(100 days)
The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.
Acceptance Criteria and Device Performance Study for Pristine™ Long-Term Hemodialysis Catheter (K203767)
The information provided describes the substantial equivalence determination for the Pristine™ Long-Term Hemodialysis Catheter (K203767) by comparing it to a predicate device, the Pristine™ Hemodialysis Catheter (K182443). The regulatory submission focuses on demonstrating that the new device meets the same performance criteria as the previously cleared predicate device, with additional testing for specific design changes.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the subject device met "all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)."
For the specific design changes in the subject device, the verification testing was performed to the "exact same acceptance criteria as K182443."
The following table summarizes the acceptance criteria categories mentioned and the general reported performance. Specific numerical acceptance values are not provided in this document but are implied to be identical to those established for the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional and Workmanship Analysis (Luers) | Met established acceptance criteria (same as K182443). |
| Luer Occlusion | Met established acceptance criteria (same as K182443). |
| Luer Assembly Tensile | Met established acceptance criteria (same as K182443). |
| Leak Decay | Met established acceptance criteria (same as K182443). |
| Tunneler (Shaft to Tunneler Tensile) | Met Bard's acceptance criteria (additional test for design change). |
| Tunneler (Damage after Removal) | Met Bard's acceptance criteria (additional test for design change). |
| Sterile Barrier Visual Inspection | Met Bard's acceptance criteria (additional test for design change). |
| Sterile Barrier Integrity (Bubble Leak, Dye Leak) | Met Bard's acceptance criteria (additional test for design change). |
| Minimum Seal Width | Met Bard's acceptance criteria (additional test for design change). |
| External Literature Pouch Damage | Met Bard's acceptance criteria (additional test for design change). |
| Label Legibility | Met Bard's acceptance criteria (additional test for design change). |
| Tray Cracking | Met Bard's acceptance criteria (additional test for design change). |
| Component Movement and Damage | Met Bard's acceptance criteria (additional test for design change). |
| Peel Force Test (Poly to Poly, Poly to Tyvek) | Met Bard's acceptance criteria (additional test for design change). |
| All other original verification and validation testing for the predicate device | Remained the same and was unchanged, implying established acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "All samples used for final testing of each product attribute were representative of finished products." However, specific numerical sample sizes for each test are not provided.
The data provenance is implied to be from internal laboratory testing conducted by the manufacturer, C. R. Bard, Inc. The document does not specify country of origin for the data nor explicitly state if it was retrospective or prospective, but given the context of design verification and validation, it would be considered prospective testing of newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The study described is a device performance verification and validation study against established engineering and performance criteria, not a study involving human interpretation of medical images or expert consensus for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. As this is a physical device performance study, there's no "adjudication" in the sense of reconciling multiple expert opinions. Test results are compared against pre-defined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document describes a design verification and validation study for a medical device against pre-defined engineering acceptance criteria, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This document pertains to a physical medical device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the pre-established engineering and performance specifications and acceptance criteria for the device's physical and functional attributes. These criteria are derived from applicable standards, guidance documents, test protocols, and customer inputs, which would have been established internally by the manufacturer and validated during the predicate device's clearance.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This is a device performance study, not a machine learning model development or validation study; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. As there is no training set, the establishment of ground truth for it is irrelevant to this document.
§ 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.