(269 days)
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.
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.
This document is a 510(k) summary for the KANEKA LACRIFLOW lacrimal stent. It establishes substantial equivalence to predicate devices and focuses on bench testing and biocompatibility rather than performance metrics from clinical studies.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a comparative table of quantitative performance metrics for the device (e.g., success rates, complication rates) against specific acceptance criteria. Instead, it focuses on demonstrating that the device meets in-house standards and comparing physical characteristics with predicate devices.
The bench testing section mentions two specific tests:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength of the Lacrimal duct tube: Met acceptable minimum force until breakage according to in-house standard. | 14.2 N (Average of 9 samples) (Compared to predicate: 3.56 N and 1.98 N) |
| Stiffness of the Bougie: Met acceptance criteria according to in-house standard. | Specific numerical values are not provided, only a statement of conformance. |
It's important to note that "in-house standard" implies internal benchmarks, not necessarily publicly defined or clinically validated thresholds. The document asserts that "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."
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided document.
- For the Tensile Strength of the Lacrimal duct tube, a sample size of "9 samples" is mentioned.
- For the Stiffness of the Bougie, no sample size is given.
- The document describes bench testing, which typically does not involve human data or data provenance like country of origin or retrospective/prospective collection methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document discusses bench testing and not clinical studies that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes bench testing and not clinical studies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and basic performance, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of an algorithm is not applicable here, as the device is a physical medical device (stent), not an AI algorithm.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" was established by in-house standards and direct measurement of physical properties. This is not clinical ground truth like pathology, expert consensus, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. As the device is a physical stent and the evaluation is based on bench testing and material properties, there is no "training set" in the context of an algorithm or model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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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
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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.
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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 PROBEINTUBATION SETS(K991238) | SELF RETAININGBICANALICULUSINTUBATION SET(K041869) | |
|---|---|---|---|
| Indications for Use | The LACRIFLOW isindicated in treatmentsof epiphora in patients12 months and older, incases of:-Canalicular pathologies(stenosis, obstruction,lacerations),-DuringDacryocystorhinostomy(conventional or laser),-Congenitalnasolacrimal ductobstruction. | BICANALICULARINTUBATION SETSare indicated intreatments of epiphorain infants or adults,particularly in cases of:-Canalicular pathologies(stenosis, obstruction,lacerations),-Dacryocystorhinostomy(conventional or laser),-Imperforation of thenasolacrimal duct in theinfant. | Bicanalicularintubationis indicated intreatments of epiphorain adults (not to beused in infants),particularly in casesof:-Meatic pathologies(meatic atresia)-Canalicularpathologies(canalicular stricture). |
| Tube Material | Polyurethane resin | Silicone | Silicone |
| Tube Shape | Two tubes areconnected by a rodpart | One tube | Two tubes areconnected by a rodpart |
| Size of the Tube | |||
| - Length | Standard type: 105 mmShort type: 90 mmMini type: 50 mm | Mini: 309.7mmMaxi: 311.15mm | S1-1290u: 25mmS1-1291u: 30mmS1-1292u: 35mm |
| -Outer Diameter | Tube part: 1.0 mmRod part: 0.7 mm | 0.64 mm | 0.64 mm |
| Tensile Strength ofthe Tube | 14.2 N (Average of 9samples) | 3.56 N (Average of 3samples) | 1.98N (Average of 3samples) |
| Insertion Method | The LACRIFLOWconsists of the tube andthe Bougie, and thus theBougie is used forinsertion. | BICANALICULARINTUBATION SETSare composed of a tubeconnected to a steelguide at each end, andthus the steel guide isused for insertion. | The tube has flexiblesilicone anchor-shapedheads, and thus aforceps is used forinsertion. |
| InsertionParts Assist | The Bougie | The steel guides at bothends | NA (assisted by aforceps) |
| -Length | 55 mm | Mini: 108 mmMaxi: 115 mm | NA |
| -Outer Diameter | 0.5 mm | 0.38 mm | NA |
| -Tip Shape | Straight, helicallygrooved | 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
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.
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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.
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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 (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
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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)
- A. An
Division of Neurological and Physical
Medicine Devices
510(k) Number K120886
N/A