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 Description

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 approximately 0.3mm diameter 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. After the plug is inserted into the canaliculus, the dry hydrogel will absorb lacrimal fluids and swell. The fully hydrated plug has approximately a 95% water content. At this water content, the plug becomes a gel having about the same consistency as mucus. The gel easily deforms and takes the shape of the inside of the canaliculus.

AI/ML Overview

This document is a 510(k) premarket notification for the Form Fit™ Hydrogel Canalicular Plug. It appears to be an unclassified device. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical study for diagnostic accuracy would be presented.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for many medical devices in the US. The "study" mentioned is not a performance study against acceptance criteria, but rather a comparison to justify equivalence.

Here's a breakdown of the requested information based on the provided text, noting where specific details are absent due to the nature of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or a performance study with numerical results against those criteria in the way a diagnostic device might. The "performance" described relates to its physical characteristics and how it achieves its intended function, as well as its similarity to predicate devices.

Acceptance Criteria	Reported Device Performance
Expansion upon hydration: Designed to expand to block the canaliculus effectively.	Expands to approximately three times its size to form a gel with approximately 95% water content.
Shape conformity: Needs to conform to the canaliculus.	The gel easily deforms and takes the shape of the inside of the canaliculus.
Removal mechanism: Should be easily removable if needed.	Can be easily flushed from the canaliculus using a stream of saline.
Size (dry state): Comparable to predicate devices.	Measures approximately 0.35mm diameter by 2.5mm long (similar to predicate Medennium Smart Plug).
Expanded size: Comparable to predicate devices.	Increases to approximately 1mm diameter after insertion and hydration (similar to predicate Medennium Smart Plug).
Intended Use Equivalence: Match the intended use ofpredicate devices.	Intended use matches Medennium Smart Plug and Oasis Medical collagen plugs.
Method of Operation Equivalence: Similar mechanism of action to predicate devices.	Similar one-size-fits-all design, changes shape upon insertion, absorbs lacrimal fluids, hydrates and swells to block fluid flow.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a 510(k) premarket notification based on substantial equivalence, not a clinical performance study with a test set of patient data. The "test set" here refers to a comparison of device characteristics and intended use against predicate devices. There is no mention of country of origin or retrospective/prospective data as it relates to patient outcomes or device performance testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of submission relies on comparing physical and functional characteristics to legally marketed devices, rather than establishing "ground truth" through expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as there is no "test set" in the context of expert review for performance against ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No. An MRMC comparative effectiveness study is not indicated or mentioned for this type of device (canalicular plug) or regulatory submission (510(k) for substantial equivalence).

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a physical medical device (a plug), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by the characteristics and intended use of legally marketed predicate devices. The device's "performance" is judged against its ability to be substantially equivalent to these existing devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

Summary of the Document's Approach:

The provided document describes a medical device seeking 510(k) clearance by demonstrating substantial equivalence to predicate devices. This regulatory pathway does not typically involve extensive clinical performance studies with acceptance criteria, test sets, or ground truth established by experts in the same way a diagnostic device might. Instead, the focus is on comparing the device's physical properties, mechanism of action, and intended use to existing, cleared devices. The "study" here is essentially the detailed comparison provided in the 510(k) summary (e.g., "Comparison to Predicate" section).

Summary

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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

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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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

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

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

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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 (909) 305-5400 (Phone) (909) 305-9987 (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

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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.

1. 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.

1. 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.

Regulation Number and Section

N/A