(70 days)
Not Found
No
The document describes a standard soft contact lens and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for correcting refractive conditions such as myopia, hyperopia, and astigmatism, which are functional conditions of the eye. This aligns with the definition of a therapeutic device as it is intended to treat or alleviate a medical condition.
No
The device is a soft contact lens intended for vision correction, not for diagnosing medical conditions. It corrects existing refractive errors rather than identifying them.
No
The device description clearly states it is a soft contact lens, which is a physical medical device made of polymerized material. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The BIOMEDICS 55 contact lens is a medical device that is placed on the surface of the eye to correct vision problems (myopia, hyperopia, astigmatism). It does not perform any diagnostic tests on bodily samples.
- Intended Use: The intended use clearly states it's for correcting vision in not-aphakic, normal eyes. This is a therapeutic/corrective function, not a diagnostic one.
The device description and intended use clearly indicate it's a corrective optical device, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The BIOMEDICS® 55 (ocufilcon D) soft (hydrophilic) contact lens is indicated for daily wear in normal eyes whose eyes are either myopic, hyperopic, or astigmatic in powers from -20.00 to +20.00 Diopters and astigmatic corrections from -0.25 to -10.00 Diopters. Spherical lenses may mask astigmatism of up to 2.00 Diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the evecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, corneal surface, cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eyecare practitioner
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K972303, K942214, P890023/S26, P890023/S4
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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
JAN 2 1 1999
Image /page/0/Picture/1 description: The image shows a logo with the words "OCULAR SCIENCES" on the top line. Below that is a symbol that looks like a target, followed by the words "AMERICAN HYDRON" on the next two lines. The text and symbol are all in black and white.
510(k) Summary
SUBMITTER:
Submitted on behalf of:
Company Name: Address: Phone: Fax:
Ocular Sciences, Inc. 475 Eccles Av. South San Francisco, CA 95014 (415) 583-1400 (415) 583-1108
CONTACT PERSON:
Richard E. Lippman, O.D., F.A.A.O. Official Representative and Correspondent C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852
DATE SUMMARY PREPARED: October 1, 1998
TRADE NAME:
BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
The BIOMEDICS 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4,and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Sciences, Inc.
The BIOMEDICS 55 (ocufilcon D) UV Blocking Daily Wear contact lens is substantially equivalent to the indication for use of the BIOMEDICS 55 (ocufilcon D) In Monomer Tint ocufilcon D cast molded contact lens marketed for use in the U.S. by Ocular Sciences, Inc. cleared under K972303. Additionally, the subject contact lens is equivalent and has the same characteristics and properties as the clear BIOMEDICS® 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26. The cast molding process was approved under P890023/S4. This lens is in the Lens Group IV high water ionic group as established by the FDA and located in the Guidance
000032
Corporate Offices:
475 Eccles Avenue
South San Francisco.
California 94080
800-628-5367
Ph: 650-583-1400
Canada:
110 Cochrane Drive
Markham, Ontario
L3R 9S1
Canada
Ph: 905-940-1998
England:
Reliant Close
Chandlers Ford
Eastleigh
Hampshire S053 4ND
England
Hungary:
Hársmajor u.8
1118 Budapest
Hungary
Ph: 36-1-319-6241
Fax: 36-1-319-3034
RICO:
P.O. Box 2801
Highway 538 km. 0.7
Santa Isabel Industrial Park
Santa Isabel,
Puerto Rico 00757
1
Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the BIOMEDICS® 55 (ocufilcon D) UV visibility tint cast molded Ocular Sciences, Inc.contact lens are substantially equivalent to both the clear and tinted versions of the BIOMEDICS 55 (ocufilcon D) ocufilcon D cast molded contact lenses.
DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
INDICATIONS FOR USE:
The BIOMEDICS® 55 (ocufilcon D) soft (hydrophilic) contact lens is indicated for daily wear in normal eyes whose eyes are either myopic, hyperopic, or astigmatic in powers from -20.00 to +20.00 Diopters and astigmatic corrections from -0.25 to -10.00 Diopters. Spherical lenses may mask astigmatism of up to 2.00 Diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the evecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
2
PARAMETERS AVAILABLE:
| Base Curves: | 6.50 mm to 10.8 mm |
|---|---|
| Diameters: | 12.5 mm to 18.0 mm |
| Powers: | -20.00 to +20.00 Diopters sphere |
| Cylinder Power: | -00.25 to -10.00 Diopters |
| Center Thickness: | 0.025 mm to 0.27 mm depending on power |
| Tint: | Blue Visibility tint |
ULTRAVIOLET TRANSMITTANCE CURVES
The following graph represents the transmittance of ultraviolet light in the UVA and UVB range as well as light transmittance through the visual spectrum, as compared to the human cornea and crystalline lens:
Image /page/2/Picture/4 description: The image shows a scattering of small, irregularly shaped black dots against a white background. The dots vary in size, with some appearing as tiny specks and others as slightly larger, more defined shapes. The distribution of the dots is uneven, with some areas of the image having a higher concentration of dots than others, creating a sense of randomness and dispersion.
Image /page/2/Picture/5 description: The image shows the number 000034 in a bold, sans-serif font. The numbers are evenly spaced and aligned horizontally. The image is simple and only contains the number.
3
Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UV versus a Human Cornea and a Human Lens
Image /page/3/Figure/1 description: The image is a graph comparing the percentage of light transmission through different types of lenses at different wavelengths. The x-axis represents the wavelength in nanometers, ranging from 200 to 750. The y-axis represents the percentage of transmission, ranging from 0 to 100. The graph shows the transmission of light through an Ocufilcon D contact lens with UV protection, a human cornea from a 24-year-old person, and a human crystalline lens from a 25-year-old person.
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4
Typical Transmittance Profile of -2.50 D Ocufilcon D Hydrophilic Contact Lens with UVC versus a Human Cornea and a Human Lens
Image /page/4/Figure/1 description: The image is a graph that shows the percentage of transmission of light through different materials as a function of wavelength. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750 nm. The y-axis represents the percentage of transmission, ranging from 0 to 100%. There are three lines on the graph, representing the transmission of light through Ocufilcon D contact lens, the human cornea of a 24-year-old person, and the human crystalline lens of a 25-year-old person.
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5
Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UVAM versus a Human Cornea and a Human Lens
Image /page/5/Figure/1 description: The image is a graph comparing the percentage of light transmission through different parts of the human eye and a contact lens. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750. The y-axis represents the percentage of light transmission, ranging from 0 to 100. The graph shows the transmission of light through the Ocufilcon D contact lens, the human cornea of a 24-year-old, and the human crystalline lens of a 25-year-old.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Ocular Sciences, American Hydron, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Rockville, Maryland 20852
Re: K984046 Trade Name: Biomedics ® 55 (ocufilcon D) UV Blocking Soft Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: November 6, 1998 Received: November 13, 1998
Dear Dr. Lippman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Richard E. Lippman, O.D., F.A.A.O.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of - Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications Statement
510(k) Number (if known) K984046
Device Name; Biomedics 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens
Indications for Use:
Additional Claims:
The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Presription Use | X |
|---|---|
| Over-The-Counter Use |
(Division Sign-Off)
Division of Ophthalmic Devices
(Oprtional Format 1-2-96)
510(k) Number_K984046
00001