(89 days)
The TTP J-Tube is indicated for enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated. This includes, post upper G.I. tract surgery, radiation therapy, chemotherapy, reflux and other conditions associated with nausea, vomiting and possible aspiration.
The Microvasive TTP J-Tube is a three port device designed to be placed through a Microvasive gastrostomy tube to provide gastric decompression and jejunal feeding. The Microvasive TTP J-Tube is available in two tip configurations (pigtail, & bent tip), and may be placed by either tether (pull), or guidewire techniques.
The provided document describes a 510(k) premarket notification for a medical device, the TTP J-Tube (Jejunostomy Feeding Tube). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with pre-defined acceptance criteria and detailed performance reporting as might be expected for novel devices or higher-risk classifications.
Therefore, the requested information categories related to detailed performance studies, sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance are not applicable to this 510(k) summary. The document does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial for a new product, but rather focuses on demonstrating equivalence to existing products through descriptive and limited laboratory testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The document does not specify formal, quantitative acceptance criteria for device performance in the manner of a clinical study (e.g., minimum sensitivity, specificity, or specific functional benchmarks that require statistical proof of achievement). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices and satisfactory results from limited laboratory testing.
However, the document does state:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and performance for intended use. | Laboratory testing regarding characteristics was performed with satisfactory results. |
| Biocompatibility of patient- and fluid-contact materials. | Biocompatibility assessment performed with satisfactory results. |
| Equivalence in indications for use, design, and materials to predicate devices. | Comparison of descriptive characteristics demonstrates equivalence; very similar in design and materials. |
| Meeting minimum requirements for intended use. | Information presented provides assurance that the TTP J-Tube will meet the minimum requirements that are considered acceptable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No human or animal test set is described as part of a clinical performance study. The "testing" mentioned refers to laboratory testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method
Not Applicable. No adjudication method for a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. No MRMC study was conducted or reported. The submission focuses on device equivalence, not comparative effectiveness with or without AI assistance.
6. Standalone Performance Study (Algorithm only)
Not Applicable. This is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Not Applicable. No ground truth for clinical performance is mentioned. The "truth" in this submission relates to the characteristics of the device itself and its similarity to predicate devices.
8. Sample Size for the Training Set
Not Applicable. No training set for an algorithm is described.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No ground truth for a training set is described.
Summary of the Study that "Proves" Device Meets Acceptance Criteria (in the context of a 510(k) submission):
The "study" in this context is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence to a predicate device.
- Study Design: This was a non-clinical bench testing and comparative analysis rather than a clinical trial. The approach involved:
- Descriptive Comparison: A thorough comparison of the TTP J-Tube's descriptive characteristics (e.g., components, design, materials, indications for use) with those of identified predicate devices (Bard's Jejunal Feeding/Gastric Decompression Tube and Corpak's Corflo-Ultra Jejunostomy Tube).
- Laboratory Testing: Performing laboratory tests on the TTP J-Tube to verify its safety and performance characteristics.
- Biocompatibility Assessment: Conducting a biocompatibility assessment on patient- and fluid-contact materials.
- Proof of Meeting Acceptance Criteria: The conclusion drawn by Boston Scientific Corporation is that the TTP J-Tube is substantially equivalent to the currently-marketed predicate devices. This equivalence, supported by the descriptive comparison, laboratory testing with satisfactory results, and a satisfactory biocompatibility assessment, provides "assurance that the TTP J-Tube will meet the minimum requirements that are considered acceptable for its intended use." The FDA's letter of "Substantial Equivalence" acknowledges that the company has met the requirements for this type of submission, allowing the device to be marketed.
§ 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.