(53 days)
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.
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
The provided document is a 510(k) summary for the Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens, which seeks to demonstrate substantial equivalence to a predicate device. It details non-clinical and pre-clinical testing, but explicitly states that no clinical testing was performed for this device to establish its performance or meet acceptance criteria based on human use.
Therefore, many of the requested categories related to clinical study design, sample size, ground truth, expert adjudication, or human reader effectiveness cannot be answered from this document. The document focuses on demonstrating physical, chemical, and biocompatibility equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format for performance. Instead, it provides a summary of non-clinical and biocompatibility tests that "passed." The substantial equivalence section compares the physical properties and indications for use against a predicate device. Based on the "SUMMARY OF SUBSTANTIAL EQUIVALENCE" table (page 5), the following could be considered performance characteristics and their comparison to the predicate, demonstrating their "acceptance."
| Characteristic | Acceptance Criteria (from Predicate Device - Migwang Comfort 38) | Neo Cosmo Reported Performance |
|---|---|---|
| Material USAN name | Polymacon | Polymacon |
| Water Content | 38±2% | 38±2% |
| Light Transmittance | >90% | >90% |
| Index of Refraction | 1.43 | 1.428 |
| Oxygen Permeability | 9.77 x 10^-11 (cm²/sec)(ml O2/ml * mm Hg @ 35℃) | 9.77 x 10^-11 (cm²/sec)(ml O2/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 (examples) | Titanium Dioxide; 21CFR 73.3126 etc. | Titanium Dioxide (White) etc. |
| Tint Process | Entrapment | Entrapment |
| 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 |
| 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 |
Non-Clinical Test Results (Page 6-7):
All listed tests (Tensile Testing, Solution Compatibility, various Physical Properties tests, Ocular Irritation Test, Skin Sensitization Test, Cytotoxicity Tests) reported a result of "Pass". The document does not provide specific numerical acceptance criteria for these tests, only that the device met the requirements.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable based on the provided document. The document explicitly states "The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens was not evaluated with clinical testing" (page 7). The "test sets" mentioned relate to non-clinical bench and biocompatibility testing. For example, the Ocular Irritation Study was performed "in NZW Rabbits" and the Skin Sensitization Study used "Guinea-Pig Maximization Test (GPMT)," but specific animal counts are not provided.
- Data provenance: Not explicitly stated for specific test data, but the manufacturer is Neo Vision Co., Ltd. from Korea (page 3).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies with human participants were conducted where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies with human participants were conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as no clinical studies, especially MRMC studies involving human readers and AI assistance, were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (contact lens), not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical and biocompatibility tests, the "ground truth" or standard for acceptance would be established by the relevant ISO standards, FDA guidance documents, or other recognized scientific methods for evaluating material properties and biological safety of medical devices. For instance, the Ocular Irritation and Skin Sensitization tests are performed according to established toxicological protocols (e.g., using specific animal models like NZW Rabbits and Guinea-Pigs) to determine irritation and sensitization potential. The physical property tests (Tensile, Elasticity, etc.) would have engineering standards or predicate device specifications as their reference.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable.
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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
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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.
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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-siGyeonggi-doKorea |
|---|---|
| CONTACT | Kyung Hwa Kim 82-31-889-2040export@neolens.co.kr |
| SUBMISSION DATE | April 7, 2014 |
| TRADE NAME | Neo Cosmo (Polymacon) Soft (HydrophilicContact Lens - Neo Cosmo |
| COMMON NAME | Lenses, Soft Contact, Daily Wear |
| CLASSIFICATION NAME | Class II (21 CFR 886.5925) |
| PRODUCT CODE | LPL |
| PREDICATE DEVICE | K051477 MigwangComfort 38Decision 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 ●
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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. | PartName | Raw Material | Composition(%) | Remark | Function |
|---|---|---|---|---|---|
| 1 | Base | 2-hydroxyethylmethacrylate | 99.3 | CAS No. 868-77-9 | MainElement |
| Ethylene glycoldimethacrylate | 0.7 | CAS No. 97-90-5 | Cross-linker | ||
| 2 | ColorAdditive | 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;
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| Substantial Equivalency | Soft (hydrophilic) contact lens | ||
|---|---|---|---|
| Manufacture | MiGwang Contact Lens Co., Ltd. | Neo Vision | |
| Article name | Migwang Comfort 38 | Neo Cosmo | |
| MaterialUSAN name | Polymacon | Polymacon | |
| Type | Spherical, Toric | Spherical, Toric | |
| FDA Classification | Lenses, Soft Contact, Daily Wear(Class II) | Lenses, Soft Contact, DailyWear (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)(ml02/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 521CFR 73.3121 | Reactive Black 521CFR 73.3121 | |
| Tint Process | Entrapment | Entrapment | |
| Indication | Soft Contact Lenses for dailywear are indicated for thecorrection of visual in aphakic and Contact Lens is indicated fornon-aphakic persons with non-diseased eyes with myopia orhyperopia and/or possessesrefractive astigmatism notexceeding 5.00 diopter, and/orare presbyopia.NOTE: Refractive astigmatismand presbyopia N/A for spherical | The Neo Vision Neo Cosmo(Polymacon) Soft (hydrophilic)daily wear for the correction ofvisual acuity in aphakic andnon-aphakic persons withnon-diseased eyes withmyopia or hyperopia. Thelens may be worn by personswho exhibit refractiveastigmatism of 0.50 dioptersor less where the astigmatism | |
| lenses. | does not interfere with visual | ||
| acuity. | |||
| The lens is available clear orcolored and may be sued toenhance or alter the apparentcolor of the eye. | |||
| Eye care practitioners mayprescribe the lens frequentreplacement wear withcleaning, disinfecting andschedule replacement. notexceeding 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 centerthickness | 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 |
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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 REPORTNUMBER | TESTRESULT |
|---|---|---|
| Tensile Testing | TP-001/TR-001 | Pass |
| Solution Compatibility (Cleaning CycleTesting) | Protocol per FDAGuidance – Attached/Report 13-0400 | Pass |
| Physical Properties of the Neo Cosmo | MTK-6310 | Pass |
| Physical Properties of the Neo Vision NeoCosmo | MSK-1241 | Pass |
| Physical Properties of the NEO Toric | MSK-1242 | Pass |
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| 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 REPORTNUMBER | TESTRESULT |
|---|---|---|
| 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 SoftContact Lens in NZW Rabbits | TBH-0375(KG-2013-121) | Pass |
| Skin Sensitization Study of Neo Cosmo softcontact lens using Guinea-Pig MaximizationTest (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.
§ 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.