(89 days)
No
The summary describes contact lenses and their materials, indications for use, and performance testing related to material properties and biocompatibility. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Can this device be considered a therapeutic device?
Yes.
The "Intended Use / Indications for Use" section explicitly states that the Boston XO® and Boston XO2® Scleral Lens designs are indicated for "therapeutic use" for the management of irregular and distorted corneal surfaces and for eyes with ocular surface disease.
No
This device is a contact lens indicated for correcting refractive ametropia and managing irregular corneal conditions. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the device is a physical contact lens made from specific materials, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the Boston contact lenses as devices intended for placement on the eye for the correction of vision and management of certain corneal conditions. They are not used to analyze biological samples taken from the body.
The device is a medical device, specifically a contact lens, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
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® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) 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).
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) 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.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
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)
Non-clinical Testing: A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses with Tangible TM Hydra-PEG surface technology. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the device demonstrate that:
- The finished lenses are not toxic and not irritating,
- Bioburden levels are below the acceptance criteria (
§ 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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 12, 2019
Bausch & Lomb, Incorporated % Mr. Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
Re: K183167
Trade/Device Name: Boston ES® (enflufocon A); Boston EO® (enflufocon B); Boston XO® (hexafocon A); and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 11, 2019 Received: January 15, 2019
Dear Mr. Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
J Angelo Green -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses
Indications for Use (Describe)
The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
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® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) 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).
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) 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 Keratits), 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.
3
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
BAUSCH- Health 510(k) Premarket Notification
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.
K183167 The assigned 510(k) number is:
I. SUBMITTER
| Date Prepared: | November 1st, 2018 |
|---|---|
| ---------------- | -------------------- |
| Name:
Address: | Bausch & Lomb Incorporated
1400 North Goodman St.
Rochester, NY 14609
United States |
|-------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Glenn A. Davies
Director Global Regulatory Affairs |
| Phone number: | (585) 338-8215 |
| Consultant: | Bret Andre
EyeReg Consulting, Inc.
6119 Canter Ln.
West Linn, OR 97068 |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon
A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Daily wear rigid gas permeable contact lens |
| Classification
Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory
Class: | Class II |
| Product Code: | HQD |
5
Purpose of 510(k) Submission:
Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses-cleared under 510(k) K053124, K013762. K071266. K071043 and K171404-are modified to include the Tangible™ Hydra-PEG surface coating-which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible Hydra-PEG treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses.
III. PREDICATE DEVICE
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG are substantially equivalent to the following predicate devices:
- "Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses" By Bausch & Lomb Incorporated 510(k) numbers; K053124, K013762, K071266, K071043 and K171404
- . "Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lenses" By Contamac Ltd. 510(k) number; K161100 -reference predicate
IV. DEVICE DESCRIPTION
Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
The surface properties of: enflufocon A, enflufocon B, and hexafocon B materials uncoated and coated with Tangible Hydra-PEG are depicted in the following table:
6
BAUSCH Health
510(k) Premarket Notification
| enflufocon A | enflufocon B | hexafocon A | hexafocon B | |
|---|---|---|---|---|
| Sessile Drop Contact | ||||
| Angle ± Standard | ||||
| Deviation | Coated: 10.2°±1.2° | |||
| Uncoated: 59.6°±5.9° | Coated: 10.0°±0.0° | |||
| Uncoated: 62.7°±6.0° | Coated: 10.0°±0.0° | |||
| Uncoated: 63.4°±4.0° | Coated: 10.0°±0.0° | |||
| Uncoated: 65.4°±3.3° |
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K053124, K013762, K071266, K071043 and K171404.
V. INDICATIONS FOR USE
The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
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® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) 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
7
BAUSCH- Health
510(k) Premarket Notification
corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology are substantially equivalent to the uncoated lenses (predicate devices cleared under K053124. K013762. K071266. K071043 and K171404) in terms of the following:
- Proprietary contact lens material formulation and USAN
- Intended use - daily wear contact lenses
- Actions
- 트 Indications for use / Contraindications
- 트 Lens designs and available parameters
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston X02® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology are substantially equivalent to the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (cleared under K161100) in terms of the following:
- 트 Thermoset copolymers derived from fluorosilicone acrylate monomers
- Tangible™ Hydra-PEG surface coating .
The following matrix illustrates the production method, lens function and material characteristics of the Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology, as well as the predicate devices.
8
BAUSCH-Health
510(k) Premarket Notification
510(k) Premarket Notification
| | Boston ES® (enflufocon A),
Boston EO® (enflufocon B),
Boston XO® (hexafocon A) and
Boston XO2® (hexafocon B)
with Tangible™ Hydra-PEG | Boston ES® (enflufocon A),
Boston EO® (enflufocon B),
Boston XO® (hexafocon A)
and Boston XO2® (hexafocon
B) | Optimum GP with
Tangible™ Hydra-
PEG
(roflufocon C, D, E) |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Device | Predicate Device
(K053124, K013762, K071266,
K071043 and K171404) | Predicate Device
(K161100) |
| Functionality | The contact lenses act as a refractive
medium that focus light rays from near
and distant objects on the retina | The contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina |
| Intended Use | Daily Wear | Daily Wear | Daily Wear |
| Indication for Use | The Boston ES® (enflufocon A) and Boston EO®
(enflufocon 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 gas permeable 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 lenses may be
disinfected using a chemical disinfection system
only.
The 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 gas permeable 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 lenses may be disinfected using a chemical
disinfection system only.
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® (hexafocon A) and Boston
XO2® (hexafocon B) Contact Lenses (Scleral) for
daily wear are indicated for therapeutic use for the
management of irregular and distorted corneal
surfaces where the subject:
1.cannot be adequately corrected with spectacle
lenses
2.requires a rigid gas permeable contact lens
surface to improve vision
3.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 | The Boston ES® (enflufocon A) and Boston
EO® (enflufocon 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
gas permeable 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 lenses may be disinfected using
a chemical disinfection system only.
The 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
gas permeable 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 lenses may be disinfected using
a chemical disinfection system only.
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® (hexafocon A) and Boston
XO2® (hexafocon B) Contact Lenses
(Scleral) for daily wear are indicated for
therapeutic use for the management of
irregular and distorted corneal surfaces where
the subject:
1.cannot be adequately corrected with
spectacle lenses
2.requires a rigid gas permeable contact lens
surface to improve vision
3.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 | Indicated for daily wear for
the correction of visual acuity
in aphakic and not aphakic
persons with non-diseased
eyes with myopia or hyperopia
and/or presbyopia. The lens
may also be prescribed for
management of irregular
corneal conditions such as
keratoconus and post graft
fitting. |
| | dystrophy, Cogan's dystrophy).
The Boston XO® (hexafocon A) and Boston
XO2® (hexafocon B) 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. | 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).
The Boston XO® (hexafocon A) and Boston
XO2® (hexafocon B) 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. | |
| Production Method | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| USAN name | enflufocon A
enflufocon B
hexafocon A
hexafocon B | enflufocon A
enflufocon B
hexafocon A
hexafocon B | roflufocon C, D, E |
| Water Content (%) |