(277 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes.
The device is intended for use during dilation of the obstructed nasolacrimal duct, which is a therapeutic intervention to treat a medical condition.
No
The device is described as a "lacrimal duct catheter" intended for "dilation of the obstructed nasolacrimal duct." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly details a physical, sterile, single-use balloon catheter made of stainless steel and polyethylene terephthalate, designed for mechanical dilation. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the dilation of the obstructed nasolacrimal duct. This is a therapeutic procedure performed directly on the patient's body to treat a physical obstruction.
- Device Description: The device is a physical catheter with a balloon designed for mechanical dilation. It is used to physically open a blocked duct.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition. IVDs are used in vitro (outside the body) to examine specimens.
This device is a medical device used for a therapeutic intervention, not a diagnostic test.
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 polyethylene terephthalate 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, dacryocystorhinostomy ostium
Indicated Patient Age Range
patients over 12 months of age and under 30 months of age (2mm catheter)
children over 30 months of age (3mm catheter)
adults (5mm catheter)
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 to ISO10993: Cytotoxicity (PASS), Sensitization (PASS), Irritation (PASS).
ISO Guinea Pig Maximization Sensitization Test: The test article did not elicit a sensitization response.
ISO Intracutaneous Reactivity Test: Requirements met.
Rabbit Pyrogen Test (Material Mediated) - ISO: Considered non-pyrogenic and meets requirements.
ISO Acute Systemic Injection Test: Requirements met.
MEM Elution GLP Report: All test method acceptance criteria were met, showing non-cytotoxicity.
Inflation/Deflation Time: PASS - inflation and deflation can be accomplished within a specified time.
Fatigue Testing: PASS - repeatability of balloon inflation without failure.
Rupture Testing: PASS - balloons will not burst at or below maximum recommended burst pressure.
Tensile Testing: PASS - all bonds can withstand tensile forces greater than those experienced during clinical use.
ISO 594-1 Testing (6% Luer taper for syringes): Gauging (PASS), Liquid Leakage (PASS), Air Leakage (PASS), Separation Force (PASS).
Stress Cracking: PASS.
Packaging Validation: Transportation (ASTM D169) (PASS), Seal Peel Test (PASS), Dye Migration Test (ASTM F1929) (PASS), Aerosol Challenge Test (PASS), Accelerated Aging Test (3.3 weeks @ 55± 4°C simulating 0.5 year shelf life) (PASS).
EO Sterilization Validation: PASS - microbiological challenge utilizing the half-cycle (overkill) method, using a biological indicator challenge following ISO11135.
Conclusions from non-clinical performance data: The data shows that the DacryoCath is substantially equivalent to the predicate as a lacrimal duct balloon catheter.
Clinical performance data: A review of the published peer-reviewed literature was conducted to review appropriate uses, adverse events, and clinical experience with this device type.
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
K113508
AUG 3 1 2012
510(k) SUMMARY
Suite 246
Armadillo Medical, LLC,
5363 Balboa Blvd.
Encino, CA 91316 TEL: 855.255.3310
510(k) Owner
Contact person
FAX: 818.783.9059 Robyn Scopis Regulatory Consultant to Armadillo Biomedical Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: 949.422.3853 FAX: 949.552.2821 EMAIL: robyn@regulatoryspecialists.com
Date summary was prepared
August 20, 2012
Name of device Common Name Classification Name Regulation Product Code Predicate
DacryoCath Lacrimal duct balloon catheter Lacrimal Stents and Intubation Sets Pre-Amendment OKS K935233
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 polyethylene terephthalate 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.
1
K//3508
Description continued:
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 predicate and the DacryoCath were compared in the following areas and found to have similar technological characteristics and to be equivalent:
Material Characteristics
Both the Predicate and DacryoCath are made of Stainless Steel and Polyethylene.
Design Characteristics
Both the Predicate and DacryoCath are designed to be used as lacrimal duct balloon catheters.
Operating Characteristics
Both the Predicate and DacryoCath are operated by placing the catheter into the canaliculus, inflate the balloon to 8atm with 10cc sterile saline, and inflate for 90seconds to dilate the obstructed nasolacrimal duct.
Intended Use
Both the Predicate and DacryoCath have the same intended use: The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct
2
2
Technological Characteristics Similar technological characteristics continued: Balloon Length -3 mm Predicate - 15mm DacryoCath - 15mm Balloon Length - 5mm Predicate - 10mm DacryoCath - 10mm
The predicate and the DacryoCath were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined. through non-clinical performance testing, to not have any impact on the safety or efficacy of the DacryoCath when used as indicated:
15/13508
Length of Catheter Predicate - 24cm DacryoCath - 15.24cm Balloon Length (2mm Balloon only) Predicate - 13mm DacryoCath - 15mm Irrigation Port -Predicate - None Available DacryoCath - Yes
The following non-clinical performance tests were conducted:
Biocompatibility to ISO10993
| Cytotoxicity | PASS |
|---|---|
| Sensitization | PASS |
| Irritation | PASS |
ISO Guinea Pig Maximization Sensitization Test
The test article did not elicit a sensitization response under the conditions of this assay.
ISO Intracutaneous Reactivity Test
The requirements of ISO Intracutaneous Reactivity have been met by the test article.
Rabbit Pyrogen Test (Material Mediated) - ISO
3
The USP 0.9% Sodium Chloride for Injection (NaCl) extract of the test article, Lot #23054 - lacrimal balloon catheters, was evaluated for its potential to produce a pyrogenic response when tested in New Zealand White rabbits. Based on the criteria of the protocol, the test article is considered non-pyrogenic and meets the requirements of the Pyrogen Test, ISO10993-11 guidelines.
3
Non-clinical performance tests continued:
ISO Acute Systemic Injection Test
The requirements of the ISO Acute Systemic Injection Test have been met by the test article.
MEM Elution GLP Report
The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. An extract of the test article was added to cell monolayers and incubated. The cell monolayers were examined and scored based on the degree of cellular destruction. All test method acceptance criteria were met.
Inflation/Deflation Time PASS
Inflation/Deflation Time testing was conducted to show that the inflation and deflation of the balloons using conventional techniques can be accomplished within a specified time.
Fatigue Testing
Fatigue testing was conducted to determine the repeatability of balloon inflation without failure using the recommended inflation pressure.
Rupture Testing
PASS
PASS
15113508
Rupture testing was done on balloons of each diameter and length. Test results show that the balloons will not burst at or below the maximum recommended burst pressure.
Tensile Testing
PASS
Tensile testing was done to test the bond strength at locations where joining methods are used for bonding components of the catheter. Testing demonstrated that all bonds can withstand tensile forces greater than those that may be experienced during clinical use.
ISO 594-1 Testing
PASS
ISO 594-1 testing was conducted for the 6% (Luer) taper for syringes. Under this guidance, the following tests were conducted:
Gauging Liquid Leakage Air Leakage Separation Force
Stress Cracking
| Packaging Validation | PASS | |
|---|---|---|
| Transportation | ASTM D169 | PASS |
| Seal Peel Test | PASS | |
| Dye Migration Test | ASTM F1929 | PASS |
| Aerosol Challenge Test | PASS | |
| Accelerated Aging Test | PASS | |
| 3.3 weeks @ 55± 4°C | ||
| Simulating 0.5 year shelf life |
4
Non-clinical performance tests continued:
EO Sterilization Validation
PASS A microbiological challenge utilizing the half-cycle (overkill) method, using a biological indicator challenge following ISO11135.
Conclusions from non-clinical performance data
After performing non-clinical performance studies, the data shows that the DacryoCath is substantially equivalent to the predicate as a lacrimal duct balloon catheter.
Clinical performance data
A review of the published peer-reviewed literature was conducted to review appropriate uses, adverse events, and clinical experience with this device type.
5
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 3 1 2012
Armadillo Biomedical, LLC c/o Ms. Robyn Scopis Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K113508
Trade/Device Name: DacryoCath Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OKS Dated: August 20, 2012 Received: August 29, 2012
Dear Ms. Scopis:
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
6
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
for
Sincerely yours,
Kesia 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
7
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: DacryoCath by Armadillo Biomedical, LLC
Indications for Use:
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
- b. 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.
× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
CLCLy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113508
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