SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE

K111856 · Apothecary Products, Inc. · LRX · Jul 14, 2011 · Ophthalmic

Device Facts

• Record ID: K111856
• Device Name: SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
• Applicant: Apothecary Products, Inc.
• Product Code: LRX · Ophthalmic
• Decision Date: Jul 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

Device Story

Contact lens cases for storage of soft, RGP, or hard contact lenses during chemical disinfection. Devices feature dual wells with either screw-top caps (Soft Grip, Deluxe models) or integral hinged, self-sealing caps (Econo-Mate model). Wells labeled 'R' and 'L' for lens orientation. Used by patients at home; non-sterile; not for heat disinfection. Provides secure containment for lenses during chemical soaking/disinfection process.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility assessments and 8-hour leak testing to ensure device integrity.

Technological Characteristics

Dual-well contact lens storage cases. Models include screw-top caps or integral hinged, self-sealing caps. Labeled 'R' and 'L'. Materials verified via biocompatibility testing. Non-sterile. Chemical disinfection only; not for heat disinfection.

Indications for Use

Indicated for storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. Contraindicated for use with heat disinfection.

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

• Polaris Contact Lens Case (K093377)
• K991206
• K042578

Submission Summary (Full Text)

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pothecary Products, Inc.°

JUL 1 4 2011

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 (c)

The assigned 510(k) number is: _K111856

| Applicant: | Apothecary Products, Inc.<br>11750 12th Avenue South<br>Burnsville, MN 55337 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | James Jenkins<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | March 11, 2011 |
| Name of Device: | Contact Lens Case, |
| | Model: Soft Grip Contact Lens Case; 68013, 68012 |
| | Model: Econo-Mate Contact Lens Case: K1010 |
| | Model: Deluxe Contact Lens Case; K1020 |
| Device Classification Name: | Soft (hydrophilic) contact lens care products |
| Common or usual name: | Contact Lens Case |
| Classification: | Class II, 21 CFR 886.5928 |
| Product Code: | LRX |
| Predicate Device information: | K093377; K991206; K042578 |
| Device Description: | The API Soft Grip Contact Lens Cases and Deluxe<br>Contact Lens Cases are designed for storage of<br>contact lenses with adjoining dual wells that have<br>screw top caps. The cases are labeled with an 'R' or<br>'L' to distinguish right and left lenses. The Econo-Mate<br>Contact Lens Cases have two adjoining wells with<br>integral hinged, self-sealing caps in which respective<br>contact lenses are immersed. The cases are also<br>labeled with an 'R' or 'L' to distinguish right and left<br>lenses. The cases are available in a variety colors. |

disinfection.

The applicant devices are not sterile and not for heat-

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Image /page/1/Picture/0 description: The image shows the logo for Apothecary Products, Inc. The logo features a symbol resembling a mortar and pestle enclosed within a circle, followed by the text "Apothecary Products, Inc." The "Inc." is followed by the registered trademark symbol. The text is in a serif font and appears to be a professional logo design.

Intended Use: The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

#### Comparison to Predicate Devices:

The API devices have the same intended use, similar design and materials as the predicate devices and are substantially equivalent with regards to safety and effectiveness.

Discussion of Non-Clinical Tests Performed in Determination of Substantial Equivalence:

Biocompatibility testing performed by third party laboratories demonstrated the materials are safe for use in contact lens storage and disinfection.

The applicant contact lens cases were subjected to an 8 hour leak test to ensure devices are effective against leaking. All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria per test plan and have demonstrated to be effective against leaking.

| Attribute | API Contact Lens Case<br>Applicant Device; Soft Grip<br>Model 68012 & 68013 | Reliance Design & Mfg Corp,<br>Polaris Contact Lens Case,<br>Model #201 (K093377) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Contact Lens Case | Contact Lens Case |
| Intended Use | The API Soft Grip, 68012,<br>68013; Contact Lens Cases are<br>intended for the storage of soft<br>(hydrophilic), rigid gas<br>permeable (RGP), or hard<br>contact lenses during chemical<br>disinfection. For use in storage<br>during chemical disinfection<br>only. Do not use during heat<br>disinfection. | Polaris Contact Lens Case is for<br>the storage of soft (hydrophilic),<br>rigid gas permeable or hard<br>contact lenses. It is to be used<br>with chemical disinfectants only.<br>It is not to be used in heat<br>disinfection. |
| Disinfection Type | Chemical<br>(Not Heat) | Chemical<br>(Not Heat) |
| Design | Two adjoining wells with screw<br>top caps into which respective<br>lenses are immersed. | Two adjoining wells screwed<br>with screw top into which<br>respective lenses are immersed. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

Apothecary Products, Inc. c/o Mr. Bhavesh Sheth Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, OH 44087

JUL 1 4 2011

Re: K111856

Trade/Device Name: Soft Grip Contact Lens Case (Models 68012 and 68012); Deluxe Contact Lens Case (Model K1020), Econo-Mate Contact Lens Case (Model K1010) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: June 28, 2011 Received: June 29, 2011

Dear Mr. Sheth:

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.

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

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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.htm1.

Sincerely yours,

Kesia Alexander

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

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## Indications for Use

#### 510(k) Number (if known): KIII956

Device Name: Contact Lens Case

Indications for Use:

The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE).

Denise Hayle

(Division Sign-Off)

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

510(k) Number K111856