BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:

BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Device Description

The BIOFINITY (comfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high oxygen permeability (Dk). The lens material, comfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. The lenses are made by cast molding. The lens will be manufactured in spherical, aspherical, toric and multifocal configurations with the following features and properties:

• Chord Diameter: 13.5 mm to 15.0 mm
• Center Thickness: 0.05 mm to 0.50 mm
• Base Curve: 8.0 mm to 9.5 mm
• Power Range: -20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric): -0.25 to -10.00 D
• Add Power (Multifocal): +0.50 to +3.00D
• Refractive Index (hydrated): 1.40
• Water Content: 48% by weight in normal saline
• Oxygen permeability: 128 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg], 34°C, Coulometric method

The lens is supplied sterile in blister packs containing a buffered saline solution. Blister labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterifization process.

AI/ML Overview

The "BIOFINITY (comfilcon A) Soft Contact Lens" study aimed to demonstrate substantial equivalence to predicate devices, namely CIBA Vision SEE3™ (lotrafilcon A) and CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses. The study focused on performance and safety for daily wear. Due to the nature of the device (contact lenses), acceptance criteria and performance are primarily assessed through physical, optical, chemical, and clinical measures, rather than typical AI model metrics like sensitivity/specificity.

Here's an analysis based on the provided text, adapted to the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices across various physical, chemical, optical, and clinical parameters. The study aimed to show no significant differences in performance and safety compared to the predicate device, CIBA Vision Focus Night & Day.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices and "no significant difference")	Reported Device Performance (BIOFINITY)
Visual Acuity Performance	No significant difference compared to predicate device (CIBA Vision Focus Night & Day).	Showed no significant difference compared to predicate device.
Clinical Adverse Events	No significant difference in patient complaints or slit lamp observations compared to predicate device. No serious or significant adverse events attributable to the device.	Showed no significant difference of clinical adverse events compared to predicate device. No serious or significant adverse events attributable to the device.
Biocompatibility	Pass ISO 10993 standards for cytotoxicity, maximization sensitization, ocular irritation, and systemic toxicity.	All results passed with no evidence of adverse clinical effects.
Material Properties	Substantially equivalent physical, optical, and chemical properties to predicate devices (SEE3™ and O2OPTIX™).	Presented in a table of characteristics, indicating substantial equivalence in most properties while noting differences in others (e.g., water content, Dk, surface treatment, modulus, tensile strength, elongation to break). The submission argues these differences do not preclude substantial equivalence for the intended use given other studies.
Leachable Substances	Low or below measurable levels.	Determined to be low or below measurable levels.

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

Sample Size: The document does not explicitly state the specific number of participants in the human clinical studies. It mentions "a study of daily wear."
Data Provenance: The study was a "Human Clinical Studies" which implies prospective data collection, specifically a clinical trial. The country of origin for the data is not specified, but the manufacturer is based in the UK and Applicant in the USA.

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

This section is not directly applicable in the context of ground truth for an AI algorithm. For a contact lens clinical study:

Experts: The clinical study would have involved ophthalmologists or optometrists who conducted the visual acuity assessments and slit lamp observations.
Qualifications: While not explicitly stated, these would be medical professionals with expertise in ophthalmology and contact lens fitting/assessment.

4. Adjudication Method for the Test Set

This term is not typically used for clinical studies of medical devices like contact lenses in the same way it would be for an AI algorithm's ground truth. Clinical studies usually involve:

Clinical Assessments: Visual acuity, slit lamp examinations, and patient complaints would have been recorded by the clinical investigators.
Data Analysis: Statistical analysis would then be performed on the collected data to compare the new device to the predicate device.
Expert Review: The overall results and findings would be reviewed by regulatory affairs specialists and potentially medical experts to determine safety and efficacy.

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

Not applicable. This study is for a physical medical device (contact lens), not an AI algorithm assisting human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed.

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

Not applicable. This study concerns a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For this type of device, what constitutes "ground truth" revolves around established clinical endpoints and validated measurement techniques:

Clinical Outcomes:
- Visual acuity: Measured objectively using standard eye charts.
- Ocular health: Assessed via slit lamp examination by clinicians for signs of adverse events (e.g., corneal edema, infiltrates, hyperemia).
- Patient symptoms/complaints: Reported directly by study participants.
Biocompatibility Standards: Compliance with ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity) serves as a "ground truth" for material safety.
Physicochemical Measurements: Laboratory measurements of material properties (e.g., Dk, water content, modulus, refractive index) compared against established ranges or predicate devices.

8. The Sample Size for the Training Set

Not applicable. This study did not involve an AI algorithm with a distinct training set. The "training" for a physical device involves material formulation, manufacturing process development, and quality control, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the development of the contact lens itself would stem from extensive research and development in polymer science, optics, and biocompatibility, guided by regulatory requirements and clinical needs for contact lens performance.

Summary

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Image /page/0/Picture/0 description: The image shows the text "DEC 6 2005" at the top. Below that is the text "K052560". The bottom of the image shows the word "CooperVision" with a registered trademark symbol.

510(k) SUMMARY

1. Applicant Name and Address	CooperVision, Inc.5870 Stoneridge Dr.Suite 1Pleasanton, CA 94588USA(800) 972-6724
2. Contact	Jack P. Douglas, Ph.D.Dept. of Regulatory Affairs(925) 251-6666
3. Manufacturer Information	CooperVision, Inc.Hamble Ln.HambleSO31 4NHUnited KingdomContact: Martin NewmanTelephone: +44 (0) 7795 414 801
4. Device Identification	Common Name:Trade Name:Class. Name:Classification:Product Code:	Soft Contact LensBIOFINITY ( comfilcon A ) SoftContact LensSoft (hydrophilic) Contact Lens -Daily WearClass II [21 CFR 886.5925]LPL

5. Device Description

• Chord Diameter	13.5 mm to 15.0 mm
• Center Thickness	0.05 mm to 0.50 mm
• Base Curve	8.0 mm to 9.5 mm
• Power Range	-20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric)	-0.25 to -10.00 D
• Add Power (Multifocal)	+0.50 to +3.00D
• Refractive Index (hydrated)	1.40
• Water Content	48% by weight in normal saline
• Oxygen permeability	128 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg],34°C, Coulometric method

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Image /page/1/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a stylized font. To the right of the name is a square containing a spiral shape.

6. Intended Use

SPHFRICAL AND ASPHERICAL:

TORIC:

MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

(comfilcon A), BIOFINITY Toric (comfilcon A) and BIOFINITY Multifocal The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

7. Predicate Device(s)

- CIBA Vision SEE3™ (lotrafilcon A) Soft Contact Lenses [K970746]
♦ CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses (K033919)

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Image /page/2/Picture/0 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a square containing a stylized eye. There is a registered trademark symbol to the upper right of the square.

8. Characteristics of Substantial Equivalence

Characterisues of Substantial Equivalence
The BIOFINITY (comfilcon A) Soft Contact Lens is substantially equivalent to the ClBA Vision SEE3TM The DIOTH CF (confidentify Beto PTIX™ (lotrafilcon B) Soft Contact Lenses. All of these lenses are (corrapicon 7) and CIDT - Tionic 3,00 Linie) silicone hydrogel lenses. All of these lenses are Class II and have categorized as Ofoup I (10w water, nomone) Sheons Trategor relieve summarizes the primary features for this comparison, illustrating the similarities and differences.

	CooperVision	CIBA Vision	CIBA Vision
	BIOFINITY	SEE3™	O2 Optix™
	[Current Submission]	[K970746]	[K033919]
Material	comfilcon A	lotrafilcon A	lotrafilcon B
	silicone hydrogel	silicone hydrogel	silicone hydrogel
Category (Group)	Group I	Group I	Group I
	(low water, nonionic)	(low water, nonionic)	(low water, nonionic)
Manufacturing Method	Cast Molded	Cast Molded	Cast Molded
Indication	Daily Wear	Daily Wear	Daily Wear
Replacement	Monthly	Monthly	Two weeks
Water Content (%)	48	24	33
Oxygen Permeability - Dk @	128 x 10-11	140 x 10-11	110 x 10-11
34°C [(cm2/sec) x (ml
O2)/(ml x mm Hg)]*
Refractive Index	1.40	1.43	1.42
Light Transmittance (%)	> 97	> 99	> 96
Modulus (MPa)	0.8 ± 0.1	1.4 ± 0.1	1.0 ± 0.1
Tensile Strength (Mpa)	0.50 ± 0.07	0.80 ± 0.08	0.73 ± 0.16
Elongation to Break (%)	130 ± 2	128 ± 22	186 ± 39
Surface Treatment	No	Yes	Yes
Color Additive	Phthalocyanine Blue	None	Phthalocyanine Blue
Tint Process	IMT	N/A	IMT
Chord Diameter Range(mm)	13.5 to 15.0	13.0 to 15.0	13.0 to 15.0
Base Curve Range (mm)	8.0 to 9.5	8.0 to 9.2	8.0 to 9.2
Center Thickness (mm)	0.08 @ -3.00D	0.08 @ -3.00D	0.08 @ -3.00D
Power Range	-20.00D to +20.00D	-20.00D to +20.00D	-20.00D to +20.00D
Chord Diameter (Nominal)	14.0	13.8	14.2
Base Curve	8.6	8.4, 8.6	8.6
Powers	-20.00D to +20.00D	+0.25 to +6.00, 0.25D steps-0.25 to -8.00, 0.25D steps-8.50 to -10.00, 0.50D steps	-1.00 to -6.00, 0.25D steps
	in 0.25 steps

coulometric method

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Image /page/3/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a square with a stylized eye inside of it. There is a registered trademark symbol next to the square.

9. Physicochemical Studies

The physical, optical and chemical properties of the lenses as assessed by various test methods show substantial I hi properal with the predicate devices as illustrated in the preceding table. Additional studies were conducted equired.org what leachable substances were either low or below measurable levels to assuage any concerns for its intended use.

10. Toxicology Studies

Animal GLP studies were conducted and determined that BIOFINITY lenses were biocompatible for the intended use as assessed using ISO 10993 standards for cytotoxicity, maximization sensitization, ocular irritation, and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the BIOFINITY lens.

11. Human Clinical Studies

Clinical studies were conducted to demonstrate substantial equivalence of the BIOFINITY lens as compared with the CIBA Vision Focus Night & Day based on performance and safety. In a study of daily wear, assessment of visual acuity performance showed no significant difference between the two products. Safety as assessed by patient complaints or/and slit lamp observations showed no significant difference of clinical adverse events between the two products. There were no serious or significant adverse events attributable to the device during the study.

12. Conclusions

Based on evaluations of material, manufacturing methods, lens parameters and indicated use, the BIOFINIT Y lens is substantially equivalent with the predicate, marketed lenses. Based on evaluation of chemical properties, biocompatibility and clinical studies, the BIOFINITY lens has been shown to be safe for its indicated use.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird, composed of three curved lines representing wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 6 2005

Cooper Vision, Inc. c/o Jack P. Douglas, Ph.D. 5870 Stoneridge Dr. Suite 1 Pleasanton, CA 94588

Re: K052560

Trade/Device Name: Biofinity (comfilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 15, 2005 Received: September 16, 2005

Dear Dr. Douglas:

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.

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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) 827-8910. 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number [if known]: K052560

Device Name: BIOFINITY (comfilcon A) Soft Contact Lens

Indications for Use:

SPHERICAL AND ASPHERICAL:

TORIC:

MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-(tiropia and trypereply and worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Additional Claims:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K052560
Prescription Use(Per 21 CFR 801.109)

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.