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The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.

The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.

Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs.

The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.

There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

This document describes the performance testing and acceptance criteria for the "Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible" (Device Name: Retrieval Balloon Catheter), submitted under 510(k) K211021.

It is important to note that this submission does not involve Artificial Intelligence (AI) or machine learning. Therefore, information concerning human reader improvement with AI, standalone algorithm performance, or training set details are not applicable to this medical device submission. The device is a physical medical instrument, not a diagnostic AI tool.

1. Acceptance Criteria and Reported Device Performance

The submission states that "Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device."

While specific numerical acceptance criteria and precise performance values are not detailed in this public summary, the document indicates that the following tests were conducted and the proposed device met the acceptance criteria and supported substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes for each of the bench tests, shelf-life tests, or biocompatibility tests. It states that "Performance testing was conducted" and "results of the tests below were evaluated as substantially equivalent."
• Data Provenance: The tests are described as bench tests and laboratory evaluations conducted by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., which is located in Nanjing, Jiangsu Province, China. The data is retrospective in the sense that it was collected prior to the submission for regulatory review. It is not patient or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

This is not applicable as the described tests are laboratory-based performance and safety evaluations of a physical medical device, not a diagnostic AI tool requiring expert image interpretation or clinical consensus for ground truth. The "ground truth" for these tests relates to engineering specifications, material properties, and biological safety standards. These are established by validated test methods and established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like "2+1" or "3+1" are relevant for establishing ground truth in clinical data (e.g., for diagnostic accuracy studies involving human readers or AI), not for bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance.

This is not applicable. This submission is for a physical medical device (Retrieval Balloon Catheter) and does not involve AI or machine learning. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. As stated, this device is a physical medical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations of this device is based on:

• Engineering Specifications: Meeting predefined dimensional tolerances, force requirements, fluid flow rates, and fatigue limits.
• International Standards: Compliance with recognized standards such as ISO 11607 (packaging), ISO 11135 (sterilization), and ISO 10993 (biocompatibility).
• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is demonstrating substantial equivalence to a legally marketed predicate device (Extractor™ Pro Retrieval Balloon Catheter cleared under K102082) in terms of technology, safety, and performance.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

This is not applicable. There is no "training set" to establish ground truth for.

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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.

This looks like a 510(k) summary for a medical device called a "Stone Retrieval Balloon Catheter." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain the information you requested about acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for a training set.

The document explicitly states: "No clinical study is included in this submission." This means there isn't a study proving the device's clinical performance against acceptance criteria in the way you've described for AI/diagnostic devices.

The "Non-Clinical Performance Testing" section lists various standards (e.g., ISO, ASTM, USP) that the device complies with, but it does not provide specific acceptance criteria (e.g., "sensitivity > 90%") or the results of meeting those criteria in the context of an AI-driven or diagnostic device study. The non-clinical tests are primarily focused on material properties, biocompatibility, sterilization, and packaging integrity, which are standard for this type of medical device.

Therefore, I cannot fulfill your request for these particular details based on the provided text, as this document pertains to a medical device clearance application that relies on demonstrating substantial equivalence to a predicate device rather than a clinical performance study with AI components.

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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

The subject Stone Retrieval Balloon is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some models, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some models, the balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters, or 13mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with a outer diameter of 2.4mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. EO Sterilization and use for single use only.

The provided document is a 510(k) Premarket Notification for a Stone Retrieval Balloon. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML device performance. The performance data provided is related to bench testing to demonstrate substantial equivalence to a predicate device, not, for example, the performance of an AI algorithm in image interpretation.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device described is a physical medical instrument (a stone retrieval balloon) used for endoscopic removal of biliary stones. There is no mention of any artificial intelligence, machine learning, or software component that would involve image analysis, diagnostic capabilities, or human-AI interaction.
• Focus on Substantial Equivalence: The entire 510(k) submission is built around demonstrating that the "Stone Retrieval Balloon" is substantially equivalent to existing predicate devices (Tri-Ex Extraction Balloon and 3-Lumen Extraction Balloon). This involves comparing technical characteristics, materials, and bench performance, not the diagnostic accuracy or efficacy of an AI system.
• Performance Data: The "Performance Data" section (5.8) explicitly states: "The Stone Retrieval Balloon meets all design specifications and medical for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to physical and material properties, not AI performance metrics.
• No Clinical Test: Section 5.9 explicitly states: "No Clinical test is included in this submission." This further reinforces that there isn't a study proving a specific performance metric against a clinical outcome or ground truth in the way an AI/ML device would be evaluated.

In summary, the provided document does not describe the acceptance criteria or a study that proves an AI/ML device meets those criteria, as the device in question is a physical medical instrument without an AI/ML component.

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