(107 days)
The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. The Rhapsody Port and Catheter are safe to use in an MRI environment.
grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood.
The provided text is for a 510(k) summary for a medical device called "Rhapsody MRI," which is an implanted port and catheter. This document focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its MRI compatibility. Therefore, the "acceptance criteria" and "study" described are related to verifying this compatibility, not the performance of an AI algorithm.
Based on the provided text, here's a breakdown of the requested information, interpreted in the context of a medical device submission rather than an AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| MRI Compatibility | The Rhapsody MRI meets all established acceptance criteria for performance testing and design verification testing related to MRI compatibility. |
| Substantial Equivalence | The product is identical to the GrantAdler Rhapsody Access Port with different labeling and testing performed to demonstrate its substantial equivalence as an MRI Compatible Device. |
| Intended Use (General) | Indicated for reliable repeated access of the vascular system for fluid/medication delivery and blood sampling. Safe to use in an MRI environment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a specific test set in the way one would for an AI/ML study (e.g., number of images or patients). Instead, it refers to "performance testing and design verification testing" related to MRI compatibility. This likely involved a set of physical devices being subjected to various MRI conditions to assess their safety and function.
- Sample Size: Not specified in terms of numerical units like "patients" or "cases." The context suggests a set of physical devices tested.
- Data Provenance: Not specified, but likely refers to internal testing conducted by the manufacturer (GrantAdler Corporation). It is not retrospective or prospective in the clinical study sense; rather, it's product testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept of "experts establishing ground truth" is not directly applicable in the context of this device's submission. The "ground truth" here is the physical interaction of the device with an MRI environment, and its safe and effective function. This would be established through engineering and electromagnetic compatibility testing standards, not expert subjective review.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data, typically in diagnostic imaging studies where there's subjectivity. Here, the assessment is based on objective measurements and adherence to engineering standards for MRI compatibility.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device approval, not an AI/ML algorithm submission. An MRMC study is designed to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for this device.
6. Standalone Performance Study (Algorithm Only)
No. This refers to a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Physical and electronic measurements: Demonstrating the device's behavior in an MRI field (e.g., heating, artifact generation, displacement).
- Adherence to recognized standards: Likely ISO, ASTM, or similar standards for MRI compatibility of implanted devices.
- Functional performance: Ensuring the port and catheter continue to function as intended after exposure to MRI.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.