(112 days)
Not Found
No
The summary describes rigid gas permeable contact lenses and their materials, with no mention of AI or ML capabilities, image processing, or data-driven algorithms.
No.
The device is indicated for correction of refractive ametropia and management of irregular corneal conditions, which are not considered therapeutic interventions in the context of device regulation.
No
The device description and intended use clearly state that these are contact lenses for vision correction and management of corneal conditions, not for diagnosing diseases.
No
The device description clearly states it is a rigid gas permeable contact lens material, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are contact lenses for the correction of refractive ametropia and management of irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device description details the materials used to make contact lenses. This aligns with a medical device for direct patient use, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Boston XO (hexafocon A), Boston EO (enflufocon B), and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-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 lenses may be disinfected using a chemical disinfection system only.
Product codes
HQD
Device Description
Boston XO (hexafocon A) is a rigid gas permeable material, composed of siloxanyl fluoromethacrylate copolymer available with or without an ultraviolet absorber.
The Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) are rigid gas permeable contact lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer available with or without an ultraviolet absorber.
The physical and optical properties of the lenses are:
Property: BOSTON XO; Specific Gravity: 1.27; Refractive Index: 1.425; Visible Light Transmittance: 92% average; UV Blocker: UV 49; Water Content:
§ 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
510(K) SUMMARY BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), and BOSTON ES (enflufocon A) Rigid Gas Permeable Contact Lenses for Daily Wear
1. Applicant's Name and Address
Bausch & Lomb, Inc. 1400 North Goodman Street Rochester. NY 14609
-
- Contact Person Debra Ketchum Manager,Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-8638
3. ldentification of Device
| Common Name: | contact lens-rigid gas permeable (hydrophobic) | |
|---|---|---|
| Trade Name: | Boston XO (hexafocon A), Boston EO | |
| (enflufocon B), and Boston ES (enflufocon A) | ||
| Daily Wear Contact Lens | ||
| Classification: | Class II ophthalmic (21CFR 886.5916) | |
| Device classification: | Class II (21 CFR 886.5916) | |
| Pro Code: | HQD |
Predicate Devices:
K053124 and K013762: Boston XO (hexafocon A), Boston EO (enflufocon B), Boston ES (enflufocon A)
| 510(k) | Clearance Date | Device Description |
|---|---|---|
| K053124 | 1/30/2006 | Boston XO, Boston EO, |
| Boston ES | ||
| K013762 | 4/3/2002 | Boston XO, Boston EO, |
| Boston ES |
1
4. Description of device
Boston XO (hexafocon A) is a rigid gas permeable material, composed of siloxanyl fluoromethacrylate copolymer available with or without an ultraviolet absorber.
The Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) are rigid gas permeable contact lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer available with or without an ultraviolet absorber.
| Property | BOSTON XO | BOSTON EO | BOSTON ES |
|---|---|---|---|
| Specific Gravity | 1.27 | 1.23 | 1.22 |
| Refractive Index | 1.425 | 1.429 | 1.443 |
| Visible Light | |||
| Transmittance | 92% average | 92% average | 92% average |
| UV Blocker | UV 49 | UV 49 | UV 49 |
| Water Content |