(260 days)
The Cope Pediatic Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations.
The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.
This bundled submission includes two devices: Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. Both subject devices include two suture anchors that are identical.
The Cope Pediatric Gastrointestinal Suture Anchor Set is available in two set configurations. Both set configurations are supplied with two suture anchors that are identical. The first suture anchor is pre-loaded in the lancet-tip introducer needle. The second suture anchor may come pre-loaded in the blunt-tip backload needle. A wire guide is supplied if the second suture anchor comes pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The anchor is either 2 cm or 1.3 cm long. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 19-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 19-gauge stainless steel cannula and 3 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.025-inch stainless steel coil and 80 cm in length. Again, the wire guide is only supplied in the set configuration that the suture anchor is pre-loaded in the introducer needle.
The Enterostomy Suture Anchor Set is supplied with two suture anchors, the lancet-tip introducer needle, the blunt-tip backload needle, the wire guide, and the dilator. The suture anchors are pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 18-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 18-gauge stainless steel cannula and 5 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.035-inch stainless steel coil and 80 cm in length. The wire guide is coated in polytetrafluoroethylene. The dilator is made of 8 French polyethylene tubing and 20 cm in length. The distal end of the dilator is tapered to 0.035 inches in diameter.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding Cook Incorporated's Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of an AI/ML device.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not available within this document.
This document describes a medical device, not an AI/ML system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance or AI model validation.
Here's an breakdown of what is available and why the requested information for an AI/ML device is not applicable:
-
A table of acceptance criteria and the reported device performance:
- Not applicable for AI/ML performance. The document lists "Bench Testing (including time zero and applicable three year accelerated aged testing)" and "Biocompatibility Testing" as performed. These tests confirm design input requirements and biocompatibility, but no specific quantitative performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) with corresponding acceptance criteria are provided in a table format. The conclusion states the device meets design input requirements, implying successful completion of these physical and biological tests.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for AI/ML performance. No "test set" in the context of observational data (e.g., medical images or patient records) is mentioned. The testing described is physical/chemical "Bench Testing" and "Biocompatibility Testing" on the device itself.
-
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 for AI/ML performance. No ground truth establishment by medical experts is mentioned, as this is a physical medical device, not a diagnostic AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for AI/ML performance. No adjudication method for expert review of data is mentioned.
-
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 is a physical medical device, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an AI algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable for AI/ML performance. The "ground truth" for this device would be its physical properties (e.g., tensile strength, dimensions) and biological compatibility, verified through laboratory testing against established engineering standards and biocompatibility guidelines (e.g., ISO 10993-1).
-
The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
-
How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
In summary, the provided document is a regulatory approval (510(k) clearance) for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar intended use, technological characteristics, and a battery of engineering and biocompatibility tests. It does not contain information relevant to the performance evaluation of an AI/ML-driven medical device, which would require data sets, ground truth establishment, and statistical performance metrics.
§ 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.