(24 days)
Not Found
No
The document describes standard soft contact lenses and their material properties, with no mention of AI or ML technology.
No
The device is a contact lens used for vision correction, not for treating a disease or illness.
No
Explanation: The device is a contact lens used for vision correction (myopia or hyperopia), which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly describes a physical contact lens made from a material (hioxifilcon A) that is machined, polished, and hydrated. This is a hardware medical device, not a software-only one.
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, tissue) to provide information about a person's health.
- Device Function: The provided description clearly states that these are soft contact lenses intended for the correction of visual acuity by being placed on the cornea of the eye. They are a medical device, but they are not used to analyze biological samples outside of the body.
The information provided focuses on the physical properties of the contact lenses and their intended use for vision correction, which is consistent with a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Resolution 5X (Spherical) (hioxifilcon A) 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 5X (Toric) (hioxifilcon A) 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
LPL
Device Description
The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon A, 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 cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon A) 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 58% water by weight. The physical properties of the lens are:
Refractive Index: 1.515 (dry) 1.404 (hydrated)
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Water Content: 58% ±2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 20 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
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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)
"Resolution 45 (Spherical) and Ultra Gel (Toric)" manufactured by Opti-Center Laboratories Inc., "BENZ-G 5X" manufactured by Benz Research and Development, K952620
Reference Device(s)
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
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.
| The assigned 510(k) number is: | K992589 |
|---|---|
| Applicant information: | |
| Date Prepared: | July 28, 1999 |
| Name: | |
| Address | Opti-Center Laboratories Inc. |
| 4375 Ouimet Street | |
| Sherbrooke (Quebec) Canada J1L 1X5 | |
| Contact Person: | |
| Phone number: | Robert Mercure |
| (819) 564-8114 | |
| USA Consultant: | Med-Vice Consulting, Inc. |
| Martin Dalsing | |
| Phone number | (970) 243-5490 |
Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | Resolution 5X (Spherical) and Ultra Gel 5X (Toric) |
| (Hioxifilcon A) Soft Daily Wear Contact Lens, (Clear & | |
| Blue Visibility Tint, Lathe-cut from Lens Blank) |
1
Equivalent Devices:
The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices in terms of intended use and design. Predicate devices include: "Resolution 45 (Spherical) and Ultra Gel (Toric)" manufactured by Opti-Center Laboratories Inc., and the "BENZ-G 5X" manufactured by Benz Research and Development.
Device Description:
The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon A, 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 cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon A) 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 58% water by weight. The physical properties of the lens are:
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 58% ±2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | $20 X 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). |
Intended Use:
The Resolution SX (Spherical) (hioxifilcon A) 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 5X (Toric) (hioxifilcon A) 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.
The Resolution 5X (Spherical), Ultra Gel 5X (Toric) (Dioxiflicon A) Soft Dally Wear Contact Lens (Clear & Blue Visibility Tint, Inthe-cut from Lens Blank) .
2
510(k) Premarket Notification
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 (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 5X, 510(k) #K952620. 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 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank), as well as the predicate devices.
| | Characteristic | Resolution 5X
(Spherical) | Ultra Gel 5X (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 | 58% | 58% | 58%, 48% |
| b. | Polymer Content | 42% | 42% | 42%, 52% |
| c. | Polymer | hioxifilcon A | hioxifilcon A | hioxifilcon A,
hioxifilcon B |
| d. | DK Value | 20 | 20 | 20, 15 |
| e. | Refractive Index | 1.404 (hydrated) | 1.404 (hydrated) | 1.404, 1.404 |
| f. | Specific Gravity | 1.136 (hydrated) | 1.136 (hydrated) | 1.136, 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three human profiles visible within the eagle's body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1999
Opti- Center Laboratories, Inc. c/o Mr. Martin Dalsing MED-VICE CONSULTING, INC. 623 Glacier Drive Grand Junction, CO 81503
Re: K992589
Trade Name: Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (Hioxifilcon A) Soft Daily Wear Contact Lens, (Clear & Blue Visibility Tint, Lathe-cut from Lens Bank) Regulatory Class: II Product Code: 86 LPL Dated: July 28, 1999 Received: August 2, 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. Ralph 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 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Device Name: Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)
INDICATIONS FOR USE:
. .
The Resolution 5X (Spherical) (hioxifilcon A) 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 5X (Toric) (hioxifilcon A) 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 | K992589 |
|---|---|
| --------------- | --------- |
| Prescription Use | x |
|---|---|
| (Per 21 CFR 801.109) |
or
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |