POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS

K040914 · Exero Products, Inc. · LRX · May 27, 2004 · Ophthalmic

Device Facts

• Record ID: K040914
• Device Name: POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
• Applicant: Exero Products, Inc.
• Product Code: LRX · Ophthalmic
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Indications for Use

Poly Vial / PolyPak Contact Lens Case storage system by Exero Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lenses during chemical disinfection.

Device Story

Poly Vial / PolyPak is a contact lens storage system consisting of two polypropylene vials and a base (PolyPak) for orientation. Features integrated Thermoplastic Elastomer (TPE) seal in caps for leak-proof storage. Used by contact lens wearers for chemical disinfection and storage of hard, RGP, and soft lenses. Device provides 3.2ml overflow capacity per well to ensure lens immersion. Simple mechanical operation: user places lenses in vials, fills with solution, and presses cap onto base to engage seal. Benefits patient by providing secure, leak-proof container for lens maintenance.

Clinical Evidence

Bench testing only. Non-clinical studies conducted per FDA 1997 Guidance for Industry Premarket Notification for Contact Lens Care Products. Testing included ISO 10993-5 in-vitro cytotoxicity (MEM elution and agar diffusion), USP systemic injection toxicity, and ISO 10993-10 acute ocular irritation. All results confirmed non-cytotoxic and non-toxic status.

Technological Characteristics

Materials: Polypropylene body/cap, Thermoplastic Elastomer (TPE) seal. Design: Two-vial system with 3.2ml capacity per well. Principle: Mechanical hermetic seal via TPE-to-flange engagement. No energy source, software, or connectivity.

Indications for Use

Indicated for storage of hard, RGP (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection. No specific patient population age or gender restrictions.

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

• Alcon Contact Lens Case (K971618)
• Alcon Contact Lens Case (K974281)
• Paragon Lens Carrier (K993486)
• Paragon Lens Carrier (K993487)
• Paragon Contact Lens Case (K993486)
• CyherCases (K013232)
• #900G (Lens Vial w/ gasket and cap) (K030987)

Submission Summary (Full Text)

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

MAY 2 7 2004

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENES

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

The assigned 510(k) number is:

K040914

Applicant information:

Date Prepared:

April 5, 2004

Name Address

Exero Products, Inc. 623 Glacier Drive Grand Junction, CO 81503

Contact Person Troy Dalsing Phone number: 970 243 5490

Medvice Consulting, Inc. Official Correspondent Martin Dalsing 970 243 5490

Device Information;

Device Classification: Class II

LRX (0) Product Code

Contact Lons Case Classification Name:

Contact Lens Case

Trade Name

Poly Vial / PolyPak, Contact Lens Case and Storage System Container for Ophthalmics

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

## Equivalent Devices:

The Poly Vial / PolyPak Soft Contact Lens Case is substantially equivalent to the following predicate devices.

Predicate devices:

Alcon Contact Lens Case Manufactured/distributed by Alcon Laboratories. 510(k) number; K971618

Alcon Contact Lens Case Manufactured/distributed by Alcon Laboratories 510(k) number, K974281

Paragon Lens Carrier Manufactured/distributed by Paragon Vision Sciences. 510(k) number; K993486, K993487

Paragon Contact Lens Case Manufactured/distributed by Paragon Vision Sciences 510(k) number, K993486

CyherCases Manufactured/distributed by Bausch & Lomb. 510(k) number; K013232

#900G (Lens Vial w/ gasket and cap) Manufactured/distributed by Pelican Products, Inc. 510(k) munber: K030987

#### Device Description:

The Poly Vial / PolyPak by Exero Products consists of a polypropylene body, polypropylene cap, with an integrated Thermoplastic Elastomer (TPE) seal in the cap that provides a hermetically sealed container for leak proof storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lonses during chemical disinfection The storage system consists of two removable side-by-side Poly Vials that rest on a PolyPak that clearly identifies the left from the right. The PolyVials are closed by simply pressing the cap down onto the base that engages the Thermoplastic Elastomer integrated in the cap to the flange portion of the polypropylene base.

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

#### Performance:

The PolyVial / PolyPak contact lens case is designed to have an overflow capacity of 3.2ml in each lens well. This will be sufficient volume to assire that the contact lens will remain immersed under use conditions.

## Intended Use:

Poly Vial / PolyPak Contact Lens Case storage system by Exero Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lenses during chemical disinfection.

#### Description of Safety:

A series of in-vitro and in-vivo toxicological and chemical studies were performed to access the safety and effectiveness of the Poly Vial / PolyPak Contact Lens Cases and Storage System Containers by Exero Products in accordance with the guidelines set forth in the FDA's May 1, 1997 Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. All studies were conducted in compliance with Good Laboratory Practice Regulation for Nonclinical Laboratory Studies. A summary of these results from the studies is presented below.

### Toxicology

In-Virro Cytotoxicity ISO Elution (MEM Extract): ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the ANSI/AAMI/ISO Elution Test and was considered noncytotoxic.

In-Vitro Cytotoxicity ISO Agar Diffusion (Direct). ISO 10993-5 / USP 27 was conducted in accordance with standards on test article. The test article meets the requirements of the USP and ISO Agarose Overlay Method test and was considered noncytotoxic.

In Vivo USP Systemic Investion Toxicity. The lens material meets the requirements of the systemic injection test and is considered non-toxic

In Vivo Quar Initation Test (ISO): ISO 10993-10 Acute ocular intration test was performed and did not cause a positive irritation response to the eyes of the test animals.

## Substantial Equivalence:

PolyPak / PolyPak Contact Lens Case and Storage System Containers by Exero Products is substantially equivalent in terms of indications for use, safety and effectiveness to the prodicate devices as previously depicted, and does not raise different questions of safety and effectiveness than the predicate devices.

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

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 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 in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2004

Medvice Consulting, Inc. c/o Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K040914

Trade/Device Name: PolyVial / PolyPak, Contact Lens Case and Storage System Container for Ophthalmics Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: April 5, 2004 Received: April 8, 2004

Dear Mr. Dalsing:

We have reviewed your Section 510(k) promarket 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Martin Dalsing

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

A. halyl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE STATEMENT

Device Name:

Poly Vial / PolyPak, Contact Lens Case and Storage System Container for Ophthalmics

INDICATIONS FOR USE:

PolyVial / PolyPak Contact Lens Case storuge system by Exero Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lenses during chemical disinfection

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR
Louise W. Brown, Ph.D.

Over-The-Counter Use

Wendell W. Brown, Ph.D.
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

K040914 510(k) Number