(175 days)
Not Found
No
The document describes the physical properties and intended use of soft contact lenses, with no mention of AI or ML technology.
No.
The device is indicated for the correction of visual acuity, which is a refractive correction and not a therapeutic treatment for a disease or condition.
No
The device is a soft contact lens indicated for the correction of visual acuity, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical contact lens made from a specific material (hioxifilcon B) with physical properties like refractive index, water content, and oxygen permeability. It is a tangible medical device, not software.
Based on the provided text, 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 description clearly states that these are soft contact lenses intended for the correction of visual acuity in individuals with myopia or hyperopia and/or astigmatism. They are placed on the eye, not used to analyze a sample from the body.
- Lack of Diagnostic Purpose: The intended use is purely for vision correction, not for diagnosing any disease or condition.
The information provided describes a medical device used for vision correction, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Ultra Gel (Toric) (hioxifileon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are:
Refractive Index: 1.515 (dry) 1.404 (hydrated)
Color Pigment Name: Phthalocyanine Blue
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Water Content: 48 % ±2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Not Found
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.
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
3/29/99
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant information:
Date Prepared:
October 1, 1998
| Name: | Opti-Center Laboratories Inc. |
|---|---|
| Address | 4375 Ouimet Street |
| Sherbrooke (Quebec) Canada JIL 1X5 | |
| Contact Person: | Robert Mercure |
| Phone number: | (819) 564-8114 |
| USA Consultant: | Med-Vice Consulting, Inc. |
|---|---|
| Martin Dalsing | |
| Phone number | (970) 243-5490 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | Resolution 45 (Spherical) and Ultra Gel (Toric) |
| (hioxifilcon B) Soft Daily Wear contact Lens, (Clear & Blue | |
| Visibility Tint, Lathe-cut from Lens Blank) |
1
Equivalent Devices:
The Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices in terms of intended use and design. Predicate devices include: "Horizon 55 Spherical & Westhin Toric" manufactured by Westcon Contact Lens, and the "BENZ-G 3X" manufactured by Benz Research and Development.
Device Description:
The Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifileon B) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are:
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Color Pigment Name | Phthalocyanine Blue |
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 48 % ±2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | 15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt |
| method). |
Intended Use:
The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Ultra Gel (Toric) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters.
2
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Opti-Center Laboratories, Inc. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X, 510(k) #K964528. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.
The following matrix illustrates the production method, lens function and material characteristics of the Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank), as well as the predicate devices.
| | Characteristic | Resolution 45
(Spherical) | Ultra Gel (Toric) | PREDICATE
DEVICES |
|-----|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION
METHOD | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Refractive medium that
focuses light rays from
distant, intermediate and
near objects on the
retina, while
compensating for
refractive error. | Refractive medium that
focuses light rays from
near, intermediate and
distant objects on the
retina, while
compensating for
refractive error. | Refractive medium that
focuses light rays from
near, intermediate and
distant objects on the
retina, while
compensating for
refractive error. |
| 3.) | MATERIAL | Hydrophilic Polymer | Hydrophilic Polymer | Hydrophilic Polymer |
| a. | Water Content | 48% | 48% | 55%, 48% |
| b. | Polymer Content | 52% | 52% | 45%, 52% |
| c. | Polymer | hioxifilcon B | hioxifilcon B | methafilcon A,
hioxifilcon B |
| d. | DK Value | 15 | 15 | 18.2, 15 |
| e. | Refractive Index | 1.404 (hydrated) | 1.404 (hydrated) | 1.408, 1.404 |
| f. | Specific Gravity | 1.136 (hydrated) | 1.136 (hydrated) | 1.090, 1.136 |
| g. | Light Transmission | greater than 95% T | greater than 95% T | greater than 95% T |
Substantial Equivalence Matrix
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1999
Mr. Martin Dalsing Official FDA Correspondent Opti-Center Laboratories 623 Glacier Drive Grand Junction, CO 81503
Re: K983496
Trade Name: Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank) Regulatory Class: II Product Code: 86 LPL Dated: January 20, 1999 Received: January 26, 1999
Dear Mr. Dalsing:
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 .
4
Page 2 - Mr. Martin Dalsing
· 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. Roeyl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health ...... .
Enclosure
5
INDICATIONS FOR USE STATEMENT
Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Device Name: Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)
INDICATIONS FOR USE:
The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Ultra Gel (Toric) (hioxifileon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983496
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)