The STENTube lacrimal intubation device is a sterile, single-use, prescription device intended for use as an in situ (up to 11 months) device for various ophthalmic procedures.
The STENTube lacrimal intubation device is indicated for use for the following:

Maintenance of lacrimal outflow post-primary DCR surgical procedure
Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete obstruction
Reconstruction of the canaliculi

Device Description

The Quest Medical, Inc. STENTube is a sterile, hand held, ophthalmic surgical device. The STENTube is a large diameter lacrimal intubation set consisting of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube. The STENTube intubation set is single-use, biocompatible, and non-pyrogenic. The STENTube is packaged with 1 device per pouch, and 2 pouches per carton. It is available by prescription only. The STENTube is used following a procedure in the lacrimal system, such as a Dacryocystorhinostomy (DCR), to clear any blockage to the lacrimal passage. The tubes are inserted with the purpose of keeping the passages open for a period of time during the healing process.

AI/ML Overview

Here's an analysis of the provided text regarding the STENTube Lacrimal Intubation Set:

This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It is not a study proving the device meets acceptance criteria based on clinical performance. Instead, it argues that the new device (STENTube) is as safe and effective as its predicate (Ryder International Lacrimal Intubation Set, K962151) primarily due to technological characteristics and non-clinical performance data.

Therefore, most of the requested information regarding clinical studies, acceptance criteria, sample sizes, ground truth, and expert adjudication is not applicable or not provided in this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a 510(k) for substantial equivalence, not a clinical performance study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device through technological characteristics and non-clinical testing.

Acceptance Criteria (Implied)	Reported Device Performance (STENTube)
Safety: Biocompatibility, non-pyrogenic	"single-use, biocompatible, and non-pyrogenic" (Section D)
Effectiveness: Maintaining lacrimal outflow, reconstruction of canaliculi (same as predicate)	Indications for Use are identical to the predicate device: 1. Maintenance of lacrimal outflow post-primary DCR surgical procedure 2. Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete obstruction 3. Reconstruction of the canaliculi (Section E & Indications for Use document). The document claims the device "performed as well or better than the predicate device" based on bench testing and "demonstrates it is as safe and as effective as the predicate device." (Section G)
Technological Characteristics: Materials, design	"The STENTube has the same technological characteristics compared to the predicate device. It has the same design and materials." (Section F). Minor modifications: "Only the length of some of the components has been modified, and a shrink tube component was added." (Section F)
Sterilization Method	"Sterilization method has been updated" (Section F) - implicitly meets new or updated criteria.
Shelf Life	"shelf life extended to 3 years" (Section F) - implicitly implying it meets new criteria for this extended shelf life.
Physical Specifications	"Verification and Validation tests were performed to ensure the modified STENTube continued to meet or exceed specification in accordance to the Design Requirements." (Section G) - These specifications are stated to be "the same as for the predicate device."

2. Sample size used for the test set and the data provenance

Not applicable. No clinical test set data is described. The non-clinical performance data refers to "Verification and Validation tests" and "benchtesting," but no sample sizes or data provenance (country of origin, retrospective/prospective) are mentioned for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set was used, and therefore no ground truth was established by experts in the context of clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set was used, and therefore no adjudication method was employed.

5. 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

Not applicable. This device is a physical medical device (lacrimal intubation set), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the clinical sense. For the non-clinical performance data, the "ground truth" would be the engineering specifications and performance characteristics derived from the predicate device and internal design requirements.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The "training set" for the design and specifications would be the knowledge and data from the predicate device's design and performance.

9. How the ground truth for the training set was established

Not applicable. As above, no training set in the AI sense. The "ground truth" for the design was established by the predicate device's established safety and effectiveness and by the medical community's understanding of the requirements for lacrimal intubation sets.

Summary

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

K113118

510(k) Summary

Pursuant to 21CFR807.92(c), Quest Medical Inc. provides the following Summary Statement for this Premarket Notification.

JUL 3 1 2012

A. Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 USA 972-390-9800 / 800-627-0226; Fax 972-390-2881 Amy Clendening-Wheeler July 31, 2012
B. Trade/Device name: STENTube® Lacrimal Intubation Set Product Code: OKS Device Classification Name: Lacrimal Stents and Intubation Sets Regulatory Class: Unclassified
். Predicate Device: Ryder International Lacrimal Intubation Set, K962151
D. The Quest Medical, Inc. STENTube is a sterile, hand held, ophthalmic surgical device. The STENTube is a large diameter lacrimal intubation set consisting of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube. The STENTube intubation set is single-use, biocompatible, and non-pyrogenic. The STENTube is packaged with 1 device per pouch, and 2 pouches per carton. It is available by prescription only. The STENTube is used following a procedure in the lacrimal system, such as a Dacryocystorhinostomy (DCR), to clear any blockage to the lacrimal passage. The tubes are inserted with the purpose of keeping the passages open for a period of time during the healing process.
ட். The intended use and the Indications for use for the STENTube are the same as for the Predicate device, with the exception of an update to the device name.

Intended Use

The STENTube lacrimal intubation device is a sterile, single-use, prescription device intended for use as an in situ (up to 11 months) device for various ophthalmic procedures.

Indications for Use

The STENTube lacrimal intubation device is indicated for use for the following:

1. Maintenance of lacrimal outflow post-primary DCR surgical procedure

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

1. Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete obstruction
  K113118

fuge 2.4 2

1. Reconstruction of the canaliculi
ப் Technological Characteristics: The STENTube has the same technological characteristics compared to the predicate device. It has the same design and materials. Only the length of some of the components has been modified, and a shrink tube component was added, Sterilization method has been updated and the shelf life extended to 3 years.
். Non-clinical Performance Data: There was no additional testing required as a result of the Risk Assessments performed for the modification to the STENTube. Verification and Validation tests were performed to ensure the modified STENTube continued to meet or exceed specification in accordance to the Design Requirements. Those specifications are the same as for the predicate device. There were no clinical tests performed. The benchtesting concluded that the modified device, the STENTube, performed as well or better than the predicate device. Testing for the STENTube demonstrates it is as safe and as effective as the predicate device.
- H. Information Verification.

This summary statement:

a. Includes only information that is also covered in the body of the 510(k);
b. Does not contain any puffery or unsubstantiated labeling claims;
Does not contain any raw data, i.e. contains only summary data; ﻥ ﻧ
d. Does not contain any trade secret or confidential commercial information;
Does not contain any patient identification information. e.

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

DEPARTMENT OF HEALTH & HUMAN SERVICE

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 eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 3 1 2012

Quest Medical, Inc. c/o Ms. Amy Clendening-Wheeler Sr. Regulatory Affairs Specialist One Allentown Parkway Allen, Texas 75001

Re: K113118

Trade/Device Name: STENTube® Lacrimal Intubation Set Regulation Name: Lacrimal Stents and Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: June 29, 2012 Received: July 02, 2012

Dear Ms. Clendening-Wheeler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

Page 2 - Ms. Amy Clendening-Wheeler

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K113118

STENTube® Lacrimal Intubation Set Device Name:

Indications for Use: The STENTube Lacrimal Intubation Set is indicated for the following:

Maintenance of lacrimal outflow post-primary DCR surgical procedure 1.
Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete 2. obstruction
Reconstruction of the canaliculi 3.

Prescription Use (Part 21 CFR 801 Subpart D)

. AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page i of i

510(k) Number $_$ K113118

Regulation Number and Section

N/A