(183 days)
The device is intended for intra-operative short term use in the biliary tree to aid in the removal of ductal stones and debris.
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.
This 510(k) premarket notification describes a medical device, the LMI Biliary Catheter, which is a physical device used in a surgical procedure. Therefore, the questions related to AI/algorithm performance, ground truth, training/test sets, and expert review are not applicable in this context. These questions are typically relevant for AI/ML-based diagnostic or prognostic devices.
However, I can extract information related to the acceptance criteria and how the device meets them based on the provided text.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device. The performance is therefore demonstrated by showing that the new device is "the same" as the predicate device in key aspects.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to a Predicate Device (ABI Cathlab Silicone Biliary Catheter, K910917) | "The design parameters and intended use of the "DEVICE" are the same as the substantially equivalent catheter. The "DEVICE" utilizes the same materials of construction and packaging as the substantially equivalent catheter." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device submission, not an AI/ML-based device relying on a test set of data. The "testing" involves demonstrating manufacturing quality, material compatibility, and adherence to design specifications to show substantial equivalence.
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. Ground truth for an AI/ML model is not relevant to this physical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI-assisted diagnostic or prognostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable. This is not an AI/ML-based device.
9. How the ground truth for the training set was established
Not applicable.
{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
§ 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.