DCS LACRIMAL STENT

K113316 · Dcs Surgical, Inc. · OKS · Nov 8, 2012 · OP

Device Facts

• Record ID: K113316
• Device Name: DCS LACRIMAL STENT
• Applicant: Dcs Surgical, Inc.
• Product Code: OKS · OP
• Decision Date: Nov 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.

Device Story

DCS Lacrimal Stent is a sterile, single-use, hollow flexible medical-grade silicone tube; 1.0 mm internal diameter; 15.5 mm length. Designed for extra-ductal intubation; positioned distally in paranasal cavities and proximally at medial fornix conjunctival reflection. Used by clinicians during lacrimal system reconstruction to facilitate tear fluid drainage. Device provides mechanical bypass for canalicular pathologies. Performance verified via bench and cadaver testing for tensile strength and flow profile. Radiation sterilized.

Clinical Evidence

No clinical data. Performance verified via bench testing (tensile strength, internal flow profile) and cadaver testing. Biocompatibility testing performed per ISO 10993 for prolonged contact duration.

Technological Characteristics

Medical grade silicone tubing; 1.0 mm internal diameter; 15.5 mm total length; 2.5 mm by 6.0 mm punctum collar. Radiation sterilized per ANSI/AAMI/ISO 11137-2. Single-use. Mechanical device; no software or electronics.

Indications for Use

Indicated for patients requiring lacrimal system repair, including intubation and bypass for canalicular pathologies.

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

• Gunther-Weiss Pre-Amendment Jones Tubes
• FCI Ophthalmics Mono-Crawford Nasolacrimal Intubation Device (K061404)
• Eagle Vision, Inc. Lacrimal Stents and Intubation Sets (K030353)

Submission Summary (Full Text)

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K 113316

DCS Surgical, Inc. Page 1 of 3, Tab 5 Summary

DCS Lacrimal Stent Premarket Notification [510(k)] Submission

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## Premarket Notification [510(k)] Summary

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| Submission Date: | November 1, 2011 | |
|-------------------------|----------------------------------------|-------------------------------------------------|
| Trade Name: | DCS Lacrimal Stent | |
| Common Name: | Lacrimal Stent and Intubation Sets | |
| Classification /Name: | Unclassified | |
| Device Code: | OKS | |
| Manufacturer's Name: | DCS Surgical, Inc. | |
| Address: | 1110 Linden Ave.<br>Boulder, CO 80304 | |
| Corresponding Official: | Harry Ross, MD | |
| Title: | CEO / President | |
| Address: | 1110 Linden Ave.<br>Boulder, CO. 80304 | |
| Telephone: | 303-929-9909 | |
| Predicate Devices: | | |
| Gunther-Weiss | Pre-Amendment Jones Tubes | |
| FCI Ophthalmics | K061404 | Mono-Crawford Nasolacrimal Intubation<br>Device |
| Eagle Vision, Inc. | K030353 | Lacrimal Stents and Intubation Sets |

Indication for Use:

The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.

#### Device Description:

The DCS Lacrimal Stent is a sterile, single-use lacrimal stent. The DCS Lacrimal Stent is a hollow flexible silicone lacrimal stent designed to be positioned distally in the paranasal cavities and proximally at the medial fornix conjuntival reflection. It is

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KI13316 2/3

DCS Surgical, Inc. Page 2 of 3, Tab 5 Summary

DCS Lacrimal Stent Premarket Notification [510(k)] Submission

composed of a medical grade silicone tube with an internal diameter of 1.0 mm and with a total length of 15.5 mm.

| Manufacturer<br>(Device) /<br>Attributes | Gunther Weiss<br>(Jones Tubes) | DCS Surgical<br>(Lacrimal Stent) | FCI Ophthalmics<br>K061404<br>Mono-Crawford Naso-<br>Lacrimal Intubation<br>Device (Monokas) | Eagle Vision<br>K030353<br>Lacrimal Stents<br>and Intubation Sets<br>(MonoStents) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indication for<br>Use | Intended for use during repair of the<br>lacrimal system for intubation and bypass<br>to canalicular pathologies. | Lacrimal Stents are intended for use in<br>lacrimal system reconstruction. This<br>includes, but is not limited to, treatment of<br>epiphora; canalicular pathologies such as<br>stenosis; obstruction or laceration; and<br>conditions requiring<br>dacryocystorhinostomy. | | |
| Device Class;<br>Product Code | 21 CFR 886.4350;<br>Class I; HNL | Unclassified; Product Code OKS | | |
| Material | Pyrex Glass | Medical Grade Silicone Tubing | | |
| Stent Outer<br>Diameter | 2.0 mm | 1.5 mm to<br>2.25 mm | 0.64 mm | 0.9 mm |
| Punctum Collar<br>Diameter | 3.0 to 5.5 mm range<br>of diameters | 2. 5 mm by<br>6.0 mm | 3.0 mm and<br>4.0 mm | 1.6 mm by<br>2.1 mm |
| Stent Length | 9 mm to 40 mm<br>range of lengths | 15.5 mm | 50 mm | .50 mm |
| Packaging and<br>Sterility | User prepared for<br>steam or gas<br>sterilization | Tyvek Pouch; Radiation Sterilized for Single Use Only | | |

#### Comparison Table of the DCS Lacrimal Stent to the Predicates

Device dimensions are suitable for the intended uses. Any differences in technology are in regards to the manner by the devices are designed, with the narrower / longer 510(k) predicates for intra-ductal intubation and the wider / shorter Jones Tubes and DCS Lacrimal Stents for extra-ductal intubation. These differences do not raise any new questions of safety or effectiveness.

#### Performance Testing

The performance of the DCS Lacrimal Stent was verified by bench and cadaver testing to have adequate tensile strength and internal flow profile for intubation of the nasal punctum and lacrimal anatomy to facilitate the drainage of tear fluid from the eye.

#### Biocompatibility

The medical grade silicone material used in the DCS Lacrimal Stent was successfully tested for biocompatibility and is suitable for the intended use as a prolonged contact

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DCS Surgical, Inc. Page 3 of 3, Tab 5 Summary

DCS Lacrimal Stent Premarket Notification [510(k)] Submission

duration device, externally communicating with tissue, bone, dentin, as described in ISO 10993. The biocompatibility is substantially equivalent to the 510(k) predicate devices and there are no new types of safety questions.

#### Sterilization

The Device is labeled sterile, for single-use only. The packaging and contents are radiation sterilized by a validated process to a Sterility Assurance Level (SAL) of 10° per ANSI/AAMI/ISO 11137-2 for radiation sterilization of health care products.

#### Substantial Equivalence

The DCS Lacrimal Stent was evaluated in accordance with 21 CFR 807.87(d - g) to verify substantial equivalence to the predicate devices. The applicable predicates are identified in the comparison table provided in this summary. The attributes and technological comparisons to the predicates support the substantial equivalence of the DCS Lacrimal Stent for its intended use. Combined with the product performance and biocompatibility testing, the DCS Lacrimal Stent is substantially equivalent in function. technology and intended use to the commercially available predicate devices. Anv differences between the DCS Lacrimal Stent and the predicates do not raise any new types of safety or effectiveness questions.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DCS Surgical, Inc. % Harry Ross, M.D. CEO/President 1110 Linden Avenue Boulder, CO 80304

Re: K113316

Trade/Device Name: DCS Lacrimal Stent Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: OKS Dated: October 22, 2012 Received: October 24, 2012

Dear Dr. Ross:

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 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

NOV 8 2012

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#### Page 2 - Dr. Harry Ross

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 Y. 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

: :

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510(k) Number (if known): K113316

Device Name: DCS Lacrimal Stent

Indications for Use:

The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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R113316 510(k) Number_