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

AI/ML Overview

The presented document, K113316, is a Premarket Notification [510(k)] Summary for the DCS Lacrimal Stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format of a clinical trial with statistical performance endpoints are not applicable in this 510(k) summary.

Instead, the submission focuses on demonstrating that the DCS Lacrimal Stent is substantially equivalent to existing predicate devices based on:

Intended Use: The DCS Lacrimal Stent's intended use is compared to that of predicate devices.
Technological Characteristics: Key device attributes like material, dimensions, and sterilization methods are compared.
Performance Testing (Bench and Cadaver): Verification of physical properties relevant to the device's function.
Biocompatibility: Confirmation that the material is suitable for its intended prolonged contact.

The document does not describe a clinical study with a test set, ground truth, experts, or statistical performance data for the device.

Here's an breakdown based on the information provided and what is typical for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for substantial equivalence, formal "acceptance criteria" with a "reported device performance" are not presented as they would be in a clinical trial. Instead, the submission argues for equivalence based on technological characteristics and functional testing.

Acceptance Criteria (Demonstrated Equivalence through)	Reported Device Performance (Summary of Findings)
Intended Use Equivalence: The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies, which aligns with the general intent of predicate lacrimal stents.	The intended use is deemed substantially equivalent to predicate devices, particularly Gunther-Weiss (Jones Tubes) and broadly with FCI Ophthalmics and Eagle Vision stents.
Technological Characteristics Equivalence: Material, dimensions (outer diameter, punctum collar diameter, length), and packaging/sterilization are comparable or do not raise new safety/effectiveness concerns.	Material: Medical Grade Silicone Tubing (similar to other modern stents). Dimensions: Stent outer diameter (1.5mm to 2.25mm), Punctum collar diameter (2.5mm by 6.0mm), Stent length (15.5mm) are within the range or comparable to predicates, with differences attributed to design for intra- vs. extra-ductal intubation. Packaging/Sterility: Tyvek Pouch; Radiation Sterilized for Single Use Only, achieving SAL of 10^-6, comparable to modern sterile medical devices.
Performance Testing: Adequate tensile strength and internal flow profile for intubation and fluid drainage.	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 tear fluid drainage. Specific numerical values or detailed test results are not provided in this summary.
Biocompatibility: Medical grade silicone is suitable for prolonged contact, externally communicating with tissue.	Successfully tested according to ISO 10993, demonstrating suitability for intended use and substantial equivalence to predicate devices, raising no new safety questions.
Sterilization: Radiation sterilization to a Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11137-2.	Device is labeled sterile, single-use, and radiation sterilized by a validated process to SAL of 10^-6.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. The performance testing mentions "bench and cadaver testing," but does not specify sample sizes for these tests, nor the data provenance in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The 510(k) summary refers to internal performance testing (bench and cadaver) and biocompatibility studies. There is no mention of a test set requiring expert-established ground truth in the context a clinical study.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no described test set requiring expert adjudication in this 510(k) summary.

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

This is not applicable. The DCS Lacrimal Stent is a physical medical device, not an AI-based diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This is not applicable. The DCS Lacrimal Stent is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

7. The Type of Ground Truth Used

For the performance testing (bench and cadaver), the "ground truth" would implicitly be the established engineering and physiological standards for tensile strength, flow dynamics, and material biocompatibility, rather than expert consensus, pathology, or outcomes data from a clinical trial. The specific metrics and how they were evaluated clinically for "ground truth" are not detailed in this summary.

8. The Sample Size for the Training Set

This is not applicable/not provided. The device is a physical stent and does not involve AI or machine learning, thus no training set in that context.

9. How the Ground Truth for the Training Set was Established

This is not applicable/not provided for the reasons stated in point 8.

Summary

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K 113316

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

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

Tab 5

Premarket Notification [510(k)] Summary

NOV 8 2012

1/3

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.Boulder, CO 80304
Corresponding Official:	Harry Ross, MD
Title:	CEO / President
Address:	1110 Linden Ave.Boulder, CO. 80304
Telephone:	303-929-9909
Predicate Devices:
Gunther-Weiss	Pre-Amendment Jones Tubes
FCI Ophthalmics	K061404	Mono-Crawford Nasolacrimal IntubationDevice
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:

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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(Device) /Attributes	Gunther Weiss(Jones Tubes)	DCS Surgical(Lacrimal Stent)	FCI OphthalmicsK061404Mono-Crawford Naso-Lacrimal IntubationDevice (Monokas)	Eagle VisionK030353Lacrimal Stentsand Intubation Sets(MonoStents)
Indication forUse	Intended for use during repair of thelacrimal system for intubation and bypassto canalicular pathologies.	Lacrimal Stents are intended for use inlacrimal system reconstruction. Thisincludes, but is not limited to, treatment ofepiphora; canalicular pathologies such asstenosis; obstruction or laceration; andconditions requiringdacryocystorhinostomy.
Device Class;Product Code	21 CFR 886.4350;Class I; HNL	Unclassified; Product Code OKS
Material	Pyrex Glass	Medical Grade Silicone Tubing
Stent OuterDiameter	2.0 mm	1.5 mm to2.25 mm	0.64 mm	0.9 mm
Punctum CollarDiameter	3.0 to 5.5 mm rangeof diameters	2. 5 mm by6.0 mm	3.0 mm and4.0 mm	1.6 mm by2.1 mm
Stent Length	9 mm to 40 mmrange of lengths	15.5 mm	50 mm	.50 mm
Packaging andSterility	User prepared forsteam or gassterilization	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 (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 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

: :

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_

Regulation Number and Section

N/A