The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

The CIBA Vision® Toric (Iotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.

The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eves. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or comeal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Device Description

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges: Diameter Range: 13.0 to 15.0 mm, Base Curve Range: 8.0 to 9.2 mm, Power Range: -20.00D to +20.00D, Center Thickness: varies with power (0.080 mm for -3.00D spherical). Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling. Lenses have the following properties: Refractive index: 1.42 (hydrated), Light transmittance: > 96 %, Water content : 33% by weight in normal saline, Oxygen permeability: 110 x 10 -11 [(cm² /sec)(ml O2 /ml●mmHg)] measured at 35°C (intrinsic Dk-Coulometric method). Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (CIBA Vision® (lotrafilcon B) Soft Contact Lenses) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than establishing comprehensive acceptance criteria and detailed clinical study results in the way a pivotal trial might.

Therefore, many of the requested elements (e.g., specific acceptance criteria values, detailed device performance metrics, sample sizes for test/training sets in an AI context, expert qualifications, MRMC study details, standalone algorithm performance, and ground truth for training) are not explicitly present in this type of regulatory submission for a contact lens. The document establishes safety and effectiveness through comparisons to an existing, approved device.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format with specific performance metrics as one might expect for a novel diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating "substantial equivalence" to a predicate device. The general criteria relate to safety and comparable performance in clinical use.

Implied Acceptance Criteria and Reported Performance (based on "substantial equivalence"):

Acceptance Criteria Category	Implied/Reported Device Performance
Biocompatibility & Non-toxicity	The modified device (lotrafilcon B) material and extracts are equivalent to the predicate and remain non-toxic and non-irritating.
Physical & Material Properties	Lens physical and material properties of the modified device are consistent with industry marketed lenses, and equivalent to the predicate lens. This includes parameters like: - Refractive index: 1.42 (hydrated)- Light transmittance: > 96 %- Water content: 33% by weight in normal saline- Oxygen permeability: 110 x 10 -11 [(cm² /sec)(ml O2 /ml●mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Compatibility with Lens Care Products	The lens material is compatible with commonly available lens care products.
Overall Clinical Performance (Vision)	Demonstrated similar overall performance in clinically relevant areas of vision compared to the control lens.
Overall Clinical Performance (Health)	Demonstrated similar overall performance in clinically relevant areas of health compared to the control lens.
Overall Clinical Performance (Comfort)	Demonstrated similar overall performance in clinically relevant areas of comfort compared to the control lens.
Overall Clinical Performance (Fit)	Demonstrated similar overall performance in clinically relevant areas of fit compared to the control lens.
Safety (General)	The modified lens remains non-toxic and biocompatible. Clinically, the lens has performed satisfactorily in a daily wear investigation.
Effectiveness (General)	Results verify that the modified lens has material characteristics comparable to or better than other currently marketed soft contact lenses.
Packaging & Sterility	Blister pack packaging system compatibility and integrity demonstrated (used for other marketed products). Effectively steam sterilized in a validated autoclave.
Shelf-Life	Shelf-life established through stability product expiration actions; studies ongoing to extend.
Equivalence to Predicate (Overall)	The modified (lotrafilcon B) contact lens is equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics. Any differences do not affect safety and effectiveness.

Study Information (as inferable from the document)

Given that this is a 510(k) for a contact lens and not an AI/software device, many of the AI-specific questions are not applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document states "The two-month clinical evaluation was conducted..." but does not specify the number of subjects (sample size) for the clinical study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were likely conducted to meet FDA requirements for US market approval. They were "conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812)," implying a clinical trial environment. The nature (retrospective/prospective) is implicitly prospective as it describes a "two-month clinical evaluation" in which the lens "was investigated."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and study type. Clinical performance (vision, health, comfort, fit) would have been assessed by eye care professionals participating in the clinical study, but there's no mention of "ground truth establishment" by a separate panel of experts in the way an AI diagnostic device would require.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable to this type of clinical study for a contact lens. Clinical outcomes are typically assessed by the investigator(s) and potentially monitored by study coordinators/sponsors, not through an adjudication panel for "ground truth."
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a contact lens. The effectiveness was assessed by comparing the device to a "control lens" (predicate device) in terms of clinical performance during daily wear. There is no "AI assistance" component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a contact lens; there is no algorithm or AI component to operate in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the "ground truth" (or more accurately, the clinical endpoints) were based on physician assessments of vision, health, comfort, and fit, and potentially patient reported outcomes (for comfort, for example). This is essentially outcomes data and expert clinical assessment. For non-clinical tests, it would be direct measurement against established physical/mechanical standards.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for it.

Summary

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

CIBA Vision® Corporation 4-Mar-04, v02 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Page 1 of 4 Lotrafilcon B Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

510(k) Summary: K033919

1. Submitter Information:

Company:	CIBA Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Alicia M. Plesnarski, RACDirector, Global Regulatory Affairs
Telephone:FAX:Date Prepared:	678-415-3924678-415-34544 March 2004

Device Name: 2.

Soft Contact Lens Common Name: .
CIBA Vision® (lotrafilcon B) Trade/Proprietary Name: .
Daily Wear Soft Contact Lens Classification Name: .
Class || [21 CFR 886.5925 (b) (1)] Device Classification: .

3. Predicate Device:

The CIBA Vision® (lotrafilcon B) lens is a modification in surface treatment of the The CIDA Vision's Excelens™ (lotrafilcon B) soft contact lens. Both are in Predicate Group 1 (low water, nonic polymer). CIBA Vision obtained FDA 510(k) r DA Group 1 (low water, nomonio posythe for daily wear on April 9, 2002 (K020139).

4. Description of Device:

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated.

Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:

13.0 to 15.0 mm Diameter Range: .
8.0 to 9.2 mm Base Curve Range: �
-20.00D to +20.00D Power Range: .
varies with power (0.080 mm for -3.00D spherical) Center Thickness: .

Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

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

CIBA Vision.A Novartis Company	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
	4-Mar-04, v02Page 2 of 4

Lotrafilcon B Soft Contact Lenses

510(k) Summary of Safety and Substantial Equivalence

Lenses have the following properties:

1.42 (hydrated) Refractive index: ◆
96 % Light transmittance: .
33% by weight in normal saline Water content : .
110 x 10 -11 Oxygen permeability .

[(cm² /sec)(ml O2 /ml●mmHg)]

measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed packaging System has been domenation are effectively steam sterilized in a validated lens products, and packagou forloos are labeled with the lens parameters, lot number and autoclave. Dilster pack ochtainers article date has been established through stability product capiration action the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

5. Indications for Use:

The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical The GIDA Vision (ibramoon b) Sphropia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical The OlDA Vision - Pho (lottails (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.

The CIBA Vision® Progressives (Iotrafilcon B) soft contact lens is indicated for the optical The CIDA Vision - Progression (myopia and hyperopia) and/or presbyopia in phakic or conection of rendority and opes who may require a reading addition of +3.00 aphake persons who may have up to approximately 1.50 diopters of astigmatism.

The CIBA Vision® Progressive Toric (Iotrafilcon B) soft contact lens is indicated for the The of creetion of refractive ametropia (myopia, astigmatism and opitical Correction - en Tenaotro "anstropia" (1)-pisseased eyes. The lenses may be presbyopla) in phalks of aprilance persons (D) or less of refractive and/or corneal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection The lefises may be presonbod for daily woul while one one professional.

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

CIBAVision.	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
A Novartis Company	4-Mar-04, v02Page 3 of 4

Lotrafilcon B Soft Contact Lenses

510(k) Summary of Safety and Substantial Equivalence

6. Description of Safety and Substantial Equivalence:

A series of non-clinical tests and clinical studies were performed to demonstrate the substantial equivalence of the device modification and establish substantial equivalence Substantial oqurralerice. All testing was conducted in accordance with the May 1994 FDA to the premier. All tooling was 510(k) Guidance Document for Class II Contact guidenne three i romornot not applicable device regulations. Results verify that the modified lens remains non-toxic and biocompatible, and has material characteristics mounted lens Temains Than other currently marketed soft contact lenses. Clinically, the Comparable to of bettler than other samonily wear investigation. Results from all tests lens has performed satisfacterily in a atin't results of the substant of the substante (control) lenses.

Nonclinical Testing:

A series of pre-clinical testing was performed to verify equivalence of the modified A Senes of the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).

The results of all non-clinical testing on the modified (lotrafilcon B) contact lens demonstrate:

The lens material and extracts of the modified device are equivalent to the predicate . and remain not toxic and non-irritating.
Lens physical and material properties of the modified device are consistent with . industry marketed lenses, and equivalent to the predicate lens.
The lens material is compatible with commonly available lens care products. .

Clinical Testing:

The (lotrafilcon B) contact lens was investigated in daily wear clinical study. The twomonth clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812). The study I raction and publication regulation of the modified lens as compared to an FDA approved and commercially available contact lens.

Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to the control lens when used under daily wear conditions.

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

	CIBA Vision A Novartis Company
	CIBA Vision® Corporation
	11460 Johns Creek Parkway
	Duluth, Georgia USA 30097
	4-Mar-04, v02
	Page 4 of 4
	Lotrafilcon B Soft Contact Lenses
	510(k) Summary of Safety and Substantial Equivalence

Substantial Equivalence:

The modified (lotrafilcon B) contact lens is equivalent to the predicate lens and similar to The modified (iotramoon D) offically to mater content (33% water) and ionic other daily weal son contact lenses in torno of water water water and indications Characteristics (i DA Choup in the nemonth hemoney, not chemical, not heat, disinfection regimen.

Any differences which may exist between the (lotrafilcon B) soft contact lens and other Any differences which may oxlet betwoon the (retrailed) affect the safety and effectiveness of the device.

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

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

CIBA VISION c/o Ms. Alicia M. Plesnarski, RAC Director, Global Regulatory Affaire 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K033919

Trade/Device Name: CIBA Vision® (lotrafilcon B) Soft Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: December 16, 2003 Received: December 18, 2003

Dear Ms. Plesnarski:

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.

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

Page 2 - Ms. Alicia M. Plesnarski, RAC

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

A helyl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement, v03, 8-Mar-04, Page 1 of 1 Premarket Notification 510(k) Ki)33919: (lotrafilcon B) Soft Contact Lens for Daily Wear

INDICATIONS FOR USE STATEMENT

510(k) Number:

K033919

Device Name:

CIBA Vision® (lotrafilcon B) Soft Contact Lenses

: 广

Indications For Use:

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Prescription Use:
(21 CFR Part 801 Subpart D)

510(k) Number_

AND/OR

Over the Counter Use 0 (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

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.