(106 days)
These instruments have been designed to be used with Olympus endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.
The Single Use 3-Lumen Extraction Balloon V, model B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A and B-V443Q-B is a balloon catheter, included three kinds of premeasured syringe, to endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.
The provided document is a 510(k) summary for a medical device called "Single Use 3-Lumen Extraction Balloon V". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study against specific acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this type of submission.
However, I can extract the information that is present and highlight what is missing based on your request.
Analysis of the Provided Document:
The document describes a medical device seeking 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the new device is at least as safe and effective as a legally marketed predicate device (i.e., it is "substantially equivalent"). The emphasis is on comparing the new device's characteristics to a predicate, not on proving performance against predefined acceptance criteria from a clinical trial.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide specific quantitative acceptance criteria or a "reported device performance" table in the context of a clinical study. Instead, it demonstrates "substantial equivalence" by comparing the new device's specifications to a predicate device. The "performance" is implied by the similarity to the predicate and the lack of significant changes that would affect safety or effectiveness.
| Characteristic Compared | Predicate Device (B-230Q-A, B-230Q-B from K033333, and K063677 for 20mm balloon) | Subject Device (B-V2xxP/Q, B-V4xxP/Q) | Implied "Acceptance" / Basis for Equivalence |
|---|---|---|---|
| Intended Use | Endoscopically remove stones, remove bile sludge, facilitate contrast injection into biliary system | Endoscopically remove stones, remove bile sludge, facilitate contrast injection into biliary system | Identical intended use. This is a primary criterion for substantial equivalence. |
| Method of Operation | Not explicitly detailed, but implied to be standard balloon catheter operation | Not explicitly detailed, but implied to be standard balloon catheter operation | "does not incorporate any significant changes in ... method of operation." |
| Materials | Not explicitly detailed | Not explicitly detailed | "does not incorporate any significant changes in ... material." |
| Design | Over-the-wire type guidewire port (for B-230Q-A/B) | Changes: |
- Guidewire port structure: "Over the wire type" (P-models), "Monorail type" (Q-models)
- Maximum diameter of balloon: $\phi$ 15mm (P/B-V2xxQ models), $\phi$ 20mm (P/B-V4xxQ models). (Predicate had $\phi$ 15mm with $\phi$ 20mm cleared via K063677)
- Max outer diameter of sheath: $\phi$ 2.7mm (B-V233P), $\phi$ 3.2mm (B-V433P), $\phi$ 2.9mm (B-V243Q), $\phi$ 3.2mm (B-V443Q) vs $\phi$ 2.55mm (Predicate)
- Compatible channel diameter: $\phi$ 2.8mm or larger (B-V233P) / $\phi$ 3.2mm or larger (B-V433P/B-V243Q/B-V443Q) vs $\phi$ 2.8mm or larger (Predicate)
- Working Length: 1900mm (P-models) vs 1950mm (Predicate)
- Structure for attaching to endoscope (Hook): Provided (Subject) vs Not provided (Predicate)
- Pre-measured syringes: Different volumes for inflation (listed in table) | "does not incorporate any significant changes in ... design that could affect the safety or effectiveness of the device." The identified changes in design (guidewire port, balloon diameter, sheath diameter, working length, hook) are considered not to impact safety or effectiveness such that new clinical data would be required. The larger balloon diameter was previously cleared for the predicate family. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not describe a clinical "test set" or a clinical study with a sample size for performance evaluation. The submission is based on engineering and performance testing to demonstrate substantial equivalence, not a clinical trial.
- Data Provenance: Not applicable, as no clinical test set data from patients is presented.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided as the submission does not involve a clinical study requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
- This information is not provided as no clinical test set or adjudication process is described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- An MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. This type of study is typically for diagnostic imaging devices involving human interpretation, which is not the case for an extraction balloon catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this device. An extraction balloon catheter does not have an "algorithm-only" or "standalone" performance in the way a diagnostic AI algorithm would. Its performance is mechanical and procedural when used by a human operator.
7. The Type of Ground Truth Used
- This information is not provided as the submission relies on engineering design specifications, biocompatibility, sterilization validation, and non-clinical performance testing (e.g., burst pressure, force to fracture, dimensional accuracy) rather than clinical ground truth (pathology, expert consensus, outcomes data) derived from patient studies. The "ground truth" here is compliance with engineering standards and comparison to a legally marketed predicate.
8. The Sample Size for the Training Set
- This information is not applicable. This is a medical device (catheter) and not an AI or machine learning algorithm that typically uses a "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 8.
Summary of 510(k) Approach in this Document:
This 510(k) submission relies on a "traditional" substantial equivalence pathway. The manufacturer asserts that the new device shares the same intended use and fundamental scientific technology as the predicate device. Any differences in technological characteristics (e.g., guidewire port type, balloon diameter options, sheath diameter, working length, presence of a hook) are deemed not to raise different questions of safety and effectiveness, or that any questions raised are answered by existing scientific data or non-clinical performance testing (which would be referenced in the full 510(k) submission, though not detailed in this summary). The conclusion explicitly states that the new device "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This statement is the core "proof" of substantial equivalence from the manufacturer's perspective.
§ 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.