Search Results

The Boehringer Laboratories Gastric Sizing Tube is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

The Boehringer Laboratories Gastric Sizing Tube is a single patient use, non-sterile device which consists of a 76 cm long, thermoplastic elastomer (Styrene-Ethylene-Styrene) tube of either 32 French, 36 French, or 40 French diameter, with a low density polyethylene (LDPE) slide valve-connector at the proximal end of the tube. The tube has multiple holes and a rounded end, distal from the slide valve, and contains a stainless steel support spring inside the lumen of the tube at the distal end. The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The slide valve is used to switch between open for suction/irrigation and closed/vent. The tube serves as a sizing guide.

Here's an analysis of the provided 510(k) summary regarding the Boehringer Laboratories Gastric Sizing Tube, focusing on the acceptance criteria and the study (or lack thereof) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily focused on equivalence to predicate devices and adherence to established standards for medical devices and biocompatibility. The performance reported is that the device meets or exceeds these criteria, primarily through non-clinical bench testing.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. The tests are described as performance testing and primarily involve bench testing of the device itself (e.g., dimensional analysis, strength tests).
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or engineering setting, not on patients. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective). The studies are inherent to the device's design and manufacturing process.

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

• This section is not applicable to this 510(k) submission. The "ground truth" for the non-clinical performance tests is based on engineering specifications, recognized international standards (like ISO 80369-1, ISO 10993-5, ISO 10993-10), and comparisons to predicate device characteristics. There's no mention of expert consensus required to establish the truth for, for example, a tube's burst strength or material biocompatibility, as these are objectively measurable against defined standards.

4. Adjudication Method for the Test Set

• This section is not applicable. Adjudication typically refers to expert review in clinical studies to resolve disagreements in interpretations or diagnoses. Here, the testing is objective and based on engineering and biocompatibility standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study evaluates how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance, which is not relevant for a gastric sizing tube. The submission is for a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• No, a standalone (algorithm only) study was not done. This device is a physical, non-AI medical instrument. The concept of an "algorithm only" performance study is not applicable here.

7. The Type of Ground Truth Used

• The "ground truth" for the performance criteria is derived from:
  • Engineering Specifications: Designed physical boundaries and performance targets for the device.
  • International Standards: Compliance with recognized standards such as ISO 80369-1 for connectors and ISO 10993 series for biocompatibility.
  • Predicate Device Characteristics: The characteristics of the legally marketed predicate devices serve as a benchmark for equivalence in terms of function and safety profile.

8. The Sample Size for the Training Set

• This section is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• This section is not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” that proves the device meets the acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing. This testing demonstrates that the Boehringer Laboratories Gastric Sizing Tube's physical and material properties meet established engineering standards, regulatory requirements, and are comparable to (or better than) the predicate devices it claims substantial equivalence to.

The non-clinical tests included:

• Dimensional Analysis
• Valve-Connector to Tube Joint Strength Test
• Tube Distal End Kink Test
• Support Spring to Tube Stability Test
• Age Test
• ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General Requirements Compliance
• Suction Tubing Fitting Connector Test

Additionally, biocompatibility studies were conducted:

• Cytotoxicity study per AAMI/ANSI/ISO 10993-5: 2009
• Intracutaneous study per AAMI/ANSI/ISO 10993-10: 2010
• Maximization Sensitization study per AAMI/ANSI/ISO 10993-10: 2010

The conclusion states that based on the intended use, technological characteristics, and performance testing, the device is "as safe, as effective, and performs as well as the predicate devices," thereby meeting the criteria for substantial equivalence.

Ask a specific question about this device