(205 days)
TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute 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.
TruFlow™ Short-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- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.
The provided document describes the 510(k) premarket notification for the TruFlow™ Dialysis Catheters. The assessment for this device relied on functional testing and comparison to predicate devices, rather than clinical studies or an AI-driven approach.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Specifications | "The results of the testing indicated that the TruFlow™ Dialysis Catheters function according to specifications." This implies successful in-vitro testing. |
| Biocompatibility | "The materials used in the device are biocompatible." |
| Substantial Equivalence | The device was found to be "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is the overarching acceptance criterion for 510(k) clearance. |
| Similarity in materials, design, and function to predicate devices | "Clinical studies were not deemed necessary regarding the TruFlow™ Dialysis Catheters due to their similarity in materials, design and function to the Medcomp Dialysis Catheters." |
Study Information
1. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "In-vitro testing" and "Biocompatibility testing" but does not quantify the number of devices or data points involved in these tests.
- Data Provenance: The studies were in-vitro (laboratory testing) and biocompatibility testing. This means the data was generated in a controlled laboratory environment and not from human subjects. The country of origin for the data is not specified other than the applicant's location (St. Paul, MN, USA). The studies were likely prospective in nature within the lab.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for functional and biocompatibility testing is typically based on established engineering standards and laboratory protocols, not expert consensus in the way a clinical study would be.
3. Adjudication method for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or outcomes, not for functional and biocompatibility laboratory testing.
4. 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:
- No MRMC comparative effectiveness study was done. This is not an AI device. The study focused on the functional and biocompatibility performance of a physical medical device (dialysis catheter) compared to predicate devices.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is not an AI device.
6. The type of ground truth used:
- Functional Testing: The ground truth would be based on established engineering specifications and performance standards for dialysis catheters (e.g., flow rates, pressure resistance, structural integrity).
- Biocompatibility Testing: The ground truth would be based on international standards for biocompatibility of medical devices (e.g., ISO 10993 series), which define acceptable biological responses to materials in contact with the body.
7. The sample size for the training set:
- Not applicable. This device is a physical medical catheter, not an AI model requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.