K Number

Device Name

Manufacturer

ARMADILLO BIOMEDICAL, LLC

Date Cleared

2015-01-12

(97 days)

Product Code

OKS

Regulation Number

N/A

Type

Special

Panel

Ophthalmic

Reference & Predicate Devices

K113508

Predicate For

N/A

Intended 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.

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.

AI/ML Overview

This document describes the DacryoCATH, a lacrimal duct balloon catheter, and its substantial equivalence to a predicate device based on non-clinical performance tests. It does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance, as it is a physical medical device.

Therefore, many of the requested categories related to AI/algorithm studies cannot be filled from the provided text.

Here's a breakdown of the available information based on the provided text, and where gaps exist for the requested AI/algorithm-specific details:

Acceptance Criteria and Device Performance (as inferred from the non-clinical tests):

Instead of 'acceptance criteria' in the context of an AI-driven device, the document focuses on the safety and performance characteristics of a physical catheter. The "reported device performance" refers to the successful completion of these non-clinical tests, indicating the new design is substantially equivalent to the predicate.

Acceptance Criteria (Inferred from Non-Clinical Tests)	Reported Device Performance
Biocompatibility (Cytotoxicity, Sensitization, Irritation) to ISO 10993	Met - device shown to be biocompatible
Cycle inflation/deflation time	Met - appropriate inflation/deflation performance
Fatigue testing	Met - device withstands repeated use cycles
Rupture testing	Met - device withstands pressure without rupturing
Tensile testing	Met - device has appropriate tensile strength

Information not present for an AI/Algorithm Study:

Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device's non-clinical testing.
Number of experts used to establish ground truth for the test set and qualifications: Not applicable for a physical device's non-clinical testing. Ground truth in this context would implicitly be the physical standards met or not met during testing.
Adjudication method: Not applicable. Performance is determined by test results against established physical parameters.
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: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for biocompatibility and mechanical performance.
The sample size for the training set: Not applicable as this is a physical device.
How the ground truth for the training set was established: Not applicable.

Additional Information Available from the Document:

Device Name: DacryoCATH
Regulation Number: Unclassified (product code OKS)
Regulatory Class: Class II
Predicate Device: K113508, DacryoCATH
Reason for 510(k) Submission (Special 510(k)): Change in patient contact materials and design.
Material Changes:
- Balloon Material: Changed from PET - polyethylene terephthalate to Nylon 12.
- Hypotube: Changed from 304 stainless steel 24 gauge regular wall (OD .022" and ID .010") to 304 Stainless steel 24 gauge thin wall (OD .020" and ID .012").
- Collar: Addition of a 304 stainless steel collar welded onto the proximal hypotube (previously none).
Conclusion: After performing non-clinical performance studies, the data shows that the DacryoCATH (with the new design) is substantially equivalent to the predicate.

Summary

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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

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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

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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

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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.

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 - polyethyleneterephthalate	Nylon 12
Hypotube	304 stainless steel 24gauge regular wall (OD.022" and ID .010")	304 Stainless steel 24gauge thin wall (OD.020" and ID .012")
Collar	None.	304 stainless steelcollar will be weldedonto the proximalhypotube

The following non-clinical performance tests were conducted:

Biocompatibility to ISO 10993 Cytotoxicity Sensitization Irritation

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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.

Regulation Number and Section

N/A