(365 days)
Not Found
Not Found
No
The summary describes a physical medical device (a catheter) and its intended use and performance characteristics. There is no mention of software, algorithms, image processing, AI, ML, or any data sets used for training or testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is described as treating patients with obstructive jaundice, sepsis, and hepatic decompression, which are conditions that require medical intervention, thus making the device therapeutic.
No
The device is a Percutaneous Biliary Drainage Catheter intended for treatment, not diagnosis. It's used for drainage and decompression, not for identifying a medical condition.
No
The device description clearly identifies the device as a "Percutaneous Biliary Drainage Catheter," which is a physical medical device, not software. The summary focuses on the physical characteristics and performance of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat patients with obstructive jaundice, sepsis, hepatic decompensation, and pre-operative decompression. This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a catheter designed for insertion into the bile duct. This is a medical device used for drainage, not for analyzing samples outside the body.
- Anatomical Site: The anatomical site is the bile duct and duodenum, which are internal organs within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is mechanical drainage.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Percutaneous Biliary Drainage Intended Use: Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.
Product codes
Not Found
Device Description
The proposed Percutaneous Biliary Drainage Catheter is identical to the predicate Navarre Locking Pigtail Universal Drainage Catheter in that they have identical tip-locking mechanisms. They differ only in the length of the distal ported section, catheter length, addition of a flexible cannula, number of drain holes, and the addition of a biliary septum to inject fluids into the bile duct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bile duct and duodenum
Indicated Patient Age Range
Not Found
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
Laboratory tests for cytotoxicity showed that the Percutaneous Biliary Drainage Catheter is non-cytotoxic. Qualification tests demonstrate that the physical characteristics of the catheter are equivalent to predicate devices. In conclusion, the laboratory results show that the Percutaneous Biliary Drainage Catheter design does not raise any new questions of safety and efficacy and that the Biliary Catheter is substantially equivalent to the current Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System. TM
Key Metrics
Not Found
Predicate Device(s)
Navarre Locking Pigtail Universal Drainage Catheter, Navarre Universal Drainage Catheter, Cook Ultrathane™ Biliary Drainage Catheter, Medi-tech VTCB Biliary System™
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
K955110
piyy
510(k) SUMMARY
A. Submitter Information
| Submitter's Name: Navarre Biomedical Ltd. | ||||||
|---|---|---|---|---|---|---|
| --------------------------------------------- | -- | -- | -- | -- | -- | -- |
Address: 2545 Fernbrook Lane North Plymouth, MN 55447
Telephone Number: 612/449-6131
Fax Number: 612/449-6101
Contact Person: Kelly Behrendt
Submission Preparation Date: November 2, 1995
B. Device Information
| Trade Name: | Navarre Percutaneous Biliary Drainage Catheter |
|---|---|
| Common Name: | Biliary Drainage Catheter |
| Classification | |
| Name: | Biliary Catheter (21 CFR 876.5010) |
| Predicate Device: | This 510(k) summary identifies the Navarre Locking |
| Pigtail Universal Drainage Catheter and the Navarre | |
| Universal Drainage Catheter, as substantially | |
| equivalent to the proposed Navarre Percutaneous | |
| Biliary Drainage Catheter. The Biliary Catheter is also | |
| substantially equivalent to the predicate Cook | |
| Ultrathane™ Biliary Drainage Catheter and the Medi- | |
| tech VTCB Biliary System™ designs. | |
| Device Description: | The proposed Percutaneous Biliary Drainage Catheter |
| is identical to the predicate Navarre Locking Pigtail | |
| Universal Drainage Catheter in that they have identical |
1
K955-110 P2 of 4
tip-locking mechanisms. They differ only in the length of the distal ported section, catheter length, addition of a flexible cannula, number of drain holes, and the addition of a biliary septum to inject fluids into the bile duct.
The intended use of the Percutaneous Biliary Drainage Intended Use: Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.
- C. Comparison of Required Technological Characteristics
The Percutaneous Biliary Drainage Catheter is substantially equivalent to the commercially-available Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System™. The Biliary Catheter differs technologically from Navarre predicates only in that it has a modified metallic reinforcement, a more flexible cannula, and a biliary septum. Testing showed that the Percutaneous Biliary Drainage Catheter does not raise any new questions of safety and effectiveness.
2
| Characteristics | Proposed
Navarre
Percutaneous
Biliary Drainage
Catheter | Predicate
Navarre
hydrophilic
Universal
Drainage
Catheter | Predicate Navarre
Locking Pigtail
Universal
Drainage Catheter | Predicate
Cook
Ultrathane
Biliary
Catheter | Predicate
Medi-tech
VTCB Biliary
System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------|
| a. Product
Labeling | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent |
| b. Intended Use | Obstructive
jaundice, sepsis,
hepatic
decompensation and
pre-operative
decompression | Nephrostomy,
abscess and general
drainage | Abscess, cyst, and
general purpose
drainage | Identical to
proposed
catheter | Identical to
proposed
catheter |
| c. Physical
Characteristics | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent |
| d. Anatomical Sites | Bile duct and
duodenum | Kidney and general
drainage sites | Abscessed sites | Identical to
proposed
catheter | Identical to
proposed
catheter |
| e. Target
Population | Patients with
obstructive
jaundice, sepsis and
hepatic
decompensation and
pre-operative
decompression | Patients requiring
kidney, abscess, or
other general
drainage
applications | Patients with
abscess and general
drainage needs | Identical to
proposed
catheter | Identical to
proposed
catheter |
| f. Performance
Testing | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent | Substantially
equivalent |
| g. Safety
Characteristics | Identical | Identical | Identical | Substantially
equivalent | Substantially
equivalent |
Comparison of Required Characteristics
.
3
- D. Summary of Nonclinical Tests
Laboratory tests for cytotoxicity showed that the Percutaneous Biliary Drainage Catheter is non-cytotoxic. Qualification tests demonstrate that the physical characteristics of the catheter are equivalent to predicate devices. In conclusion, the laboratory results show that the Percutaneous Biliary Drainage Catheter design does not raise any new questions of safety and efficacy and that the Biliary Catheter is substantially equivalent to the current Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System. TM