(183 days)
No
The device description focuses on the physical components and materials of a catheter with a balloon, and there is no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is described as aiding in the removal of ductal stones and debris in the biliary tree, which is a therapeutic intervention.
No
The device's intended use is "to aid in the removal of ductal stones and debris," which describes a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, wire, silicone tube, balloon, luer connector, and packaging, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of stones and debris from the biliary tree during surgery. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for physical manipulation within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and interventional.
N/A
Intended Use / Indications for Use
The device is intended for intra-operative short term use in the biliary tree to aid in the removal of ductal stones and debris.
Product codes
78FGE
Device Description
The catheter consists of a single lumen stainless steel wire reinforced silicone lube that is end formed to create a rounded leading nose. A silicone balloon is bonded to the cather at the end form. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The "DEVICE" is packaged in an ErO breathable tray for protection and then sealed in an ErO breathable pouch. It is EtO sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only By or On the Order of a Physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510K NOTIFICATION PAGE 1 OF 18
MAY 1 0 1996
LMI BILIARY CATHETER
l
LUCAS MEDICAL, INC. 1751 S. DOUGLASS ROAD, ANAHEIM CA 92806
MAY 10 1996
SIUK SUMMARY
PURPOSE: Pursuant to the Federal Food, Drug, and Cosmetic Act, as amended May 28, 1976, Section 510(k), please consider the attached document as Lucas Medical, Inc. 's notification of introduce the LMI Biliary Catheter for commercial distribution. The common names for the device are silicone Biliary catheter,
BACKGROUND: This 510K submission should be considered as a new application. On March 17, 1995, a 510K was submitted for this product and was issued a reference number of K951310. Additional information was requested on April 4. 1995. In accumulating the data to answer the questions raised, the extension time allotted by the FDA expired. This new STOK submission addresses those earlier questions.
MANUFACTURING & STERILIZATION SITES: The manufacturing and packaging facility is: Lucas Medical Inc., 1751 S. Douglass Road. Anaheim CA 92806. The establishment registration number is: 2029386. Sterilization will be performed by Griffith MicroScience (Establishment Registration Number: 2011/71) 4900 S. Gilford, Los Angeles CA 90058.
DESCRIPTION: The catheter consists of a single lumen stainless steel wire reinforced silicone lube that is end formed to create a rounded leading nose. A silicone balloon is bonded to the cather at the end form. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The "DEVICE" is packaged in an ErO breathable tray for protection and then sealed in an ErO breathable pouch. It is EtO sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only By or On the Order of a Physician.
CLASSIFICATION: The "DEVICE" is a Class II Medical device and has a classification number of 78FGE and is reviewed it the Gastroenterology and Urology Review Panel.
INTENDED USE: The device is intended for intra-operative short term use in the biliary tree to aid in the removal of ductal stones and debris.
PRINCIPLE OF OPERATION: Biliary catheters are generally used in surgical procedures for removal of gall stones in the biliary duct. Access to the bile duct is made through the choledochotomy. The cather is inserted into the bile duct and advanced beyond the region where stones and debris are present. The balloon is carefully inflated to occlude the bile duct while not overly distending it, and then gently withdrawn to push the stones and debris out of the access point. Once the bile duct has been cleared, the remaining choledochotomy is surgically closed.
SUBSTANTIAL EQUIVALENCE: The "DEVICE" is substantially equivalent to the ABI Cathlab Silicone Biliary Catheter which was approved under 510(k) notification KV10917. The design parameters and intended use of the "DEVICE" are the same as the substantially oquivalent catherer "The "DEVICE" utilizes the same materials of construction and packaging as the substantially equivalent catherer