(316 days)
The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Power-Trialysis™ Short-Term Dialysis catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.
The provided text describes a 510(k) premarket notification for a medical device called the Power-Trialysis Short-Term Dialysis Catheter (K133456). This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K083675) rather than establishing novel performance criteria for a new type of device. As such, the structure of the provided information does not perfectly align with a typical AI/software device study seeking to establish performance against defined acceptance criteria.
The "acceptance criteria" here are generally that the new device performs as safely and effectively as the predicate device. The study described is a series of engineering and performance tests comparing the subject device to the predicate device to confirm this substantial equivalence.
Here's an attempt to structure the information based on your request, with clarifications where the provided text doesn't directly map to the question:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical catheter, the "acceptance criteria" are generally based on meeting the performance established by the predicate device and relevant industry standards. The reported performance confirms these criteria were met.
| Acceptance Criteria Category | Specific Test/Performance Requirement | Reported Device Performance (Summary) |
|---|---|---|
| Material Biocompatibility | Hemolysis testing: In accordance with ASTM F1841:1997 (R 2005) | Device met acceptance criteria. |
| Material/Device Integrity (Chemical Exposure) | Leak, Static Burst, Tensile, Shaft to Hub Tensile testing: Following chemical conditioning | Device met acceptance criteria. |
| Device Integrity (Mechanical Stress) | Occluded Power Injection and Assembly Leak Post Occluded Power Injection testing | Device met acceptance criteria to address lower static burst threshold of modified device. |
| Device Integrity (Repeated Use) | Assembly Burst testing: Post multiple power injections | Device met acceptance criteria, material did not weaken. |
| Functional Performance (Dialysis) | Dialysis Flow testing: Satisfy established flow rate requirements under labeled procedural pressures | Catheter configurations satisfied established flow rate requirements. |
| Functional Performance (Structural Integrity) | Catheter Collapse for Dialysis Lumens testing: Will not collapse at established pressure requirements | Catheter lumens did not collapse at required pressures. |
| Functional Performance (Power Injection) | Gravity Flow testing: Determine flow rate of normal saline through power injectable lumen | Performed; results implicitly met acceptance criteria for flow. |
| Functional Performance (Power Injection) | Catheter Collapse for Power Injectable Lumen testing: Determine flow rate through power injectable lumen at vacuum pressure | Performed; results implicitly met acceptance criteria for flow under vacuum. |
| Usability/Compatibility | Guidewire Fit testing: Ensure use compatibility between catheters and guidewires | Ensured use compatibility. |
| Clinical Monitoring Capability | Central Venous Pressure Monitoring testing: Verify capabilities in simulated environment | Capabilities verified in simulated environment. |
| Sterilization Efficacy | Sterilization Validation: Added length does not adversely impact sterilant residual levels (ISO 10993-7: 2008) | Added length did not adversely impact sterilant residual levels. |
| Overall Equivalence | Demonstrates substantial equivalence to predicate device (K083675) across indications for use, technological characteristics, and safety/performance. | Subject device met all predetermined acceptance criteria and demonstrated substantially equivalent performance to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many catheters were tested for hemolysis or burst strength). It refers to "verification and validation activities" and "performance data" but does not quantify the number of units tested.
- Sample Size for Test Set: Not explicitly stated for each individual test. Implied to be sufficient for engineering validation studies following design controls (21 CFR §820.30).
- Data Provenance: The studies were conducted by Bard Access Systems, Inc. in the US, as part of their 510(k) submission. These are prospective engineering and performance tests on manufactured devices, not retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a 510(k) submission for a physical device like a catheter. The "ground truth" for the performance tests (e.g., flow rate, burst pressure, tensile strength) is based on measurable physical properties and objective engineering standards (e.g., ISO, ASTM). The "experts" involved would be the engineers, technicians, and quality control personnel conducting and reviewing these tests, whose qualifications would be in engineering, materials science, or related fields. The document does not specify the number or specific qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable in the context of physical performance testing against objective standards. The results of tests like burst pressure or hemolysis are quantitative and compared directly to predetermined specifications or standards, without the need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human reader performance is being evaluated with and without AI assistance. The Power-Trialysis Short-Term Dialysis Catheter is a physical medical device, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Objective Engineering Standards: Adherence to established international and national standards (e.g., ASTM F1841, ISO 10555-1, ISO 10993-7).
- Predicate Device Performance: Performance data from the legally marketed predicate device (K083675) serves as a benchmark for substantial equivalence.
- Design Specifications: Internal design requirements and specifications for the catheter's physical and functional properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and the concept of a "training set" is generally used for machine learning models, not for engineering validation of a catheter. The manufacturing process for these devices would involve process validation and quality control, which are distinct from machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" in the machine learning sense, there is no ground truth established for it.
§ 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.