Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biocompatibility of a mechanical device (tube and bougie) for dilating lacrimal ducts. There is no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is intended for the treatment of epiphora, a medical condition, by dilating the lacrimal duct, which directly addresses the underlying pathology.

Diagnostic

No

The device is intended for the treatment of epiphora due to lacrimal duct obstructions by physical dilation, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the LACRIFLOW consists of physical components: the Lacrimal duct tube and the Bougie, which are intended for physical insertion and manipulation.

IVD (In Vitro Diagnostic)

Based on the provided information, the LACRIFLOW is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
LACRIFLOW's Function: The LACRIFLOW is a physical device (a tube and a bougie) intended to be inserted into the lacrimal duct system to treat blockages. It is a therapeutic device, not a diagnostic one that analyzes biological samples.
Intended Use: The intended use clearly states it's for "treatments of epiphora" and describes its function in dilating lacrimal ducts. This is a direct intervention on the patient's anatomy, not an analysis of a sample.
Device Description: The description details the physical components and their function in dilating the lacrimal duct, which is a mechanical action within the body.
Performance Studies: The performance studies focus on the physical properties of the device (tensile strength, stiffness) and its biocompatibility, which are relevant for an implanted or inserted medical device, not an IVD.

Therefore, the LACRIFLOW is a medical device, but it falls under a different classification than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended 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.

Product codes (comma separated list FDA assigned to the subject device)

OKS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lacrimal punctum, lacrimal canaliculus, nasolacrimal duct

Indicated Patient Age Range

12 months and older

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)

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.
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.

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.

K991238, K041869

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

Regulation Number and Section

N/A

Summary

0

Kane

510(k) Summary

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

TEL:(800)526-3522 FAX:(212)705-4350

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: 1-800-526-3522 Fax: 1-212-705-4350 Email: hhiguchi@kaneka.com

Application Correspondent c.

Fumiaki Kanai, Ph.D. President and CEO 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: kanaif@mici.co.jp

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

1

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

TEL:(800)526-3522 FAX:(212)705-4350

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.

2

K120886
Page 3 of 5

K9U6K9

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

TEL:(800)526-3522 FAX:(212)705-4350

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

510(K) SUMMARY 3 OF 5

.

3

K120886
Page 4 of 5

Kanz

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

TEL:(800)526-3522 FAX:(212)705-4350

	diameter	Maxi: 1.01 mm
-Material	Stainless steel	Stainless steel	NA
Sterilization	Yes
(Ethylene Oxide)	Yes
(Ethylene Oxide)	Yes
(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.

4

Капек

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

TEL:(800)526-3522 FAX:(212)705-4350

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.

5

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.

6

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 (800) 638-2041 or (301) 796-7100 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

7

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)

A. An

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