Search Results
Found 1 results
510(k) Data Aggregation
(107 days)
The AbbVie J is intended to provide long-term enteral access for administration to the small intestine. The AbbVie J is indicated for the administration of the medication DUOPA (carbidopa enteral suspension).
The AbbVie J (List Number 62918) is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J intestinal tube (polyurethane), Guide Wire (Teflon™-coated stainless steel), Y-Connector, Click Adaptor. The kit is supplied sterile (ethylene oxide). The AbbVie J is inserted through the AbbVie PEG with the aid of the guide wire. The guide wire is used to aid insertion and is removed once the tube is in place. The intestinal tube's tip is placed in the small intestine for the administration of medication in a home and/or healthcare facility environment. A Y-Connector and Click Adaptor are included in the AbbVie J kit to connect the AbbVie PEG and intestinal tubes.
Here's an analysis of the provided text regarding the device AbbVie J, focusing on acceptance criteria and study details.
Crucial Note: Based on the provided document, the device described (AbbVie J, K142816) is a Gastrointestinal Tube and Accessories (Product Code KNT). This is a physical medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of AI assistance for human readers, standalone algorithm performance) are not applicable to this submission. The "performance data" section for this type of device focuses on biocompatibility and physical integrity/functionality, not diagnostic or predictive accuracy.
Acceptance Criteria and Study to Prove Device Meets Criteria (for AbbVie J, K142816)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation (intracutaneous reactivity) | Passed | |
| Systemic toxicity (acute) | Passed | |
| Subchronic Toxicity (subacute toxicity) | Passed | |
| Pyrogen Testing | Passed | |
| Genotoxicity | Passed | |
| Implantation | Passed | |
| Non-Clinical Performance | Conformance to EN 1615:2000 (Enteral feeding catheters) | Acceptable |
| Conformance to ISO 80369-1:2010 (Small-bore Connectors) | Acceptable | |
| Food Contact Testing (21 CFR 177.2600) | Materials acceptable for food contact use (per extractable limits) | |
| Guide Wire Performance (ISO 11070) | Evaluated and deemed acceptable | |
| MR Compatibility (FDA Guidance) | Passed compatibility testing | |
| Compatibility with DUOPA medication | Passed compatibility testing | |
| Clinical Performance | No clinical evaluations performed or relied upon | N/A (Substantial equivalence demonstrated without clinical data) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For this physical device, "test set" primarily refers to the samples used in laboratory-based performance and biocompatibility testing. The document doesn't specify the number of individual units or test repetitions for each specific test, but it indicates the tests were conducted according to relevant standards.
- Data Provenance: Not explicitly stated regarding country of origin, but the tests were conducted according to FDA-recognized international (ISO, EN) and US (FDA Blue Book, CFR) standards. All testing appears to be retrospective, typically conducted during the device development and validation phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts/Qualifications: Not applicable in the context of diagnostic accuracy. For the performance and biocompatibility testing, ground truth is established by the results of standardized laboratory assays and physical tests interpreted by qualified personnel in accredited labs. The document does not specify the number or qualifications of these individuals, which is standard for this type of submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the objective, laboratory-based testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- MRMC Study: No. This device is not an AI/SaMD.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This device is not an AI/SaMD.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is established through objective, validated laboratory testing methods described in the referenced international standards (ISO, EN) and US regulations (21 CFR). For example:
- Biocompatibility: Standardized cell culture assays, animal models, and analytical chemistry.
- Physical Performance: Measurements of physical properties like tensile strength, flow rate, connector integrity, and material extractables, compared against established pass/fail criteria in the referenced standards.
- MR Compatibility: Measurement of induced heating, artifact, and force/torque in an MR environment following standardized protocols.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This device does not use machine learning or AI.
Ask a specific question about this device
Page 1 of 1