(28 days)
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):
• Used to drain pancreatic ducts
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers.
The pancreatic stents are provided in straight or single pigtail shapes. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on the application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end.
All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker are dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.
This K223592 submission is for a Special 510(k) to update the MRI safety information in the product labeling of the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers. The device itself is identical to its predicate, and therefore, an extensive clinical study to prove device performance in terms of its intended use (draining pancreatic ducts) was not conducted. Instead, the "acceptance criteria" and "study" described below relate specifically to demonstrating compliance with updated FDA guidance for MRI safety labeling.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (related to MRI Safety) | Reported Device Performance |
|---|---|
| Compliance with ASTM F2052 (Measurement of Magnetically Induced Displacement Force) | Demonstrated compliance with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, May 2021, which includes ASTM F2052. |
| Compliance with ASTM F2213 (Measurement of Magnetically Induced Torque) | Demonstrated compliance with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, May 2021, which includes ASTM F2213. |
| Compliance with ASTM F2182 (Measurement of Radio Frequency Induced Heating) | Demonstrated compliance with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, May 2021, which includes ASTM F2182. |
| Compliance with ASTM F2119 (Evaluation of MR Image Artifacts) | Demonstrated compliance with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, May 2021, which includes ASTM F2119. |
| Updated labeling aligns with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021). | Labeling was updated to align with the guidance. The MRI safety status has not changed. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission does not involve human or animal test subjects for its performance evaluation focusing on MRI safety. The "test set" would consist of the specific configurations and sizes of the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers that were subjected to the bench testing described. The document does not specify the exact number of devices tested, only that "Performance testing (bench) was completed." The data provenance is laboratory bench testing, not from any specific country or retrospective/prospective study with patients.
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)
This is not applicable to an MRI safety bench testing study. The "ground truth" for these tests are the established standards and methodologies outlined in the ASTM documents. Compliance is determined by whether the device's behavior during testing falls within the specified parameters of the ASTM standards, not by expert consensus on clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert review is needed to establish ground truth from patient data. This submission relies on standardized physical measurements and engineering evaluations.
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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant and delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on accepted engineering and physics principles as codified in specific ASTM standards for evaluating medical devices in the MR environment. These standards dictate acceptable limits for displacement force, torque, heating, and artifact generation.
8. The sample size for the training set
Not applicable. Since no AI/ML algorithm is involved, there is no training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.