(70 days)
PMA N16-895, K942365
No
The summary describes a rigid gas permeable contact lens with a specific aspheric design for multifocal correction. There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis, treatment, or device function. The performance study relies on traditional clinical trial methods and visual acuity measurements.
Yes.
The device is a contact lens indicated for the correction of visual acuity in patients with certain refractive errors, which is a therapeutic purpose.
No.
This device is a contact lens intended for correcting visual acuity, not for diagnosing medical conditions.
No
The device description clearly states it is a rigid gas permeable contact lens, which is a physical hardware device.
No, 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 BOSTON® MULTIVISION Contact Lens is a medical device worn on the eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it is for "correction of visual acuity" and is a "contact lens."
Therefore, based on the provided information, the device is a contact lens for vision correction, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
Product codes
Not Found
Device Description
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
The lens parameters available are:
Chord Diameter: 7.0 to 11.5 mm (to prescription)
Center Thickness: 0.07 to 0.65 mm (varies with power and diameter
Base Curve: 5.0 to 9.0 mm in 0.01 mm steps
Power: +20.00 to -20.00 in 0.12 D increments for distance +1.50 D nominal add
Optical Zone: To prescription
All physical, optical and chemical properties are equivalent to the BOSTON ES (enflufocon A) material as cleared in 510(k) K943177. See attached summary. The physical properties of the subject contact lens are as follows:
Oxygen Permeability: 31 x 10-11 (cm³O₂ • cm)/(cm² • sec • mmHg) @ 35°C (standard deviation=3)
Wetting Angle: 52° ±3
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
POLYMER TECHNOLOGY
1400 N. GOODMAN STREET · ROCHESTER, NEW YORK 14692
Image /page/0/Picture/2 description: The image shows a black and white abstract design. The design features a large, curved shape that takes up most of the image. A smaller, rectangular shape is positioned near the bottom right of the curved shape, creating a contrast between the two forms. The overall composition is simple yet striking, with the stark contrast between black and white enhancing the visual impact.
MAY - 6 1997
510(x) SUMMARY
SUBMITTED BY:
Polymer Technology a division of Wilmington Partners, L.P. ﻴﺘ 1400 North Goodman Street
Rochester, NY 14692
TRADE/PROPRIETARY NAME
BOSTON® ESTM MULTIVISION (enflufocon A) Contact Lens
CLASSIFICATION NAME:
Contact Lens - rigid gas permeable
COMMON/USUAL NAME:
Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material
PREMARKET NOTIFICATION NUMBER:
CONTACT PERSON:
Contact Person:
Telephone No .: Fax No .: E-mail Address:
Douglas J. Fortunato Director, Regulatory Affairs (716) 338-5477 (716) 338-0702 dfortunato@bausch.com
1
POLYMER TECHNOLOGY 1400 N. GOODMAN STREET . ROCHESTER, NEW YORK 14692
で
Image /page/1/Picture/2 description: The image is a black and white graphic. The majority of the image is a solid black shape that resembles a semi-circle or a rounded shape. In the lower center of the image, there is a white rectangular shape that extends upwards into the black area. The overall composition is simple, with a strong contrast between the black and white elements.
イヤービュームファイ
INDICATIONS FOR USE:
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
STATEMENT OF EQUIVALENCE:
The BOSTON ES MULTIVISION (enflufocon A) contact lens is made of the same material as BOSTON ES (enflufocon A), a daily wear fluoro silicone acrylate contact lens material as cleared under 510(k) Premarket Notification No. K943177. The United States Adopted Name (USAN) enflufocon A is unchanged. Substantial equivalence is also determined by the design equivalence to the BAUSCH & LOMB Occasions " (polymacon) Visibility Tinted Multifocal Contact Lens as approved under PMA N16-895; and the BOSTON ENVISION aspheric single vision, back surface design as cleared under 510(k) Premarket Notification No. K942365. Equivalence in design is determined by both lens designs being aspheric, in which a series of different radius curves from center to edge of the lens are used to describe the back surface of the lens, and create the 'add' effect for the multifocal power.
DEVICE DESCRIPTION:
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for
2
OLYMER TECHNOLOGY 1400 N. GOODMAN STREET · ROCHESTER, NEW YORK 14692
Image /page/2/Picture/1 description: The image shows a black and white abstract shape. The shape is mostly black, with a small white portion at the bottom. The black portion is curved on the top and left sides, and has a small rectangular cutout on the right side.
central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
The lens parameters available are:
| Chord Diameter: | 7.0 to 11.5 mm (to prescription) |
|---|---|
| Center Thickness: | 0.07 to 0.65 mm (varies with power and |
| diameter | |
| Base Curve: | 5.0 to 9.0 mm in 0.01 mm steps |
| Power: | +20.00 to -20.00 in 0.12 D increments for |
| distance | |
| +1.50 D nominal add | |
| Optical Zone: | To prescription |
All physical, optical and chemical properties are equivalent to the BOSTON ES (enflufocon A) material as cleared in 510(k) K943177. See attached summary. The physical properties of the subject contact lens are as follows:
| Oxygen Permeability: | 31 x 10-11 (cm³O₂ • cm)/(cm² • sec • mmHg)
@ 35°C (standard deviation=3) |
|----------------------|-----------------------------------------------------------------------------|
| Wetting Angle: | 52° ±3 |
| Water Content: |