(147 days)
The SlimPort™ Dual Low Profile Implanted Port is indicated for patient therapies requiring repeated access to the vascular system can be used for infusion of medications. I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
The SlimPort™ Dual Low Profile Implanted Port has a small, narrow, low, smoothly-shaped profile which minimizes port pocket size, incision size, and tissue displacement. It has an inner titanium dual reservoir assembly with two distinct isolated reservoirs; a one-piece, dual, peanutshaped solid silicone septum; and a two piece plastic port shell which secures the inner reservoir and septum. The port stem is oriented axially (in line) with the two port reservoirs.
The port will be distributed with two (2) different dual lumen attachable catherers: either a silicone 7 Fr Groshong® (valved, closed tip) dual lumen catheter or a silicone 7 Fr open-ended dual lumen catheter. Port access is performed by percutaneous needle insertion using a non-coring needle. The port may be placed in the chest or arm with the catheter tip located at the junction of the superior vena cava and the right atrium. The device placement site is determined by the clinician, based on medical judgement and patient anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SlimPort™ Dual Low Profile Implanted Port, based on the information available in the 510(k) summary:
Given that this is a 510(k) summary for a medical device (Implanted Port) and not an AI/ML diagnostic device, many of the requested fields (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable as they pertain to clinical or diagnostic studies, not device performance testing focused on physical and mechanical properties.
Acceptance Criteria and Device Performance Study for SlimPort™ Dual Low Profile Implanted Port
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "The SlimPort™ Dual Low Profile Implanted Port system meets all the acceptance criteria of the testing performed". However, specific numerical acceptance criteria are not explicitly detailed in the provided text. The document lists the types of tests performed. For the purpose of this response, "Reported Device Performance" is understood as the general statement that the device met those criteria, as specific performance values are not given.
| Port Guidance Testing | Catheter Guidance Testing | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| 150% Elongation and Leak Test | (Catheter elongation) | Meet requirements for elongation and leak integrity (implied by "meets all acceptance criteria") | Met criteria |
| Pull to Failure Test | (Tensile strength of catheter) | Meet requirements for pull strength/tensile strength (implied) | Met criteria |
| Non-Cyclic Creep Test | NA | Meet requirements for non-cyclic creep (implied) | Met criteria |
| Cyclic Creep Test | (Catheter flexural fatigue tolerance) | Meet requirements for cyclic creep/flexural fatigue (implied) | Met criteria |
| Connection Burst Test | (Catheter burst pressure) | Meet requirements for connection burst pressure (implied) | Met criteria |
| Septum Puncture Life Test | NA | Meet requirements for septum puncture life (implied) | Met criteria |
| Septum Pressure Integrity Test | NA | Meet requirements for septum pressure integrity (implied) | Met criteria |
| Clearance Kinetics Test | NA | Meet requirements for clearance kinetics (implied) | Met criteria |
| Gravity Flow Rates Test | (Catheter flow rate) | Meet requirements for gravity flow rates/catheter flow rate (implied) | Met criteria |
| Priming Volume Test | NA | Meet requirements for priming volume (implied) | Met criteria |
| Test Device Conditioning | NA | Meet requirements for device conditioning (implied) | Met criteria |
| Summary | |||
| Physical Characterization | (Dimensions) | Meet specific dimensional requirements (implied) | Met criteria |
2. Sample size used for the test set and data provenance
- Sample Size: Not specified in the provided text. The document refers to "bench testing" but does not give the number of units tested for each criterion.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective for bench testing. The data originates from bench testing conducted by the manufacturer, Bard Access Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is undergoing performance testing for its physical and mechanical properties against pre-defined engineering and safety standards, not a clinical diagnostic assessment requiring expert ground truth establishment.
4. Adjudication method for the test set
- Not Applicable. As no expert clinical assessment or diagnostic interpretation is involved, there is no need for an 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 is a physical medical device, not an AI/ML-powered diagnostic tool. No human reader studies or AI assistance are involved in its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering/Performance Standards and Predicate Device Equivalence. The "ground truth" for this type of device testing is adherence to established FDA Guidance documents (Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports" and Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters") and demonstration of substantial equivalence to a predicate device (Plastic Dual Attachable Port, K912702). The "ground truth" is that the device performs safely and effectively according to these predefined technical specifications and comparable to the predicate.
8. The sample size for the training set
- Not Applicable. This is a physical device undergoing performance testing, not an AI/ML model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was a series of bench tests (laboratory-based physical and mechanical performance evaluations) conducted by Bard Access Systems, Inc. The testing was performed according to:
- FDA's Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports"
- FDA's Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters."
The specific tests included evaluations of material properties (elongation, tensile strength), structural integrity (pull to failure, non-cyclic creep, cyclic creep, connection burst), functional aspects (septum puncture life, septum pressure integrity, clearance kinetics, gravity flow rates, priming volume), and physical dimensions.
The conclusion drawn from these tests was that the SlimPort™ Dual Low Profile Implanted Port system met all the acceptance criteria derived from these guidance documents and demonstrated substantial equivalence to the predicate device (Plastic Dual Attachable Port, K912702). While specific numerical results or the exact number of units tested are not provided in this 510(k) summary, the overall statement is that the product passed these performance evaluations.
§ 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.