← Product Code OKS · K170247 # Lacriflow CL (K170247) _Kaneka Pharma America, LLC · OKS · Apr 18, 2017 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K170247 ## Device Facts - **Applicant:** Kaneka Pharma America, LLC - **Product Code:** OKS - **Decision Date:** Apr 18, 2017 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** OP - **Attributes:** Therapeutic, Pediatric ## Intended Use The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of. Canalicular pathologies (stenosis, obstruction, lacerations), During Dacryocystorhinostomy (conventional or laser), Congenital nasolacrimal duct obstruction. ## Device Story Lacriflow CL is a lacrimal stent system used to treat epiphora by dilating obstructed lacrimal ducts. The device consists of a lacrimal duct tube and a bougie. The bougie acts as an insertion tool to place the tube into the lacrimal canaliculus or other obstructed sites; once the tube is positioned, the bougie is removed. The device is intended for use by clinicians in a medical setting. By maintaining patency in the lacrimal duct, the device facilitates tear drainage, potentially relieving symptoms of epiphora. The device is single-use and sterile. ## Clinical Evidence Bench testing only. Design verification tests were performed to evaluate the impact of device modifications, including penetration tests, simulated insertion tests, bending tests, and insertion load measurements. The device met all verification requirements per 21 CFR 820.30. ## Technological Characteristics Lacrimal stent system consisting of a lacrimal duct tube and a bougie. Materials are consistent with the predicate device (stainless steel rings removed). Features a hydrophilic coating on the device surface (excluding the tip). Sterilized via Ethylene Oxide. Single-use. Dimensions include standard (105 mm) and short (90 mm) lengths. ## Regulatory 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 - LACRIFLOW ([K120886](/device/K120886.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is printed in a clear, sans-serif font. April 18, 2017 Kaneka Pharma America LLC % Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0033, Japan Re: K170247 Trade/Device Name: Lacriflow CL Regulatory Class: Unclassified Regulatory Name: Unclassified Product Code: OKS Dated: March 21, 2017 Received: March 22, 2017 Dear Izumi Maruo: 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 Image /page/0/Picture/11 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 a stylized image of three human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ 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 (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 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. # Denise L. Hampton -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) K170247 Device Name Lacriflow CL Indications for Use (Describe) The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of. - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction. Type of Use (Select one or both, as applicable): | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036 TEL:(212)705-4343 FAX:(212)705-4395 #### 510(k) Summary #### a. Owner/Company name, address KANEKA PHARMA AMERICA LLC 546 Fifth Avenue, 21st Floor New York, NY 10036 USA #### b. Contact Masaaki Fukunishi Director KANEKA PHARMA AMERICA LLC 546 Fifth Avenue, 21st Floor New York, NY 10036 USA Phone: 1- 212-705-4343 Fax: 1- 212-705-4395 Email: masaaki.fukunishi @kaneka.com ### c. Application Correspondent Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan | Phone: | 011-81-3-3818-8577 | |--------|--------------------| | Fax: | 011-81-3-3818-8573 | | Email: | maruo@mici.co.jp | ### d. Date prepared January 23, 2017 ### e. Name of device | Trade Name: | LACRIFLOW CL | |----------------------------|-------------------------------------| | Common Name: | Lacrimal stent | | Classification Name: | Lacrimal Stents and Intubation Sets | | Classification Regulation: | Unclassified | | Product Code: | OKS | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Kaneka" in a sans-serif font. The word is written in all lowercase letters and is a dark blue color. The letters are bold and have rounded edges. The background is white. Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036 TEL:(212)705-4343 FAX:(212)705-4395 #### f. Predicate devices The LACRIFLOW CL is substantially equivalent to the following legally marketed device: | 510(k): | K120886 | |---------------|-----------| | Trade name: | LACRIFLOW | | Product code: | OKS | #### g. Description of the device The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site. #### h. Indications for Use #### Indications for Use The LACRIFLOW CL is indicated in treatments of epiphora in-patients 12 months and older. in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction. #### i. Statement of substantial equivalence The LACRIFLOW CL was modified from the LACRIFLOW (K120886). The Indications for Use of the LACRIFLOW CL is unchanged from the LACRIFLOW (K120886). The LACRIFLOW CL contains the following modifications as compared to the LACRIFLOW (K120886); - O Elimination of stainless steel rings on both sides of the tube part - O Change in the shape of the tips of the lacrimal duct tube - No openings on both ends of the lacrimal duct tube - Change in the hydrophilic coating area - O The LACRIFLOW CL does not contain the "Mini" model {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Kaneka" in a bold, sans-serif font. The letters are all capitalized and in a blue color. The background is white, which makes the blue letters stand out. Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036 TEL:(212)705-4343 FAX:(212)705-4395 Following comparison table provides technological characteristic between the subject and the predicate device; | Table 1. Comparison table between LACRIFLOW CL and the LACRIFLOW (K120886). | | |-----------------------------------------------------------------------------|--| |-----------------------------------------------------------------------------|--| | | SUBJECT DEVICE | PREDICATE DEVICE | | |------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | | LACRIFLOW CL | LACRIFLOW (K120886) | | | Indications for Use | Same as the predicate | The LACRIFLOW is indicated in
treatments of epiphora in patients
12 months and older, in cases of:
-Canalicular pathologies
(stenosis, obstruction,
lacerations),
-During Dacryocystorhinostomy
(conventional or laser),
-Congenital nasolacrimal duct
obstruction. | | | Prescription use | Yes | Yes | | | Product Code | Same as the predicate | OKS | | | Tube Shape | Same as the predicate | Two tubes are
connected by a rod
part | | | Tip Shape | Pointed and no opening | Rounded and opening in both
ends | | | Hydrophilic coating | Surface of the device except the
tip part is coated | Entire surface of the device is
coated | | | Size of the Tube | | | | | | - Length | Standard type: 105 mm
Short type: 90 mm | Standard type: 105 mm
Short type: 90 mm
Mini type: 50 mm | | | -Outer Diameter | Same as the predicate | Tube part: 1.0 mm
Rod part: 0.7 mm | | Tensile Strength of the Tube | Same as the predicate | 14.2 N (Average of 9 samples) | | | Insertion Method | Same as the predicate | The LACRIFLOW consists of the
tube and the Bougie, and thus the
Bougie is used for insertion. | | | Insertion Assist Parts | Same as the predicate | The Bougie | | | | -Length | Same as the predicate | 55 mm | | | -Outer Diameter | Same as the predicate | 0.5 mm | | | -Tip Shape | Same as the predicate | Straight, helically grooved | | | -Tip Diameter | Same as the predicate | The same as the outer diameter | | | -Material | Same as the predicate | Stainless steel | | Sterilization | Same as the predicate | Yes
(Ethylene Oxide) | | | Single-Use Only | Same as the predicate | Yes | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Kaneka" in a bold, sans-serif font. The word is written in a blue color. The letters are evenly spaced and the overall appearance is clean and professional. TEL:(212)705-4343 FAX:(212)705-4395 The modification from the LACRIFLOW (K120886) includes material change. However, this change is caused by elimination of stainless steel ring and the LACRIFLOW (K120886) contains all materials used for the LACRIFLOW CL. Therefore, this modification does not alter the fundamental scientific technology of the device. A risk analysis was conducted to assess the impact of the modifications on the subject device in accordance with our design control and ISO 14971. The design verification tests completed as follows: {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Kaneka" in a sans-serif font. The word is written in blue. The background is white. Table 2. Summary of design verification tests | Modification | Performance test | |-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Elimination of stainless steel rings on both
sides of the tube parts | Penetration test of the tip with the Bougie was
performed. | | Change in the shape of the tips of the lacrimal
duct tube | Simulated insertion test was performed.
Bending test for the tip was performed. | | Change in the hydrophilic coating area | Inserting load was measured.
Visual inspection regarding extraneous matter,
abnormality which prevents use, coating
droplet was performed. | In accordance with design control requirements in 21 CFR 820.30, the subject device met all verification tests listed above. We determined that following modifications would not cause harm; - O The LACRIFLOW CL does not contain the "Mini" model - No openings on both ends of the lacrimal duct tube In conclusion, the LACRIFLOW CL is substantially equivalent to the LACRIFLOW (K120886). #### a. Conclusion The LACRIFLOW CL has the identical indications for use to the LACRIFLOW (K120886). The results of design verification tests based on the risk analysis demonstrate that the LACRIFLOW CL is substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/device/K170247](https://fda.innolitics.com/device/K170247) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com