(97 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a balloon catheter, with no mention of AI or ML.
Yes
The device is used to dilate an obstructed nasolacrimal duct, which is a therapeutic intervention.
No
The device is a catheter used for the dilation of an obstructed nasolacrimal duct, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components such as a stainless steel hypotube core, nylon balloon tubing, and a Y-hub with luer ports, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states this device is a catheter with a balloon used for the mechanical dilation of an obstructed nasolacrimal duct. It is used within the body to physically open a blockage.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely interventional.
Therefore, based on the provided information, this device is a surgical or interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
Product codes (comma separated list FDA assigned to the subject device)
OKS
Device Description
The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasolacrimal duct, lacrimal duct
Indicated Patient Age Range
over 12 months of age and under 30 months of age, over 30 months of age, adults
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)
Non-clinical performance tests were conducted: Biocompatibility (ISO 10993: Cytotoxicity, Sensitization, Irritation) and Product Validations (Cycle inflation/deflation time, Fatigue testing, Rupture testing, Tensile testing).
Conclusions from non-clinical performance data: After performing non-clinical performance studies, the data shows that the DacryoCATH is substantially equivalent to the predicate.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.
January 12, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Armadillo Biomedical, LLC % Mr. Greg Holland Regulatory Consultant Regulatory Specialists. Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K142914
Trade/Device Name: DacryoCATH Regulation Number: Unclassified Regulation Name: Lacrimal Stents and Intubation Sets Regulatory Class: Class II Product Code: OKS Dated: December 12, 2014 Received: December 15, 2014
Dear Mr. Holland:
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 device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142914/S002
Device Name DacryoCATH
Indications for Use (Describe)
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked
dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Attachment 1
| 5. 510(k) Summary | ||
|---|---|---|
| -- | -- | ------------------- |
510(k) SUMMARY
- 510(k) Owner Armadillo Biomedical LLC 5363 Balboa Blvd., Suite 246 Encino, CA 91316
- Contact person Greg Holland Requlatory Consultant to Armadillo Biomedical LLC Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: 949.262-0411 FAX: 949.552.2821 EMAIL: greg@regulatoryspecialists.com
November 3, 2014 Date summary was prepared
Name of Device Common Name Classification Name Regulation Class Panel Product Code Predicate
DacroCath Lacrimal duct balloon catheter Lacrimal Stents and Intubation Sets Pre-Amendment Unclassified Ophthalmic OKS K113508, DacryoCATH
Description
The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has
4
a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
Intended Use
The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.
Indications for Use
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
Technological Characteristics
The technological characteristics of the DacryoCATH remain unchanged from the predicate K113508. This Special 510(k) is being submitted for a change in patient contact materials and design.
| Original K113508 | New Design | |
|---|---|---|
| Balloon Material | PET - polyethylene | |
| terephthalate | Nylon 12 | |
| Hypotube | 304 stainless steel 24 | |
| gauge regular wall (OD | ||
| .022" and ID .010") | 304 Stainless steel 24 | |
| gauge thin wall (OD | ||
| .020" and ID .012") | ||
| Collar | None. | 304 stainless steel |
| collar will be welded | ||
| onto the proximal | ||
| hypotube |
The following non-clinical performance tests were conducted:
Biocompatibility to ISO 10993 Cytotoxicity Sensitization Irritation
5
Product Validations: Cycle inflation/deflation time Fatigue testing Rupture testing Tensile testing
Conclusions from non-clinical performance data:
After performing non-clinical performance studies, the data shows that the DacryoCATH is substantially equivalent to the predicate.