(96 days)
P890012
No
The document describes a standard contact lens and its manufacturing process, with no mention of AI or ML technologies.
No.
The device is a contact lens intended for daily wear to correct refractive errors (myopia and hyperopia) and protect against UV radiation, not to treat a disease or condition.
No
This device is a contact lens intended for the correction of refractive ametropia (myopia and hyperopia), which is a treatment or correction, not a diagnosis.
No
The device description clearly describes a physical contact lens made of a specific material (netrafilcon A) and manufactured through a thermal curing process. This is a hardware device, not software.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Gentle Touch UV contact lens is a device that is placed on the eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for "correction of refractive ametropia" and "help to protect against transmission of harmful UV radiation." These are therapeutic and protective functions, not diagnostic testing.
The information provided about the device's material, manufacturing, and performance studies relates to its physical properties and safety for use as a contact lens, not its ability to diagnose a condition based on in vitro testing.
N/A
Intended Use / Indications for Use
The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes
86 LPL
Device Description
The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The safety of GentleTouch (netrafilcon A) has been established (PMA P890012). The preclinical studies on GentleTouch UV with the In-monomer-tint, UV absorbing monomer and new molding process were conducted to assure that the safety of this material, netrafilcon A, has not been altered by these changes.
a. Cytotoxicity: The negative controls and positive controls performed as anticipated. Under the condition of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the USP.
b. Systemic Injection: Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the USP requirements.
c. Ocular irritation: Under the conditions of this study, the SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.
Residual Analysis: Samples of lenses were extracted in saline and the extracts analyzed by high performance liquid chromatography and spectraphotometric method to determine if extractables from the material would be detected. There were no extractables detected.
Lens Compatibility with the Recommended Lens Care Regimen: Any changes in parameters through 30 cycles were within manufacturing tolerances. Cycling in the ReNu Multipurpose System, in heat disinfection or in the AOSept System did not adversely affect measured lens parameters relative to the uncycled control lenses. Tint color was still evident after 30 cycles and is still effective as a handling tint.
Light Transmittance: The ultraviolet spectra of cycled lenses was individually measured before and after cycling. All variances were within the experimental tolerance. It can be considered that there was no significant difference between the light transmittance before and after cycling.
Key Metrics
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Predicate Device(s)
P890012
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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JUN 28 1999
Summary of Safety and Effectiveness
A. General Information
| 1. Name and Address of Applicant: | Wesley Jessen Corporation
333 East Howard Avenue
Des Plaines, IL 60018 | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Joseph F. Foos
Vice President
Scientific Affairs
Phone: (847) 294-3306
Fax: (847) 294-3853 | | |
| 2. Name of the Device: | | | |
| Proprietary Name: | GentleTouch™ UV (netrafilcon A) | | |
| Device Classification: | As per 21 CFR Section 886.5925 Soft
(hydrophilic) daily wear contact lenses are
classified as Class II device | | |
Product Code:
86 LPL
B. Indication for use:
The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact (ens is indicated for daily wear for the correction of refractive ametropia (myopla and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafileon A) lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye.
C. Description of device:
The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.
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Physical Properties
| Physical Test | GentleTouch UV |
|---|---|
| Refractive Index (21 °C) | 1.394 |
| Light Transmittance | 95% min. |
| Water Content | 65% |
| Oxygen Permeability* | 31 |
*Note: Permeability Coefficient Dk x 10°4 (ccO2mm)/(cm² sec mmHg), measured by the OX-Tran(R) *H" technology embodied in the new ASTM method F-1927.
Mechanical Properties
The GentleTouch UV contact lenses were compared to the current lathed GentleTouch lenses for tensile properties. The measured tensile properties show that the molded lenses are equivalent to the lathed lenses.
Toxicology
The safety of GentleTouch (netrafilcon A) has been established (PMA P890012). The preclinical studies on GentleTouch UV with the In-monomer-tint, UV absorbing monomer and new molding process were conducted to assure that the safety of this material, netrafilcon A, has not been altered by these changes. The studies are summarized below:
a. Cytotoxicity:
The negative controls and positive controls performed as anticipated. Under the condition of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the USP.
b. Systemic Injection:
Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the USP requirements.
C. Ocular irritation:
Under the conditions of this study, the SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.
2
Residual Analysis
Samples of lenses were extracted in saline and the extracts analyzed by high performance liquid chromatography and spectraphotometric method to determine if extractables from the material would be detected. There were no extractables detected.
Lens Compatibility with the Recommended Lens Care Regimen
Any changes in parameters through 30 cycles were within manufacturing tolerances. Cycling in the ReNu Multipurpose System, in heat disinfection or in the AOSept System did not adversely affect measured lens parameters relative to the uncycled control lenses. Tint color was still evident after 30 cycles and is still effective as a handling tint.
Light Transmittance:
The ultraviolet spectra of cycled lenses was individually measured before and after cvcling. All variances were within the experimental tolerance. It can be considered that there was no significant difference between the light transmittance before and after cycling.
D. Safety & Effectiveness:
GentleTouch UV Soft (Hydrophilic) Contact Lenses are comparable to the previously marketed GentleTouch lenses of the same material as approved under PMA (P890012).
The approval of 510(k) K961299, marketed as Precision UV™ (vasurfilcon A) substantiates the safe and efficacious use of the IMT (D&C Green No.6 dve) as a handling tint and the UV absorbing monomer. UVAM, is also the same UV absorber utilized in Precision UV (K944722 & K982988). The use of the IMT (D&C Green No. 6, C.I. No. 61565) for tinting GentleTouch UV (netrafilcon A) hydrophilic soft contact lenses will be in accordance with the color additive listing provisions of 21 Code of Federal Regulations § 74.3206.
E. Conclusion
A thorough series of pre-clinical, toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint (IMT), UV absorbing monomer (UVAM) and molding process are equivalent to the original lathe process and the final lens specifications are substantially equivalent to the prior approved lathed process.
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Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right.
Public Health Service
JUN 28 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph F. Foos Vice President Scientific Affairs Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018-5903
Re: K991000
Trade Name: Gentle Touch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (visitint with D & C Green #6, cast-molded)
Regulatory Class: II Product Code: 86 LPL Dated: May 27, 1999 Received: June 1, 1999
Dear Mr. Foos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895, A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Joseph F. Foos
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorentbal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS STATEMENT
510(k) Number (if known):
Device Name:
GentleTouch™ UV (netrafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Indication for Use:
The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the comea and into the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEFDED) Conference of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The Counter | |
|---|---|---|---|---|
| (Division Sign-Off) Division of Ophthalmic Devices | ||||
| js |
K 991000
510(k) Number ...