(115 days)
Not Found
No
The summary describes a physical medical device (a silicone tube with metallic probes) and its intended use and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is used to treat various canalicular pathologies and lacrimal duct obstructions, which directly addresses medical conditions.
No
Explanation: The device, the Crawford Bicanaliculus Intubation, is described as a "bicanalicular intubation device" used for nasolacrimal intubation to address conditions like canalicular pathologies or congenital lacrimal duct obstruction. It is a therapeutic or interventional device designed to treat or manage a condition, not to diagnose it.
No
The device description clearly states it is a "bicanalicular intubation device that consists of a silicone tube that is attached at each end to a flexible metallic Crawford probe," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Crawford Bicanaliculus Intubation is a physical device used to intubate the nasolacrimal duct. It is inserted into the body to maintain patency or facilitate drainage.
- Intended Use: The intended use describes a surgical procedure (nasolacrimal intubation) to address anatomical issues (stenosis, lacerations, obstruction) or as part of another surgical procedure (dacryocystorhinostomy). This is a therapeutic or procedural use, not a diagnostic test performed on a sample.
The device is a surgical instrument used in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
N/A
Intended Use / Indications for Use
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 .
Product codes (comma separated list FDA assigned to the subject device)
OKS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasolacrimal
Indicated Patient Age Range
12 months of age 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)
NonClinical Tests: 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.
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
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
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.
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Crawford Bicanaliculus Intubation (FCI SAS) 510(k) Summary
Intended Use
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 .
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.
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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
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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
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4. Indications for Use Statement
510(k) Number (if known):
-Device-Name: -- Crawford-Bicanaliculus-Intubation-
Indications for Use:
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 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
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510(k) Number K121142