AC LENS BRANDED CONTACT LENS CASE

K120969 · Arlington Contact Lens Services,Inc. · LRX · Jul 11, 2012 · Ophthalmic

Device Facts

• Record ID: K120969
• Device Name: AC LENS BRANDED CONTACT LENS CASE
• Applicant: Arlington Contact Lens Services,Inc.
• Product Code: LRX · Ophthalmic
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.

Device Story

AC Branded Contact Lens Case consists of a base with dual adjoining wells and two screw-top caps; capacity >3.0 ml per well for full lens immersion. Used by contact lens wearers or practitioners for storage and chemical disinfection of soft, rigid gas permeable, or hard contact lenses. Device features R/L markings on wells/caps and non-vented caps. Operated manually by the user; provides a container for chemical disinfection solutions. Benefits include safe storage and maintenance of contact lenses when not in use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene (ABS) copolymer. Design: Dual-well container with screw-top, non-vented caps. Capacity: >3.0 ml per well. Features: R/L markings on wells/caps. Intended for chemical disinfection only; not compatible with heat disinfection.

Indications for Use

Indicated for storage and chemical disinfection of soft, rigid gas permeable, or hard contact lenses by wearers or practitioners. Not for use with heat disinfection systems.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Contact Lens Case (K071081)

Submission Summary (Full Text)

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K120969

## 510(k) Summary 807.92(c)

JUL 1 1 2012

| SPONSOR | 807.92(a)(1) |
|-----------------|-----------------------------------------|
| Company Name: | Arlington Contact Lens Services, Inc. |
| Company Address | 4265 Diplomacy Dr. Columbus, Ohio 43228 |
| Telephone: | 614-921-2522 |
| Contact Person: | Peter Clarkson |

Summary Preparation Date: March 13. 2012

| DEVICE NAME | 807.92(a)(2) |
|----------------------|-----------------------------------------------|
| Trade Name: | Contact Lens Case (Multiple Brand Names) |
| Common/Usual Name: | Contact Lens Case |
| Classification Name: | Soft (hydrophilic) contact lens care products |
| Regulation Number: | 886.5928 |
| Product Code: | LRX |
| Device Class: | Class II |

#### PREDICATE DEVICE

Legally Marketed Equivalent Device

| Company | Device Name | K Number |
|---------------------------------------------------------|-------------------|----------|
| Ningbo Kaida Rubber and Plastic<br>Technology Co., Ltd. | Contact Lens Case | K071081 |

#### DEVICE DESCRIPTION

The AC Branded Contact Lens Cases consists of a lens case base with dual adjoining wells for the containment of fluid. The case cover are two screw top caps. All the variant models have a capacity of over 3.0 ml in each case well, thus, any contact lens can be fully immersed into the chambers.

#### DEVICE INTENDED USE

The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.

| COMPARISON OF TECHNICAL CHARACTERISTICS | | | 807.92(a)(6) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | Comparison Elements<br>Comments of the contract of the control of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the<br>Call College And Concellent College Collection College Company Come Company Come Company Come Comments of Children | AC Lens Applicant Device | Predicate Device |
| Device Name | Multiple Brand Names | Multiple Brand Names<br>(K071081) | |
| Classification Name | Contact Lens Case | Contact Lens Case | |
| Product Code | LRX | LRX | |
| Comparison Statement | The applicant device has same classification information<br>as the predicate device. | | |
| Intended Use | The applicant contact case is<br>to be used by the contact lens<br>wearer or practitioner for<br>storing soft, rigid gas<br>permeable or hard contact<br>lenses while not in use.<br>Intended for chemical<br>disinfection only. Not<br>designed for heat<br>disinfecting system. | The Applicant contact lens<br>case is a lens care product to<br>be used by the contact lens<br>wearer or practitioner for<br>storing contact lenses while<br>not being worn. The<br>applicant device is not<br>designed for heat<br>disinfecting system. Use<br>only with chemical<br>disinfection. | |
| Indications | Storage and Disinfection of<br>Soft, Rigid Gas Permeable or<br>Hard Contact Lenses. | Storage and Disinfection of<br>Soft, Rigid Gas Permeable or<br>Hard Contact Lenses. | |
| Disinfection Type | Chemical Disinfection, Not<br>Heat Disinfection | Chemical Disinfection, Not<br>Heat Disinfection | |
| Design | Two adjoining wells with<br>screw top into which<br>respective lenses are<br>immersed | Two adjoining wells with<br>screw top into which<br>respective lenses are<br>immersed | |
| Main Material | Polypropylene (PP) and<br>Acrylonitrile-Butadiene-<br>Styrene copolymer (ABS) | SK Corporation<br>Polypropylene (PP) R370Y<br>with certificated quality<br>Acrylonitrile-butadiene-<br>styrene copolymer (ABS) PA<br>- 757K. | |
| Comparison Statement | The applicant device has a similar design and uses the<br>same materials as the predicate device. The only<br>difference is the colorant | | |
| Screw on Caps | Yes | Yes | |
| R/L indications on well<br>bottom and/or cap top | Yes | Yes | |
| Non-vented caps | Yes | Yes | |

#### 807.92(a)(4)

807.92(a)(5)

#### Page 1 of 3

807.92(a)(3)

**807.92(a)(1)**

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# CONCLUSION

### 807.92(b)(3)

The applicant contact lens case is similar to the predicate device in

- . intended use,
- materials and ●
- design. .

The applicant contact lens case introduces no new questions concerning safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Arlington Contact Lens Services, Inc. c/o Christian Smith Consultant, Smith Associates, Inc. 1468 Harwell Ave Crofton, MD 21114

JUL 1 1 2012

Re: K120969

Trade/Device Name: AC Lens Branded Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: June 13, 2012 Received: June 14, 2012

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Christian Smith

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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm

Sincerely yours,

R. D. Feldman, MD

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

Enclosure

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# Indications for Use

510(k) Number (if known): K120969

Device Name: Contact Lens Case

Indications for Use:

The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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


(Division Sign-Off)

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

510(k) Number K120969