(15 days)
Not Found
No
The device description and intended use are for a standard contact lens, with no mention of AI/ML capabilities or image processing. The performance studies focus on lens compatibility and clinical performance, not algorithmic performance.
Yes
Explanation: The device is a contact lens indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is a treatment for a medical condition.
No
The device is a contact lens designed for vision correction, not for diagnosing medical conditions. Its intended use is to correct refractive errors (myopia, hyperopia, and astigmatism).
No
The device description clearly states it is a physical contact lens made of a copolymer, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive ametropia (vision correction) in living individuals. This is a therapeutic and corrective function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a physical contact lens designed to be worn on the eye. It does not describe a reagent, instrument, or system used to examine specimens from the human body for diagnostic purposes.
- Lack of Diagnostic Claims: There are no mentions of diagnosing a disease, condition, or state of health. The focus is solely on correcting vision.
- Performance Studies: The performance studies mentioned relate to the compatibility and clinical performance of the contact lens itself when used with care systems, not the diagnostic accuracy of a test.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The BAUSCH & LOMB Phoenix (hilafilcon A) 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 non-diseased eves, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The BAUSCH & LOMB Phoenix (hilaffilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The BAUSCH & LOMB Phoenix (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)phenylaminolanthraquinone). 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 Phoenix (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
• Toric (Cylinder): 0 to 10 diopters
• Toric Axis: 0° to 180°
Each BAUSCH & LOMB Phoenix (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 lens, the base curve, sphere power, diameter and expiration date.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens has the same technological characteristics as the predicate device, the BAUSCH & LOMB® Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens. The established safety profile (toxicology, physicochemical properties, manufacturing / chemistry) of the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is equivalent to the predicate device.
The SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens was cleared on March 11, 1998, File Number K974780. File K974780 included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K 983 894
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB Phoenix (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 Phoenix (hilafilcon A) Visibility Tinted Contact Lens
3. Predicate Device:
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate device.
1
Description of Device 4.
The BAUSCH & LOMB Phoenix (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)phenylaminolanthraquinone). 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 Phoenix (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 |
| • Toric (Cylinder): | 0 to 10 diopters |
| • Toric Axis: | 0° to 180° |
Each BAUSCH & LOMB Phoenix (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 lens, the base curve, sphere power, diameter and expiration date.
2
INDICATIONS FOR USE ળં
The BAUSCH & LOMB Phoenix (hilafilcon A) 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 non-diseased eves, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The BAUSCH & LOMB Phoenix (hilaffilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
6. Description of Safety and Substantial Equivalence
The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens has the same technological characteristics as the predicate device, the BAUSCH & LOMB® Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens. The established safety profile (toxicology, physicochemical properties, manufacturing / chemistry) of the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is equivalent to the predicate device.
The SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens was cleared on March 11, 1998, File Number K974780. File K974780 included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing.
The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is therefore substantially equivalent to the predicate device, the BAUSCH & LOMB® Soft ens TM one day disposable (hilafilcon A) Visibility Tinted Contact Lens, and does not raise new questions of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
BAUSCH & LOMB Dennis Hahn Manager, Regulatory Affairs 1400 North Goodman St. Rochester, NY 14692
Re: K983894 Trade Name: Bausch & Lomb Phoenix (hilafilcon A ) Visibility Tinted Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: October 30, 1998 Received: November 3, 1998
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, Manager, Regulatory Atlairs
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. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
510(k) Number (if known): K983894
BAUSCH & LOMB Phoenix (hilafilcon A)Visibility Tinted Contact Lens Device Name:
Indications for Use:
The BAUSCH & LOMB Phoenix (hilafilcon A) 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 non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
Claims:
- The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision 1. correction in powers ranging from +20.00D to -20.00D.
-
- The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision correction of refractive astigmatism of up to 10.00 diopters.
-
- The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact may be disinfected using a chemical disinfection system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| ------------------ | ---------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices |
| 510(k) Number | K983894 |
|---|---|
| --------------- | --------- |
| Over-The-Counter-Use | _________________ |
|---|---|
| ---------------------- | ------------------- |