STENTUBE LACRIMAL INTUBATION SET

K113118 · Quest Medical, Inc. · OKS · Jul 31, 2012 · OP

Device Facts

• Record ID: K113118
• Device Name: STENTUBE LACRIMAL INTUBATION SET
• Applicant: Quest Medical, Inc.
• Product Code: OKS · OP
• Decision Date: Jul 31, 2012
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

STENTube is a sterile, single-use, hand-held ophthalmic surgical device. It consists of two malleable stainless steel probes attached to a flexible silicone tube. Used by surgeons following lacrimal system procedures (e.g., DCR) to maintain patency of the lacrimal passage during the healing process. The device is inserted into the lacrimal system and remains in situ for up to 11 months to prevent blockage. It provides a physical stent to keep passages open, facilitating patient recovery and reducing the risk of post-surgical obstruction.

Clinical Evidence

No clinical tests were performed. Bench testing and verification/validation tests were conducted to ensure the modified device met design requirements and specifications equivalent to the predicate device.

Technological Characteristics

Materials: stainless steel probes, silicone tube. Design: hand-held lacrimal intubation set. Features: malleable probes, shrink tube component. Sterilization: updated method. Shelf life: 3 years. Single-use, sterile, non-pyrogenic.

Indications for Use

Indicated for maintenance of lacrimal outflow following primary Dacryocystorhinostomy (DCR) surgery, maintenance of lacrimal outflow following failed open DCR surgery with complete obstruction, and reconstruction of the canaliculi.

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

• Ryder International Lacrimal Intubation Set (K962151)

Submission Summary (Full Text)

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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 [phone] 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

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

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- 3. 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.

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# 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

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## 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 [phone] or [phone] 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

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## 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

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510(k) Number \$_\$ K113118