(84 days)
Not Found
No
The document describes a standard contact lens with a tinting process. There is no mention of any computational analysis, image processing, or adaptive algorithms that would indicate the use of AI or ML.
No
The device is a contact lens indicated for correction of visual acuity and to enhance/alter eye color, not for therapeutic purposes like treating a disease or injury.
No
The device is a contact lens intended for correcting visual acuity and altering eye color, not for diagnosing conditions. It modifies vision and appearance rather than identifying diseases or conditions.
No
The device description clearly describes a physical contact lens made of polymacon material with added color additives. It details the manufacturing process and material composition, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity and to enhance/alter eye color. This is a therapeutic and cosmetic purpose, not for diagnosing a disease or condition.
- Device Description: The description focuses on the physical properties and composition of the contact lens itself, not on any components or processes designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens 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 to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution.
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.
As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additive effect is formed by reacting one or more of the color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are
Refractive Index: 1.43 (hydrated)
Light Transmission (tinted): greater than 90%
Water Content: 38% ± 2%
Oxygen Permeability: 8.4 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fat 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
Eyecare practitioners
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.
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
SPECIAL 510(k) SUMMARY
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: | |
|---|---|
| -------------------------------- | -- |
Applicant information:
Date Prepared:
September 19, 2005
Marietta Vision 397 N. Sessions Street Marietta, GA 30060
| Name: |
|---|
| Address: |
Contact Person: Phone number:
John Patterson 770 792 0208
FDA US Agent/ Medvice Consulting, Inc. Official Correspondent: Martin Dalsing Phone number (970) 243-5490 Fax number (970) 243-5501
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | Marietta Contact Lens (polymacon), Tinted Daily Wear |
| Contact Lens |
1
Unmodified Predicate Devices:
The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is substantially equivalent to Marietta Vision's own unmodified predicate devices:
-
- Addvantage 38 (Polymacon), K942302, Marietta Vision,
-
- Marietta Contact Lens, color enhanced, K002647, Marietta Vision.
Description of Modified Device:
The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution.
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.
As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additive effect is formed by reacting one or more of the color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are
| Refractive Index | 1.43 (hydrated) |
|---|---|
| Light Transmission (tinted) | greater than 90% |
| Water Content | 38% ± 2% |
| Oxygen Permeability | 8.4 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fat |
| method). |
2
Intended Use:
The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens 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 to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Technological Characteristics Comparison:
The technological characteristics of the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens as compared to the technological characteristics of the unmodified predicate devices are illustrated in the following table.
3
| Technological Characteristic / Device | Marietta Contact Lens
(polymacon), Tinted
Daily Wear Contact
Lens
Modified Device | Addvantage 38
(polymacon),
Unmodified Device
K942302 | Marietta Contact Lens
Color Enhanced,
Unmodified Device
K002647 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear
for the correction of
visual acuity in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or
hyperopia. | Indicated for daily wear
for the correction of
visual acuity in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or
hyperopia. | Indicated for daily wear
for the correction of
visual acuity in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or
hyperopia. |
| Functionality | The contact lenses act as
a refractive medium that
focus light rays from
near and distant objects
on the retina. | The contact lenses act as
a refractive medium that
focus light rays from
near and distant objects
on the retina. | The contact lenses act as
a refractive medium that
focus light rays from
near and distant objects
on the retina. |
| Indications | Daily wear, Soft
(hydrophilic) contact
lens | Daily wear, Soft
(hydrophilic) contact
lens | Daily wear, Soft
(hydrophilic) contact
lens |
| Production
Method | Lathe-Cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 1 Trade/Device Name: Marietta (polymacon) Tinted Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 11, 2005 Received: November 17, 2005
Dear Mr. Dalsing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Martin Dalsing
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Marietta Vision Special 510(k): Device Modification, Premarket Notification
INDICATIONS FOR USE STATEMENT
Device Name:
Marietta Contact Lens (polymacon), Tinted Contact Lens.
INDICATIONS FOR USE:
The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visua acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the ler may be cleaned and disinfected using a chemical (not heat) lens care system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaur Wanta
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K052606
Over-The-Counter Use
(Optional Format 1-2-96)
(Optional Format 1-2-96)