(66 days)
P860022/S40, K161461
Not Found
No
The document describes rigid gas permeable contact lenses and their intended uses. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The application is for labeling revisions, not a new device or technology.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "Boston XO Scleral Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces" and "The Boston XO Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease." Similar statements are made for the Boston XO2 lenses.
No
Explanation: The text describes contact lenses used for vision correction and therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly states that the device is a "Rigid Gas Permeable (RGP) Contact Lens," which is a physical hardware component. The 510(k) summary focuses on the material and designs of these physical lenses, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the BOSTON XO and BOSTON XO2 Contact Lenses are rigid gas permeable contact lenses worn on the eye. Their intended use is for correcting refractive errors and managing irregular corneal conditions and ocular surface diseases.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical device placed on the eye for therapeutic and vision correction purposes.
Therefore, the function and intended use of these contact lenses do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BOSTON XO® (hexafocon A) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses 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).
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
Boston XO Scleral Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g.ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. 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 a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
BOSTON XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses 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).
BOSTON XO2 Contact Lenses are 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.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
Boston XO2 Scleral Contact Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO2 Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. 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 a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
Product codes (comma separated list FDA assigned to the subject device)
HOD, HQD
Device Description
The Boston XO and Boston XO2 Rigid Gas Permeable (RGP) Contact Lenses are fluoro silicone acrylate copolymer rigid gas permeable contact lenses available in a variety of tints and may contain an ultraviolet light absorber. The hemispherical shells are available in several lens designs including spherical, aspherical, toric, scleral and irregular cornea designs.
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
Not Found
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)
No performance data is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P860022/S40, K161461
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an 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
July 17, 2017
BAUSCH + LOMB Incorporated % Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street, Suite A250 Wilmington, MA 01887
Re: K171404
Trade/Device Name: BOSTON XO® (hexafocon A), BOSTON XO2® (hexafocon B) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: May 10, 2017 Received: May 12, 2017
Dear Ellen M. Beucler:
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.
1
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
2
Indications for Use
510(k) Number (if known) K171404
Device Name
BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
BOSTON XO® (hexafocon A) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses 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).
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
Boston XO Scleral Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. 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 a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K171404
Device Name
BOSTON XO2® (hexafocon B) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
BOSTON XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses 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).
BOSTON XO2 Contact Lenses are 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.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
Boston XO2 Scleral Contact Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO2 Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. 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 a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
510(k) Summary
1. Applicant Information
Bausch + Lomb Inc. 1400 North Goodman Street Rochester, NY 14609 USA
| Contact: | Glenn Davies, O.D.
Senior Director Regulatory Affairs |
|----------------|----------------------------------------------------------|
| Phone: | (585) 338-8215 |
| Fax: | (585) 338-0702 |
| email: | glenndavies@bausch.com |
| Date Prepared: | July 11, 2017 |
2. Device Information
| Classification name: | Rigid Gas Permeable Contact Lens |
|---|---|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5916 (Rigid Gas Permeable Contact Lenses) |
| Product code: | HQD |
| Proprietary name: | Boston XO® (hexafocon A) and Boston XO2® |
| (hexafocon B) Rigid Gas Permeable Contact Lens |
3. Predicate Devices
Bausch + Lomb Inc. claims substantial equivalence to Boston Scleral Contact Lens, PMA No. P860022/S40 approved March 1, 1994 and BostonSight PD Prosthetic Device cleared in K161461 on July 25, 2016.
4. Description of Device
The Boston XO and Boston XO2 Rigid Gas Permeable (RGP) Contact Lenses are fluoro silicone acrylate copolymer rigid gas permeable contact lenses available in a variety of tints and may contain an ultraviolet light absorber. The hemispherical shells are available in several lens designs including spherical, aspherical, toric, scleral and irregular cornea designs.
7
5. Indications for Use
Boston XO (hexafocon A) and Boston XO2 (hexafocon B) 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 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 Boston XO2 (hexafocon B) Contact Lenses are 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.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
The Boston XO and XO2 Scleral Lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
8
5. Indications for Use (continued)
The Boston XO and XO2 Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), 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 a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
6. Performance Data
There are no changes to the Boston XO (hexafocon A) and Boston XO2 (hexafocon B) Rigid Gas Permeable contact lens material or lens designs as part of this application. These materials have been previously cleared for scleral lens designs. This application is for labeling revisions. No performance data is required.
7. Substantial Equivalence
In support of the expanded indications for Boston XO and XO2 to include scleral lens indications the following statements apply.
- Boston XO and XO2 Rigid Gas Permeable Scleral Contact Lenses are fluoro silicone acrylate contact lenses that use similar actions and technological characteristics as the predicate devices (see Table 1 and Table 2).
- . The Boston XO and XO2 Rigid Gas Permeable Scleral Lenses present the same risks and benefits as the predicate devices and are as safe and effective as the predicate devices when used according to the labeled directions for use and requested indications.
Therefore, the Boston XO and XO2 Rigid Gas Permeable Scleral Lenses are substantially equivalent to the BostonSight PD Prosthetic Device and the Boston Scleral Contact Lens.
9
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| | Boston XO & XO2 Scleral Lens
(hexafocon A and hexafocon B) | BostonSight PD
Prosthetic Device
(oprifocon A) | Boston Scleral Lens
(oprifocon A) | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | K171404 | K161461 | P860022/S040 | |
| | Subject Device | Predicate Device | Predicate Device | |
| Indication for Use | BOSTON XO (hexafocon A) and XO2® (hexafocon B) 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 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 Contact Lenses are 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.
Furthermore, eyes suffering fromcertain ocular surface disorders may benefit fromthe physical protection,
aqueous hydrated environment and the saline bath provided by scleral lens designs.
Boston Xo and XO2 Scleral Contact Lens designs for daily wear are indicated for therapeutic use for the
management of irregular and distorted corneal surfaces where the subject:
- cannot be adequately corrected with spectacle lenses
- requires a rigid gas permeable contact lens surface to improve vision
- is unable to wear a comeal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to comeal infections, trauma, tractions as a
result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or comeal
transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid
marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy,
granular comeal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The Boston XO and XO2 Scleral
Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g.
ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal
stemcell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal bums), 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 fromthe presence of an
expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use
for a distorted comea or ocular surface disease, the Boston Scleral Lenses may concurrently provide
correction of refractive erroг.
lenses may be disinfected using a chemical disinfection (not heat) system only. | | | |
| Actions/Operational
Principles | When placed on the eye the Rigid Gas Permeable Contact Lens acts as a
refracting mediumto focus light rays on the retina to improve visual acuity. | 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 erroг.
When placed on the eye the Rigid Gas
Permeable Contact Lens acts as a refracting
medium to focus light rays on the retina to
improve visual acuity. | Indicated for eyes having significantly reduced
vision due to the presence of a distorted
comeal surface that:
- precludes satisfactory spectacle lens
correction 2) demonstrates significantly
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.
Furthermore, eyes suffering from certain ocular
surface disorders may benefit from the physical
protection and the saline bath provided by a
scleral lens.
When placed on the eye the Rigid Gas
Permeable Contact Lens acts as a refracting
medium to focus light rays on the retina to
improve visual acuity. | |
| Product Code | HQD | HQD | HQD | |
| Common name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | |
| Device Class | II | II | II* | |
| CFR Reference | 21 CFR 886.5916 | 21 CFR 886.5916 | 21 CFR 886.5916 | |
| Production Method | Lathe Cut | Lathe cut | Lathe cut | |
| FDA Group # | Group # 3 Fluom Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | |
| | Boston XO & XO2
Contact Lens
K171404 | | BostonSight PD
Prosthetic Device
(oprifocon A) | Boston Scleral Lens
(oprifocon A) |
| | | | K161461 | P860022/S040 |
| | Subject Devices | | | |
| | Boston XO
(hexafocon A) | Boston XO 2
(hexafocon B) | Predicate Device | Predicate Device |
| Refractive Index | 1.415 | 1.424 | 1.423 | 1.423 |
| Specific Gravity | 1.27 | 1.19 | 1.24 | 1.24 |
| Wetting Angle | 49° | 38° | 56° | 56° |
| Hardness | 81 | 78 | 81 | 81 |
| Modulus | 1500 Mpa | 1160 Mpa | 1300 Mpa | 1300 Mpa |
| Visible Light Transmittance | > 92% | > 95% | > 95% | > 95% |
| Tint* | Clear, Blue, Ice Blue,
Violet, Green | Clear, Blue, Ice Blue,
Violet, Green | Clear | Clear |
| Water Content |