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510(k) Data Aggregation
(110 days)
Lap-Band System Calibration Tube
The LAP-BAND® System Calibration Tube is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
The Lap-Band® System Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen Calibration Tube utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6-inch tubing with a stopcock for filling the balloon.
The provided text is a 510(k) summary for the ReShape Lifesciences Lap-Band System Calibration Tube. It describes the device, its indications for use, and the basis for substantial equivalence to a predicate device. The information required to answer your request, specifically regarding detailed acceptance criteria and the study that proves the device meets them, is primarily found in the "Performance Data" section.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Burst Test of Calibration Tube Balloon | The balloon must remain intact while inflated to four (4) times its recommend fill volume (25cc x 4 = 100cc). | Pass |
| Sensor Tip Force to Pull | The sensor tip (distal tip) must be 1.5 times greater than the acceptance criteria of the calibration balloon pull (1.5 x 13 = 19.5lbf). | Pass |
| Force to Remove StopCock | The stopcock must withstand a force of 1 lbf. | Pass |
| Pull Force of Bushing | The bushing must withstand a force of 1 lbf. | Pass |
| Pull force of Fill Tube | The fill tube adhesive joint must withstand a force of 1 lbf. | Pass |
| Adhesive Strength Balloon Pull | The balloon must withstand 13 lbf. | Pass |
| End Connector Pull Force | The end connector must withstand 6 lbf. | Pass |
| Hybrid Calibration Tube Suction Functional Testing | Hybrid calibration tube must remove all of the saline in glass beaker within 1 minute. | Pass |
| Pull Force Fill Tube / Over-Mold Testing | The fill tube or over-mold joint must withstand a force of 1 lb. This component's only function is to provide a path for inflation of the balloon. | Pass |
| Pull Force of Proximal Tubing / Over-Mold Testing | The proximal tubing or over-mold joint must withstand a force of 1 lb. | Pass |
Biocompatibility Testing:
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity Study Using the ISO Elution Method | Observations for test and negative control at 24, 48 and 72 hours. Presence or absence of a confluent monolayer, vacuolization, cellular swelling and crenation and the percentage of cellular lysis are recorded. Scoring was nontoxic, intermediate, or toxic. | The CTE Score was N (non-toxic at 24, 48 and 72 hours). |
| ISO Sensitization Study in the Guinea Pig | The response, pattern, character, and duration of any test animal reactions are compared to any reactions in the controls. Any dermal inflammatory response at the test sites greater than that seen in any control condition is considered evidence of a potential allergic response. | No evidence of delayed dermal contact sensitization was observed. |
| ISO Vaginal Irritation Study in the Rabbit | Each animal was observed daily for general health and external signs of irritation around the opening of the vaginal vestibule. After euthanization, tissue sections were evaluated. Macroscopic reactions were compared between test and control animals. Microscopic evaluation scores for all SC test animals were added together and divided by the number of test animals to obtain the SC average. The CSO averages were similarly calculated. The Irritation Index was scored from zero to 16, with zero as nonirritant and 16 severe irritant. | The microscopic SC and CSO extracts were a nonirritant. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes (number of units tested) for each specific bench test. It only provides the "Pass" result, indicating that the tested units met the criteria.
- Data Provenance: The studies were described as "bench" and "animal studies." There is no information regarding the country of origin of the data, nor whether the studies were retrospective or prospective experiments on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes bench testing and biocompatibility testing for a medical device (calibration tube), not a diagnostic AI system or a study requiring human expert assessment for ground truth. Therefore, there were no "experts" in the sense of clinicians establishing ground truth for a diagnostic test set. The acceptance criteria are based on engineering and material science standards (e.g., force, volume, material properties).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, this is not a study assessing human or AI diagnostic performance requiring adjudication of interpretations. The tests described are objective, quantitative measurements or qualitative observations (e.g., presence/absence of allergic response) against predefined criteria.
5. 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 vs without AI assistance:
- Not applicable. This document pertains to the clearance of a physical medical device (a calibration tube) and its performance in bench and animal studies to demonstrate substantial equivalence, not a diagnostic AI system. Therefore, no MRMC study with human readers assisting AI was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data in this context is defined by the pre-defined acceptance criteria based on established engineering principles, material science, and ISO standards for biocompatibility. For example, for the Burst Test, the ground truth is simply whether the balloon remained intact at the specified pressure. For biocompatibility, it's the observed biological reactions (or lack thereof) compared to ISO standards.
8. The sample size for the training set:
- Not applicable. This device is not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI system, there is no "ground truth for a training set."
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