The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and 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.

Device Description

The Bausch + Lomb Naturelle Cosmetically Tinted daily disposable (hilafilcon B) Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The printed ink pattern consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and the lens is 59% water by weight when immersed in a sterile saline solution. The lens monomer may be tinted blue with Reactive Blue Dye 246 (1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone, CFR Part 73.3106).

AI/ML Overview

The provided document describes a 510(k) submission for the Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens. The submission claims substantial equivalence to a predicate device, Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens (K061157).

This submission is for a cosmetic contact lens, which is typically evaluated for safety and effectiveness through non-clinical testing rather than complex clinical studies involving AI. Therefore, many of the requested categories related to AI performance, multi-reader studies, and ground truth establishment will not be applicable.

Here's the information extracted from the document, with "N/A" (Not Applicable) for categories that don't fit this type of device submission:

Acceptance Criteria and Device Performance for Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that "conformity to predetermined specifications" was part of the performance testing. However, it does not explicitly list quantitative acceptance criteria with corresponding performance results in a table format. Instead, it relies on demonstrating that the device's functional characteristics are equivalent to the predicate device and that non-clinical testing ensures safety and effectiveness. The table below presents the comparative technological characteristics provided, which serve as the basis for demonstrating equivalence to the predicate. The "Acceptance Criteria" here are implied to be "same as predicate" or within acceptable ranges for cosmetic differences.

Property	Acceptance Criteria (Implicit: Same as Predicate/FDA Guidance)	Reported Device Performance (Naturelle Daily Disposable)
Water Content %	59% (Same as Predicate)	59% (Same)
Refractive Index	1.4036 (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Oxygen Permeability (Dk)	22 x 10^-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Light Transmittance	Approx. 95% C.I.E. Y value (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Specific Gravity	1.119 (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Diameter mm	13.5 to 15.0 mm (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Base Curve mm	7.8 mm to 9.5 mm (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Spherical Power, Diopters	+20.00 D to -20.00 D (Same as Predicate)	+20.00 D to -20.00 D (Same)
Center Thickness mm	0.05 mm to 0.75 mm (Same as Predicate)	(Assumed same, not explicitly stated as "Same")
Print Pattern	NA for Predicate (Visibility Tint)	Cosmetically Tinted Print area 8.2 to 13.0 mm (Difference noted, addressed by non-clinical testing)

Study Proving Device Meets Acceptance Criteria:

The device's conformity is established through non-clinical testing, which includes:

Toxicology / Biocompatibility:
- ISO Ocular Irritation Study
- ISO Systemic Toxicity
- In-Vitro Cytotoxicity
Chemistry / Leachables:
- Leachable Monomer and Additives
Physical and Mechanical Properties

The document states: "The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the provided document. For non-clinical tests like toxicity and physical property measurements, standard laboratory sample sizes are typically used (e.g., number of animals for in-vivo tests, number of lenses for physical property tests), but these are not detailed here.
Data Provenance: Not specified, but generally, such tests are conducted in controlled laboratory environments, often in the country of manufacture or certified testing facilities. The tests are prospective in nature, meaning they are performed specifically for this device evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

N/A. This device does not involve a "ground truth" established by human experts in the way AI algorithms do. Safety and performance are assessed through objective laboratory tests and comparison to established standards and the predicate device.

4. Adjudication Method for the Test Set:

N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of imaging or clinical cases, which is not relevant to the non-clinical testing of a contact lens.

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:

N/A. This is not an AI-assisted device. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This is not an AI algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by established scientific principles, validated testing methodologies (e.g., ISO standards), and the performance characteristics of the legally marketed predicate device. For example, for biocompatibility, the ground truth is "no significant ocular irritation" or "no significant systemic toxicity," as determined by the specific ISO tests.

8. The Sample Size for the Training Set:

N/A. This device does not involve a training set as it is not an AI algorithm or a device requiring machine learning.

9. How the Ground Truth for the Training Set was Established:

N/A. This device does not involve a training set.

Summary of Equivalence Claim and Lack of Clinical Studies:

The submission relies heavily on the claim of "substantial equivalence" to the predicate device (K061157). The key statement is: "The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device." The addition of the cosmetic tint was specifically addressed through "appropriate testing... to demonstrate that the differences do not impact the safety or efficacy of the device." This indicates that the non-clinical tests were crucial for validating that the cosmetic feature did not introduce new risks or alter the lens's fundamental performance characteristics.

Summary

{0}------------------------------------------------

K112192 OCT 2 5 2011

510(k) SUMMARY

Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens

1.0 Submitter Information:

Bausch & Lomb
1400 N. Goodman Street
Rochester, NY 14609

Contact: Tricia Garrett
Senior Specialist, Global Regulatory Affairs
1400 North Goodman Street
Rochester, NY 14609
(585) 338-6706 (office)
(585) 338-0702 (fax)
Tricia.m.garrett@bausch.com

2.0 Device Name:

Trade Name:	Bausch & Lomb Naturelle Daily Disposable(hilafilcon B) Cosmetically Tinted Contact Lens
Common Name:	soft (hydrophilic) contact lens
Device Classification:	Class II (21 CFR 886.5925 (b) (1))

3.0 Predicate Device

The predicate device is Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in K061157 on June 22, 2006.

4.0 Device Description

{1}------------------------------------------------

5.0 Intended Use

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

The intended use is identical to that cleared under K061157.

Technological Characteristics (comparison to Predicate Device) 6.0

The table below shows a side-by-side comparison of the predicate device to the modified device:

Property	Bausch & Lomb SofLens® DailyDisposable (hilafilcon B)Visibility Tinted Contact Lens	Naturelle Daily Disposable(hilafilcon B) CosmeticallyTinted Contact Lens
Water Content %:	59%	Same
Refractive Index:	1.4036
OxygenPermeability (Dk):	22 x 10-11[cm³O₂(STP) xcm]/(sec x cm² x mmHg)@35°C(polarographic method)
LightTransmittance:	C.I.E. Y value - approximately95%
Specific Gravity:	1.119
Diameter mm:	13.5 to 15.0 mm
Base Curve mm:	7.8 mm to 9.5 mm
Spherical Power,Diopters:	+20.00 D to -20.00 D
Center Thicknessmm:	0.05 mm to 0.75 mm
Print Pattern:	NA	Cosmetically Tinted Printarea 8.2 to 13.0 mm

{2}------------------------------------------------

7.0 Summary of Non-Clinical Testing

As recommended in the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted:

Toxicology / Biocompatibility
- o ISO Ocular Irritation Study
- ISO Systemic Toxicity o
- o In-Vitro Cytotoxicity
Chemistry / Leachables ●
- Physical and Mechanical Properties o
- o Leachable Monomer and Additives

The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user.

8.0 Clinical Testing

The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

9.0 Substantial Equivalence

The Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens that is the subject of this Special 510(k) submission maintains the identical intended use, technological and functional characteristics as the predicate device. Where cosmetic differences exist between the two devices, appropriate testing has been conducted to demonstrate that the differences do not impact the safety or efficacy of the device. Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is substantially equivalent to the previously cleared Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in K061157 on June 22, 2006.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" which are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bausch & Lomb C/O Tricia Garrett Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

MAY 31 2012

Re: K112192

Trade/Device Name: Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: MVN Dated: September 23, 2011 Received: September 26, 2011

Dear Ms. Garrett:

This letter corrects our substantially equivalent letter of October 25, 2011.

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 (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 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

{4}------------------------------------------------

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

KI12192 510(k) Number (if known):

Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Device Name: Tinted Contact Lens

Indications for Use:

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112192

Regulation Number and Section

§ 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.