LACRIFAST

K120886 · Hiroyasu Higuchi · OKS · Dec 17, 2012 · OP

Device Facts

• Record ID: K120886
• Device Name: LACRIFAST
• Applicant: Hiroyasu Higuchi
• Product Code: OKS · OP
• Decision Date: Dec 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

LACRIFLOW is a lacrimal stent system used to treat epiphora by dilating obstructed lacrimal ducts. The device consists of a polyurethane resin lacrimal duct tube and a stainless steel bougie. The bougie acts as an insertion tool to place the tube into the lacrimal canaliculus or nasolacrimal duct; once positioned, the bougie is removed, leaving the tube in place to maintain patency. The device is intended for clinical use by healthcare professionals. By mechanically dilating the obstructed site, the stent facilitates tear drainage, potentially relieving symptoms of epiphora. The device is single-use and sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Performance testing included tensile strength of the lacrimal duct tube and stiffness of the bougie, both meeting in-house standards. Biocompatibility testing included cytotoxicity, irritation, sensitization, acute and chronic systemic toxicity, implantation (2-week and 9-week), genotoxicity, hemolysis, and pyrogen/LAL testing, with no concerns raised.

Technological Characteristics

Materials: Polyurethane resin (tube), stainless steel (bougie). Dimensions: Tube length 50-105mm, outer diameter 1.0mm; bougie length 55mm, outer diameter 0.5mm. Principle: Mechanical dilation via indwelling stent. Sterilization: Ethylene oxide. Single-use. No software or electronic components.

Indications for Use

Indicated for patients 12 months and older with epiphora due to canalicular pathologies (stenosis, obstruction, lacerations), congenital nasolacrimal duct obstruction, or during Dacryocystorhinostomy (conventional or laser).

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

• FCI CRAWFORD PROBE INTUBATION SETS (K991238)
• SELF RETAINING BICANALICULUS INTUBATION SET (K041869)

Submission Summary (Full Text)

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## Kane

510(k) Summary

Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036

TEL:[phone] FAX:[phone]

DEC 1 7 2012

- Owner/Company name, address a. Kaneka Pharma America LLC 546 Fifth Avenue, 215t Floor New York, NY 10036 USA
## b. Contact

Hiroyasu Higuchi Vice President KANEKA PHARMA AMERICA LLC 546 Fifth Avenue, 2156 Floor New York, NY 10036 USA.

Phone: [phone] Fax: [phone] Email: [e-mail]

### Application Correspondent c.

Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

Phone: [phone] Fax: [phone] Email: [e-mail]

- d. Date prepared
March 23, 2012

### Name of device e.

Trade Name: Common Name: Classification Name: Classification Regulation: Unclassified Product Code:

LACRIFLOW Lacrimal stent Lacrimal Stents and Intubation Sets OKS

> 510(K) SUMMARY 1 OF 5

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Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036

TEL:[phone] FAX:[phone]

#### f. Predicate devices

The LACRIFAST is substantially equivalent to the following legally marketed devices:

| 510(k): | K991238 |
|---------------|---------------------------------------------|
| Trade name: | FCI CRAWFORD PROBE INTUBATION SETS |
| Product code: | OKS |
| 510(k): | K041869 |
| Trade name: | SELF RETAINING BICANALICULUS INTUBATION SET |
| Product code: | OKS |

### Description of the device g.

The LACRIFLOW is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW 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 insertion of 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 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

Following table is comparison between the LACRIFLOW and the predicates.

The Indications for Use of the LACRIFLOW is similar to that of the FCI CRAWFORD PROBE INTUBATION SETS (K991238). The elastic tube is inserted and placed inside the lacrimal drainage system in the application of the LACRIFLOW and the predicates, and thus the fundamental technology of the LACRIFLOW and the predicate is same.

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K120886
Page 3 of 5

# K9U6K9

Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036

## TEL:[phone] FAX:[phone]

| | LACRIFLOW | FCI CRAWFORD PROBE<br>INTUBATION SETS<br>(K991238) | SELF RETAINING<br>BICANALICULUS<br>INTUBATION SET<br>(K041869) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LACRIFLOW is<br>indicated in treatments<br>of epiphora in patients<br>12 months and older, in<br>cases of:<br>-Canalicular pathologies<br>(stenosis, obstruction,<br>lacerations),<br>-During<br>Dacryocystorhinostomy<br>(conventional or laser),<br>-Congenital<br>nasolacrimal duct<br>obstruction. | BICANALICULAR<br>INTUBATION SETS<br>are indicated in<br>treatments of epiphora<br>in infants or adults,<br>particularly in cases of:<br>-Canalicular pathologies<br>(stenosis, obstruction,<br>lacerations),<br>-Dacryocystorhinostomy<br>(conventional or laser),<br>-Imperforation of the<br>nasolacrimal duct in the<br>infant. | Bicanalicular<br>intubation<br>is indicated in<br>treatments of epiphora<br>in adults (not to be<br>used in infants),<br>particularly in cases<br>of:<br>-Meatic pathologies<br>(meatic atresia)<br>-Canalicular<br>pathologies<br>(canalicular stricture). |
| Tube Material | Polyurethane resin | Silicone | Silicone |
| Tube Shape | Two tubes are<br>connected by a rod<br>part | One tube | Two tubes are<br>connected by a rod<br>part |
| Size of the Tube | | | |
| - Length | Standard type: 105 mm<br>Short type: 90 mm<br>Mini type: 50 mm | Mini: 309.7mm<br>Maxi: 311.15mm | S1-1290u: 25mm<br>S1-1291u: 30mm<br>S1-1292u: 35mm |
| -Outer Diameter | Tube part: 1.0 mm<br>Rod part: 0.7 mm | 0.64 mm | 0.64 mm |
| Tensile Strength of<br>the Tube | 14.2 N (Average of 9<br>samples) | 3.56 N (Average of 3<br>samples) | 1.98N (Average of 3<br>samples) |
| Insertion Method | The LACRIFLOW<br>consists of the tube and<br>the Bougie, and thus the<br>Bougie is used for<br>insertion. | BICANALICULAR<br>INTUBATION SETS<br>are composed of a tube<br>connected to a steel<br>guide at each end, and<br>thus the steel guide is<br>used for insertion. | The tube has flexible<br>silicone anchor-shaped<br>heads, and thus a<br>forceps is used for<br>insertion. |
| Insertion<br>Parts Assist | The Bougie | The steel guides at both<br>ends | NA (assisted by a<br>forceps) |
| -Length | 55 mm | Mini: 108 mm<br>Maxi: 115 mm | NA |
| -Outer Diameter | 0.5 mm | 0.38 mm | NA |
| -Tip Shape | Straight, helically<br>grooved | Rounded olive shape | NA |
| -Tip Diameter | The same as the outer | Mini: 0.75 mm | NA |

510(K) SUMMARY 3 OF 5

.

.

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K120886
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## Kanz

Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036

TEL:[phone] FAX:[phone]

| | diameter | Maxi: 1.01 mm | |
|-----------------|-------------------------|-------------------------|-------------------------|
| -Material | Stainless steel | Stainless steel | NA |
| Sterilization | Yes<br>(Ethylene Oxide) | Yes<br>(Ethylene Oxide) | Yes<br>(Ethylene Oxide) |
| Single-Use Only | Yes | Yes | Yes |

As shown in the comparison table, the indications for use of the LACRIFLOW is similar to the FCI CRAWFORD PROBE INTUBATION SETS (K991238). In addition, as described above, the fundamental technology that the elastic tube is inserted and placed inside the lacrimal drainage system of the LACRIFLOW and the predicate is same. In the comparison table, there are some differences in characteristics between the LACRIFLOW and the predicates including the FCI CRAWFORD PROBE INTUBATION SETS (K991238) and the SELF RETAINING BICANALICULUS INTUBATION SET (K041869). Regarding the LACRIFLOW and the FCI CRAWFORD PROBE INTUBATION SETS (K991238), the tube shape and tube length are different because of difference of final step before the implantation. The FCI CRAWFORD PROBE INTUBATION SETS (K991238) needs to be tied both end, however, the LACRIFLOW does not need that step because the tube part is thicker than the lacrimal canaliculus. Regarding the LACRIFLOW and the SELF RETAINING BICANALICULUS INTUBATION SET (K041869), the tube length is different because the SELF RETAINING BICANALICULUS INTUBATION SET (K041869) is intended to be implanted in lacrimal canaliculus, not in nasolaclimal duct. In addition, the material of the Tube and insertion method including insertion assist part of the LACRIFLOW are different from the predicates. Therefore, performance testing, sterilization, biocompatibility testing, and risk analysis were performed in order to evaluate safety and effectiveness of the LACRIFLOW. In conclusion, those testing and analysis demonstrated that the LACRIFLOW did not raise any new safety or effectiveness concerns.

#### i. Risk Analysis

The LACRIFLOW was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory.

### k. Bench Testing

The following bench tests were performed to ensure the safety and effectiveness of the Lacriflow and the conformance to in-house standards, and compare the characteristics with the predicate.

- · Tensile Strength of the Lacrimal duct tube
The tensile strength of the Lacrimal duct tube met acceptable minimum force until breakage when tested according to in-house standard.

### · Stiffness of the Bougie

The stiffness of the Bougie met acceptance criteria when tested according to in-house standard.

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## Капек

Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor New York, NY 10036

TEL:[phone] FAX:[phone]

Result of the all performance tests showed that the LACRIFLOW was compliant with in-house standards and the test result did not raise any new safety and effectiveness concern.

### l. Biocompatibility Testing

In order to evaluate biocompatibility for the LACRIFLOW, we performed following biocompatibility tests;

- · Cytotoxicity
- · Irritation
- · Sensitization
- · Acute Systemic Toxicity
- · 4-week and 13-week Systemic Toxicity
- · Implantation (2-week and 9-week)
- · Genotoxicity
- · Hemolysis
- · Pyrogen test
- · LAL test

In the biocompatibility testing reports, no biocompatibility concern was raised.

### m. Conclusion

The LACRIFLOW has the similar intended use to the FCI CRAWFORD PROBE INTUBATION SETS (K991238). The elastic tube is inserted and placed inside the lacrimal canaliculus in the application of the LACRIFLOW and the predicates, and thus the fundamental technology of the LACRIFLOW and the predicate is same. Although the LACRIFLOW has some different characteristics from the predicates including the FCI CRAWFORD PROBE INTUBATION SETS (K991238) and the SELF RETAINING BICANALICULUS INTUBATION SET (K041869), the LACRIFLOW did not raise any new safety or effectiveness concerns as the results of performance testing, sterilization validation, biocompatibility testing and risk analysis. Based on such testing and analysis, we concluded that the LACRIFLOW is substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a symbol representing human services, with a stylized depiction of an abstract shape.

December 17, 2012

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Kaneka Pharma America LLC c/o Fumiaki Kanai, Ph.D. President and CEO, MIC International 4-1-17 Hongo Bunkyo-ku, Tokyo, 13-0033, Japan

Re: K120886

Trade/Device Name: LACRIFLOW Lacrimal Stent Regulation Number: None Regulation Name: Lacrimal Stents and Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: November 9, 2012 Received: November 13, 2012

Dear Dr. Kanai:

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.

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Page 2 - Dr. Fumiaki Kanai

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-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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

**Kesia Y. Alexander**

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

K120486 510(k) Number (If known):

Device Name: LACRIFLOW

## Indications for Use

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.

Image /page/7/Picture/8 description: The image contains a large, bold, black letter X. The X is centrally located and dominates the frame. The background is plain white, providing a stark contrast that emphasizes the shape of the letter.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

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)

27. A. An

Division of Neurological and Physical
Medicine Devices
510(k) Number K120886