(15 days)
The Vaxcel™ and Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
The Vaxcel™ and Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence | Tested and compared to predicate devices (K032008, K031844, K032375). All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
Important Note: The provided document is a 510(k) premarket notification summary. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new performance criteria or conducting extensive clinical trials to "prove" a device meets them in the way a PMA (Premarket Approval) submission for novel devices might. The acceptance criteria here are largely framed around equivalence and biocompatibility, as opposed to specific clinical performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" with a particular sample size for performance evaluation. The substantial equivalence argument relies on comparison to predicate devices, which likely involved in vitro testing or mechanical performance assessments rather than a clinical human subject test set.
- Data Provenance: Not specified, but likely refers to lab-generated data from retrospective testing performed by the manufacturer to compare the new device to its predicates. There is no mention of prospective clinical studies or country of origin for any human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Given the nature of a 510(k) summary relying on substantial equivalence and biocompatibility, the concept of "ground truth" as established by medical experts for a clinical test set is not present. The assessment for substantial equivalence would have been performed by the manufacturer's engineers and quality control personnel.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not mention any multi-reader multi-case studies or any studies involving human readers, either with or without AI assistance. This device is a medical implant, not an imaging or diagnostic device that would typically involve human reader performance.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is a physical implantable port system and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: For biocompatibility, the ground truth would be established by standardized laboratory testing protocols (ISO 10993) and the assessment against established biological safety limits. For substantial equivalence, the "ground truth" is adherence to design specifications and performance characteristics that are comparable to the predicate devices, likely verified through engineering specifications, in vitro testing parameters, and material analyses. There is no mention of pathology, expert consensus, or outcomes data used to establish "ground truth" in a clinical sense for this 510(k) submission.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The development and testing would involve engineering prototypes and manufacturing samples.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable, as there is no training set for this type of device.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.