(262 days)
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
The AbbVie™ PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following: AbbVie PEG Tube (polyurethane), Reel of Thread with double thread and Introducer Device, Puncture Cannula with safety (air) valve, Disposable Scalpel, Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip, and Tube Clamp.
The provided document does not contain information regarding a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting with human subjects or an AI component.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (EndoVive™ Initial Placement PEG Kit, K030855) through non-clinical performance data.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. | "The material composition of the AbbVie PEG shows acceptable performance across all protocols tested for biocompatibility per ISO 10993-1:2009..." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Enteral Feeding Catheters | Conformance to EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. | "The AbbVie PEG was assessed for conformance to standard EN 1615:2000...and shown to be acceptable." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Small-bore Connectors | Conformance to ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements. | "An assessment of the AbbVie PEG has been completed and shown to be acceptable per ISO 80369-1:2010..." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Food Contact Safety | Conformance to 21 CFR 177.2600 Indirect Food Additives: Polymers, Rubber articles intended for repeated use per the extractable limits. (This implies specific extractable limits for various substances). | "Food contact testing was conducted on the AbbVie PEG and demonstrated that the materials that constitute the AbbVie PEG are acceptable for food contact use. The study was conducted as described in 21 CFR 177.2600...per the extractable limits." (Stated as acceptable, no specific values or thresholds reported in this summary, but implies compliance with regulatory extractable limits). |
| Safety and Effectiveness | Overall substantial equivalence to the predicate device, meaning no differences that would affect the safety or effectiveness of the device as compared to the predicate device, and no new issues of safety or effectiveness are raised. (This is a cumulative qualitative assessment rather than a specific numeric criterion). | "The information provided within this pre-market notification demonstrates that the AbbVie PEG has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, EndoVive Initial Placement PEG Kit. The differences between the two devices do not raise new issues of safety or effectiveness." (This is the overarching conclusion of the 510(k) submission based on comparison and non-clinical testing). |
2. Sample size used for the test set and the data provenance:
- No clinical test set was used. The document explicitly states: "No clinical evaluations were performed or relied upon for the determination of substantial equivalence."
- The non-clinical tests (biocompatibility, standards conformance, food contact) would have involved material samples and device prototypes, but specific sample sizes for these tests are not provided in this summary. The provenance would be the test labs where these non-clinical tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth establishment was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set requiring adjudication 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. This device is a medical tube, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical tube, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" was established by conformance to established international and national standards (ISO 10993-1, EN 1615, ISO 80369-1) and regulatory requirements (21 CFR 177.2600).
- For the overall substantial equivalence claim, the ground truth was the characteristics and performance of the legally marketed predicate device (EndoVive™ Initial Placement PEG Kit).
8. The sample size for the training set:
- Not applicable, as this device is not an AI/machine learning product and does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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.