BostonSight PD Prosthetic Device is substantially equivalent to the Boston" Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear (predicate device) in the following key areas:

- · Device Design
- · Therapeutic indications for use

The BostonSight PD Prosthetic Device is substantially equivalent to the BostonSight IC Corneal & Scleral Lens (predicate device) in the following key areas:

- Components/Materials/Formulation
- · Manufacturing Process
- Manufacturing Facility
- Final Packaging & Wet Shipping

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The BostonSight PD Prosthetic Device is substantially equivalent to the predicate device as depicted in the following table, and does not raise different questions of safety and effectiveness than the predicate device identified previously.

The following table depicts the pre-clinical characteristics of the BostonSight PD Prosthetic Device, as well as the predicate device(s).

| | BostonSight PD Prosthetic<br>Device<br>Subject Device | BostonSight IC Corneal<br>& Scleral Lens<br>(K153066)<br>Predicate Device | Boston® Scleral<br>(itafluorofocon B)<br>RGP Contact Lens<br>(P860022/S40)<br>Predicate Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Indicated for therapeutic use in eyes with<br>ocular surface disease from dry eye (e.g.<br>ocular Graft-versus-Host disease,<br>Sjögren's syndrome, dry eye syndrome),<br>limbal stem cell deficiency (e.g.Stevens-<br>Johnson syndrome, chemical and thermal<br>burns, radiation), disorders of the skin<br>(e.g. atopy, ectodermal dysplasia),<br>neurotrophic keratitis (e.g. Herpes<br>simplex, Herpes zoster, Familial<br>Dysautonomia), and corneal exposure<br>(e.g. anatomic, paralytic) that might<br>benefit from the presence of an expanded<br>tear reservoir and protection against an<br>adverse environment. When prescribed<br>for therapeutic use for distorted cornea or<br>ocular surface disease, the BostonSight<br>PD Prosthetic Device may incidentally<br>provide correction of refractive error. | Indicated for the correction of<br>refractive error in aphakic and not<br>aphakic persons. The lenses may<br>be prescribed in otherwise non-<br>diseased eyes that require a rigid<br>gas permeable lens for the<br>management of irregular corneal<br>conditions such as keratoconus,<br>pellucid marginal degeneration or<br>following penetrating keratoplasty<br>or refractive (e.g. LASIK)<br>surgery. | Indicated for eyes having<br>significantly reduced vision<br>due to the presence of a<br>distorted corneal surface that:<br>1) precludes satisfactory<br>spectacle lens correction 2)<br>demonstrates significantly<br>improved rigid contact lens<br>corrected vision 3) is<br>incapable of wearing<br>traditional corneal lenses<br>because of the inability to<br>achieve adequate lens<br>centration/stability and/or<br>tolerance to physical contact<br>with a lens. Furthermore,<br>eyes suffering from certain<br>ocular surface disorders may<br>benefit from the physical<br>protection and the saline bath<br>provided by a scleral lens. |
| Device and<br>Classification | Class II<br>Lenses, Rigid Gas Permeable, Daily<br>Wear<br>HQD | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>HQD<br>(reclassified from Class II<br>to Class II in 1994) |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate |
| Water Content | <1% | <1% | <1% |
| UV Absorber/Blocker<br>available | YES | YES | YES |