(29 days)
ReShape Calibration Tubes™ are 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™ is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures and is available in three larger sizes. The trade name has been changed Gastrointestinal Boundary Identifier (GIBI HD ™) to ReShape Calibration Tubes ™ for these three (3) sizes.
The ReShape Calibration Tubes™ provide visible and tactile delineation of the gastroesophageal (GE) junction, and its location relative to the esophageal hiatus and antrum of the stomach. The device provides the ability to decompress the stomach, drain and remove gastric fluid and act as a sizing guide (Figure 1).
This document is a 510(k) premarket notification for a medical device called "ReShape Calibration Tubes™". The purpose of this submission is not to introduce a new device with novel performance criteria, but rather to establish substantial equivalence to a previously cleared predicate device due to a change in device name, minor edits to the Directions For Use (DFU), and the addition of a contraindication.
Therefore, the typical structure for describing acceptance criteria and a study proving a device meets them (as would be expected for a new device with performance claims) is not directly applicable here. This document primarily focuses on demonstrating that the changes made do not alter the established safety and effectiveness of the device as previously cleared.
Based on the provided text, here's how to address your request:
Key Takeaway: The device's performance was not re-evaluated in a new study for this 510(k) submission. Its performance has been established through the clearance of its predicate device (Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, K221898). The current submission leverages the established performance of the predicate device to demonstrate substantial equivalence for the modified device.
1. A table of acceptance criteria and the reported device performance
Since this submission is based on substantial equivalence to a predicate device and no new performance data was generated for this specific submission, there isn't a direct "table of acceptance criteria and reported device performance" as you might find for a de novo submission or a device with new performance claims.
Instead, the acceptance criteria are implicitly that the ReShape Calibration Tubes™ are substantially equivalent to the predicate device (GIBI HD ™ Calibration Tube, K221898) across all relevant characteristics. The "performance" is considered to be the same as the predicate.
Here's how we can conceptualize it from the document:
| Characteristic/Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (Same as Predicate) |
|---|---|
| Intended Use (same as predicate) | Same |
| Principle of Operation (same as predicate) | Same |
| Device Design (same as predicate) | Same |
| Materials of Construction (same as predicate) | Same |
| Usability (established via bench studies for predicate) | Same (no new studies for this submission) |
| Safety (established via bench studies for predicate) | Same (no new studies for this submission) |
| Effectiveness (established via bench studies for predicate) | Same (no new studies for this submission) |
| Product Code (KNT) | Same |
| Regulatory Class (Class II) | Same |
| Regulation Number (21 C.F.R. 876.5980) | Same |
| Regulation Name (Gastroenterology-Urology) | Same |
| Outer Diameter / French Size (nominal, distal tip, deflated balloon) | Same across all sizes |
| Tubing (Dual lumen) | Same |
| Distal Side Holes (3 aspiration holes) | Same |
| Distal Tip (Molded tip with 12 aspiration eyelets) | Same |
| Connector for Suction (Adapter for room suction included) | Same |
| Balloon + Inflation Valve (Inflation capacity ≥ 100 cc min) | Same |
| Tubing Material (Silicone) | Same |
| Markings (Indication marks at 30, 35, 40, 45, 50, 55, and 60 cm) | Same |
| Sterility (Non-sterile, disposable, single patient use) | Same |
| Shelf Life (2 years) | Same |
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 explicitly states: "Bench testing was not conducted and remains same as the predicate device cleared under K221898." Therefore, there is no new test set, sample size, or data provenance information provided in this submission. The basis for substantial equivalence relies on the established performance of the predicate device.
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)
Not applicable. As no new testing or clinical studies were conducted for this submission, no new ground truth was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no new testing or clinical studies were conducted for this submission, no adjudication method was used.
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 device is a calibration tube used in surgical procedures, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (calibration tube), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this submission, the "ground truth" is effectively the established safety and effectiveness of the predicate device (GIBI HD ™ Calibration Tube, K221898) based on prior regulatory clearance. The current submission's "ground truth" for its acceptance is that its modifications do not alter its substantial equivalence to that predicate device. The document does not detail how the predicate's original performance data was established (e.g., specific ground truth for its bench studies).
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not an AI/ML algorithm.
§ 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.