(90 days)
Duet™ Catheter System: The Duet™ Long-Term Hemodialysis Catheter System is recommended for use in attaining short-term and long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The Duet™ Long-Term Hemodialysis Catheter System is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The catheters may be inserted percutaneously into the internal jugular vein, subclavian or external jugular vein.
Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit: Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit is intended to replace extension leg assemblies on the Duet™ Long-Term Hemodialysis Catheter System. To replace Extension Leg Assembly where there is a minimum of 6.0 cm of viable catheter on the Duet™ Long-Term Hemodialysis Catheter System.
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The provided text is a 510(k) Summary for the Duet™ Long-Term Hemodialysis Catheter System and its Repair Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a dedicated study proving device performance against those criteria in a traditional sense (like a clinical trial with specific performance endpoints).
Here's a breakdown of the requested information based on the provided text, and where the information is absent or not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not explicitly present in the provided 510(k) summary. The summary states: "Performance standards have not been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act."
Instead of explicit acceptance criteria and performance data, the submission relies on demonstrating substantial equivalence. The "Summary of Substantial Equivalence" section states: "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Duet™ Catheter System and Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."
This implies that the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics, safety, and performance to the predicate devices. The document does not report specific quantitative performance metrics for the Duet™ system such as flow rates, durability, or infection rates, and therefore, an explicit table comparing these to acceptance criteria cannot be formed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. A 510(k) summary focuses on equivalence, and while performance testing is mentioned, details about the test set (sample size, data provenance, e.g., country of origin, retrospective/prospective) are not included.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. This type of information is usually relevant for studies involving subjective assessments, like image interpretation for AI algorithms. For a medical device like a catheter system, "ground truth" would typically refer to objective measurements of physical properties, biocompatibility, and functional performance, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Similar to point 3, adjudication methods (like 2+1 or 3+1 for consensus building) are typically used for subjective assessments or when there's ambiguity in establishing ground truth, which is not the primary focus of demonstrating substantial equivalence for a physical medical device like this.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical medical device (catheter system), not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and not provided. This question is relevant for AI algorithms. The device in question is a physical catheter system for hemodialysis.
7. The Type of Ground Truth Used
For a physical device like the Duet™ catheter system, "ground truth" would generally refer to objective measurements of its physical and functional properties deemed essential for its intended use and equivalent to predicate devices. While not explicitly detailed, safety and performance testing would involve:
- Material properties: Biocompatibility, tensile strength, kink resistance.
- Functional characteristics: Flow rates, ability to withstand intended pressures, durability.
- Sterilization efficacy.
- Design conformity to established engineering and medical device standards.
These "ground truths" would be established through laboratory testing and engineering verification, rather than clinical outcomes data or pathology reports in the context of this specific 510(k) submission. There is no mention of pathology or outcomes data being used as "ground truth" within this document.
8. The Sample Size for the Training Set
This information is not provided and is not applicable for this type of device submission. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for this type of device submission.
§ 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.