(110 days)
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine. The AbbVie NJ is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
The AbbVie NJ (List Number 62903) is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated stainless steel Stylet. The kit is supplied sterile (ethylene oxide). The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.
The provided text describes a 510(k) submission for the AbbVie NJ device, a naso-jejunal tube. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a novel device. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not available in the provided text.
Based on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance criteria for the device itself. Instead, the focus is on demonstrating conformance to standards and biocompatibility. | Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation (intracutaneous reactivity), Systemic toxicity (acute), Pyrogen Testing, and Implantation tests. |
| Product Specific Performance: Conformance to BS EN 1615:2000 for enteral feeding catheters and enteral giving sets. | Found to be acceptable per ISO 80369-1:2010. |
| Material Compatibility: Compatibility with DUOPA medication. | Passed compatibility testing with the medication DUOPA. |
| Substantial Equivalence: Device is identical to the predicate device (AbbVie NJ, K133129) and the new indication does not alter intended use or impact safety/effectiveness. | Demonstrated by stating identity to predicate device and no change in intended use or safety/effectiveness due to the new indication. |
2. Sample size used for the test set and the data provenance:
- The document states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." This implies that there was no specific test set or clinical data of human subjects to evaluate the device's performance in a clinical setting against acceptance criteria.
- The "test set" for performance evaluation consisted of the physical device undergoing various laboratory tests (biocompatibility, product-specific performance, material compatibility). The sample size for these laboratory tests is not specified in the provided text, nor is the data provenance in terms of country of origin or retrospective/prospective nature.
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 or animal studies were conducted, there were no human subjects or cases requiring expert consensus for ground truth. The "ground truth" for the laboratory tests would be the accepted standards and methods for those tests.
4. Adjudication method for the test set:
- Not applicable. No clinical data requiring adjudication was generated or relied upon.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." Therefore, no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (naso-jejunal tube), not a software algorithm or AI model.
7. The type of ground truth used:
- The "ground truth" implicitly used for this submission is based on established international and FDA-recognized standards and test methods for biocompatibility (ISO 10993 series), product-specific performance (BS EN 1615:2000, ISO 80369-1:2010), and material compatibility. The successful completion of these tests serves as the "ground truth" for meeting the regulatory requirements for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See 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.