(81 days)
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.
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.
The provided document is a 510(k) premarket notification for the Lacriflow CL device. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (Lacriflow K120886). The primary focus of the document is to demonstrate "substantial equivalence" to the predicate device, especially considering modifications made.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this document is implicitly defined by demonstrating that the modified Lacriflow CL device performs comparably to the predicate Lacriflow (K120886) and that the modifications do not introduce new safety or effectiveness concerns. The performance is assessed through specific verification tests rather than against explicit numerical thresholds for clinical outcomes (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Penetration Test of Tip with Bougie (following elimination of stainless steel rings) | Performed (stated to meet verification tests). |
| Simulated Insertion Test (following change in tip shape) | Performed (stated to meet verification tests). |
| Bending Test for Tip (following change in tip shape) | Performed (stated to meet verification tests). |
| Inserting Load Measurement (following change in hydrophilic coating area) | Performed (stated to meet verification tests). |
| Visual Inspection for Extraneous Matter, Abnormality, Coating Droplet (following change in hydrophilic coating area) | Performed (stated to meet verification tests). |
| Overall substantial equivalence to predicate device (K120886) | Concluded that Lacriflow CL is substantially equivalent to Lacriflow (K120886) based on identical indications for use and satisfactory design verification tests. |
2. Sample Size for Test Set and Data Provenance
The document describes design verification tests. These are engineering/performance tests conducted on the device components or the device itself, not clinical studies involving human patients.
- Sample Size for Testing: For the "Tensile Strength of the Tube," the predicate device's performance is listed as "14.2 N (Average of 9 samples)." This is the only explicit sample size mentioned in relation to a performance characteristic. For the other "Performance tests" listed in Table 2, specific sample sizes are not provided in this document.
- Data Provenance: Not applicable as these are laboratory/engineering tests described, not clinical data from patients.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" here is defined by engineering specifications and comparative performance to the predicate device, verified through laboratory testing. There is no mention of experts establishing ground truth for a test set in the context of clinical, diagnostic, or interpretive performance.
4. Adjudication Method for Test Set
Not applicable. This is a technical performance assessment, not a clinical study requiring adjudicated interpretations of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a lacrimal stent, and the evaluation focuses on its physical and functional equivalence to a predicate device, not on diagnostic accuracy improvements with AI assistance for human readers.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or described. This device is a physical medical device, not an AI/algorithmic diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" for the evaluation described in this document is based on:
- Engineering Specifications and Performance Standards: The device's physical properties and functional performance (e.g., tip penetration, insertion load, bending strength, visual integrity) are evaluated against established engineering parameters and expectations for medical devices of this type.
- Predicate Device Performance: Comparison to the known performance and characteristics of the legally marketed predicate device (Lacriflow K120886) serves as a benchmark for substantial equivalence.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable. As there's no training set for an AI/machine learning model, this point is irrelevant.
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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
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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
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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) |
|---|---|
| -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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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 |
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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
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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 intreatments of epiphora in patients12 months and older, in cases of:-Canalicular pathologies(stenosis, obstruction,lacerations),-During Dacryocystorhinostomy(conventional or laser),-Congenital nasolacrimal ductobstruction. | |
| Prescription use | Yes | Yes | |
| Product Code | Same as the predicate | OKS | |
| Tube Shape | Same as the predicate | Two tubes areconnected by a rodpart | |
| Tip Shape | Pointed and no opening | Rounded and opening in bothends | |
| Hydrophilic coating | Surface of the device except thetip part is coated | Entire surface of the device iscoated | |
| Size of the Tube | |||
| - Length | Standard type: 105 mmShort type: 90 mm | Standard type: 105 mmShort type: 90 mmMini type: 50 mm | |
| -Outer Diameter | Same as the predicate | Tube part: 1.0 mmRod 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 thetube and the Bougie, and thus theBougie 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 |
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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:
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Table 2. Summary of design verification tests
| Modification | Performance test |
|---|---|
| Elimination of stainless steel rings on bothsides of the tube parts | Penetration test of the tip with the Bougie wasperformed. |
| Change in the shape of the tips of the lacrimalduct 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, coatingdroplet 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.
N/A