(92 days)
The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
The PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ implantable port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ implantable ports can be identified subcutaneously by feeling the top of the septum which includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port.
The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).
The provided document is a 510(k) premarket notification summary from the FDA, and it does not contain the detailed acceptance criteria and study data typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical performance for an AI/ML component.
Therefore, for aspects related to an AI/ML device's performance, human reader studies, and AI-specific ground truth establishment, the information is not present in this document. This document describes a medical device (implantable port) with an enabling technology (ECG for tip positioning), but it doesn't describe an AI/ML-driven diagnostic or prognostic device that would require the typical performance metrics associated with AI.
However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim for the overall device, particularly for the new ECG-enabled feature.
Here's an attempt to answer your questions based on the provided text, highlighting where the requested information is absent or not applicable given the nature of the device and submission:
Device: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port and related models.
Core Technology Change: The addition of ECG enablement for catheter tip placement confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS).
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted to demonstrate substantial equivalence, and states that "All testing passed the predetermined acceptance criteria." However, it does not provide a table with specific quantitative acceptance criteria or the numerical reported device performance for each test. It only lists the types of tests performed.
| Test Category | Specific Tests Mentioned | Acceptance Criteria & Reported Performance |
|---|---|---|
| ECG Functionality | ECG Accuracy Verification | "facilitate accurate reproduction of source ECG signals" (Qualitative statement), "All testing passed the predetermined acceptance criteria." (General statement) |
| Mechanical/Physical | Catheter Air Leak, Catheter Air Burst, Catheter Flow Rate, Catheter Tensile Strength, Lateral Stem Tensile Strength, Multiple Power Injections, Needle Retention Tensile Strength, Port Bottom Thickness, Port Reservoir Height, Port Subassembly Air Burst, Port Subassembly Air Leak, Port Subassembly Tensile Strength, Port System Burst (Power Injection), Port System Flow Rate, Port System Injection Rate, Septum Obturation, Stem Catheter Burst, Stem Catheter Leak, Stem Connection Tensile, Port Identification | "All testing passed the predetermined acceptance criteria." (General statement, no specific values given) |
| Compatibility | Magnetic Resonance Imaging Compatibility | (No specific criteria listed, assumed to meet MRI compatibility standards) |
| Packaging & Usability | Packaging Validation, Usability | "All testing passed the predetermined acceptance criteria." (General statement) |
| Shelf Life | (Implied by changes to shelf life, tested to ensure device performance met requirements after shelf life testing) | "All testing passed the predetermined acceptance criteria." (General statement), "the device performance met requirements after shelf life testing." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for any of the performance tests. The testing described appears to be laboratory/bench testing of the device components/full device, not human clinical trial data.
- Data Provenance: This is not a clinical study involving human data in the traditional sense for evaluating the device's performance in a patient population (beyond basic "indications for use"). The testing described is pre-market validation conducted by the manufacturer, likely at their facilities or certified labs. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the context of clinical data for an AI/ML model.
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)
- Not Applicable: This device is a medical implant, not an AI/ML diagnostic or prognostic system that relies on expert consensus to establish ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is derived from engineering specifications, established medical device testing standards (e.g., ISO, ASTM), and the fundamental physics/physiology of ECG signals for tip placement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As this is not a study requiring expert readers or interpretation, there is no adjudication method.
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 filing is for an implantable port device, not an AI-based diagnostic tool that would typically undergo an MRMC study. The "ECG Enabled" feature is an alternative method for real-time tip placement (vs. fluoroscopy/X-ray), not an AI assisting human interpretation of images. The BD Sherlock 3CG+™ TCS (the system responsible for interpreting the ECG signals) has its own separate 510(k) and likely its own performance data (K180560 is referenced).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device itself (the port) does not have a standalone "algorithm only" performance. The ECG enablement relies on the separate BD Sherlock system. The performance tests evaluate the physical and electrical properties of the port that allow it to be used with the ECG system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering/Physical Standards & Reference Data: The ground truth for the performance tests includes:
- Pre-determined acceptance criteria based on industry standards (e.g., ISO 11607-1, ASTM D4332, ASTM D4169, ISO 10555, NF S 94-370).
- Internal Risk Assessment procedures.
- FDA Guidance documents (e.g., "Guidance on 510(k) Submissions for Implanted Infusion Ports," "Applying Human Factors and Usability Engineering to Medical Devices").
- Functionality requirements (e.g., accurate reproduction of source ECG signals, no air leaks, appropriate flow rates).
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device that requires a training set. The device's function is mechanical and electrical, not data-driven learning.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant to this submission.
In summary, the provided document is a regulatory submission for a physical medical device (an implantable port) that has been modified to be compatible with an existing ECG-based tip positioning system. The "performance data" presented is primarily a list of engineering and functional tests to demonstrate that the new design maintains safety and effectiveness and is substantially equivalent to predicate devices, not data from a clinical study on an AI/ML model.
§ 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.