(70 days)
The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.
S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the "Optical Connection Inc." contact lenses.
It's important to note that this 510(k) submission is for contact lenses, a medical device in a different category than typical AI/ML-driven diagnostics. Therefore, many of the requested fields, particularly those related to "AI performance," "expert ground truth," "MRMC studies," "training set," and "adjudication methods" are not applicable or described in the context of this type of device. Medical devices like contact lenses primarily rely on physicochemical properties, biocompatibility, and clinical performance (in terms of vision correction and safety) which are established through different types of testing.
Acceptance Criteria and Device Performance for Optical Connection Inc. Contact Lenses (K040900)
1. Table of Acceptance Criteria and Reported Device Performance
For contact lenses, "acceptance criteria" and "performance" are typically related to the physical and chemical properties of the material and the lens design, as well as the safety of the materials. The summary does not provide specific numerical "acceptance criteria" against which a single "reported device performance" value is compared in a pass/fail manner for each characteristic. Instead, it demonstrates substantial equivalence to predicate devices by comparing their properties.
However, based on the comparative table, we can infer the target values (which act as de facto acceptance criteria by being "comparable to predicate devices") and the properties of the new device.
| Characteristic | Inferred Acceptance Criteria (Comparable to Predicate) | Reported Device Property (S 42 UV, T 42 UV, M 42 UV) |
|---|---|---|
| Material | hefilcon A (for key predicates) or methafilcon A (for multifocal predicate) | hefilcon A |
| Material Classification | Hydrophilic Lens Group 1 or Group 4 | Hydrophilic Lens Group 1 |
| Water Content | 42% (for primary predicates) or 55% (for multifocal predicate) | 42% |
| Visible Light Transmittance | ~98% (for predicates) | 98% |
| UV Transmittance | < 10% (for UV-blocking predicates) or N/A (for non-UV predicates) | < 10% |
| Dk (Oxygen Permeability) (35°C) | ~13.250 x 10^-11 to 19.5 x 10^-11 (for predicates) | 13.375 x 10^-11 |
| Powers | Ranges reflecting predicate devices (e.g., +20.00 to -20.00 Diopters) | +20.00 to -20.00 Diopters |
| Color | blue visibility or clear | blue visibility |
| Refractive Index | ~1.416 to 1.417 (wet) | 1.416 |
| Specific Gravity | ~1.031 to 1.039 (or N/A for some predicates) | 1.039 |
| Method of Manufacture | Molded | Molded |
| Biocompatibility | Non-toxic and non-irritating (based on tests) | Non-toxic and non-irritating |
| Sterility | Lenses remain sterile until expiration | Confirmed by shelf-life testing |
| UV Blocking Compound | No unsafe amounts in extracts | No unsafe amounts in extracts |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of physicochemical testing. These tests are typically performed on representative batches of the manufactured product to ensure consistency. For biocompatibility, testing is often done on a smaller, standardized set of samples.
- Data Provenance: Not explicitly stated, but these are typically laboratory tests performed by the manufacturer or contracted labs, often adhering to international standards for medical device testing. There's no mention of country of origin for specific "data" in the sense of clinical patient cohorts, as this is pre-market notification based on substantial equivalence, not a clinical trial. The study is prospective in the sense that these tests were performed explicitly for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is Not Applicable (N/A) for this type of medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging or clinical outcomes, is not relevant here. The "ground truth" for material properties is established through standardized laboratory measurement techniques and validated analytical chemistry methods, performed by trained lab personnel, not "experts" establishing a consensus.
4. Adjudication Method for the Test Set
- This is Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of medical data. For contact lens material testing, there isn't typically such a process; measurements are objective and quantitative.
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
- This is Not Applicable (N/A). This submission is for a physical medical device (contact lenses), not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is Not Applicable (N/A). As stated previously, this is a contact lens submission, not an AI/ML algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for this submission consists of:
- Physicochemical Measurements: Objective, quantitative data obtained through validated laboratory testing methods (e.g., refractometry for refractive index, Dk measurement for oxygen permeability, gravimetric analysis for water content, spectrophotometry for light transmittance, etc.). These methods are the 'ground truth' for material properties.
- Biocompatibility Testing: Results from standardized biological safety tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity Tests) according to ISO or FDA guidelines, which confirm the material is non-toxic and non-irritating.
- Shelf-life Testing: Stability and sterility testing over time to ensure the device remains safe and effective until its expiration date.
8. The Sample Size for the Training Set
- This is Not Applicable (N/A). There is no AI/ML model involved here, hence no "training set."
9. How the Ground Truth for the Training Set Was Established
- This is Not Applicable (N/A). No training set exists for this type of device submission.
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Optical Connection Inc.
510(k) Summary
Submitter Information:
Optical Connection, Inc. a subsidiary of St. Shine Optical Co., Ltd. 3315 Almaden Expressway, Suite 25 San Jose, CA, 95125
| Contact Person: | Garold L. Edwards, O.D., F.A.A.CRegulatory Consultant |
|---|---|
| Telephone: | (408) 221-3860 |
| Fax: | (831) 335-0166 |
- Date Prepared: March 23, 2004
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | S 42 UV Single Vision (hefilcon A) Soft(Hydrophilic) Contact Lens for Daily Wear |
| T 42 UV Toric (hefilcon A) Soft (Hydrophilic)Contact Lens for Daily Wear | |
| M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic)Contact Lens for Daily Wear | |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |
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Predicate Devices:
The molded Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lenses and Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic Contact Lens were selected as the predicate devices.
Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) and Saview 55 Multifocal (methafilcon A) devices are manufactured in the same facility, under the same quality system, using the same molding, tinting, packaging and sterilization processes.
Description of Devices:
S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.
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Comparison to Predicate Devices
| Lens typePredicatedevice 510(k) | S 42 UV SingleVision, T 42 UVToric andM 42 UV Multifocal(hefilcon A) Soft(Hydrophilic)Contact Lenses forDaily Wear(molded) | S 42 UV SingleVision, T 42 UVToric andM 42 UV Multifocal(hefilcon A) Soft(Hydrophilic)Contact Lenses forDaily Wear(lathe-cut) | Specialty 42 andSpecialty 42 Toric(hefilcon A) Soft(Hydrophilic)Contact Lenses forDaily Wear | Specialty 42 UV andSpecialty 42 UVToric (hefilcon A)Soft (Hydrophilic)Contact Lenses forDaily Wear | Saview 55Multifocal(methafilcon A) Soft(Hydrophilic)Contact Lens forDaily Wear |
|---|---|---|---|---|---|
| K000376 | K011089 | ||||
| K030548 | |||||
| Material | hefilcon A | hefilcon A | hefilcon A | hefilcon A | methafilcon A |
| Materialclassification | Hydrophilic LensGroup 1 | Hydrophilic LensGroup 1 | Hydrophilic Lens Group1 | Hydrophilic Lens Group1 | Hydrophilic Lens Group4 |
| Indication foruse | myopia, hyperopia,astigmatism, andpresbyopia | myopia, hyperopia,astigmatism, andpresbyopia | myopia, hyperopia andastigmatism | myopia, hyperopia andastigmatism | myopia, hyperopia andpresbyopia |
| Watercontent | 42% | 42% | 42% | 42% | 55% |
| Visible lighttransmittance | 98% | 98% | 98% | 98% | 97.6% |
| UVtransmittance | < 10% | < 10% | N/A | < 10% | N/A |
| Dk (35°C) | 13.375 x 10 -11 | 13.375 x 10 -11 | 13.250 x 10 -11 | 13.375 x 10 -11 | 19.5 x 10 -11 |
| Powers | +20.00 to -20.00Diopters | +20.00 to -20.00Diopters | +20.00 to -20.00Diopters | +20.00 to -20.00Diopters | +12.00 to -20.00Diopters; continuousadd power to +3.25 |
| Color | blue visibility | blue visibility | clear or blue visibility | blue visibility | blue visibility |
| Refractiveindex | 1.416 | 1.416 | 1.417 | 1.416 | 1.3974 (wet) |
| Specificgravity | 1.039 | 1.039 | 1.031 | 1.039 | N/A |
| Method ofmanufacture | Molded | Lathe-cut | Moulded | Molded | Molded |
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Indications for Use:
The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.
Description of Safety and Substantial Equivalence:
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.
Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. 42 UV lenses were extracted and evaluated for presence of the UV blocking compound. Results showed no evidence of unsafe amounts of this compound in the extracts. Physicochemical testing of 42 UV lenses demonstrated equivalency to the predicate devices.
Conclusion:
Information submitted in the 510(k) establishes that S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) contact lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Optical Connection, Inc. c/o Garold L. Edwards, O.D., F.A.A.O. Regulatory Consultant 3315 Almaden Expressway, Suite 25 San Jose, CA 95118
Re: K040900
Trade/Device Name: rade/Device Name:
S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) S 42 UV Single Vision (nemoon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) 1 42 UV Multifocal (hefileon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 23, 2004 Received: April 6, 2004
Dear Dr. Edwards:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your boother 5. only programially equivalent (for the indications for releved above and have acceminate marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provision in way 20, 1970, the onactions with the provisions of the Federal Food, Drug, and Cosmetic have been receasined in are are a proval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the act include requirements for annual registration, listing of devices, good oonarols provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is olassinod (600 above) and Existing major regulations affecting your device can be inay oc subject to subli additions, 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 I lease be advisod that i Dr is issual.org ur device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all I cacration and regulations annument limited to: registration and listing (21 CFR Part 807); the Her s requirements, metading, vanufacturing practice requirements as set forth in the quality labeling (21 OF RT art 807), good nort 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 yours,
A. Kely C. 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
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Indications for Use
510(k) Number: K040900
Device Names:
S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Indications for Use:
S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR -
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Evg
510(k) Number [K040900](https://510k.innolitics.com/search/K040900)
§ 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.