(213 days)
The Syncro-Blue Tube™ functions as a conduit to facilitate enteral feeding, and may be used in the pediatric, adult or elderly patient who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short- to moderate-term feeding support, such as posttrauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.
The Syncro-Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The modified device will be marketed in one length (23.6" [60cm]) and one French size (8 Fr). During placement of the tube, an external magnet is used to assist the physician in placing the tube into the small bowel. The Syncro-Blue Tube has a stylet with a reed switch positioned near its distal tip. The reed switch is connected by wires to an external LED/battery pack that lights in response to the presence of the external steering magnet. The reed switch is located at the distal end of the stylet. The distal tip of the stylet contain magnets which are attracted to the steering magnet. When the tube is positioned, the stylet is removed from the device, making the Syncro-Blue Tube MRI Safe.
The Syncro-Blue Tube, The Magnetically Guided Enteral Feed Tube, as described in the provided document, underwent several performance tests to demonstrate substantial equivalence to a legally marketed predicate device (Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube cleared under K072787). The document, however, does not provide specific acceptance criteria values or detailed performance results against those criteria. It also does not involve an AI algorithm, so many of the requested criteria related to AI/ML device studies are not applicable.
Here's a breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists the types of performance tests conducted but does not specify the numerical acceptance criteria for each test or the precise quantitative results achieved by the Syncro-Blue Tube. It generally states that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate device."
| Test Category | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Tensile | Not specified | Demonstrated substantial equivalence. |
| Aspiration, Flow | Not specified | Demonstrated substantial equivalence. |
| Magnet Capture / Magnetic Guidance | Not specified | Demonstrated substantial equivalence. |
| Flexibility / Column Strength / Pushability | Not specified | Demonstrated substantial equivalence. |
| Biocompatibility | Not specified | Demonstrated substantial equivalence. |
| Simulated Use | Not specified | Demonstrated substantial equivalence. |
| Radiopacity | Not specified | Demonstrated substantial equivalence. |
| LED Turn-on Distance | Not specified | Demonstrated substantial equivalence. |
| Connector Compatibility Testing | Not specified | Demonstrated substantial equivalence. |
Study Information:
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Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes used for each of the performance tests.
- The data provenance is not explicitly mentioned, but the tests were "laboratory tests," implying they were conducted in a controlled environment, likely in the US or a similar regulatory setting. It is a retrospective summary of bench testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a physical medical device (feeding tube) and the performance tests are engineering and biological evaluations, not diagnostic interpretations requiring expert ground truth in the context of image or data analysis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable for the type of device and tests described. Adjudication is typically for resolving discrepancies in expert interpretations, which is not relevant here.
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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 question is not applicable as the device is a physical medical device and does not involve AI or human readers for interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these performance tests would be defined by established engineering and biological standards and specifications for tensile strength, flow rates, magnetic responsiveness, flexibility, biocompatibility, radiopacity, etc. The document implies compliance with these standards by stating substantial equivalence to a predicate device.
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The sample size for the training set:
- This question is not applicable as the device does not involve a training set for an AI/ML algorithm.
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How the ground truth for the training set was established:
- This question is not applicable as the device does not involve a training set for 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.