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ReShape Calibration Tubes™ are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The Gastric Balloon Suction Catheter is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The ReShape Calibration Tubes™ (Model B-2032, B-2040, and B-2017) and the Gastric Balloon Suction Catheter (Model B-2020) are manufactured by our company, ReShape Lifesciences. These catheters are flexible gastric tubes designed to be used in gastric and bariatic surgical procedures. The catheters provide visible and tactie delineation of the gastroesophageal (GE) junction and its location relative to the esophageal hiatus and antrum of the stomach. These devices provide the ability to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

This document is a 510(k) Premarket Notification from the FDA regarding ReShape Lifesciences' Calibration Tubes and Gastric Balloon Suction Catheter. It is a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria as requested in the prompt.

The document states:

• "There are no changes to the principle of operation or technological characteristics of the devices."
• "The minor differences between the predicate devices include the material change to the black length marking ink/paste printed on the outer shaft of the catheters. Other minor labeling updates include product name change, the addition of a general contraindication, and labeled shelf life, which have no impact on the substantial equivalence."
• "The final finished subject devices with the proposed design modification have been tested in accordance with applicable ISO 10993 standards and in compliance with 21 CFR Part 58, and concluded non-cytotoxic, non-sensitizing, and non-irritant."
• "The labeled shelf life of 7 years is supported by leveraging the shelf life data of Model B-2017 previously cleared under K220455 with appropriate rationale."
• "No bench testing, packaging study, usability study, or sterility are deemed applicable or necessary for these with proposed modifications."

This indicates that the modifications were minor and largely related to material changes and labeling, not a fundamental change requiring a new, extensive performance study as one might expect for a novel AI/software device. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than conducting new, large-scale clinical trials.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert involvement, MRMC studies, or training sets because the provided text does not contain this information. The document is a regulatory approval, not a detailed scientific study report.

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The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.

The Cook Gastric Sizing Balloon Catheter is a medical device and thus does not involve AI or algorithms, human readers, or image-based diagnostics. The provided context is a 510(k) premarket notification for a medical device, which outlines its substantial equivalence to an existing predicate device rather than presenting a study to prove its performance against specific acceptance criteria in the way an AI/algorithm would.

Therefore, many of the requested points are not applicable. Below is an interpretation of the available information in the context of a medical device submission, focusing on the available "Test Data" rather than an "acceptance criteria and reported device performance" as might be found for an AI model.

Acceptance Criteria and Reported Device Performance

• Analysis of Cuff Diameter Over Time
• Analysis of Cuff Pressure and Diameter at Various Inflation Volumes |
  | Biocompatibility | - Biocompatibility |
  | Overall Assurance | The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon. |

Study Information (Based on Available Data)

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "tests" were conducted, but does not specify sample sizes for these tests or the data provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, "ground truth" is typically established through direct physical measurements and standardized test procedures rather than expert consensus on interpretive data.
3. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting data (e.g., medical images) where there might be inter-reader variability. This is not relevant for the type of physical performance tests described for this device.
4. 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 versus without AI assistance: Not applicable. This device is a physical catheter, not an AI or algorithm, and does not involve human readers for interpretation in the context of its primary function.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical instrument, not an algorithm.
6. The type of ground truth used: For the mechanical performance tests, the ground truth would be the objective measurements obtained from the physical testing (e.g., actual burst volume, measured diameter and pressure at various inflation volumes). For biocompatibility, the ground truth would be established by standard biological assays and tests confirming the material's safety for contact with human tissue.
7. The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set." Device development involves iterative design and testing, but not in the machine learning sense of a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation:

The Cook Gastric Sizing Balloon Catheter's substantial equivalence was established by comparing it to a predicate device (Gastric Balloon Suction Catheter by BioEnterics, K002838) based on similar indications for use, materials of construction, and technological characteristics. The provided "Test Data" primarily focuses on physical performance characteristics and biocompatibility, as expected for a physical medical device. These tests were conducted to "assure reliable design and performance under the specified testing parameters" and to provide "reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon."

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