(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.
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December 29, 2022
Boston Scientific Corporation Kerri Laplaca Principal Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, Massachusetts 01752
Re: K223592
Trade/Device Name: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: December 1, 2022 Received: December 1, 2022
Dear Kerri Laplaca:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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statutes and regulations administered by other Federal agencies. You must 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Je An-S" in a large, bold, sans-serif font. The letters are black against a white background. There is a faint watermark in the background, but it does not obscure the main text. The text appears to be a title or heading.
Je Hi An, PhD Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223592
Device Name
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Kerri LaPlaca Principal Regulatory Affairs Specialist Phone: (508) 382-0549 E-mail: kerri.laplaca@bsci.com
Date Prepared: December 2, 2022
2. Device
| Trade Name: | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX)Pancreatic Delivery System and Pushers |
|---|---|
| Common Name: | Stents, Drains, and Dilators for the Biliary Ducts |
| Product Code: | FGE |
| Device Class: | Class 2 |
| Device Panel: | Gastroenterology/ Urology |
| Classification Regulation: | 21 CFR 876.5010, Biliary catheter and accessories |
3. Predicate Device
4. Device Description
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
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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.
5. Indications for Use
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
6. Technological Characteristics
The proposed Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers is identical to the predicate device.
7. Substantial Equivalence
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers is identical to the predicate device. The purpose of this Special 510(k) is to update the MRI safety information in the product labeling to align with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021). The MRI safety status has not changed. The design requirements are not impacted by the labeling updates. Therefore, the subject is considered substantially equivalent to the predicate device.
8. Performance Data
Performance testing (bench) was completed to demonstrate with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021. The testing included the following:
· ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
· ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Maqnetic Resonance Environment
· ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
· ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
The performance (bench) testing demonstrated that the proposed Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers comply with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021, and are considered substantially equivalent to the predicate devices.
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9. Conclusion
Boston Scientific has demonstrated that the proposed Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers with updated instructions for use are compliant with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021, and is substantially equivalent to the currently marketed predicate device Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K133700).
§ 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.