(246 days)
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).
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.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called RITLENG®+ and RITLENG®+ PVP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the same way one might describe a novel diagnostic AI algorithm.
Therefore, the information about acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission, where the "study" is primarily a non-clinical comparison and testing against established specifications and predicate device characteristics.
Here's the breakdown based on the provided text:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The RITLENG®+ device is a bicanalicular lacrimal stent. For a 510(k) submission, the "acceptance criteria" are predominantly related to the device's technical specifications, safety, and functionality being comparable to a predicate device, as well as meeting relevant standards. The "study" refers to the non-clinical tests performed to demonstrate this equivalence and performance.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device | "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." |
| Material Biocompatibility | Meets ISO 10993 standards and comparable to predicate device material | "The implant part of both devices is made from the identical grade silicone... The biocompatibility of the device is supported by cytotoxicity testing per ISO 10993-5, three sets of chemical characterization testing ... per ISO 10993-18, and toxicological risk assessment." Also supported by "biocompatibility information of the materials used in the subject device to the materials used in the cleared predicate." |
| Sterilization | Achieves SAL 10-6 via Ethylene Oxide (EO) | "Both devices are packaged in a double Tyvek pouch and sterilized by Ethylene Oxide to a sterility level of SAL 10-6." "Ethylene oxide sterilization specifications... were performed to the applicable standards." |
| Wettability (Optional Feature) | Comparable to predicate device's coated option | "The silicone tube of both devices may be coated with polyvinylpyrrolidone (PVP) to improve its wettability." |
| Physical Design/Functionality | Meets established specifications for new features (self-retaining) and overall function | "RITLENG®+ has been designed and tested to the applicable standards. All nonclinical test results met the established specifications for the device." "The results from non-clinical testing demonstrate RITLENG®+ meets the established specifications for the device..." |
| Packaging & Shelf-Life | Meets applicable standards | "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." |
| Manufacturing Quality Control | In-process and final product controls assure manufacturing within specifications | "In-process controls and final product quality controls, including finished product release testing and inspection, assure that RITLENG®+ is manufactured within specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of clinical data for an AI/diagnostic device. The "tests" mentioned are non-clinical bench tests (e.g., cytotoxicity, chemical characterization, sterilization efficacy, material testing, package integrity, stability studies). Therefore, terms like "sample size," "data provenance," "country of origin," and "retrospective/prospective" are not applicable in the way they would be for a clinical study on human subjects or an AI product's performance. The "samples" for testing would be units of the device itself or its constituent materials. The provenance of this physical testing data is from the manufacturer (FCI SAS) and the testing laboratories they contracted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The ground truth for non-clinical tests is based on scientific and engineering standards and validated test methodologies, not expert consensus in a medical diagnostic sense. For example, "ground truth" for cytotoxicity is determined by cell viability assays against established thresholds, not by a panel of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" requiring expert adjudication in the context of this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is a conventional medical device (lacrimal stent), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a conventional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is primarily based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility), validated test methods, and comparison to the characteristics of the predicate device. For instance:
- Biocompatibility: Results of cytotoxicity, chemical characterization tests against established safety thresholds.
- Sterility: Absence of microorganisms to a sterility assurance level (SAL) of 10^-6, confirmed by validated sterilization processes.
- Physical Properties: Measurement of dimensions, material strength, etc., against predefined specifications.
- Intended Use: Direct comparison of the stated indications for use with the predicate device.
8. The sample size for the training set
This is not applicable. This is a conventional medical device, not an AI product that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable.
{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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| 510(k) Number: | K201892 |
|---|---|
| 510(k) Owner: | France Chirurgie Instrumentation SAS (FCI S.A.S.)20-22 rue Louis Armand75015 Paris, FranceTelephone:+33 1 53 98 98 98Facsimile:+33 1 53 98 98 99 |
| Contact Person: | Barbara S. Fant, Pharm.D.Clinical Research Consultants, Inc.3308 Jefferson AvenueUpper LevelCincinnati, OH 45220Phone:(513) 961-8200Facsimile:(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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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.
N/A