(190 days)
The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T™Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means.
The Endovive™ Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.
The Endovive™ Initial Placement Gastrostomy Kit and the Securi-T™ Initial Placement Gastrostomy Kits are used during initial placement for direct feeding, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube is used for the replacement of direct feeding tubes used for direct feeding.
The provided text is a 510(k) summary for medical devices (gastrostomy kits and tubes). It states that the proposed devices are identical to predicate devices, and therefore, no additional performance testing was performed.
Because of this, there is no information about specific acceptance criteria or a study proving that the devices meet them in the traditional sense of a performance evaluation against predefined metrics. The submission relies on establishing substantial equivalence to previously cleared devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.
Here's a breakdown of the available and unavailable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided. The submission asserts substantial equivalence because "The proposed devices are identical to the predicate devices." No specific performance acceptance criteria or reported performance data for the new devices (as distinct from the predicates) are presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. No new performance testing was conducted, so there is no test set or related data provenance.
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/Not provided. As no new performance testing was conducted, there was no need for experts to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No new performance testing was conducted, so 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/Not provided. This is a medical device (gastrostomy kit/tube), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Since no performance study was conducted for the proposed devices, no ground truth was established within the scope of this submission. The "ground truth" for the clearance of these devices rests on their substantial equivalence to predicate devices, which were themselves cleared based on prior regulatory pathways.
8. The sample size for the training set
- Not applicable/Not provided. There is no training set mentioned or implied as no new performance data or AI model development is being described.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set, there is no ground truth establishment for it.
Summary of the 510(k) Approach:
The core of this 510(k) submission is the assertion of substantial equivalence to predicate devices. The manufacturer states:
- "The proposed devices are identical to the predicate devices and therefore, no additional performance testing was performed."
- "A thorough comparison of the descriptive characteristics between the proposed gastrostomy devices and the predicate devices show equivalence."
The FDA's letter (Page 3-4) confirms that they reviewed the submission and "determined the device is substantially equivalent... to legally marketed predicate devices." This means the acceptance criteria and proof of meeting them are implicitly tied to the previous clearances of the predicate devices based on their established safety and effectiveness.
§ 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.