(110 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 indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR (List Number 62910) or 20 FR (List Number 62912) and 35 cm in length.
The product components include the following:
- AbbVie PEG Tube (polyurethane) .
- External Fixation Plate (silicone, radio-opaque) with integrated Tube Clip and ●
- Tube Clamp. ●
Additionally, the kit includes the following components: - Reel of thread .
- Introducer device ●
- Puncture cannula with safety (air) valve and ●
- Disposable scalpel. ●
The kit is supplied sterile (ethylene oxide).
The AbbVie PEG is intended to allow the introduction of the AbbVie J intestinal tube for administration of medication in a home and/or healthcare facility environment. The AbbVie PEG is inserted through an incision in the abdominal wall over the stomach. The AbbVie J intestinal tube is placed through the PEG in order to deliver medication to the small intestine.
The provided document is a 510(k) summary for the AbbVie PEG device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving novel clinical effectiveness or for providing acceptance criteria tables and detailed study designs that are common in PMAs or clinical trials for new medical devices.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding performance metrics in the way one would expect for a diagnostic or interventional device with specific quantitative endpoints. Instead, the "performance data" section focuses on demonstrating the device's conformance to established biocompatibility and product-specific standards, as well as its substantial equivalence to a predicate device.
The performance data reported are more qualitative confirmations of compliance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility Testing | |
| Cytotoxicity | Compliant with ISO-10993 and FDA Guidance |
| Sensitization | Compliant with ISO-10993 and FDA Guidance |
| Irritation (intracutaneous reactivity) | Compliant with ISO-10993 and FDA Guidance |
| Systemic toxicity (acute) | Compliant with ISO-10993 and FDA Guidance |
| Subchronic Toxicity (subacute toxicity) | Compliant with ISO-10993 and FDA Guidance |
| Pyrogen Testing | Compliant with ISO-10993 and FDA Guidance |
| Genotoxicity | Compliant with ISO-10993 and FDA Guidance |
| Implantation | Compliant with ISO-10993 and FDA Guidance |
| Product Specific Performance Testing | |
| Conformance to EN 1615:2000 | Assessment completed and shown to be acceptable |
| Conformance to ISO 80369-1:2010 | Assessment completed and shown to be acceptable |
| Food contact testing (21 CFR 177.2600) | Materials acceptable for food contact use, per extractable limits |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the document for the performance tests mentioned (biocompatibility, product-specific). These tests are typically conducted on device materials or components rather than clinical subject cohorts. No clinical "test set" in the traditional sense was used because no animal or clinical studies were performed or relied upon for substantial equivalence.
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)
This information is not applicable as no clinical studies with "ground truth" established by experts were conducted or presented. The submission relies on laboratory testing and comparison to standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies requiring expert adjudication were conducted.
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
This information is not applicable. The device is a physical medical tube (Percutaneous Endoscopic Gastrostomy tube) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical tube, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as no clinical ground truth was established for the performance evaluation presented. The "ground truth" for the performance data in this submission is compliance with recognized standards and regulations (e.g., ISO, EN, CFR).
8. The sample size for the training set
This information is not applicable as this device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary: The provided document is a 510(k) summary for a physical medical device (AbbVie PEG) seeking substantial equivalence to a predicate. The "acceptance criteria" and "study" described are primarily focused on biocompatibility testing and conformance to engineering/safety standards for the device materials and design, rather than clinical performance metrics or AI algorithm validation. Therefore, many of the requested details about clinical studies, expert-established ground truth, and AI training/testing are not present in this type of submission. The key claim is that the device is identical to the predicate device with the exception of the proposed indication for use with DUOPA, and this new indication does not alter the intended use or impact safety/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.