(29 days)
The Dual Port Wizard™ replacement gastrostomy device is indicated for percutaneous placement of a low-profile gastrostomy feeding and decompression device into an established, appropriately sized stoma. The Dual Port Wizard™ Feeding/Decompression Tube (REF 00220W) is the only device which should be used for feeding, gastric decompression or medication administration with the Dual Port Wizard replacement gastrostomy device.
The Wizard™ is a low profile, balloon-type, feeding device designed for percutaneous insertion through an established, appropriately sized stoma tract. The device is held in place by the distal balloon, which remains in situ within the stomach, and an external bolster. Within the bolster are two ports. One side port is used to inflate the retention balloon and the second, surface port mates with the accompanying feeding/decompression tube to administer enteral nutritional fluid or expel gas or gastric contents.
The provided text describes modifications to an existing gastrostomy device and states that "Bench testing, biocompatibility, and post-risk analysis assessment of the modifications to the Wizard™ demonstrate that design verification/validation activities meet the predetermined acceptance criteria for a safe and effective device."
However, the document does not explicitly list the specific acceptance criteria, nor does it provide a detailed study report with performance metrics against those criteria. It only makes a general statement that the criteria were met.
Therefore, for categories where specific information is requested (like sample size, number of experts, adjudication methods, details of comparative or standalone studies, and ground truth establishment), the information is not present in the provided 510(k) summary. I can only report what is stated directly in the text.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Device Performance:
| Criterion | Description | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Modifications to the device should maintain or improve safety and effectiveness. | "Bench testing, biocompatibility, and post-risk analysis assessment of the modifications to the Wizard™ demonstrate that design verification/validation activities meet the predetermined acceptance criteria for a safe and effective device." |
| Material Classification | All correlating material changes must be within the same classification as other cleared feeding tubes. | "All correlating material changes are within the same classification as other cleared feeding tubes." |
| Mating with Feeding/Decompression Tube | The device must properly mate with the interlocking feeding/decompression tube. | "The only dimensional modification to the Wizard™ Low Profile Replacement Gastrostomy Device is related to the mating of an interlocking feeding/decompression tube." (Implies successful mating was demonstrated) |
Note: The document does not provide quantitative or specific acceptance criteria (e.g., "burst pressure must exceed X psi") or detailed numerical performance results from the bench testing.
2. Sample Size Used for the Test Set and Data Provenance
The document states "Bench testing" was performed, but does not specify the sample size used for these tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective data), as the tests were on the device itself, not patient data in the typical sense of AI/clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" here would refer to the standards by which the bench tests were judged successful or unsuccessful, but the document does not detail how these standards were established or by whom.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation of data. Since the document describes "bench testing" of a physical device, this concept does not apply in the usual sense for this submission, and no such method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human interpretation, which is not the nature of this product (a gastrostomy device).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study (in the context of an algorithm) was not done. The device is a physical medical device, not an algorithm. Bench testing would be analogous to standalone testing for a physical product, but not in the AI sense.
7. The Type of Ground Truth Used
For the "bench testing," the "ground truth" would be defined by engineering specifications, design requirements, and possibly industry standards for gastrostomy devices. The document implies these predetermined acceptance criteria were the ground truth, but does not explicitly detail them (e.g., specific forces, flow rates, durability metrics).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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.