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510(k) Data Aggregation
(110 days)
AbbVie PEG
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.
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(262 days)
ABBVIE PEG
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.
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