(53 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard contact lens, with no mention of AI or ML technologies.
No.
The device is a contact lens used for vision correction (myopia or hyperopia) and cosmetic purposes (altering eye color), not for treating a disease or condition.
No
This device is a contact lens intended for daily wear to correct visual acuity. It is not described as being used to diagnose conditions but rather to correct existing refractive errors.
No
The device description clearly outlines a physical contact lens made of polymacon, a hydrophilic polymer, with specific dimensions and materials. It is a tangible medical device, not software.
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 in aphakic and non-aphakic persons with myopia or hyperopia, and to enhance or alter the apparent color of the eye. This is a therapeutic or cosmetic use, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used for vision correction and appearance modification.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties, biocompatibility, and sterilization of the contact lens, which are relevant to its safety and efficacy as a medical device, not as a diagnostic tool.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent repacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is available as a single vision lens. The lens material, polymacon is hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate(62%) and water(38%).
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is colored with one or a combination of one or more of the following color additives: Titanium dioxide (white), C.I Pigment blue 36, Iron oxides, C.I. Pigment green 7, C.I. Pigment violet 23, D&C Yellow No.10.
Neo Vision Neo Cosmo is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera with the following dimensions:
- Diameter: 13.8mm to 14.5mm
- Base Curve: 8.0mm to 9.0mm
- Center Thickness: 0.05mm to 0.135 (varies with power)
- Powers: 0.00D to -10.00D
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and a portion of the adjacent sclera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care 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)
The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens has been subjected to property evaluation, moist heat (steam) sterilization evaluation and biocompatibility evaluation, and has successfully passed all testing.
Performance Testing:
- Tensile Testing: Pass
- Solution Compatibility (Cleaning Cycle Testing): Pass
- Physical Properties of the Neo Cosmo: Pass
- Physical Properties of the Neo Vision Neo Cosmo: Pass
- Physical Properties of the NEO Toric: Pass
- Physical Properties of the NEXT: Pass
- Physical Properties of the NEW GREEN: Pass
- Physical Properties of the NEO CLEAN: Pass
Biocompatibility Testing:
- Ocular Irritation Test: Pass
- Skin Sensitization Test: Pass
- Cytotoxicity Test (Proliferation Inhabition Test): Pass
- Cytotoxicity Test (Agar Diffusion Test): Pass
- Ocular Irritation Study of Neo Cosmo Soft Contact Lens in NZW Rabbits: Pass
- Skin Sensitization Study of Neo Cosmo soft contact lens using Guinea-Pig Maximization Test (GPMT): Pass
Summary Clinical Testing:
The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens was not evaluated with clinical testing.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol representing the human form, composed of three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7. 2014
Neo Vision Co., Ltd. % Albert Rego Ph.D. Regulatory Consultant Albert Rego, Ph.D., Inc. 27001 La Paz Road, Suite 312 Mission Viejo, CA 92691
Re: K142275
Trade/Device Name: Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: July 31, 2014 Received: August 15, 2014
Dear Dr. Rego:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
Page 2 -
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation
(21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142275
Device Name
Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent repacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
(As required by 21 CFR 807)
| SUBMITTED BY | Neo Vision Co., Ltd.
17th Floor, U-Tower, 1029 Yeongdeok-
Dong, Giheung-gu, Yongin-si
Gyeonggi-do
Korea |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT | Kyung Hwa Kim 82-31-889-2040
export@neolens.co.kr |
| SUBMISSION DATE | April 7, 2014 |
| TRADE NAME | Neo Cosmo (Polymacon) Soft (Hydrophilic
Contact Lens - Neo Cosmo |
| COMMON NAME | Lenses, Soft Contact, Daily Wear |
| CLASSIFICATION NAME | Class II (21 CFR 886.5925) |
| PRODUCT CODE | LPL |
| PREDICATE DEVICE | K051477 Migwang
Comfort 38
Decision Date: 03/10/2006 |
DEVICE DESCRIPTION
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is available as a single vision lens. The lens material, polymacon is hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate(62%) and water(38%).
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is colored with one or a combination of one or more of the following color additives: Titanium dioxide (white), C.I Pigment blue 36, Iron oxides, C.I. Pigment green 7, C.I. Pigment violet 23, D&C Yellow No.10.
Neo Vision Neo Cosmo is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera with the following dimensions:
- Diameter: 13.8mm to 14.5mm
- Base Curve: 8.0mm to 9.0mm ●
- Center Thickness: 0.05mm to 0.135 (varies with power) ●
- Powers: 0.00D to -10.00D ●
4
The physical properties of the lens are:
- I Refractive Index: 1.43
- I Light Transmittance: >95% .
- I Water Contents: 38% .
- I Oxygen Permeability: 9.5 X 10-11(cm2/s) [ml X mmHg) at 35°C .
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens consists of:
| No. | Part
Name | Raw Material | Composition
(%) | Remark | Function |
|-----|-------------------|-----------------------------------|--------------------|------------------|------------------|
| 1 | Base | 2-hydroxyethylmethacrylate | 99.3 | CAS No. 868-77-9 | Main
Element |
| | | Ethylene glycol
dimethacrylate | 0.7 | CAS No. 97-90-5 | Cross-
linker |
| 2 | Color
Additive | Titanium dioxide (white) | $\leq$ 0.04 | CFR No. 73.3126 | Color |
| | | Iron oxides | | CFR No. 73.3125 | Color |
| | | C.I. Pigment violet -23 | | CFR No. 73.3107 | Color |
| | | D & C Yellow No. 10 | | CFR No. 73.3110a | Color |
| | | C.I. Pigment green -7 | | CFR No. 73.3124 | Color |
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens is packaged in either in a vial package or a blister package.
The vial package is a 5mL Borosilicate glass vial filled with NaCI 0.85 ~0.95 w/v% solution. The cap is aluminum with a locking rubber (Chlorobutyl rubber for medical use).
The blister package consists of 3mL Polypropylene filled with NaCI 0.85 ~0.95 w/v% solution with an aluminum sealing film sheet.
INDICATIONS FOR USE
The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent replacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
This device is substantially equivalent to the predicate devices in its intended use and technological characteristics, manufacturing process specified in following table;
5
| Substantial Equivalency | Soft (hydrophilic) contact lens | ||
|---|---|---|---|
| Manufacture | MiGwang Contact Lens Co., Ltd. | Neo Vision | |
| Article name | Migwang Comfort 38 | Neo Cosmo | |
| Material | |||
| USAN name | Polymacon | Polymacon | |
| Type | Spherical, Toric | Spherical, Toric | |
| FDA Classification | Lenses, Soft Contact, Daily Wear | ||
| (Class II) | Lenses, Soft Contact, Daily | ||
| Wear (Class II) | |||
| Water Content | 38±2% | 38±2% | |
| Light Transmittance | >90% | >90% | |
| Index of Refraction | 1.43 | 1.428 | |
| Oxygen permeability | 9.77 * 10-11 (cm²/sec)(ml O2/ml * | ||
| mm Hg @ 35℃) | 9.77 * 10-11 (cm²/sec)(ml | ||
| 02/ml * mm Hq @ 35℃) | |||
| Manufacturing Method | Lathe-cut | ||
| (semi molded) | Lathe-cut | ||
| (semi molded) | |||
| Sterilization | Steam Validated Autoclave | Steam Validated Autoclave | |
| Packaging | Blister Pack & vial | Blister Pack & vial | |
| Visibility tint | Titanium Dioxide; | ||
| 21CFR 73.3126 | Titanium Dioxide(White); | ||
| 21CFR 73.3126 | |||
| Visibility tint | Iron Oxides; | ||
| 21CFR 73.3125 | Iron Oxides(Red); | ||
| 21CFR 73.3125 | |||
| Visibility tint | C.I Pigment Green 7; | ||
| 21CFR 73.3124 | C.I Pigment Green 7; | ||
| 21CFR 73.3124 | |||
| Visibility tint | (Phthalocyaninato(2-)) Copper; | ||
| 21CFR 74.3045 | (Phthalocyaninato(2-)) | ||
| Copper; | |||
| 21CFR 74.3045 | |||
| Visibility tint | C.I. Reactive Black 5 | ||
| 21CFR 73.3121 | Reactive Black 5 | ||
| 21CFR 73.3121 | |||
| Tint Process | Entrapment | Entrapment | |
| Indication | Soft Contact Lenses for daily | ||
| wear are indicated for the | |||
| correction of visual in aphakic and Contact Lens is indicated for | |||
| non-aphakic persons with non- | |||
| diseased eyes with myopia or | |||
| hyperopia and/or possesses | |||
| refractive astigmatism not | |||
| exceeding 5.00 diopter, and/or | |||
| are presbyopia. | |||
| NOTE: Refractive astigmatism | |||
| and presbyopia N/A for spherical | The Neo Vision Neo Cosmo | ||
| (Polymacon) Soft (hydrophilic) | |||
| daily wear for the correction of | |||
| visual acuity in aphakic and | |||
| non-aphakic persons with | |||
| non-diseased eyes with | |||
| myopia or hyperopia. The | |||
| lens may be worn by persons | |||
| who exhibit refractive | |||
| astigmatism of 0.50 diopters | |||
| or less where the astigmatism | |||
| lenses. | does not interfere with visual | ||
| acuity. | |||
| The lens is available clear or | |||
| colored and may be sued to | |||
| enhance or alter the apparent | |||
| color of the eye. | |||
| Eye care practitioners may | |||
| prescribe the lens frequent | |||
| replacement wear with | |||
| cleaning, disinfecting and | |||
| schedule replacement. not | |||
| exceeding 5.00 diopter, | |||
| and/or are presbyopia. | |||
| Powers | +25.00 ~ -25.00 Diopter | +25.00 ~ -25.00 Diopter | |
| Total diameter | 12.8 ~ 14.8 | 13.5 ~ 14.5 | |
| Geometrical center | |||
| thickness | 0.03 ~ 0.30 | 0.03 ~ 0.50 | |
| Curvature | 8.0 ~ 9.5 | 8.3 ~ 9.0 | |
| Optic zone | 6.0 ~ 12.5 | 6.0 ~ 12.5 | |
| Radial edge thickness | 0.03 ~ 0.12 | 0.03 ~ 0.05 | |
| Color | brown, gray, aqua, blue, violet, | ||
| green | brown, gray, aqua, blue | ||
| Toxicity(Safety) | Non-Toxic | Non-Toxic | |
| Tensile Strength (MPa) | 0.427 | 0.425 | |
| % Elongation to Break | 128% | 127% | |
| Module of Elasticity | |||
| (MPa) | 0.338 | 0.350 | |
| Breaking Force (N) | 0.449 | 0.439 |
6
SUMMARY NON-CLINICAL TESTING
The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens has been subjected to property evaluation, moist heat (steam) sterilization evaluation and biocompatibility evaluation, and has successfully passed all testing.
PERFORMANCE TESTING
| TEST TITLE | FINAL REPORT
NUMBER | TEST
RESULT |
|----------------------------------------------------|------------------------------------------------------------|----------------|
| Tensile Testing | TP-001/TR-001 | Pass |
| Solution Compatibility (Cleaning Cycle
Testing) | Protocol per FDA
Guidance – Attached/
Report 13-0400 | Pass |
| Physical Properties of the Neo Cosmo | MTK-6310 | Pass |
| Physical Properties of the Neo Vision Neo
Cosmo | MSK-1241 | Pass |
| Physical Properties of the NEO Toric | MSK-1242 | Pass |
7
| Physical Properties of the NEXT | MSK-1243 | Pass |
|---|---|---|
| Physical Properties of the NEW GREEN | MSK-1244 | Pass |
| Physical Properties of the NEO CLEAN | MSK-1245 | Pass |
BIOCOMPATIBILITY TESTING
| TEST TITLE | FINAL REPORT
NUMBER | TEST
RESULT |
|---------------------------------------------------------------------------------------------------------|---------------------------|----------------|
| Ocular Irritation Test | MTK-6310 | Pass |
| Skin Sensitization Test | MTK-6310 | Pass |
| Cytotoxicity Test
(Proliferation Inhabition Test) | MTK-6310 | Pass |
| Cytotoxicity Test
(Agar Diffusion Test) | MTK-6310 | Pass |
| Ocular Irritation Study of Neo Cosmo Soft
Contact Lens in NZW Rabbits | TBH-0375
(KG-2013-121) | Pass |
| Skin Sensitization Study of Neo Cosmo soft
contact lens using Guinea-Pig Maximization
Test (GPMT) | TBH-0376
(KG-2013-122) | Pass |
SUMMARY CLINICAL TESTING
The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens was not evaluated with clinical testing.
CONCLUSION
Based on analyzing the device characteristics, bench performance and sterilization testing, and biocompatibility testing, it is the conclusion of Neo Vision Co., Ltd., that the Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens is safe and effective for its intended use.