(126 days)
The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
The CRE™ Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.
A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.
Here's an analysis of the provided text regarding the CRE Dilatation Balloon, focusing on the acceptance criteria and the study used to demonstrate its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical/Physical Performance | Meets required specifications for all components, subassemblies, and/or full devices. | "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." | The specific "required specifications" are not detailed in the document. This is a general statement that the device passed internal benchmarks. |
| Safety and Effectiveness | Supports the safety and effectiveness for indicated uses (dilation of strictures of the biliary tree and Sphincter of Oddi). | "A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE™ Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy." | The device's safety and effectiveness were supported by reviewing existing clinical literature, implying no new clinical trials were conducted for this 510(k) submission. |
| Substantial Equivalence | Identical in design, materials, and manufacturing processes to a predicate device. | "The proposed CRE™ Wireguided Balloon Dilatation Catheter is identical in design, materials, and manufacturing processes to the predicate CRE™ Wireguided Balloon Dilatation Catheter (K110833)." | This is a primary acceptance criterion for 510(k) clearances. The device is claimed to be identical to a previously cleared model for these key aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for a test set involving the new CRE™ Wireguided Balloon Dilatation Catheter. The primary performance demonstration relies on in-vitro testing and a clinical literature search.
- Data Provenance:
- In-vitro testing: Performed internally by Boston Scientific Corporation. No country of origin is specified, but it can be inferred as originating from the manufacturer's own labs. This is typically prospective in nature for a new device's engineering verification.
- Clinical Literature Search: This implies the use of existing published data from various sources (not specified). This would be retrospective data from prior studies on similar devices or the predicate device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The document does not describe a clinical study where a "test set" with ground truth established by experts was used for the new device. The clinical literature review likely synthesized findings from multiple studies, where individual studies might have involved expert assessments, but this is not broken down here. For the in-vitro testing, "ground truth" would be the engineering specifications and performance metrics.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical "test set" requiring expert adjudication is described for the new device itself beyond the literature review, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not performed for this 510(k) submission. The document relies on in-vitro testing and a clinical literature review for performance data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a medical instrument (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here. The device's performance is inherently tied to its physical interaction and use by a human clinician.
7. The Type of Ground Truth Used
- For the in-vitro testing: The ground truth would be defined by engineering specifications and performance criteria established prior to testing.
- For the clinical literature search: The "ground truth" is inferred from the collective findings and conclusions of the peer-reviewed scientific literature regarding the safety and effectiveness of similar dilatation catheters. This most closely aligns with expert consensus or outcomes data reported in those studies.
8. The Sample Size for the Training Set
- Not applicable. This 510(k) pertains to a medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not an AI/ML algorithm, there is no "training set" or corresponding ground truth establishment process to describe.
Summary of Device Performance Study:
The Boston Scientific CRE™ Wireguided Balloon Dilatation Catheter's performance demonstration for 510(k) clearance relied on two primary pillars:
- In-vitro testing: This involved laboratory tests to ensure the device components and assemblies met predefined engineering specifications. The specific tests or their results are not detailed, but the document states they "met the required specifications." This type of testing is fundamental for demonstrating the physical integrity and functional performance of a medical device.
- Clinical Literature Search: Instead of conducting new clinical trials, the manufacturer performed a literature review. This review compiled existing data and studies on similar or predicate devices to support the safety and effectiveness of balloon dilatation catheters for the specified indications (alimentary tract strictures, Sphincter of Oddi dilatation). This approach is common for 510(k) submissions, particularly when a new device is substantially equivalent to a well-established predicate.
The crucial aspect of this submission, explicitly stated, is that the proposed device is identical in design, materials, and manufacturing processes to a previously cleared predicate device (K110833). This "substantial equivalence" is the cornerstone of its clearance without extensive new clinical data.
§ 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.