(34 days)
The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
The Ported Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. This application is for the addition of a 15.5F catheter to the PVAS system and a dilating lead-in to replace the sheath during insertion. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F or 15.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the Dacron cuff of a tunneled catheter.
The provided text describes a 510(k) premarket notification for a medical device called the DermaPort Ported Vascular Access System (PVAS™). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format of a diagnostic or AI-driven device.
Therefore, many of the requested elements for a diagnostic device study description (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets) are not applicable or available in this type of regulatory submission.
The "acceptance criteria" here are implicitly related to the safety and functionality of the physical device modifications remaining within acceptable limits compared to the predicate, as evidenced by various engineering and animal tests, rather than diagnostic performance metrics.
Here is the information that can be extracted and a clear indication of what is not available based on the provided text:
Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for this type of device (physical medical device, not a diagnostic algorithm) are typically focused on engineering and functional specifications, material compatibility, and biological safety. The "reported device performance" refers to the verification that these specifications are met following modifications. Specific numerical thresholds (e.g., for safety margins, flow rates, or biomechanical strength) are not detailed in this summary.
| Acceptance Criteria Category | Reported Device Performance (Verification of Changes) |
|---|---|
| Functional / Insertion Performance | Verified that removal of the sheath, addition of dilating lead-in, and change in mesh geometry did not impact the function, performance, or safety of the device. (Tested via insertion testing). |
| Biomechanical / Tissue Interaction | Verified via histopathological analysis of the mesh following implantation in a chronic animal model and biomechanical testing of tissue ingrowth. Confirmed mesh to port removal force for modified geometry. |
| Catheter / Port Retention | Verified through catheter/port retention testing. |
| Microbial Barrier | Verified through microbial ingress testing. |
| Flow Performance (New Catheter Sizes) | Verified through flow versus pressure testing for new 15.5F catheter size. |
| Biocompatibility / Accessory Functionality | Verified through functional/biocompatibility testing for new accessories (e.g., new dilator, added suture, replaced injection caps). |
| Overall Safety and Effectiveness Comparison | "The modified PVAS does not raise new questions of safety or effectiveness." (Conclusion from the evaluation as required by risk analysis and Design Control requirements). This implies substantial equivalence to the predicate device in terms of safety and effectiveness. |
Study Details (Information Not Applicable or Available in the Provided Text)
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes engineering and animal studies for device modifications, not a clinical diagnostic performance study. Specific sample sizes for each test (insertion, histopathology, biomechanical, retention, microbial ingress, flow-pressure, biocompatibility) are not provided. The chronic animal model mentioned implies prospective animal testing, but details are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a physical medical device, not an AI or diagnostic tool requiring ground truth established by human experts in the conventional sense. Material and engineering standards/experts would be involved in defining test methods and interpreting results, but not in setting "ground truth" for a diagnostic test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable to the type of device and studies described.
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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:
- N/A. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the diagnostic sense). For this device, ground truth would be defined by engineering specifications, material standards, physiological parameters in animal models (e.g., successful tissue ingrowth in histopathology), and regulatory safety requirements. It's not "ground truth" for a diagnostic decision.
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The sample size for the training set:
- N/A. This device does not use a "training set" in the context of machine learning or algorithms. The studies are for design verification and validation of physical modifications.
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How the ground truth for the training set was established:
- N/A. As above, no training set or ground truth in this context.
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.