HYDROGEL CANALICULAR PLUG

K040912 · Partners IN Biomaterials, Inc. · LZU · Nov 16, 2004 · OP

Device Facts

• Record ID: K040912
• Device Name: HYDROGEL CANALICULAR PLUG
• Applicant: Partners IN Biomaterials, Inc.
• Product Code: LZU · OP
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum. The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases. When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.

Device Story

Hydrogel Canalicular Plug is a high-water-content, semi-rigid rod (0.35mm x 2.5mm) designed for punctal occlusion. Supplied in a disposable inserter; physician inserts device through punctal opening into canaliculus. Upon contact with lacrimal fluids, device absorbs moisture, hydrating to ~95% water content and swelling to ~1mm diameter. Hydrated state forms a soft, mucus-like gel that conforms to the internal shape of the canaliculus to block fluid flow. Device is intended to relieve dry eye symptoms, treat dry eye syndrome, prevent post-surgical complications, and improve ocular medication retention. Removal is achieved by flushing the canaliculus with saline via syringe. Used in clinical settings by ophthalmologists or optometrists.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, intended use, and functional comparison to predicate devices.

Technological Characteristics

High-water-content hydrogel; semi-rigid rod form factor; dimensions 0.35mm diameter x 2.5mm length (dry); expands to ~1mm diameter (hydrated); 95% water content when hydrated; non-mechanical, passive expansion via fluid absorption; supplied with disposable inserter.

Indications for Use

Indicated for patients with dry eye symptoms (redness, burning, reflex tearing, itching, foreign body sensation), dry eye syndrome, dry eye component of ocular surface diseases, post-surgical dry eye complications, and contact lens-related dry eye problems.

Predicate Devices

• Medennium Smart Plug (K022043)
• Oasis Medical collagen plugs (K946357)

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 9 2004

Partners in Biomaterials, Inc. c/o Mr. James Christensen 466 W. Arrow Highway, Unit H San Dimas, California 91773

Re: K040912

Trade/Device Name: Form Fit™ Hydrogel Canalicular Plug Regulatory Class: Unclassified Product Code: LZU Dated: November 29, 2004 Received: October 28, 2004

Dear Mr. Christensen:

This letter corrects our substantially equivalent letter of November 16, 2004 regarding the regulation number and name. Our letter should have not reflected a regulation number and name as your device is currently unclassified.

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 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 (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 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 (QS) regulation (21

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

Page 2 - Mr. James Christensen

CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 yours.

David Th. Whissle

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

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

Page 3 - Mr. Christensen

# Indications for Use

510(k) Number (if known): K040912

Device Name: Form Fit Hydrogel Canalicular Plug

Indications For Use:

The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum.

The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.

When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.

Prescription Use _ X (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 IF NEEDED)

| Coneurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
| (Division Sign-Off) |

Division of Ophthalmic Ea Nose and Throat Devis

510(k) Number K040912

Page 1 of

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

K040912

#### 510(k) SUMMARY - Safety and Effectiveness

## Hydrogel Canalicular Plug

## 1. Submitters Name:

Partners In Biomaterials, Inc. 466 W. Arrow Highway, Unit H San Dimas, California 91773 [phone] (Phone) [phone] (Fax) Contact: James Christensen Date Prepared: April 6, 2004

#### 2. Name of Device:

Trade Name: Hydrogel Canalicular Plug Common Name: Hydrogel Canalicular Plug Classification Name: Plug, Punctum

#### 3. Predicate Device:

The proposed device, the Hydrogel Canalicular Plug, claims substantial equivalence in intended use and method of operation to the Medennium Smart Plug (K022043). Both mugs are a one-size-fits-all design that change shape upon insertion in to the canaliculus in order to block fluid flow through the canaliculus. Both plugs are semi-rigid rods prior to insertion into the canaliculus. The Hydrogel Canalicular Plug also claims substantial equivalence to collagen plugs marketed by Oasis Medical (K946357), and others, in both equi rately to other of these plugs are approximately 0.3mm diameter by 2.5mm long. When inserted into the canaliculus, they both absorb lacrimal fluids causing them to hydrate and swell to a larger diameter and longer length.

### 4. Description of Device:

The Hydrogel Canalicular Plug is a very high water content hydrogel plug which, when exposed to lacrimal fluids, expands to approximately three times its size to form a gel which blocks the canaliculus. In its dry state, the Hydrogel Canalicular Plug measures windn brooks are camardiameter by 2.5 mm long. It is supplied loaded in a disposable Inserter to assist the doctor in placement of the plug through the punctal opening. Refer to the photos and drawings of the dry Hydrogel Canalicular Plug and Inserter contained in Attachment A.

After the plug is inserted into the canaliculus, the dry hydrogel will absorb lacrimal fluids Atter the prog is iniservated plug has approximately a 95% water content. At this water allu swell. The raily in a mes a gel having about the same consistency as mucus. The gel

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

510(K) NOTIFICATION Hydrogel Canalicular Plug 32

> easily deforms and takes the shape of the inside of the canaliculus. Refer to the photos of the hydrated Hydrogel Canalicular Plug contained in Attachment A.

> In the event that the hydrogel plug needs to be removed, it can be easily flushed from the canaliculus. Place the tip of a syringe filled with saline through the punctal opening and into the canaliculus and gently express the hydrogel plug using a stream of saline.

- 5. Statement of Intended Use
The Hydroge! Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations which can be relieved by blocking of the punctum.

The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.

When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.

- 6. Comparison to Predicate
The proposed device, the Hydrogel Canalicular Plug, claims substantial equivalence in intended use and method of operation to the Medennium Smart Plug (K022043). Both nlugs are a one-size-fits-all design that change shape upon insertion in to the canaliculus in order to block fluid flow through the canaliculus. Both plugs are semi-rigid rods measuring approximately 0.35mm in diameter prior to insertion into the canaliculus. After insertion, both plugs increase in diameter to approximately 1mm diameter in order to block flow through the canaliculus.

The Hydrogel Canalicular Plug also claims substantial equivalence to collagen plugs marketed by Oasis Medical (K946357), and others, in both size and function. Both of these plugs semi-rigid rods measuring approximately 0.35mm diameter by 2.5mm long those prago beinn . They both are inserted through the punctum and reside totally within the canaliculus. After insertion into the canaliculus, they both absorb lacrimal fluids causing them to hydrate and swell to a larger diameter and to a longer length.