(141 days)
P820065
No
The summary describes rigid gas permeable contact lenses and their materials, with no mention of AI or ML technology.
No.
The device is indicated for the daily wear correction of refractive ametropia, not for treating or curing a disease or condition.
No
This device is a contact lens used for the correction of refractive ametropia; it does not diagnose medical conditions.
No
The device description clearly states it is a rigid gas permeable contact lens material, which is a physical hardware device, not software.
No, 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 Function: The BOSTON ES®, BOSTON EO®, and BOSTON® XO Rigid Gas Permeable Contact Lenses are medical devices that are placed directly on the eye to correct vision. They do not analyze any biological samples.
- Intended Use: The intended use clearly states they are for the "daily wear correction of refractive ametropia". This is a therapeutic/corrective function, not a diagnostic one.
Therefore, based on the provided information, these contact lenses are not IVDs.
N/A
Intended Use / Indications for Use
The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
Product codes
HQD
Device Description
The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.
BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).
| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|---|---|---|---|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Light Transmittance | C.I.E. Y value - at least % | C.I.E. Y value - at least % | C.I.E. Y value - at least 92% |
| 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
APR 0 3 2002
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON® XO (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES
1. SUBMITTER INFORMATION
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609
| Contact Person: | Debra Ketchum |
|---|---|
| Manager, Regulatory Affairs | |
| Telephone No.: | (585) 338-8638 |
2. DEVICE NAME
Classification Name: rigid gas permeable (hydrophobic) contact lens
Proprietary Name: BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses
3. PREDICATE DEVICE
The BOSTON® II (itafocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P820065, on November 17, 1983, has been selected as the predicate device for the BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses.
1
DESCRIPTION OF DEVICE 4.
The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.
BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).
| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|---|---|---|---|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Light Transmittance | C.I.E. Y value | C.I.E. Y value | C.I.E. Y value |
| - at least % | - at least % | - at least 92% | |
| Water Content |