(76 days)
No
The 510(k) summary describes a standard soft contact lens made of a specific material. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on material properties and toxicology, not algorithmic performance.
No
Explanation: The device is indicated for the correction of visual acuity in persons with myopia or hyperopia, which is a refractive correction, not a therapeutic treatment for a disease.
No
Explanation: The MIERU Soft Contact Lenses are indicated for the correction of visual acuity, which is a treatment or correction function, not a diagnostic one. They help people see better, but they don't diagnose eye conditions.
No
The device description clearly describes a physical contact lens made of a specific material (etafilcon A) with defined physical properties. 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The MIERU contact lenses are designed to be worn on the eye to correct visual acuity. They are a physical device that interacts with the eye's surface, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly states the lenses are for "correction of visual acuity" in individuals with myopia, hyperopia, and astigmatism. This is a refractive correction, not a diagnostic test.
- Device Description: The description focuses on the material properties, physical characteristics, and how the lens functions on the eye. There is no mention of analyzing biological samples or detecting biomarkers.
Therefore, the MIERU contact lenses fall under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MIERU (etafilcon A) Spherical 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 MIERU (etafilcon A) Toric 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 may have astigmatism of 7.00D or less.
The MIERU (etafilcon A) Multifocal 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 are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
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
LPL
Device Description
The MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1 - trimethylol propane trimethacrylate glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.3121. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the MIERU Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for MIERU averages > 99% in the UVB range of 280nm - 315nm and 83% in the UVA range of 316 - 380nm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical 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: 1.4050 (wet)
Light Transmission (clear): greater than 95%
Light Transmission (tinted): greater than 91%
Water Content: 58 %
Specific Gravity: 1.017 (hydrated)
Oxygen Permeability: 19.9 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
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)
No clinical data is required for this submission.
The MIERU Soft Contact Lens is substantially equivalent to the predicate devices and does not raise different questions of safety and effectiveness than that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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:
Applicant information:
| Date Prepared: | January 14, 2003 |
|---|---|
| Name: | |
| Address | ClearLab PTE, Ltd. |
| 139, Joo Seng Raod #06-01 | |
| ATD Centre, Singapore 368362 | |
| Contact Person: | |
| Phone number: | |
| Fax number: | Steve Newman |
| Country code 65+ 67491090 | |
| Country code 65+ 62848534 | |
| Parent Company: | 1800 CONTACTS, Inc. |
| 66 E. Wadsworth Park Drive 3rd. Floor | |
| Draper, UT 84020 | |
| FDA US Agent/ | |
| Official Correspondent: | |
| Phone number | |
| Fax number | Medvice Consulting, Inc. |
| Martin Dalsing | |
| (970) 243-5490 | |
| (970) 243-5501 | |
| Device Information: |
Device Classification: Class II Classification Number: LPL Classification Name: Lenses, Soft Contact, Daily Wear MIERU (etafilcon A) Daily Wear Contact Lens clear and Trade Name: visibility tint, with UV blocker.
1
Equivalent Predicate Devices:
The MIERU (etafilcon A) Soft Contact Lenses are substantially equivalent to the following predicate devices:
-
- IGEL 55UV (methafilcon A), K020855, Manufactured by IGEL Visioncare Pte. Ltd.
-
- Frequency 58 (etafilcon A), K980634, manufactured by Aspect Vision Care.
-
- AcuVue 2 (etafilcon A), K962804, manufactured by Vistakon.
Device Description:
The MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1 - trimethylol propane trimethacrylate glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.3121. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the MIERU Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for MIERU averages > 99% in the UVB range of 280nm - 315nm and 83% in the UVA range of 316 - 380nm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical 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 | 1.4050 (wet) |
|---|---|
| Light Transmission (clear) | greater than 95% |
| Light Transmission (tinted) | greater than 91% |
| Water Content | 58 % |
| Specific Gravity | 1.017 (hydrated) |
| Oxygen Permeability | 19.9 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
2
Intended Use:
The MIERU (etafilcon A) Spherical 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 MIERU (etafilcon A) Toric 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 may have astigmatism of 7.00D or less.
The MIERU (etafilcon A) Multifocal 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 are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to =5.00D and have near add requirements up to 3.00D.
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.
3
Technological Characteristics:
The technological characteristics of the MIERU contact lens as compared to the technological characteristics of the predicate devices are illustrated in the following table.
| Pre-Clinical
equivalency /
Device | ClearLab800
(etafilcon A)
new device | Frequency 58
(etafilcon A)
predicate device | AcuVue 2
(etafilcon A)
predicate device | Igel 55 UV
(methafilcon A)
predicate device |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Indicated for daily
wear for the correctio
of visual acuity in
aphakic and not
aphakic persons with
non-diseased eyes wit
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. | The contact lenses ac
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 | Daily wear, Soft
(hydrophilic) contact
lens |
| Production
Method | Cast-molded | Cast-molded | Cast-molded | Cast-molded |
| FDA Group # | Group # 4 >50%
Water, Ionic Polymers | Group # 4 >50%
Water, Ionic Polymers | Group # 4 >50%
Water, Ionic Polymers | Group # 4 >50%
Water, Ionic Polymers |
| USAN name | etafilcon A | etafilcon A | etafilcon A | methafilcon A |
| Water
Uptake(%) | 58.0% | 58.0% | 58.0% | 55.0% |
| Oxygen
Permeability | 19.9 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg
@ 35 degrees C),
(revised Fatt method). | 20.2 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg
@ 35 degrees C),
(revised Fatt method). | 19.9 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg
@ 35 degrees C),
(revised Fatt method). | 19.6 x 10-11 (cm2/sec)
(ml O2/ml x mm Hg
@ 35 degrees C),
(revised Fatt method). |
| Specific
Gravity | 1.017 | 1.054 | 1.021 | 1.062 |
4
Summary of Non-Clinical Performance Data:
The following non-clinical tests were conducted as recommended by the Premarket Notification 510(k) guidance document for Daily Wear Contact Lenses, revised May 1994.
-
- Toxicology testing
- a. Cytotoxicity
- b. USP Ocular Irritation
- c. USP Systemic Injection
-
- Leachability / Residual monomer Studies
-
- Physiochemical property testing
Clinical Studies:
No clinical data is required for this submission.
Conclusions Drawn from the Studies:
The MIERU Soft Contact Lens is substantially equivalent to the predicate devices and does not raise different questions of safety and effectiveness than that of the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a stacked formation, creating a sense of depth. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2003
ClearLab PTE, Ltd. c/o Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K030167
Trade/Device Name: MIERU (etafilcon A) Daily Wear Contact Lens clear and visibility tint, with UV blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 17, 2003 Received: March 24, 2003
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, Drug, 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.
6
Page 2 - 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) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
A. halpi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT
MIERU (etafilcon A) Daily Wear Contact Lens clear and visibility tint. with Device Name: UV blocker.
INDICATIONS FOR USE:
The MIERU (etafilcon A) Spherical 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 MIERU (etafilcon A) Toric 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 may have astigmatism of 7.00D or less.
The MIERU (etafilcon A) Multifocal 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 are presbyopic. The lens may be worn by persons who exhibit no more than 2,00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
Evecare 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.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format +2-96)
signature
ision of Ophthalmic Ear. Nose and Throat Dev
510(k) Number K030167