DacryoCATH

K142914 · Armadillo Biomedical, LLC · OKS · Jan 12, 2015 · OP

Device Facts

• Record ID: K142914
• Device Name: DacryoCATH
• Applicant: Armadillo Biomedical, LLC
• Product Code: OKS · OP
• Decision Date: Jan 12, 2015
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.

Device Story

DacryoCATH is a sterile, single-use, disposable balloon catheter for nasolacrimal duct dilation. Device consists of a stainless steel hypotube core and nylon balloon tubing. Features include proximal markings for placement guidance, a distal opening for irrigation, and a Y-hub with separate luer ports for balloon inflation and irrigation. Operated by clinicians in a clinical setting. The device is inserted into the lacrimal system; the balloon is inflated to a specific diameter and pressure to dilate the obstruction. Irrigation can be performed simultaneously. The procedure aims to restore patency to the nasolacrimal duct, potentially relieving symptoms of obstruction or dacryocystitis.

Clinical Evidence

Bench testing only. Testing included ISO 10993 biocompatibility (cytotoxicity, sensitization, irritation) and product validation (cycle inflation/deflation time, fatigue, rupture, and tensile testing).

Technological Characteristics

Materials: Nylon 12 balloon, 304 stainless steel thin-wall hypotube (0.020" OD, 0.012" ID), 304 stainless steel collar. Dimensions: 15.24 cm length; 2mm, 3mm, or 5mm inflated diameters. Principle: Mechanical balloon dilation and irrigation. Single-use, sterile, non-pyrogenic. No software or electronic components.

Indications for Use

Indicated for dilation of obstructed nasolacrimal duct: 2mm catheter for patients >12 and <30 months; 3mm catheter for children >30 months; 5mm catheter for adults with functional/complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

Regulatory Classification

Identification

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Predicate Devices

• DacryoCATH (K113508)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] FAX: [phone] EMAIL: [e-mail]

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

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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.

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<br>terephthalate | Nylon 12 |
| Hypotube | 304 stainless steel 24<br>gauge regular wall (OD<br>.022" and ID .010") | 304 Stainless steel 24<br>gauge thin wall (OD<br>.020" and ID .012") |
| Collar | None. | 304 stainless steel<br>collar will be welded<br>onto the proximal<br>hypotube |

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.