The Crawford Bicanaliculus Intubation stents are intended for use for nasolacrimal intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Crawford Bicanaliculus Intubation are:

. Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
During dacryocystorhinostomy .
Congenital lacrimal duct obstruction .

Device Description

The Crawford Bicanaliculus Intubation is a bicanalicular intubation device that consists of a silicone tube that is attached at each end to a flexible metallic Crawford probe. The Crawford Bicanaliculus Intubation comes in a single length of 310 mm and is provided as a sterilized product.

AI/ML Overview

The provided text describes a 510(k) Summary for the Crawford Bicanaliculus Intubation device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or AI-related metrics.

Therefore, many of the requested categories (e.g., acceptance criteria, reported performance, sample size for test set, ground truth methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Material Equivalence: Silicone tube and flexible metallic Crawford probes are identical or very similar in grade/construction to predicate devices.	The Crawford Bicanaliculus Intubation manufactured by FCI SAS and the Crawford Probe Intubation Set (primary predicate) have "slightly different grades of silicone tube and stainless steel," but the "Mono-Crawford Naso-Lacrimal Intubation Device is constructed of an identical silicone and stainless steel grade." All three have "identical medical grade silicone tube" or "very similar grade of silicone" for the stent body.
Intended Use Equivalence: Same indications for use as predicate devices.	Intended use for nasolacrimal intubation in patients 12 months and older for canalicular pathologies, during dacryocystorhinostomy, and congenital lacrimal duct obstruction is identical to predicate devices (implied by substantial equivalence claim).
Basic Design Concept Equivalence: Similar form and function.	Described as a bicanalicular intubation device consisting of a silicone tube attached to flexible metallic Crawford probes, which is consistent with the general description of the predicate devices.
Dimensions Equivalence: Similar size.	Comes in a single length of 310 mm, which is implied to be similar to predicate devices to maintain substantial equivalence.
Sterilization Methods Equivalence: Same sterilization method.	All three devices are ethylene oxide sterilized.
Biocompatibility Equivalence: Biocompatible materials.	Biocompatibility of silicone raw materials and finished device was tested to applicable standards and met required specifications, aligning with predicate device claims.
Nonclinical Test Performance: Met established specifications for material properties.	Tensile strength tests performed before and after sterilization met established specifications. Technology transfer was validated.
Shelf-life and Storage Validation: Supported by studies.	Ethylene oxide sterilization validation studies and package integrity studies were performed according to applicable standards, supporting shelf-life and storage conditions.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. This submission relies on "substantial equivalence" to legally marketed predicate devices, not on a clinical test set with human subjects or data provenance in the way an AI/diagnostic device would. The "tests" mentioned are non-clinical (tensile strength, biocompatibility, sterilization validation).

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):

Not applicable/Not provided. No clinical test set with ground truth established by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. No clinical test set requiring adjudication is described.

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:

Not applicable/Not provided. This is a physical medical device (stent/probe), not an AI diagnostic tool. No MRMC studies were conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests, the "ground truth" was established by engineering specifications and applicable standards for material properties (tensile strength, biocompatibility) and process validation (sterilization, package integrity). There is no "expert consensus," "pathology," or "outcomes data" in the clinical sense for these tests. The ultimate "ground truth" for regulatory approval is the demonstration of substantial equivalence to already approved predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. This is a physical medical device. The concept of a "training set" is not relevant here.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As above, no training set or corresponding ground truth is relevant for this device.

Summary

{0}------------------------------------------------

Crawford Bicanaliculus Intubation (FCI SAS) 510(k) Summarv

KI21142

Page 1 of 2

9 2012 AUG

5. 510(k) Summary as required by 21 CFR8807.92(c) 510(k) Owner: FCI SAS (France Chirurgie Instrumentation) 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: July 2, 2012 Trade Name: Crawford Bicanaliculus Intubation Common name: Bicanalicular Nasal Probe Bicanalicular Nasal Intubation Set Classification Name: Lacrimal Stents and Intubation Sets Product Code: OKS

Identification of a Legally Marketed Predicate Device

The Crawford Bicanaliculus Intubation is substantially equivalent to the Crawford Probe Intubation Set marketed by FCI Ophthalmics, Inc, 510(k) Premarket Notification Number: K991238, FDA Product Code OKS; and, to the Mono-Crawford Naso-Lacrimal Intubation Device marketed by FCI Ophthalmics, Inc, 510(k) Premarket Notification Number: K061404, FDA Product Code OKS.

General Description

{1}------------------------------------------------

Crawford Bicanaliculus Intubation (FCI SAS) 510(k) Summary

Intended Use

. Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
During dacryocystorhinostomy .
Congenital lacrimal duct obstruction .

Comparison of Technological Characteristics

The Crawford intubation device was previously manufactured by a contract manufacturer and is now manufactured by FCI SAS. The Crawford Bicanaliculus Intubation manufactured by FCI SAS and the Crawford Probe Intubation Set manufactured by the contract manufacturer are identical in every respect except for the manufacturer and slightly different grades of silicone tube and stainless steel are used in the construction of each device. The Mono-Crawford Naso-Lacrimal Intubation Device is constructed of an identical silicone and stainless steel grade as the modified Crawford Bicanalicular Intubation device. All three devices have a stent body (tube) that is manufactured from an identical medical grade silicone tube (modified Crawford and Mono-Crawford) or from a very similar grade of silicone (Crawford primary predicate). The silicone used in the modified Crawford Bicanaliculus Intubation and Mono-Crawford is purchased as a silicone tube, which is then cut, and the gluing method is the same for these two devices. The silicone used in the Crawford primary predicate is extruded and then cut, and the gluing method is similar to the Crawford Bicanaliculus Intubation and Mono-Crawford. All three devices are ethylene oxide sterilized and provided in similar packaging. The stainless steel materials used in each device are medical grade with well characterized mechanical and biocompatibility properties.

Brief Summary of NonClinical Tests and Results

The technology transfer was validated, and demonstrated the capacity of FCI to manufacture the Crawford Bicanaliculus Intubation. Tensile strength tests were performed on samples before and after sterilization to validate the change in silicone grade and gluing method for the Crawford Bicanaliculus Intubation. All nonclinical test results met the established specifications for the device. The biocompatibility of the silicone raw materials and finished device was tested to the applicable standards and met required specifications. Ethylene oxide sterilization validation studies and package integrity studies were performed according to the applicable standards; and, the test results support the shelf-life and storage conditions for the device.

Basis of Substantial Equivalence

The Crawford Bicanaliculus Intubation is substantially equivalent to the Crawford Probe Intubation Set and to the Mono-Crawford Naso-Lacrimal Intubation Device in material, intended use, basic design concept, dimensions, sterilization methods, and biocompatibility, and which are all manufactured by (or for) FCI SAS and distributed in the U.S.A. by FCI Ophthalmics, Inc.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with three wing segments, symbolizing health, services, and human. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 9 2012

France Chirurgie Instrumentaion SAS c/o Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 3308 Jefferson Ave., Upper Level Cincinnati, OH 45220

Re: K121142

Trade/Device Name: Crawford Bicanaliculus Intubation Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OKS Dated: July 2, 2012 Received: July 3, 2012

Dear Dr. 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. 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

{3}------------------------------------------------

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4. Indications for Use Statement

510(k) Number (if known):

-Device-Name: -- Crawford-Bicanaliculus-Intubation-

Indications for Use:

Canalicular pathologies (e.g., congenital or ac quired stenosis, lacerations) .
During dacryocystorhinostomy .
Congenital lacrimal duct obstruction .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of GBRH, Office of Device Evaluation (ODE)

annarally

C (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page 1 of

510(k) Number K121142

Regulation Number and Section

N/A