BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

• K Number: K091339
• Device Name: BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
• Manufacturer: COOPERVISION, INC.
• Date Cleared: 2010-01-05 ( 244 days)
• Product Code: LPL MVN
• Regulation Number: 886.5925

Intended Use

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 %

Predicate Devices

K972303, K012425, K020193, P890023/S004

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes standard contact lenses and their physical properties, with no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No.
The devices are indicated for the correction of ametropia (myopia and hyperopia) and presbyopia, which are refractive errors, not diseases. While they correct a physical condition, they do not treat or cure a disease or injury in the therapeutic sense.

Diagnostic

No

Explanation: The device is a soft contact lens intended for the correction of ametropia, not for diagnosing any medical condition. Its function is to provide visual correction, not to identify or assess disease states.

SaMD (Software as a Medical Device)

No

The device is a physical contact lens made of ocufilcon D, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• Device Description and Intended Use: The description clearly states that the Biomedics 55 contact lenses are intended for the correction of vision problems (ametropia, astigmatism, presbyopia) by being placed on the surface of the eye. They are a physical device interacting with the ocular environment, not analyzing biological samples.
• Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic purposes based on such analysis, or any components typically associated with IVD tests (reagents, calibrators, controls, etc.).

Therefore, the Biomedics 55 contact lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LPL, MVN

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 Oz/ml x mm Hg at 35°C (Fatt method)
• Light Transmittance >95%
• Water Content 55 %

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

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

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K972303, K012425, K020193, P890023/S004

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

• 2. Contact Person: Lisa Hahn Director, Global Regulatory Affairs CooperVision, Inc. 1215 Boissevain Avenue Norfolk, VA 23507
     Telephone [phone] Facsimile [phone]

Soft (Hydrophilic) Contact Lenses

• 3. 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)

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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 DEVICE
K972303 |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| | ocufilcon D | ocufilcon D |
| 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
(cm²/sec) ml O₂/ml x mm
Hg at 35°C (Fatt method) | 19.6 x 10⁻¹¹ | 19.6 x 10⁻¹¹ |
| 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 the
Final Product
Saline | 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

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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, 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
• 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 %

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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

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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 [phone] or [phone] 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

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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:

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.

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