(79 days)
The BAUSCH & LOMB® Softens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 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 BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) 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 pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
Here's a breakdown of the acceptance criteria and study details for the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoints) | Reported Device Performance |
|---|---|
| Safety: A difference of 10% in the proportions of total grade 2 or greater positive slit lamp findings, between the Test and Control lenses was considered significant. | No significant differences were seen between either Test lens modalities (daily and monthly replacement schedule) and the Control lens with respect to physiological response as determined by slit lamp examination. Therefore, the Safety endpoint of the study was achieved. |
| Efficacy: Test lens is not significantly different from the Control lens in the proportions of lens visual acuities at the level of 20/40 or better. | On eye, measured Snellen visual acuity data showed no difference between the Test and Control lenses, attaining the Efficacy endpoint. |
| Substantial Equivalence to Predicate Device (General) | Both the safety and efficacy endpoints were achieved. Almost all differences between the Test and Control lenses for other parameters were attributed to inadequate lens fit due to a lack of base curve choices with the Test lens. The Sponsor concluded substantial equivalence in safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 242 eyes (121 patients).
- Data Provenance: The document does not explicitly state the country of origin. The study was a "three month clinical study," implying a prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications beyond stating that "10 investigators" participated in the study. These investigators would have performed the slit lamp examinations and visual acuity measurements.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like 2+1 or 3+1. The assessment of safety (slit lamp findings) and efficacy (visual acuity) was likely performed directly by the investigators during patient visits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compared a new medical device (contact lens) to a predicate device, focusing on safety and efficacy in patients, rather than the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is a medical device, not an AI algorithm. The concept of "standalone performance" for an algorithm is not applicable here. The study assessed the performance of the contact lens itself when worn by patients.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through:
- Clinical Observation/Assessment: Slit lamp examination findings (for safety) and Snellen visual acuity measurements (for efficacy) performed by clinical investigators. This represents a form of expert assessment based on established clinical practices.
8. The Sample Size for the Training Set
This information is not applicable. The study is a clinical trial for a physical medical device (contact lens), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no AI algorithm with a training set.
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K974780
MAR 11 1998
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens
Submitter Information: 1.
Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14692-0450
Contact Person: Dennis Hahn Manager, Regulatory Affairs Telephone No .: (716) 338-6813
2. Device Name:
Classification Name: Soft (hydrophilic) contact lens
Proprietary Name: BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens
3. Predicate Device:
The BAUSCH & LOMB SofLens66TM (alphafilcon A) Visibility Tinted Contact Lens has been selected as the predicate devices for the BAUSCH & LOMB® SoftLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens.
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DESCRIPTION OF DEVICE 4.
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) 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 pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
| Specific Gravity: | 1.075 |
|---|---|
| Refractive Index: | 1.38 |
| Light Transmittance: | C.I.E. Y value - at least 97% |
| Water Content: | 70% |
| Oxygen Permeability (Dk): | 33 x10⁻¹¹[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method) |
The BAUSCH & LOMB SofLens™ one day disposable (hilafilcon) 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 BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) 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 base curve, sphere power, diameter and expiration date.
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5. INDICATIONS FOR USE
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 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.
DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE 6.
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Contact Lens. A summary of results from the preclinical and clinical tests is provided below.
Preclinical 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 device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.
The results of the preclinical testing on the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens demonstrate that:
The physicochemical properties of the BAUSCH & LOMB® SofLens™ (hilafilcon A) one day disposable Visibility Tinted Contact Lens are equivalent to the predicate device, BAUSCH & LOMB® Soft ens66™ (alphafilcon A) Visibility Tinted Contact Lens . The slight differences in the water content of the lens materials accounts for the measured variations in the physicochemical properties between the two lens types.
The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens extracts and lens material demonstrated no toxicity or irritation.
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Clinical Testing:
A three month clinical study was completed to demonstrate that the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens (Test) is substantially equivalent in safety and efficacy to the currently marketed BAUSCH & LOMB® SofLens66™ (alphafilcon A) Visibility Tinted Contact Lens (Control), when worn by myopic phakic patients on a daily wear basis. The study was carried out in accordance with the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994.
A total of 242 eyes (121 patients) were entered into the study by 10 investigators. This was a randomized three cell study design. Patients in one cell wore a pair of the Test Lenses with daily replacement schedule (58 patients), patients in the second cell wore a pair of the Test Lenses with monthly replacement schedule (29 patients), while patients in the third cell wore a pair of Control Lenses with no scheduled replacement of lenses (30 patients). Prior to entry into the study, each patient was required to read and sign a Statement of Informed Consent. Study lenses could not be placed on a patient's eye until the Statement of Informed Consent had been completed by the patient and Investigator.
The primary endpoints for this study were:
Safety: A difference of 10% in the proportions of total grade 2 or greater positive slit . lamp findings, between the Test and Control lenses was considered significant.
. Efficacy: Test lens is not significantly different from the Control lens is the proportions of lens visual acuities at the level of 20/40 or better.
There were no significant differences seen between either Test lens modalities (daily and monthly replacement schedule) and the Control lens with respect to physiological response as determined by slit lamp examination. Therefore, the Safety endpoint of the study was achieved.
On eye, measured Snellen visual acuity data showed no difference between the Test and Control lenses, attaining the Efficacy endpoint.
Both the safety and efficacy endpoints, as defined in the study protocol, were achieved, and almost all differences between the Test and Control lenses, for other parameters can be attributed to inadequate lens fit, due to a lack of base curve choices with the Test lens. Based on these data, the Sponsor concludes that the Test lens, is substantially equivalent in both safety and efficacy to the Control lens, when used on a daily wear basis, for both daily and monthly replacement schedules.
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Substantial Equivalence
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is similar to the BAUSCH & LOMB® SofLens66™ (alphafilcon A) Visibility Tinted Contact Lens, in that both fall into the same FDA material classification grouping (Group II) and both are manufactured by the same manufacturing process (cast molding). The BAUSCH & LOMB® Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is different from the BAUSCH & LOMB® SofLens66™ (alphafilcon A) Visibility Tinted Contact Lens in that it has a different USAN name (hilafilcon A vs. alphafilcon A). The differences between these two lenses will not have any negative effect on the safety and effectiveness of the device.
All product will be sold as sterile medical devices.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized design that resembles an abstract eagle or bird-like figure. The design is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dennis Hahn Manager, Regulatory Affairs Vision Care Division Bausch & Lomb, Inc. 1400 N. Goodman Street PO Box 450 Rochester, NY 14603-0450
MAR 1 1 1998
K974780 Re:
Trade Name: Bausch & Lomb SofLens one day disposable (hilafilcon A) Visibility Tinted (D & C Green #6 and Reactive Blue 246) Contact Lens (cast moulded) for Daily Wear
Regulatory Class: II Product Code: 86 LPL Dated: December 19, 1997 Received: December 22, 1997
Dear Mr. Hahn:
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 (QS) 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. Dennis Hahn
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 at (301) 443-6597.
Sincerely yours,
Aleph Rosenthal
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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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
510(k) Number (if known): K974780
Device Name:
BAUSCH & LOMB® Soff ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens
Indications for Use:
The BAUSCH & LOMB® Softens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eves, exhibiting astigmatism of 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.
Claims:
- The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted 1. Contact Lens provides vision correction in powers ranging from +20,00D to -20,00D.
- The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted 2. Contact Lens is for single-use disposable wear.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
Daniel W.C. Brown, Ph.D.
(Division Sign-Off)
Division of Ophthalmic Devices
| 510(k) Number | K974780 |
|---|---|
| --------------- | --------- |
§ 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.