(119 days)
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
Here's a breakdown of the acceptance criteria and the study information for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™):
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to a predicate device (Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, K043272). The primary modification is the addition of a silver-impregnated sleeve. Therefore, the acceptance criteria and performance are focused on demonstrating that this modification is safe and effective, and that the new device remains substantially equivalent.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (General) | Device is substantially equivalent in intended use, materials, physical characteristics, and performance characteristics to the predicate. | The sponsor states the device is "substantially equivalent to the Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (K043272) in intended use, materials, physical characteristics, and performance characteristics." The silver-impregnated sleeve itself is deemed substantially equivalent in intended use and performance to the legally marketed VitaGuard™ silver impregnated cuff (K861563). |
| Safety and Catheter Performance (General) | The presence of the silver-impregnated sleeve does not negatively affect the safety and catheter performance. | "Testing conducted on the proposed device confirmed that the presence of the silver impregnated sleeve did not affect the safety and catheter performance of the device." This was verified using standard tests applicable to intravascular catheters published by ASTM, ISO, and KDOQI guidelines. |
| Biocompatibility | Biocompatibility at the highest level of silver loading. | Biocompatibility testing was performed at the "highest level of silver loading." |
| Silver Amount (Safety) | Total silver amount in the sleeve is within safety versus toxicity and exposure limits. | Determination of "total silver amount in sleeve to confirm safety versus toxicity and exposure limits" was conducted. Specific values are not provided, but the outcome is that it confirmed safety. |
| Silver Elution | Demonstrates controlled release of silver. | Silver elution testing was performed "to demonstrate controlled release." |
| Microbial Colonization Reduction (In-vitro) | Significant reduction in microbial colonization on the silver-impregnated sleeve after repeated challenges with specified microorganisms. | "In-vitro studies demonstrating a significant reduction, between 2.1 and 5.5 log10 reductions, in the amount of microbial colonization on the silver impregnated sleeve after repeated challenges with Staphylococcus aureus, Coagulase-negative Staphylococcus, Candida albicans, and Escherichia coli (all clinical isolates)." |
| Microbial Colonization Reduction (In-vivo - Animal Model) | Significant reduction in microbial colonization on the silver-impregnated sleeve after repeated subcutaneous inoculation of Staphylococcus aureus in a rabbit infection model, with the performance lasting for up to 30 days. | "In-vivo studies demonstrating a significant reduction, between 2.5 and 4.9 log10 reduction in the amount of microbial colonization on the silver impregnated sleeve after repeated subcutaneous inoculation of Staphylococcus aureus (clinical isolate) in a rabbit infection model." The indication states, "The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- In-vitro studies: Not explicitly stated how many samples were used for each microorganism or how many repeated challenges were performed.
- In-vivo studies: Not explicitly stated how many rabbits were used in the infection model.
- Data Provenance: The studies were prospective bench and animal testing conducted specifically for this device submission. The clinical isolates used for in-vitro and in-vivo testing indicate a connection to real-world pathogen strains, but the testing itself was performed in a controlled laboratory/animal environment. There is no mention of human clinical data from any country in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Falls outside the scope of this document. This submission details bench and animal testing. There are no human "readers" or "experts" establishing ground truth in the context of diagnostic interpretation, as this is a medical device for placement within the body, not a diagnostic imaging or AI product. The ground truth for the microbial studies would be objective laboratory measurements (e.g., colony-forming unit counts).
4. Adjudication Method for the Test Set
Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary.
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 not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device with a modified component. The "standalone" performance here refers to the device's inherent physical and antimicrobial properties, which were tested in a controlled environment without human intervention during the measurement phase.
7. The Type of Ground Truth Used
- Biocompatibility, Silver Amount, Silver Elution: Objective laboratory measurements against established standards and limits.
- Microbial Colonization Reduction (In-vitro & In-vivo): Quantitative microbiological methods (e.g., colony-forming unit counts) that directly measure the reduction in microbial load. This is an objective, empirical ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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.