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 Description

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

AI/ML Overview

The provided document is a 510(k) summary for medical devices (Eagle Vision Lacrimal Stents and Intubation Sets). This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than comprehensive de novo clinical studies with specific performance metrics and acceptance criteria in the way envisioned by the request.

Therefore, the acceptance criteria and study detailed in the request do not directly apply to this specific submission. There is no mention of a standalone algorithm or a multi-reader multi-case study for this type of medical device as it's a physical product, not an AI/software device.

However, I can extract the information relevant to a substantial equivalence determination, which serves as the "study" demonstrating it meets "acceptance criteria" for regulatory clearance.

Here's how the information maps to your request, with significant caveats due to the nature of a 510(k) for a physical device:

Acceptance Criteria and Reported Device Performance (as demonstrated by Substantial Equivalence to Predicate Devices)

Acceptance Criteria (Implied by Substantial Equivalence Standard)	Reported Device Performance (as presented in 510(k) summary)
Same Indications for Use	Matches Predicate Devices: "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." This explicitly states the same indication as the predicate devices.
Similar Technological Characteristics	Similar to Predicate Devices: - MonoStent™ Monocanalicular Stent: "[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." - EagleVision® Lacrimal Intubation Set: "[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." - EagleVision® K Type Lacrimal Intubation Set: "[comprised of] stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod." The document asserts: "The devices have similar designs and technological characteristics" to the predicate devices, specifically mentioning the use of medical grade silicone tubing and similar delivery mechanisms (stylet, malleable probes, silicone rods). Detailed technical specifications of the predicate devices are not provided in this summary, but the claim of similarity is central to the substantial equivalence argument.
Similar Principles of Operation	Same Principles: Implied through the similar indications for use and technological characteristics (i.e., stenting to maintain patency in the lacrimal system).
Safety and Effectiveness	Demonstrated through the assertion that "Descriptive characteristics were sufficient for assurance of equivalence" and a "comprehensive literature and MDR review was conducted to demonstrate that the [new devices] are substantially equivalent to the [predicate devices]." This implies that the new devices are considered acceptably safe and effective because their design, materials, and intended use are similar to devices already on the market deemed safe and effective.

Study Details (as applicable to a 510(k) Substantial Equivalence Determination)

For this 510(k) submission, the "study" is a comparative analysis against predicate devices to demonstrate substantial equivalence, rather than a clinical trial with performance metrics.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the characteristics of the new device itself, which are compared against the predicate devices. There is no patient sample size mentioned or required for this type of submission focused on substantial equivalence of physical devices.
- Data Provenance: The data provenance is from the design specifications and manufacturing materials of the new devices, and a "comprehensive literature and MDR review" of the predicate devices. This is retrospective in terms of reviewing existing data and regulatory clearances.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for a 510(k) comparison is essentially the regulatory clearance and performance history of the predicate devices.
- Qualifications of Experts: The experts involved are the product development team at Eagle Vision, Inc., who performed the design analysis and comparison, and the FDA reviewers (Division of Ophthalmic and Ear, Nose and Throat Devices) who ultimately determine substantial equivalence.
Adjudication method for the test set:
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the sense of clinical outcome assessment. The comparison against predicate devices is a regulatory and technical assessment.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is a physical lacrimal stent and intubation set, not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is not an algorithm or AI device.
The type of ground truth used:
- Ground Truth: The "ground truth" used for determining substantial equivalence relies on the established regulatory clearances (K-numbers) and the known performance and safety data of the predicate devices (EV™ Monocanalicular Stent - K883233, Lacrimal Intubation Set & DCR Set - K990672, and Ritleng Bicanaliculus Intubation Set - K955671). The assertion is that these predicate devices are safe and effective, and because the new devices are substantially equivalent, they are also safe and effective.
The sample size for the training set:
- Training Set Sample Size: Not applicable. There is no concept of a "training set" for physical medical devices in this context, nor for an AI algorithm.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable for the same reasons as above.

Summary

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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
OFFICIALCORRESPONDENT	Billy Hannaford
	RA/QA Manager
	Eagle Vision, Inc.
	8500 Wolf Lake Drive, Suite 110
	Memphis Tennessee, 38133 USA
	Tel: (901) 380-7000
	FAX: (901) 380-7001
	e-mail: billyh@eaglevis.com
TRADE NAME:	Eagle Vision Lacrimal Stents and Intubation Sets
COMMON NAME:	Monocanalicular stentsLacrimal Intubation Sets
CLASSIFICATIONNAME:	Probe, lacrimal
DEVICECLASSIFICATION:	Class II per 21 CFR § 886.4350
PRODUCT CODE	86 (HNL)
PREDICATE DEVICE:	EVT™ Monocanalicular Stent (cleared under K883233), theLacrimal Intubation Set & DCR Set (cleared under K990672), andthe Ritleng Bicanaliculus Intubation Set (cleared under K955671)

SUBSTANTIALLY EQUIVALENT TO:

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:

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of Americans.

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 (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,

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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1_of_1

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:

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

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

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

Prescription Use		OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

N/A