Spherical and Aspherical - Biomedics 55 (ocufilcon D) 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 in powers from - 20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

Toric - Biomedics 55 (ocufilcon D) 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 -5.00 diopters.

Multifocal - Biomedics 55 (ocufilcon D) 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 in powers from -20.00 to +10.00 diopters and with add powers from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for single use daily disposable wear or for planned replacement. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.

Device Description

The lenses, Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses, are a hemispherical shell available in a spheric, toric or multifocal design, intended for daily wear for frequent/planned replacement wear or for single use daily disposable wear. The lens material is equivalent to other ocufilcon D daily wear soft (hydrophilic) contact lenses cleared under several predicate device 510(k) Premarket notifications.

The lenses are in-monomer tinted from edge to edge for visibility purposes with Vat Blue 6.

The Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses are available as sphere, asphere, toric or multifocal lenses with the following dimension ranges:

Chord Diameter: 12.5 to 18.0 mm
Center Thickness: 0.025 to 0.40 mm (varies with power)
Base Curve: 6.50 mm to 10.8 mm
Spherical Powers: -20.00 D to +20.00 D
Add Powers: +0.25 D to +3.00
Cylinder Powers: -0.25 to -10.00 D
Axis: 1° to 180°

The physical properties of the lenses are:

Refractive Index at 25°C: 1.41
Oxygen Permeability (Dk): 19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method)
Light Transmittance: >95%
Water Content: 55 %

AI/ML Overview

This submission is for a contact lens, not an AI/ML device, and thus the requested information regarding acceptance criteria and studies that prove a device meets acceptance criteria, is not applicable in the typical sense for AI/ML.

Here's an analysis based on the provided document, addressing what information is available and what is not in the context of a contact lens submission:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in a formal table with specific numerical targets like for an AI model's performance metrics (e.g., sensitivity, specificity). Instead, it establishes substantial equivalence by comparing the modified device's characteristics to those of legally marketed predicate devices.

The "acceptance criteria" for this device are implicitly that its physical, chemical, and biological properties are equivalent to or within established specifications for the predicate devices, and that it is safe and effective for its indicated use.

Characteristic	Modified Device (Biomedics® 55, ocufilcon D)	Unmodified Predicate Device (K972303)
Material (USAN Name)	ocufilcon D	ocufilcon D
FDA Category (Group)	Group II Non-Ionic High Water	Group II Non-Ionic High Water
Indication for Use	Daily Wear for Frequent/Planned Replacement Wear or for Daily Disposable Wear	Daily Wear for Frequent/Planned Replacement Wear or for Daily Disposable Wear
Water Content	55%	55%
Dk (Oxygen Permeability)	19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method)	19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method)
Light Transmittance	>95%	>95%
Refractive Index	1.41	1.41
Manufacturing Method	Cast-Molded	Cast-Molded
Sterilization	Steam	Steam
Packaging	Blister Pack	Blister Pack
Blue Handling Tint	Yes (Entrapment Dye)	Yes (Entrapment Dye)
Surfactant in Final Saline	Yes	None

Study that proves the device meets the acceptance criteria:

The primary "study" proving the device meets the criteria is a substantial equivalence comparison and non-clinical testing.

Physicochemical Tests: The document states, "The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses." This confirms that the critical parameters (water content, Dk, refractive index, light transmittance) are identical to the predicate.
Toxicological Tests: "Results from in-vivo and in-vitro studies were conducted and verify that the lenses remain non-toxic and are biocompatible with the ocular environment." This demonstrates safety.
Clinical Studies: The submission states that "no clinical data is required" because "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision." This indicates that the equivalence of the technical properties is deemed sufficient by the FDA for the device to perform as safely and effectively as the predicate without requiring new human clinical trials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable in the context of this contact lens submission. There is no "test set" in the sense of a dataset for validating an algorithm. The testing involves physicochemical and toxicological evaluations of the lens material and design, not data analysis on a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no diagnostic "ground truth" establishment by experts for this type of medical device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no test set or adjudication for diagnostic performance.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable as there is no diagnostic ground truth. The "ground truth" for a contact lens would be its objectively measured physical and chemical properties, and its biological compatibility, established through laboratory methods.

8. The sample size for the training set:

Not applicable. There is no training set for a contact lens.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for a contact lens.

Summary

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

510(k) Summary - Page 1

1. Owner's Name & Address:

CooperVision, Inc. 6140 Stoneridge Mall Road, Suite 500 Pleasanton, CA 94588

JAN - 5 2010

1. Contact Person: Lisa Hahn Director, Global Regulatory Affairs CooperVision, Inc. 1215 Boissevain Avenue Norfolk, VA 23507
  Telephone (757) 664-2421 Facsimile (866) 890-1584

Soft (Hydrophilic) Contact Lenses

1. Date Prepared:
April17, 2009

4. Device Identification:

트 Trade Name:

· Biomedics® 55 (ocufilcon D)

. Common Name:

트 Classification Names:
Lenses, Soft Contact, Daily Wear (21 CFR 886.5925, Product Code LPL)

Salargest agains and San Morth having the shows of the mach the mail

Lens, Contact, (Disposable) (21 CFR 886.5925, Product Code MVN)

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

K091339

Image /page/1/Picture/1 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with a graphic of an eye inside a square to the right of the word. The registered trademark symbol is located to the right of the square.

510(k) Summary – Page 2

5. Legally Marketed Devices to Which CooperVision, Inc. is Claiming Equivalence:

Substantial Equivalence Table

	MODIFIED DEVICE	UNMODIFIED DEVICEK972303
	ocufilcon D	ocufilcon D
MaterialUSAN Name	ocufilcon D	ocufilcon D
FDA Category(Group)	Group II Non-IonicHigh Water	Group II Non-IonicHigh Water
Indication forUse	Daily Wear for Frequent/PlannedReplacement Wear or for DailyDisposable Wear	Daily Wear for Frequent/PlannedReplacement Wear or for DailyDisposable Wear
Water Content	55%	55%
DK(cm²/sec) ml O₂/ml x mmHg at 35°C (Fatt method)	19.6 x 10⁻¹¹	19.6 x 10⁻¹¹
LightTransmittance	>95%	>95%
Refractive Index	1.41	1.41
ManufacturingMethod	Cast-Molded	Cast-Molded
Sterilization	Steam	Steam
Packaging	Blister Pack	Blister Pack
Blue HandlingTint	YesEntrapment Dye	YesEntrapment Dye
Surfactant in theFinal ProductSaline	Yes	None

6. Standards

No applicable mandatory performance standards or special controls exist for this device.

allettillations in and states and the contribution in the secondination of the sedent has a le control and the section

Special 510(k) ocufilcon D

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

510(k) Summary - Page 3

Image /page/2/Picture/1 description: The image shows the number K091339 at the top. Below that is the CooperVision logo. The logo has the word Coopervision in bold letters, and to the right of that is a black square with a white eye inside of it.

7. Device Description

The lenses are in-monomer tinted from edge to edge for visibility purposes with Vat Blue 6.

The Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses are available as sphere, asphere, toric or multifocal lenses with the following dimension ranges:

Chord Diameter: 12.5 to 18.0 mm
0.025 to 0.40 mm (varies with power) Center Thickness 프 6.50 mm to 10.8 mm Base Curve: 트
-20.00 D to +20.00 D ■ Spherical Powers:
- 1 Add Powers:
  - +0.25 D to +3.00 -0.25 to -10.00 D Cylinder Powers:
- 1 1° to 180° 트 Axis

The physical properties of the lenses are:

Refractive Index at 25°C 1.41 ■
Oxygen Permeability (Dk) 19.6 x 10-11 (cm2/sec) ml Oz/ml x mm Hg at 35°C (Fatt method) ■

Childelaladolano in the letter the sidentify and interest and come of the with the children in the

Light Transmittance >95% ■
· Water Content 55 %

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

8. Predicate Devices Information:

The modified device includes sphere/asphere, toric and multifocal configurations. The predicate devices are as follows:

The predicate devices are the ocufilcon D Daily Wear Soft Contact Lenses: K972303, August 20, 1997; Predicate K012425, October 12, 2001; Devices Information K020193, February 28, 2002; and P890023/S004, August 28, 1996;

9. Nonclinical Tests Performed:

Physiochemical and toxicological studies were conducted as applicable to support a determination of substantial equivalence.

10. Conclusions of NonClinical Tests Performed:

Physiochemical: ●

The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses.

Toxicology: .

Results from in-vivo and in-vitro studies were conducted and verify that the lenses remain non-toxic and are biocompatible with the ocular environment.

11. Clinical Studies:

The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

ದಿಂದ ವಿರುದು ಮಾಡಿದೆ ಎಂದು ನಿರ್ವಹಿಸಿದರು. ವಿವಿಧಿಯ ಮುದ್ರಿ ಮಾಡಿದ್ದ ಮಾಡಿದ್ದ ಪ್ರದ

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

Image /page/4/Picture/1 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font, followed by a graphic of an eye. The eye graphic is enclosed in a square and has a registered trademark symbol next to it.

1091339

12. Conclusion:

The device will be manufactured according to specified process controls and an established quality assurance program. The device will undergo the same manufacturing, packaging and sterilization procedures as the unmodified device currently marketed by CooperVision, Inc. The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis.

Special 510(k) ocufilcon

Pg 8

Bellerathan Shamble of Architection of Richtranskinner of Shipper of Ship and Schilders and

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

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & 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. The seal is black and white.

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

CooperVision, Inc. c/o Ms. Lisa Hahn Director, Global Regulatory Affairs 1215 Boissevain Avenue Norfolk, VA 23507

JAN - 5 2010

Re: K091339

Trade/Device Name: Biomedics® 55% (ocufilcon D) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886,5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL, MVN Dated: December 11, 2009 Received: December 14, 2009

Dear Ms. Hahn:

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 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 mav 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); 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagoy/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

R. K. Thampy M.L.

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

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K091339

Device Name: Biomedics® 55 (ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear for Frequent/Planned Replacement Wear or Daily Disposable Wear

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND /OR Over-the-counter Use (21 CFR 801 Subpart C)

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

Anna Postell

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

510(k) Number t091339

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.