(85 days)
No
The document describes a physical contact lens and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is a refractive correction, not a therapeutic treatment.
No
This device is a contact lens intended for the correction of refractive ametropia (vision correction), not for diagnosing medical conditions.
No
The device description clearly states it is a "soft hydrophilic contact lens" made from a specific material, indicating it is a physical 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SofLens® daily disposable toric contact lens is a medical device designed to be worn on the surface of the eye to correct vision problems (refractive ametropia). It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for the "daily wear correction of refractive ametropia." This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the material and design of a contact lens, not a device for analyzing biological samples.
Therefore, based on the provided information, the SofLens® daily disposable toric contact lens is a medical device, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eves, exhibiting astigmatism of 5.00 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.
Product codes (comma separated list FDA assigned to the subject device)
MVN
Device Description
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370.
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 material, hilafilcon B. Testing was performed in accordance with FDA quideline 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 vear expiration date for the sterile lenses.
Clinical Testing:
The clinical performance to confirm safety and effectiveness of the lens material, hilafilcon B, was conducted on the SofLens59 (hilafilcon B) Visibility Tinted Contact Lens and cleared in the Premarket Notification K994125 on March 3. 2000. The clinical performance to confirm the safety and effectiveness of the lens modality, daily disposable, was conducted on the SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared under Premarket Notification K061157 on June 22, 2006. The Bausch & Lomb toric contact lens design was cleared in the SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens Premarket Notification K941370 on April 2, 1994.
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
080755
JUN 1 0 2008
510(K) SUMMARY Bausch & Lomb, Inc. 510(k) Premarket Notification Bausch & Lomb® SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens
Applicant's Name and Address 1.
Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609
Susan Pate 2. Contact Person Associate Manager Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-6362 susan.m.pate@bausch.com
3. Identification of Device
| Common Name: | soft contact lens (hydrophilic) |
|---|---|
| Trade Name: | SofLens® daily disposable toric (hilafilcon B) |
| Visibility Tinted | |
| Classification: | Daily Wear Contact Lens |
| Device classification: | Class II (21 CFR 886.5925) |
| Product Code: | MVN |
Predicate Devices:
The predicate devices, SofLens daily disposable (hilafilcon B) and SofLens59 (hilafilcon B) Contact Lenses, were selected to demonstrate substantial equivalence of the lens material, hilafilcon B, and replacement modality, singleuse disposable lens. The predicate device SofLens toric (alphafilcon A) Contact Lenses was selected to demonstrate substantial equivalence to the Bausch & Lomb toric lens design.
1
The SofLens daily disposable toric (hilafilcon B) Visibility Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in 510(k) Premarket Notification No. K061158 on June 22, 2006, SofLens59 (hilafilcon B) Visibility tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000 and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification No. K941370 cleared on April 2,1994.
The differences between the devices follow.
2
| Feature | SofLens daily disposable toric | SofLens daily disposable | SofLens59 | SofLens Toric |
|---|---|---|---|---|
| FDA Group | Group II | |||
| (high water/non-ionic) | Group II | |||
| (high water/non-ionic) | ||||
| Castmolded | Group II | |||
| (high water/non-ionic) | ||||
| Castmolded | Group II | |||
| (high water/non ionic) | ||||
| Castmolded | ||||
| Manufacturing | ||||
| Process | Castmolded | Castmolded | Castmolded | Castmolded |
| USAN Name | hilafilcon B | hilafilcon B | hilafilcon B | alphafilcon A |
| Indications | Toric | |||
| Daily Wear | Spherical | |||
| Daily Wear | Spherical | |||
| Daily Wear | Toric | |||
| Daily Wear | ||||
| Modality | Single-use disposable | Single-use disposable | Frequent replacement | Single-use disposable or |
| Frequent replacement | ||||
| Design Properties | ||||
| Diameter | 14.2mm | 14.2mm | 14.2mm | 14.5mm |
| Center Thickness | ||||
| (-3.00D) | 0.125mm | 0.090mm | 0.140mm | 0.190mm |
| Base Curve | 8.6mm | 8.6mm | 8.6mm | 8.5mm |
| Sphere powers | Plano to -6.00D in 0.25D | |||
| steps | ||||
| -6.50D to -9.00D in 0.50D | ||||
| steps | +6.50D to -6.50D in 0.25D | |||
| steps | ||||
| -7.00D to -9.00D in 0.50D | ||||
| steps | +6.50D to -6.50D in 0.25D | |||
| steps | ||||
| -7.00D to -9.00D in 0.50D | ||||
| steps | +6.00D to -6.00D in 0.25D | |||
| steps | ||||
| -6.50D to -9.00D in 0.50D | ||||
| steps | ||||
| Cylinder Powers | -0.75D, -1.25D, -1.75D | n/a | n/a | -0.75D, -1.25D, -1.75D, |
| -2.25D and -2.75D | ||||
| Axis | 0° to 180° in 10° | |||
| Increments | n/a | n/a | 0° to 180° in 10° | |
| Increments | ||||
| Aspheric Optics | Yes | Yes | No | No |
SIMILARITIES and DIFFERENCES
Section 5, Page 4
3
4. Description of device
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic 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.
5. Intended use
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eves, exhibiting astigmatism of 5.00 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
A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370.
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 material, hilafilcon B. Testing was performed in accordance with FDA quideline 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 vear expiration date for the sterile lenses.
Clinical Testing:
The clinical performance to confirm safety and effectiveness of the lens material, hilafilcon B, was conducted on the SofLens59 (hilafilcon B) Visibility Tinted Contact Lens and cleared in the Premarket Notification K994125 on March 3. 2000. The clinical performance to confirm the safety and effectiveness of the lens modality, daily disposable, was conducted on the SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared under Premarket
4
Notification K061157 on June 22, 2006. The Bausch & Lomb toric contact lens design was cleared in the SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens Premarket Notification K941370 on April 2, 1994.
7. Substantial Equivalence
The SofLens daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K061157 cleared on June 22, 2006; SofLens59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000; and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification K941370 cleared on April 2, 1994. The lenses are similar in that all lenses fall into FDA Group II for soft (hydrophilic) contact lenses because the ionic content is less than 1% (nonionic polymer material), the water content is greater than 50% (hilafilcon B - 59% and alphafilcon A - 66%) and are manufactured with the same manufacturing process (cast molding).
5
Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2008
Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609
Re: K080755
Trade/Device Name: Bausch & Lomb® SofLens® Daily Disposable Toric (hilafilcon B) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: MVN Dated: March 14, 2008 Received: March 18, 2008
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. Ilsting 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.
6
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, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. B. Egerlton, mD
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
7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K080755
Device Name:
SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens
Indication for Use
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 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 X
Over-the -counter-use_ ાર
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Njudiet
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K080755
Section 4, Page 2