MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS

K030353 · Eagle Vision, Inc. · OKS · Apr 25, 2003 · OP

Device Facts

• Record ID: K030353
• Device Name: MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
• Applicant: Eagle Vision, Inc.
• Product Code: OKS · OP
• Decision Date: Apr 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Device Story

Device consists of lacrimal stents and delivery systems for lacrimal system reconstruction. MonoStent™ features silicone tubing with molded silicone punctum plug and stainless steel stylet. EagleVision® Lacrimal Intubation Set uses medical grade silicone tubing attached to malleable stainless steel probes for one-step probing and stenting. EagleVision® K Type uses silicone probes with silicone rod. Used by clinicians in clinical settings to treat epiphora, canalicular obstructions, or ductal imperforations. Stents provide mechanical patency to lacrimal drainage system during healing. Benefit includes restoration of tear drainage and resolution of epiphora.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via descriptive characteristics and comprehensive literature and MDR review.

Technological Characteristics

Materials: medical grade silicone tubing, stainless steel stylets/probes. Design: monocanalicular and bicanalicular configurations. Principle: mechanical stenting of lacrimal system. Delivery: manual insertion via integrated stylet or probe. Non-electronic, non-powered.

Indications for Use

Indicated for lacrimal system reconstruction in infants and adults, including treatment of epiphora, canalicular pathologies (stenosis, obstruction, laceration), conditions requiring dacryocystorhinostomy, and nasolacrimal duct imperforation.

Regulatory Classification

Identification

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Predicate Devices

• EVT™ Monocanalicular Stent (K883233)
• Lacrimal Intubation Set & DCR Set (K990672)
• Ritleng Bicanaliculus Intubation Set (K955671)

Submission Summary (Full Text)

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# APR 2 5 2003

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

| APPLICANT | Eagle Vision, Inc. | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 8500 Wolf Lake Drive, Suite 110 | |
| | Memphis Tennessee, 38133 USA | |
| OFFICIAL<br>CORRESPONDENT | Billy Hannaford | |
| | RA/QA Manager | |
| | Eagle Vision, Inc. | |
| | 8500 Wolf Lake Drive, Suite 110 | |
| | Memphis Tennessee, 38133 USA | |
| | Tel: [phone] | |
| | FAX: [phone] | |
| | e-mail: [e-mail] | |
| TRADE NAME: | Eagle Vision Lacrimal Stents and Intubation Sets | |
| COMMON NAME: | Monocanalicular stents<br>Lacrimal Intubation Sets | |
| CLASSIFICATION<br>NAME: | Probe, lacrimal | |
| DEVICE<br>CLASSIFICATION: | Class II per 21 CFR § 886.4350 | |
| PRODUCT CODE | 86 (HNL) | |
| PREDICATE DEVICE: | EVT™ Monocanalicular Stent (cleared under K883233), the<br>Lacrimal Intubation Set & DCR Set (cleared under K990672), and<br>the Ritleng Bicanaliculus Intubation Set (cleared under K955671) | |

### SUBSTANTIALLY EQUIVALENT TO:

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively.

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems.

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## INDICATION FOR USE:

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

## TECHNICAL CHARACTERISTICS:

The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing.

The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure.

The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.

## PERFORMANCE DATA:

Descriptive characteristics were sufficient for assurance of equivalence. A comprehensive literature and MDR review was conducted to demonstrate that the MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively.

## BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are substantially equivalent to the EV™ Monocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671), respectively. All of the devices have the same indication for use, "... for use in lacrimal system reconstruction ..." The devices have similar designs and technological characteristics.

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Public Health Service

APR 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eagle Vision, Inc. c/o Mr. Billy Hannaford RA/OA Manager 8500 Wolf Lake Drive, Suite 110 Memphis Tennessee, 38133 USA

Re: K030353

Trade/Device Name: Eagle Vision Lacrimal Stents and Intubation Sets Regulation Number: 886.4350 Regulation Name: Monocanalicular stents; Lacrimal Intubation Sets Regulatory Class: II Product Code: HNL Dated: January 31, 2003 Received: February 3, 2003

Dear Mr. Hannaford:

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.

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 (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.

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Page 2 - Mr. Billy Hannaford

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 yours,

A halyi 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

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510(k) Number (if known): ريب 30 3 3 3 3

Device Name: The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set

Indications for Use:

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K030353 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <img alt="Prescription Use Check" src="prescription_check.png"/> | OR | Over-The-Counter Use ______ |
|----------------------|------------------------------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |