BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS

K071266 · Bausch & Lomb, Inc. · HQD · Aug 15, 2007 · Ophthalmic

Device Facts

• Record ID: K071266
• Device Name: BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BOSTON XO2 (hexafocon B) Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eves. BOSTON XO2 may be prescribed in otherwise non-diseased eves 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 XO2 is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Device Story

Fluoro silicone acrylate copolymer rigid gas permeable (RGP) contact lens; daily wear; corrects refractive errors and manages irregular corneal conditions; used in orthokeratology for temporary myopia reduction. Lens material contains UV absorbers and color additives. Prescribed by eye care professionals; patient self-applied. Clinical performance evaluated against predicate Boston XO; demonstrated equivalent vision quality and tolerance. Benefits include vision correction and management of corneal irregularities.

Clinical Evidence

Controlled, multi-center clinical study comparing Boston XO2 to Boston XO in adapted GP wearers. Evaluated safety (adverse events, slit lamp findings) and efficacy (vision quality, comfort, symptoms). No adverse events reported; slit lamp findings < grade 2. Vision and tolerance attributes (comfort, dryness, irritation) were at least as good as the predicate.

Technological Characteristics

Fluoro silicone acrylate copolymer RGP lens material. Contains UV absorbers (Uvinul D-49 or MHB) and color additives (D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2, D&C Red No. 17). Biocompatibility tested per ISO 10993 (cytotoxicity, ocular irritation, systemic toxicity). Bioburden stability tested per ISO 11987.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic/non-aphakic patients with non-diseased eyes. Also indicated for irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, post-refractive surgery) and orthokeratology for temporary reduction of myopia up to 5.00 diopters.

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

• Boston XO (hexafocon A) (K000795, K001960, K053124, K011945)

Submission Summary (Full Text)

{0}------------------------------------------------

K071266

# 510(K) SUMMARY BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lenses for Daily Wear

AUG 15 2007

#### 1. Applicant's Name and Address

***

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Debra Ketchum 2. Contact Person Manager, Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 [phone] [e-mail]

#### ર્જ ldentification of Device

| Common Name: | contact lens-rigid gas permeable (hydrophobic) |
|------------------------|-----------------------------------------------------|
| Trade Name: | Boston XO2 (hexafocon B) Daily Wear Contact<br>Lens |
| Classification: | Class II ophthalmic (21CFR 886.5916) |
| Device classification: | Class II (21 CFR 886.5916) |
| Product Codes: | HQD, MUW |

Predicate Devices:

The predicate device, Boston XO (hexafocon A) was selected to address material use and design (aspheric, bifocal, toric, irregular corneas, and orthkeratology).

The BOSTON XO2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 2006, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a change in the component ratios.

{1}------------------------------------------------

| K000795, K001960, K043124 and K011945: Boston XO (hexafocon A) | | |
|----------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Clearance Date | Device Description |
| K000795 | 5/26/2000 | Boston XO RGP Daily<br>Wear Contact Lenses |
| K001960 | 8/28/2000 | Boston XO RGP for Daily<br>Wear Orthokeratology<br>Contact Lenses |
| K053124 | 1/30/2006 | Boston XO, Boston EO,<br>Boston ES RGP Daily<br>Wear Contact Lenses<br>(Post Surgical) |
| K011945 | 9/12/2001 | Boston RGP Contact<br>Lenses wet shipped and<br>stored in Boston Advance<br>Comfort Formula<br>Conditioning Solution up<br>to 30 days. |

#### Description of device 4.

BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).

{2}------------------------------------------------

#### 5. Intended use

BOSTON XO2 (hexafocon B) Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eves.

BOSTON XO2 may be prescribed in otherwise non-diseased eves 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 XO2 is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

#### 6. Description of Safety and Substantial Equivalence

A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BOSTON XO2 contact lens material. A summary of results from the non-clinical and clinical tests is provided below.

- 6.1. Lens Compatibility/Cycling Study
The compatibility of BOSTON XO2 material with several GP contact lens care regimens was assessed in this study. A lens cvcling study was completed with each contact lens care regimen. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.

- 6.2. Determination of Total Extractables Substances (ISO 10340:1995(E))
Total Extractables testing was conducted on three lots of BOSTON XO2. The total amount of material extracted from BOSTON XO2 was less than that extracted from BOSTON XO the predicate device.

- 6.3. Determination of Extractable Color Additives and UV Blockers in Boston XO2 Material (ISO 10340:1995(E))
Determination of Extractable color additives and UV blockers testing was conducted on Boston XO2 material. These results are similar to those obtained when extracting Boston XO, the predicate device.

{3}------------------------------------------------

- 6.4. Cytotoxicity Study Using The ISO Agar Overlay Method (ISO 10993-5)
This in-vitro assay demonstrated the biocompatibility of this material. The test sample is placed on an agar surface directly overlaying a arowing L-929 cell monolayer to determine if the material induces a cvtopathic effect. The material did not induce cytotoxicity.

- 6.5. ISO Ocular Irritation Study (ISO 10993-10)
USP 0.9% Sodium Chloride Injection and sesame oil extracts of the Boston XO2 GP lens material was evaluated for the potential to produce an irritating effect on the ocular tissue of the rabbits. According to the criteria of the study protocol, the material is considered to be a nonirritant.

- 6.6. USP and ISO Systemic Toxicity Test (ISO 10993-11)
This study was designed to evaluate acute systemic toxicity of the BOSTON XO2 material extract following a single intravenous or intraperitoneal injection into mice. All observations of the mice were normal. The test samples meet the test requirements.

- 6.7. Bioburden of Lenses and Stability of Bioburden of Lenses Over time: Evaluation of the BOSTON XO2 material (ISO 11987:1997)
A 30-day shelf-life study for Boston XO2 lenses stored in Boston Advance Comfort Formula Conditioning Solution and Boston SIMPLUS Multi-Action solution was conducted. The average bioburden levels for BOSTON XO2 lenses stored in lens cases with Boston SIMPLUS Multi-Action Solution and Boston Advance Comfort Formula Conditioning Solution after 30 days were within the acceptable bioburden limit of < 100 cfullens.

#### Clinical data: 7.

The clinical investigation was conducted in accordance with the United States FDA regulations (21 CFR Parts 50, 54, 56 and 812), ICH Good Clinical Practices, ISO 14155-2 and the Declaration of Helsinki.

The objective of this controlled, multi-center clinical study was to evaluate the safety and efficacy of the BOSTON XO2 (hexafocon B) Gas Permeable (GP) contact lens compared to the BOSTON XO (hexafocon A) GP contact lens when worn by adapted GP contact lens wearers on a daily wear basis.

{4}------------------------------------------------

Safety Conclusions:

The use of the BOSTON XO2 (hexafocon B) gas permeable contact lens was well tolerated. There were no adverse events related to the BOSTON XO2 product.

The results of this evaluation demonstrated that treatment with the BOSTON XO2 (hexafocon B) qas permeable contact lens is safe when used as directed.

Efficacy Conclusions:

The vision provided by the BOSTON XO2 (hexafocon B) contact lens is the same as vision with the BOSTON XO (hexafocon A) contact lens. Other Symptoms/Complaint measures associated with lens tolerance (Comfort, End of Day Comfort, Burning/Stinging Upon Insertion, Irritation, Itching, Dryness, and Redness) ratings demonstrated that the BOSTON XO2 lens was at least as good as the BOSTON XO, overall, and at all follow-up visits for these attributes.

Other symptoms/complaints measures associated with lens tolerance (Comfort, End of Day Comfort, Burning/Stinging Upon Insertion, Irritation, Itching, Dryness, and Redness) ratings demonstrated that the BOSTON XO2 article was at least as good as the BOSTON XO, Overall, and at all follow-up visits for these attributes.

Discussion and Overall Conclusions:

The results of this study demonstrated that there were no major complications associated with the use of the BOSTON XO2 (hexafocon B) GP contact lens. This was supported by the fact that there were no adverse events, no test eves required medical treatment and there were no slit lamp findings greater than grade 2.

Vision measures were acceptable for the BOSTON XO2 (hexafocon B) GP contact lenses and were generally similar to the BOSTON XO contact lens. Symptoms/Complaints for various performance attributes associated with lens tolerance were also similar.

Overall, the investigators were satisfied with the vision quality that their subjects were able to obtain, the clinical performance of the lens met their expectations, and their subjects were successful wearing the BOSTON XO2 (hexafocon B) GP contact lenses.

{5}------------------------------------------------

### Conclusions drawn from studies 8. Substantial Equivalence:

Information provided in this 510(k) establishes that the BOSTON XO2 GP Contact Lens is equivalent in optical, chemical, and physical properties of the predicate device and does not raise any questions of safety and effectiveness. The clinical evaluation demonstrated safe and effective lens performance and equivalence with the predicate device.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2007

Bausch & Lomb, Inc. c/o Debra Ketchum Manager, Global Regulatory Affairs 1400 North Goodman Street Rochester NY 14609-3547

Re: K071266

Trade/Device Name: Boston XO2 (hexafocon B) Daily Wear Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD, MUW Dated: July 19, 2007 Received: July 23, 2007

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the each as 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, 2012 - 12:25 pm accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general obtaturing province, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassined (600 as a votrols. Existing major regulations affecting your device can may or subject to back as assisted 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 I lease be advised that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a averal regulations administered by other Federal agencies. You must or any I cuena statuted and registments, including, but not limited to: registration and listing (21 Comply with an the 110 - 210 - 21 - 21 - 2011; good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

## Page 2 - Debra Ketchum

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egeland, MD

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

{8}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

1071266

510(k) Number (if known): __

Device Name:

Boston XO2 (hexafocon B)

## Indication for Use

The BOSTON XO2 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.

The lens may be prescribed 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 is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------|--|
|------------------|--|

OR

| Over-the-counter-use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K071266 |
|---------------|---------|
|---------------|---------|