(294 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended to treat an obstructed nasolacrimal duct system to correct epiphora by using balloon dilation to open occluded lacrimal passages.
No
Explanation: The device is described as a "surgical device" and its purpose is "dilatation of an obstructed nasolacrimal duct system to correct epiphora," indicating it is an interventional or therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical medical device (catheter with a balloon and stainless steel tube) and mentions hardware-related testing (mechanical/functional testing, biocompatibility, physicochemical testing). There is no mention of software as a component or the primary function of the device.
Based on the provided information, the LacriCATH Lacrimal Duct Balloon Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LacriCATH Function: The LacriCATH is a surgical device used directly on the patient's nasolacrimal duct system to physically dilate an obstruction. It does not analyze any bodily fluids or tissues in vitro (outside the body).
- Intended Use: The intended use is for a surgical procedure to correct a physical obstruction, not for diagnostic testing of a sample.
Therefore, the LacriCATH is a surgical medical device, not an IVD.
N/A
Intended Use / Indications for Use
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Indications for Use Statement:
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora as a result of the following.
5 mm - LacriCATH Adult Catheter: Functional or complete nasolacrimal duct obstruction Dacryocystitis Failed DCR (Dacryocystorhinostomy)
2mm/3mm LacriCATH Pediatric catheter (intended for patients 12 months of age and older):
Congenital nasolacrimal duct obstruction Dacryocystocele
Product codes (comma separated list FDA assigned to the subject device)
OKS
Device Description
The Quest Medical, Inc. current legally marketed LacriCATH lacrimal duct catheters are sterile, hand held, ophthalmic surgical devices. The LacriCATH devices are designed to facilitate nasolacrimal duct surgeries by using balloon dilation to open occluded lacrimal passages. Each LacriCATH catheter has a stainless steel tube with positioning markers and an inflatable balloon. A luer connector on the proximal end of the catheter is attached to a separate inflation device or a syringe for inflation and deflation of the balloon. The balloon is designed to inflate to a known diameter and length at the specified pressure. The LacriCATH lacrimal duct catheters are sterile, single-use, biocompatible medical devices that are sterilized by ethylene oxide and labeled with a 3 year shelf life. The LacriCATH catheters are packaged with 1 device per pouch, and 2 pouches per carton. They are available by prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasolacrimal duct system
Indicated Patient Age Range
Adult, 12 months of age and older
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)
Preclinical (bench) testing completed for the modified LacriCATH catheters included mechanical/functional testing, biocompatibility, physicochemical testing, shelf life testing, and sterilization residuals testing. There was no additional testing required as a result of the Risk Assessments performed for the modification for the new LacriCATH catheters. Verification and Validation tests were performed to ensure the modified LacriCATH catheters 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 bench-testing concluded that the new modified LacriCATH catheters performed as well or better than the predicate device. Testing for the new LacriCATH Model numbers demonstrates they are as safe and as effective as the predicate device.
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
K113867
Page 1 of 3
510(k) Summary
Pursuant to 21CFR807.92(c), Quest Medical Inc. provides the following Summary for this Premarket Notification.
OCT 19 2012
A. Submitter Information
Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 USA 972-390-9800 / 800-627-0226; Fax 972-390-2881 Amy Clendening-Wheeler October 18, 2012
B. Device Information
Trade/Device name: LacriCATH® Lacrimal Duct Balloon Catheter Product Code: OKS Device Classification Name: Lacrimal Stents and Intubation Stents Regulatory Class: Unclassified
C. Legally Marketed Predicate Device
lolab Lacrimal Duct Catheter, K935233
D. Device Description
The Quest Medical, Inc. current legally marketed LacriCATH lacrimal duct catheters are sterile, hand held, ophthalmic surgical devices. The LacriCATH devices are designed to facilitate nasolacrimal duct surgeries by using balloon dilation to open occluded lacrimal passages. Each LacriCATH catheter has a stainless steel tube with positioning markers and an inflatable balloon. A luer connector on the proximal end of the catheter is attached to a separate inflation device or a syringe for inflation and deflation of the balloon. The balloon is designed to inflate to a known diameter and length at the specified pressure. The LacriCATH lacrimal duct catheters are sterile, single-use, biocompatible medical devices that are sterilized by ethylene oxide and labeled with a 3 year shelf life. The LacriCATH catheters are packaged with 1 device per pouch, and 2 pouches per carton. They are available by prescription only.
E. Intended Use/Indications for Use
The intended use and the Indications for use for the new LacriCATH model numbers are the same as for the predicate devices. Compared to the labeling for the predicate device, the modified labeling contains the same information but organized to be clearer to the intended user. There is no impact to the use of the device or the safety and effectiveness of the device.
1
Intended Use Statement:
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Indications for Use Statement:
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora as a result of the following.
5 mm - LacriCATH Adult Catheter: Functional or complete nasolacrimal duct obstruction Dacryocystitis Failed DCR (Dacryocystorhinostomy)
2mm/3mm LacriCATH Pediatric catheter (intended for patients 12 months of age and older):
Congenital nasolacrimal duct obstruction Dacryocystocele
ட் Technological Characteristics:
The new LacriCATH catheters have the same technological characteristics compared to the predicate device. They have the same design and mode of operation. Only the length of the catheter has been modified, and the materials for the balloon, strain relief, and adhesive were updated. The sterilization method has been updated and the shelf life extended to 3 years. Table 1 below provides a comparison of the new LacriCATH catheters to the predicate device. This table illustrates equivalency of the LacriCATH catheters with the predicate device.
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) | K935233 | Under Review |
| Brand Name | Lacrimal Duct Catheter | LacriCATH® Lacrimal Duct |
| Catheter | ||
| Model # | LDC213, LDC315, LDC508 | LDC213T, LDC315T, LDC508T, |
| Manufacturer | Iolab originally, then Quest Medical, Inc. | Quest Medical, Inc |
| Materials | ||
| Balloon, Outer | ||
| tubing | LDPE - low density Polyethylene | Nylon balloon |
| No outer tubing | ||
| Sheath/Sleeve | Teflon | SAME |
| Catheter | 304 stainless Steel | SAME |
| Adhesive | Loctite™ 4541 - medical grade cyanoacrylate | Dymax 203A-CTH-F medical grade |
| adhesive |
TABLE 1
2
| Predicate Device | Modified Device | |
|---|---|---|
| Luer Connector | Polycarbonate | SAME |
| Strain Relief | Polyether polyamide polymer | Onflex TPE |
| Material: | ||
| Markers | Medical Grade Ink - Black | SAME |
| Dimensions | ||
| Balloon Size | 2 mm diameter / 13 mm length- | |
| 3 mm diameter/ 15 mm length | ||
| 5 mm diameter/ 8 mm length | SAME | |
| Balloon Diameter | Deflated: 0.8 mm Inflated: 2 mm | |
| 0.9 mm 3 mm | ||
| 1.1 mm 5 mm | SAME | |
| Catheter Length | 245 mm | 200 mm |
| Sterilization/Pkg | ||
| Method | Gamma radiation | Ethylene Oxide (EtO) |
| Minimum SAL | $1 x 10^{-6}$ | SAME |
| Packaging | Tyvek polyethylene/Mylar pouch; heat-sealed | SAME |
| Shelf Life | Original: Indefinite as long as package integrity is not compromised | |
| Quest: 3 years | 3 years |
G. Non-clinical Performance Data:
Preclinical (bench) testing completed for the modified LacriCATH catheters included mechanical/functional testing, biocompatibility, physicochemical testing, shelf life testing, and sterilization residuals testing. There was no additional testing required as a result of the Risk Assessments performed for the modification for the new LacriCATH catheters. Verification and Validation tests were performed to ensure the modified LacriCATH catheters 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 bench-testing concluded that the new modified LacriCATH catheters performed as well or better than the predicate device. Testing for the new LacriCATH Model numbers demonstrates they are as safe and as effective as the predicate device.
Clinical Testing ાન.
None required.
ட் Conclusions
Based on the information presented in this 510(k) premarket notification, the Quest Medical LacriCATH lacrimal duct catheters is considered substantially equivalent to the currently marketed predicate device.
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 19 2012
Quest Medical, Inc. c/o Amy Clendening-Wheeler Sr. Regulatory Affairs Specialist One Allentown Parkway Allen, TX 75002
Re: K113867
Trade/Device Name: LacriCATH®Lacrimal Duct Balloon Catheter Regulation Number: None Regulation Name: Lacrimal Stents and Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: October 11, 2012 Received: October 12, 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.
4
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 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/Industrv/default.htm.
Sincerely vours.
Debrah Falls
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): KII 3867
Device Name:
Indications for Use: The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device indicated for single-use during dilatation of an obstructed nasolacrimal duct to correct epiphora as a result of the following:
5mm LacriCATH Adult catheter:
functional or complete nasolacrimal duct obstruction dacrvocystitis failed DCR (dacryocystorhinostomy)
2mm/3mm LacriCATH Pediatric catheter (intended for patients 12 months of age and older): congenital nasolacrimal duct obstruction dacryocystocele
Prescription Use X (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)
ivision Sign-Off)
Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices
510(k) Number_K113867