(246 days)
Not Found
No
The summary describes a physical medical device (a silicone tube with thread guides) for lacrimal duct intubation. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on physical and material properties, not algorithmic performance.
Yes
The device is used in the "treatment" of various canalicular pathologies and congenital duct obstructions, which directly addresses medical conditions.
No
The RITLENG®+ is described as a "self-retaining nasal bicanalicular intubation for the lacrimal ducts," used in the treatment of various lacrimal pathologies, not for diagnosis.
No
The device description clearly states it is a physical medical device consisting of a silicone tube, PEEK thread guides, and potentially a PVP coating. It is a physical intubation device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the treatment of lacrimal duct pathologies by physically intubating the ducts. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a physical tube designed for insertion into the lacrimal ducts. This aligns with a surgical or therapeutic device, not a diagnostic reagent or instrument used to analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the RITLENG®+ is a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of:
-
Canalicular pathologies (stenoses, obstructions, lacerations),
-
Congenital duct obstruction (Hasner valve stenosis),
-
Dacryocystorhinostomy (conventional or laser).
Product codes (comma separated list FDA assigned to the subject device)
OKS
Device Description
The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lacrimal ducts
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)
RITLENG®+ has been designed and tested to the applicable standards. All nonclinical test results met the established specifications for the device. In-process controls and final product quality controls, including finished product release testing and inspection, assure that RITLENG®+ is manufactured within specifications. The biocompatibility of the device is supported by cytotoxicity testing per ISO 10993-5, three sets of chemical characterization testing using different patient contacting device components per ISO 10993-18, and toxicological risk assessment based on these chemical characterization results. The biocompatibility of the subject device was also supported by biocompatibility information of the materials used in the subject device to the materials used in the cleared predicate. Ethylene oxide sterilization specifications, package integrity studies, and stability studies were performed to the applicable standards; and the test results support the shelf-life and storage conditions for the device.
The results from non-clinical testing demonstrate RITLENG®+ meets the established specifications for the device and that the test results and established specifications are substantially equivalent to those of the RITLENG® predicate device.
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.
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "FDA" is on top, followed by "U.S. FOOD & DRUG", and then "ADMINISTRATION" at the bottom.
March 11, 2021
FCI (France Chirurgie Instrumentation) SAS % Barbara S. Fant, Pharm.D. President Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati, OH 45220
Re: K201892
Trade/Device Name: Ritleng®+ and Ritleng®+ PVP Regulatory Class: Unclassified Product Code: OKS Dated: February 12, 2021 Received: February 16, 2021
Dear Barbara S. Fant:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201892
Device Name RITLENG®+ RITLENG®+ PVP
Indications for Use (Describe)
The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of:
-
Canalicular pathologies (stenoses, obstructions, lacerations),
-
Congenital duct obstruction (Hasner valve stenosis),
-
Dacryocystorhinostomy (conventional or laser).
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| 510(k) Number: | K201892 |
|---|---|
| 510(k) Owner: | France Chirurgie Instrumentation SAS (FCI S.A.S.) |
| 20-22 rue Louis Armand | |
| 75015 Paris, France | |
| Telephone: | |
| +33 1 53 98 98 98 | |
| Facsimile: | |
| +33 1 53 98 98 99 | |
| Contact Person: | Barbara S. Fant, Pharm.D. |
| Clinical Research Consultants, Inc. | |
| 3308 Jefferson Avenue | |
| Upper Level | |
| Cincinnati, OH 45220 | |
| Phone: | |
| (513) 961-8200 | |
| Facsimile: | |
| (513) 961-2858 | |
| Date: | March 4, 2021 |
| Trade Name: | RITLENG®+ |
| RITLENG®+PVP | |
| Common name: | Bicanalicular Lacrimal Stent |
| Classification Name: | Lacrimal Stents and Intubation Sets |
| Product Code: | OKS |
Identification of a Legally Marketed Predicate Device
RITLENG®+ is substantially equivalent to the RITLENG® intubation marketed by FCI Ophthalmics, Inc., 510(k) Premarket Notification Number K955671, FDA Product Code OKS.
General Description
The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.
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Intended Use
The RITLENG®+ products are indicated in the treatment of epiphora in patients of 12 months and older in cases of:
- Canalicular pathologies (stenoses, obstructions, lacerations). -
- Congenital duct obstruction (Hasner valve stenosis), -
- Dacryocystorhinostomy (conventional or laser). -
Comparison of Technological Characteristics
RITLENG®+ is substantially equivalent to the RITLENG® Intubation as both devices have the identical intended use and intubation method, with similar indications for use statements. The implant part of both devices is made from the identical grade silicone: and the silicone tube of both devices may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. Both devices are packaged in a double Tyvek pouch and sterilized by Ethylene Oxide to a sterility level of SAL 10-6.
The difference between the two devices is the addition of the two larger diameter portions of the silicone tube to the RITLENG® that create a self-retaining (autostable) feature when placed in the lacrimal ducts.
Based on this comparison, RITLENG®+ is substantially equivalent to the RITLENG® predicate device (K955671).
Brief Summary of Non-Clinical Tests and Results
RITLENG®+ has been designed and tested to the applicable standards. All nonclinical test results met the established specifications for the device. In-process controls and final product quality controls, including finished product release testing and inspection, assure that RITLENG®+ is manufactured within specifications. The biocompatibility of the device is supported by cytotoxicity testing per ISO 10993-5, three sets of chemical characterization testing using different patient contacting device components per ISO 10993-18, and toxicological risk assessment based on these chemical characterization results. The biocompatibility of the subject device was also supported by biocompatibility information of the materials used in the subject device to the materials used in the cleared predicate. Ethylene oxide sterilization specifications, package integrity studies, and stability studies were performed to the applicable standards; and the test results support the shelf-life and storage conditions for the device.
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The results from non-clinical testing demonstrate RITLENG®+ meets the established specifications for the device and that the test results and established specifications are substantially equivalent to those of the RITLENG® predicate device.
Basis of Substantial Equivalence
RITLENG®+ is substantially equivalent to the RITLENG® predicate device with respect to the intended use as a bicanalicular intubation device for the treatment of congenital lacrimal duct obstructions, and the biocompatibility of the medical grade silicone raw materials used to manufacture the device which are manufactured by FCI SAS and distributed in the USA by FCI Ophthalmics, Inc.