(365 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a silicone stent, with no mention of AI or ML.
Yes
The device is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies, which restores the normal function of the lacrimal system. Additionally, the performance studies mention that the device facilitates the drainage of tear fluid from the eye, implying a therapeutic effect.
No
The device is described as a stent for intubation and bypass, intended for repair of the lacrimal system. Its function is to facilitate drainage, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "sterile, single-use lacrimal stent" made of "medical grade silicone tube," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The DCS Lacrimal Stent is a physical device intended for intubation and bypass within the lacrimal system. It is surgically placed within the body to facilitate drainage.
- Intended Use: The intended use clearly describes a procedure performed on the patient's lacrimal system, not a test performed on a sample from the patient.
The device is a surgical implant/device used to treat a physical condition within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.
Product codes (comma separated list FDA assigned to the subject device)
OKS
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 composed of a medical grade silicone tube with an internal diameter of 1.0 mm and with a total length of 15.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lacrimal system, nasal punctum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 Intubation |
| 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
1
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 Ophthalmics
K061404
Mono-Crawford Naso-
Lacrimal Intubation
Device (Monokas) | Eagle Vision
K030353
Lacrimal Stents
and Intubation Sets
(MonoStents) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indication for
Use | Intended for use during repair of the
lacrimal system for intubation and bypass
to canalicular pathologies. | Lacrimal Stents are intended for use in
lacrimal system reconstruction. This
includes, but is not limited to, treatment of
epiphora; canalicular pathologies such as
stenosis; obstruction or laceration; and
conditions requiring
dacryocystorhinostomy. | | |
| Device Class;
Product Code | 21 CFR 886.4350;
Class I; HNL | Unclassified; Product Code OKS | | |
| Material | Pyrex Glass | Medical Grade Silicone Tubing | | |
| Stent Outer
Diameter | 2.0 mm | 1.5 mm to
2.25 mm | 0.64 mm | 0.9 mm |
| Punctum Collar
Diameter | 3.0 to 5.5 mm range
of diameters | 2. 5 mm by
6.0 mm | 3.0 mm and
4.0 mm | 1.6 mm by
2.1 mm |
| Stent Length | 9 mm to 40 mm
range of lengths | 15.5 mm | 50 mm | .50 mm |
| Packaging and
Sterility | User prepared for
steam or gas
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
2
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.
3
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
4
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
5
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
Page | of |
R113316 510(k) Number_