(27 days)
The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.
The Standard Bougie (SB38) is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide. The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.
This document is a 510(k) premarket notification for a medical device called the "Standard Bougie, 38 Fr. and Hand Pump" (K212728). The purpose of the submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of quantitative benchmarks for a novel diagnostic or treatment device. Instead, the submission for this Class II surgical accessory focuses on demonstrating substantial equivalence to a predicate device by comparing their technological characteristics and performing verification and validation activities.
The "acceptance criteria" are implicitly met if the device demonstrates equivalent performance and safety to the predicate device and introduces no new safety concerns. The "reported device performance" is demonstrated through nonclinical testing to ensure the added hand pump accessory does not negatively impact the device's original functions (suction, drainage, irrigation, insufflation, sizing) and maintains its safety profile.
Here's a summary derived from the "Overview of Substantial Equivalence" table and the "Performance Data" section:
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance (via Nonclinical Testing) |
|---|---|
| Intended Use (Same as predicate) | The Standard Bougie Hand Pump (SBHP) with Standard Bougie (SB38) shares the same intended use as the predicate device (SB38). Indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for application of suction, stomach decompression, drainage of gastric fluids, irrigation, insufflation, and as a sizing guide. |
| Technological Characteristics (Similar to predicate) | Method of Insufflation: Equivalent insufflation pressure as compared to the predicate device (Standard Bougie (SB38)). Both devices are capable of connection with hospital air and suction. The addition of the SBHP provides an option for manual insufflation using a squeeze bulb, not present in the predicate, but deemed equivalent in function and safety. |
| Packaging: SB38 packaging remains unchanged. Hand pump accessory provided in Non-sterile packaging, routinely used for non-sterile products. All other characteristics (Product Code, Regulation, Classification, How Supplied, Design Information, Typical Use, Use Environment, Patient Population, Single Patient Use, Sterility, Functionality, Catheter Diameter, Connection for suction) are identical to the predicate. | |
| No new harms introduced (through addition of hand pump) | Verification and validation activities were conducted for the SBHP to confirm that no additional harms were introduced and the risk benefit analysis remains acceptable. This was assessed through: |
- Transit and 1 year Accelerated Aging
- Performance Testing post Transit and 1 year Accelerated Aging
- Pressure Decay Testing
- Insufflation Testing
- Reliability Testing |
| Safety and Effectiveness (As safe and effective as predicate) | The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. The addition of the Standard Bougie Hand Pump does not raise any new types of questions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes nonclinical performance data (bench testing) for the accessory component (Standard Bougie Hand Pump) and confirms the existing data for the main device (Standard Bougie SB38) remains applicable.
- Sample Size for Test Set: Not explicitly stated in terms of patient numbers, as this is a nonclinical study. The "test set" refers to the devices or accessories subjected to the specified engineering tests (Transit and 1 yr Accelerated Aging, Performance Testing, Pressure Decay, Insufflation, Reliability Testing). The number of units tested per test is not detailed.
- Data Provenance: This is a submission for a medical device by Standard Bariatrics, Inc. located in Cincinnati, OH. The data would originate from internal company testing and validation activities. The document does not specify if any of the testing was conducted outside the U.S.
- Retrospective or Prospective: Not applicable as this is nonclinical (bench) testing of a medical device accessory, not a clinical study involving patients or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes nonclinical (bench) testing of a surgical accessory, not a diagnostic device that requires expert interpretation for establishing ground truth (e.g., radiologist for imaging, pathologist for tissue samples). The "ground truth" here is defined by engineering specifications, risk assessments, and established testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers interpreting data where consensus is needed to establish ground truth. The tests described are objective engineering tests.
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
This is not applicable. A multi-reader multi-case (MRMC) comparative effectiveness study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) assistance for human interpretation. The Standard Bougie and Hand Pump is a surgical accessory, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm independent of human input. The device is a physical surgical tool with a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device, in the context of its nonclinical performance evaluation, is based on:
- Engineering specifications and design requirements: The device's ability to meet its functional requirements (e.g., insufflation pressure, reliability, transit resistance, aging effects) as defined by its design.
- Risk assessment: The demonstration that the device (especially the new accessory) does not introduce unacceptable risks.
- Comparison to predicate device: The fundamental "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it performs as safely and effectively.
8. The sample size for the training set
This is not applicable. A "training set" refers to data used to train machine learning models. This document describes the regulatory submission for a physical medical device, not an AI/ML product.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (not an AI/ML product).
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.