(57 days)
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 59%
Oxygen Permeability (Dk): 22 x10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method)
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D
Each SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the diameter, sphere power, base curve and expiration date.
The provided text is a 510(k) summary for the SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail a study specifically designed to establish acceptance criteria and then demonstrate the device meets those criteria through clinical performance testing for the new device. Instead, it relies on previously conducted studies for its predicate devices.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a study's primary endpoints and statistical thresholds for a new clinical trial. Instead, it aims to demonstrate that the new device has "no change in the lens material, the manufacturing process, nor the parameters and properties" compared to its predicates, and therefore, the prior clinical data supports its safety and effectiveness.
However, we can infer some "performance" metrics from the device description which are inherent characteristics, rather than results of a specific performance study against defined criteria for this 510(k).
| Acceptance Criteria (Inferred / Stated Property) | Reported Device Performance (Device Property) |
|---|---|
| Material composition (hilafilcon B, 59% water) | Copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, 59% water |
| Water Content | 59% |
| Oxygen Permeability (Dk) | 22 x10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C |
| Light Transmittance | C.I.E. Y value - at least 97% |
| Specific Gravity | 1.119 |
| Refractive Index | 1.4036 |
| Diameter range | 13.5mm to 15.0mm |
| Center Thickness range | 0.05mm to 0.75mm |
| Powers (Spherical) range | +20.00D to -20.00D |
| Indication for Use | Daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism up to 2.00D) in aphakic and/or not-aphakic persons with non-diseased eyes; single-use disposable wear. |
| Stability/Expiration | Five-year expiration date |
2. Sample size used for the test set and the data provenance
The document states: "A series of preclinical and clinical studies have been completed and were previously submitted under submissions K994125 and K974780." And, "There is no change in the lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K994125 and K974780 supports the clinical safety and effectiveness of the subject device."
Therefore, for the current 510(k), no new clinical "test set" was used. The data provenance would be from the studies associated with the predicate devices (K994125 for SofLens®59 (hilafilcon B) and K974780 for SofLens® one day disposable (hilafilcon A)). The specifics of those previous studies (sample size, country of origin, retrospective/prospective nature) are not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no new clinical "test set" was conducted for this 510(k), this information is not applicable to this submission. The ground truth would have been established in the predicate device studies, the details of which are not provided here.
4. Adjudication method for the test set
Again, since no new clinical "test set" was conducted for this 510(k), this information is not applicable to this submission.
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. The device is a contact lens, not an AI or imaging device that uses human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a contact lens, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate clinical studies, the "ground truth" for contact lenses typically refers to parameters like visual acuity, comfort ratings, adverse event rates, and fitting characteristics assessed by ophthalmic professionals (optometrists, ophthalmologists). This would be based on clinical observation, patient feedback, and objective measurements (e.g., visual acuity, slit lamp examination), which falls under "outcomes data" and expert clinical assessment. The exact details for the predicate devices are not in this document.
8. The sample size for the training set
This is not applicable in the context of this 510(k). The device is a physical product (contact lens), not an AI algorithm that requires a training set. The "training" in this context would refer to the historical clinical data from the predicate devices that demonstrated the safety and effectiveness of the material and manufacturing process. The sample size for those predicate studies is not provided here.
9. How the ground truth for the training set was established
This is not applicable as outlined in point 8. The "ground truth" for the predicate clinical studies (which serve as the basis for this submission) would have been established through standard clinical trial methodologies for contact lenses, involving:
- Investigator assessments: Eye care professionals evaluating lens fit, ocular health, and measuring visual acuity.
- Patient subjective feedback: Questionnaires or interviews regarding comfort, vision quality, and handling.
- Adverse event reporting: Documentation of any issues observed or reported during the study.
This information would have been collected and analyzed to support the safety and effectiveness claims of the predicate devices.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens
1. Submitter Information:
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14603
| Contact Person: | Debra KetchumManager, Regulatory Affairs |
|---|---|
| Telephone No.: | (585) 338-8638 |
2. Device Name:
Classification Name: Soft (hydrophilic) contact lens
Proprietary Name: SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens
3. Predicate Devices:
SofLens® one day disposable (hilafilcon A) Visibility Tinted Contact Lens (K974780 and K011718)
SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens (K994125)
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4. DESCRIPTION OF DEVICE
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
| Specific Gravity: | 1.119 |
|---|---|
| Refractive Index: | 1.4036 |
| Light Transmittance: | C.I.E. Y value - at least 97% |
| Water Content: | 59% |
| Oxygen Permeability (Dk): | 22 x10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method) |
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
| • Diameter: | 13.5mm to 15.0mm |
|---|---|
| • Center Thickness: | 0.05mm to 0.75mm |
| • Base Curve: | 7.8mm to 9.5mm |
| • Powers (Spherical): | +20.00D to -20.00D |
Each SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the diameter, sphere power, base curve and expiration date.
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5. INDICATIONS FOR USE
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, that exhibit refractive astigmatism up to 2.00 diopters, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.
DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE 6.
A series of preclinical and clinical studies have been completed and were previously submitted under submissions K994125 and K974780.
Non-Clinical Laboratory Testing:
A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses. May 1994. The non-clinical testing can be found in the currently marketed SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000.
Stability testing has demonstrated a five year expiration date for the sterile lenses.
Clinical Testing:
There is no change in the lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K994125 and K974780 supports the clinical safety and effectiveness of the subject device.
Substantial Equivalence
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is similar to the SofLens one day disposable (hilafilcon A) and SofLens®59 (hilafilcon B) Visibility Tinted Contact Lenses in that all three lenses fall into FDA Group II for soft (hydrophilic) contact lenses because the ionic content is less than 1% (nonionic polymer material), and the water content is greater than 50% (59% and 70% water) and are manufactured with the same manufacturing process (cast molding). The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is different from the SofLens® one day disposable (hilafilcon A) Visibility Tinted Contact Lens in that the lens material has a different USAN name suffix (hilafilcon A vs. hilafilcon B),
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2006
Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street Rochester, NY 14609
Re: K061157
Trade/Device Name: Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class; Class II Product Code: MVN Dated: June 8, 2006 Received: June 9, 2006
Dear Ms. Ketchum:
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.
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Page 2 – Ms. Debra Ketchum
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, perroits 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 (240) 276-0115. Also, please note (21 - 211 - 211 - 017) process "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 Orall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Egelerisi. MUD
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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Image /page/5/Picture/0 description: The image shows the logo and address of Bausch & Lomb. The address is 1400 North Goodman Street, Rochester, NY 14609. The logo is a stylized black shape above the company name.
Indications for Use Statement
KOGII 57 510(k) Number (if known):
SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Device Name: Lens
Indications for Use:
The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Prescription Use √ AND/OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ode Fute
510(k) Number K061157
§ 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.