(28 days)
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters are indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis.
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
The catheters are long-term 12.5 French dual lumen straight polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. The catheters include a preattached in-growth cuff. Catheters will be offered in multi-unit packaging and with accessory components.
This submission is for a medical device (TruFlow™ Long-term 12.5 French Dual-lumen Dialysis Catheters), not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable.
The approval for this device is based on substantial equivalence to a legally marketed predicate device (TruFlow™ Long-term 14.5 French Dual-lumen Dialysis Catheters). The review relies on functional and biocompatibility testing, not on the performance metrics typically associated with AI/ML systems.
Here's a breakdown of the information that is relevant to this submission, framed as closely as possible to your request, but acknowledging the difference in device type:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | The results of the in-vitro testing indicated that the TruFlow™ Dialysis Catheters function according to specifications. (Specific performance metrics like flow rates, durability, etc., are not detailed in this summary document but would have been part of the underlying functional testing report). |
| Biocompatibility | Biocompatibility testing indicated that the materials used in the device are biocompatible. (Specific tests and results, e.g., cytotoxicity, sensitization, irritation, hemocompatibility, would be in the underlying biocompatibility report). |
| Substantial Equivalence (General) | The technological characteristics of the TruFlow™ Long-term 12.5 French Dual-lumen Dialysis Catheters are substantially equivalent to the predicate device (TruFlow™ Long-term 14.5 French Dual-lumen Dialysis Catheters) in terms of intended use, instructions for use, material type, device specifications, manufacturing process, and method of sterilization. |
| Intended Use | The device is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis, and can be inserted percutaneously in the internal jugular, subclavian, or femoral vein. This aligns with the intended use of the predicate device. |
| Material/Design | The catheters are long-term 12.5 French dual lumen straight polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip, including a preattached in-growth cuff. This design and material choice are considered substantially equivalent to the predicate. |
Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided document:
- Sample sized used for the test set and the data provenance: Not relevant for a physical medical device. Functional and biocompatibility tests are conducted on device samples, not "data sets."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" in the context of AI/ML is not applicable here. Device specifications and performance are typically verified against engineering standards and material science expertise.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 for a non-AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a physical device is its adherence to predefined engineering specifications, material properties, and safety standards, as verified through functional and biocompatibility testing. In this case, comparison to the predicate device's established performance also serves as a benchmark.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria (as presented in the document):
The device's acceptance is based on two primary studies:
-
Functional Testing (In-vitro):
- Description: Conducted on the TruFlow™ Dialysis Catheters.
- Purpose: To demonstrate that the catheters perform according to their design specifications. Although specific metrics (e.g., flow rates, pressure resistance, durability) are not provided in this summary, such tests would have been performed and documented in a more detailed report.
- Conclusion: The testing indicated that the TruFlow™ Dialysis Catheters function according to specifications.
-
Biocompatibility Testing:
- Description: Conducted on the catheters.
- Purpose: To ensure that the device materials are safe for human contact and do not elicit adverse biological responses.
- Conclusion: The materials used in the device are biocompatible.
Overall Conclusion from the studies (as per the document):
The results of the testing (functional and biocompatibility) indicated that the TruFlow™ Dialysis Catheters function according to specifications, and the materials are biocompatible. Therefore, the product is considered acceptable for human use, and crucially, clinical studies were not deemed necessary due to the device's similarity in materials, design, and function to the predicate device. This approach is common for devices seeking 510(k) clearance based on substantial equivalence.
§ 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.