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The NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.

Our device is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium (510 (k)# 871192) or polysulfone (510 (k)# 840788) chamber with a silicone septum and an outlet section. The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The port comes in two different sizes to accommodate different body frames. The catheter that is attached to the port is long enough to be inserted in the superior vena cava/right atrium junction to allow for fluid infusion into the heart and large blood vessels. The NorPort will also be available as part of an implantable kit. The kit contains all the tools needed to aid in catheter placement, insertion and port implantation.

The Norfolk Medical NorPort is an implanted drug delivery device (port) consisting of a reservoir with an attachable catheter system. The port is intended for repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood.

Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document states that "The NorPort family of products meets all established acceptance criteria for performance testing and design verification testing" (Page 7). While the specific quantitative acceptance criteria are not explicitly listed in a table, the document indicates that the device's performance was compared to established standards and predicate devices.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):

The overarching acceptance criterion is Substantial Equivalence to legally marketed predicate devices, which the study concluded was met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or components used for each non-clinical test (catheter to port connection, septum puncture/port leak, patency verification, static burst, tensile strength). The phrasing "data collected from the non-clinical tests" implies a test set was used, but the quantity is not provided.
• Data Provenance: The tests are described as "non-clinical tests" and "design verification testing," suggesting these were conducted in a laboratory setting, likely by the manufacturer, rather than on human or animal subjects. No information is provided about the country of origin or whether it was retrospective or prospective, but as it's non-clinical, these terms are less applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. For non-clinical performance and design verification tests of a medical device like an implantable port, the "ground truth" is typically established by engineering specifications, recognized industry standards (e.g., ISO, FDA guidance), and the performance characteristics of predicate devices. There wouldn't be human experts establishing "ground truth" in the same way as, for example, reading medical images.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret results and discrepancies are resolved by a senior expert. For non-clinical performance testing, the results are objectively measured against defined criteria, standards, or predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. An MRMC study is designed to assess the performance of a diagnostic device or AI algorithm when used by multiple human readers across multiple cases, often comparing performance with and without AI assistance. This device is an implanted drug delivery port, not a diagnostic tool or an AI-assisted interpretation system. Therefore, such a study would not be relevant or possible for this type of device.
• Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. This term also typically applies to AI or diagnostic algorithms. For a physical medical device like an implantable port, performance is inherently "standalone" in mechanical and material terms, but it functions as part of a human-in-the-loop system (physician implants, nurse accesses, patient lives with it). The non-clinical tests evaluated the device's inherent physical performance characteristics.

7. Type of Ground Truth Used

The ground truth used for evaluating the NorPort's performance was based on:

• Recognized Industry Standards: FDA Guidance on 510(k) Submissions for Implanted Infusion Ports (October 1990), BS EN ISO 10555-1:2009 (Sterile, single-use intravascular catheters Part 1: General requirements), and ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide).
• Predicate Device Performance: The NorPort's functionality and performance characteristics were compared to "currently marketed vascular ports" and explicitly to specific predicate devices: Norfolk Medical Vascular Access Port (K830000), PHS C-Port (K091099), Angiodynamics Vortex VX Port Implantable Infusion Port (K081472), and Bard PowerPort Implanted Titanium Port Chronoflex with 8 Fr. Catheter (K060812).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical implant, not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development, prototyping, and testing, but not a formal "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The design specifications and performance objectives are established through engineering design processes, regulatory requirements, and historical data from similar devices.

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