(52 days)
P860022
P860022, S007, S016, S054
No
The 510(k) summary describes a contact lens and its physical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a contact lens used for the correction of refractive ametropia, which is a medical condition. Therefore, it is a therapeutic device.
No
The device is a contact lens intended for correcting refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a Rigid Gas Permeable Contact Lens material, which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the BOSTON® EQUALENS® II is to be worn on the eye for vision correction. It does not involve analyzing any biological samples.
- The description focuses on the physical and optical properties of the contact lens material. This is consistent with a medical device intended for direct contact with the body, not for diagnostic testing.
- The performance study mentioned refers to a Premarket Application for safety and efficacy as a contact lens. This is the typical regulatory pathway for medical devices, not IVDs.
Therefore, based on the provided information, the BOSTON® EQUALENS® II is a medical device, specifically a contact lens, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.
The lens may be disinfected using a chemical disinfection system only.
Product codes
HQD
Device Description
The BOSTON® EQUALENS® II (oprifocon A) is a Rigid Gas Permeable Contact Lens material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with an ultraviolet absorber.
The color additives conform to 21 CFR Part 74. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
| Property | BOSTON EQUALENS II |
|---|---|
| Specific Gravity | 1.24 |
| Refractive Index | 1.423 |
| Light Absorbance (Absorbance Units/Inch) | 9.4 Blue 4.8 Green |
| 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
AUG 2 2 2002
K022/28
510(k) SUMMARY
FOR
BOSTON® EQUALENS® II (oprifocon A) RIGID GAS PERMEABLE CONTACT TENSES
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® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses
PREDICATE DEVICE 3.
The BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P860022, on November 30, 1987, has been selected as the predicate device for the BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses.
1
DESCRIPTION OF DEVICE 4.
The BOSTON® EQUALENS® II (oprifocon A) is a Rigid Gas Permeable Contact Lens material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with an ultraviolet absorber.
The color additives conform to 21 CFR Part 74. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
| Property | BOSTON EQUALENS II |
|---|---|
| Specific Gravity | 1.24 |
| Refractive Index | 1.423 |
| Light Absorbance | |
| (Absorbance Units/Inch) | 9.4 Blue |
| 4.8 Green | |
| Water Content |