(187 days)
The dual-lumen hemodialysis catheter permits venous access to the central circulation system for rapid fluid administration, temporary or acute hemodialysis and apheresis . It oyoton for rapid have actual an, or femoral veins of children, adolescents and small adults.
The device is a dual-lumen, polyurethane catheter, 8 French in size, with two independent non-communicating lumens, extension lines, Luer hubs and extension line clamps. Each lumen exits at the distal end of the catheter through individual ports spaced at a given distance apart. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub the lumens are connected to clear separate extension lines. Each extension line contains either a red or blue clamp. The colored clamps indicate arterial flow (outflow) or venous flow (inflow). Also, centimeter markings are placed along the length of the indwelling catheter body to facilitate proper positioning. This catheter is identical in appearance and function to the Quinton® manufactured catheter aforementioned in section 3c. Moreover, the ARROW Pediatric Two-Lumen Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size and length.
An ARROW Pediatric Two-Lumen Hemodialysis Catheterization Kit consists of a dual-lumen catheter packaged with various accessory components that are required during catheterization. These components include combinations of the following: spring wire quides. dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups and medication. Moreover, the kit also includes labeling information including instructions for use, contents sheet and various unit package labels. The contents of the kit are contained in the tray and wrapped with a CSR wrap. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in corrugated shipping cartons and labeled.
The provided text describes a Special 510(k) submission for a device modification, not a study proving acceptance criteria for a novel device. Therefore, much of the requested information (like expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.
This submission aims to demonstrate substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a device already legally marketed. The primary "study" here is a series of performance tests to show the modified device maintains its safety and effectiveness.
Here's the breakdown of the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|---|
| Material/Component Integrity | Tensile tests: | ||
| a) blue tip to catheter body | |||
| b) catheter body to juncture hub | |||
| c) extension lines to juncture hub | Likely "Meets or exceeds tensile strength of predicate device" or "No failure under simulated clinical forces." | Results demonstrated the device is safe and as effective as the legally marketed predicate device. (Specific values not provided) | |
| Functional Performance | Flow rate test | Likely "Achieves required flow rates for hemodialysis and apheresis." | Results demonstrated the device is safe and as effective as the legally marketed predicate device. (Specific values not provided) |
| Component Functionality | Extension line clamp tests: | ||
| a) clamp strength | |||
| b) un-clamp strength | Likely "Maintains secure clamping" and "Allows for un-clamping without damage or excessive force." | Results demonstrated the device is safe and as effective as the legally marketed predicate device. (Specific values not provided) | |
| Catheter Volume | Prime volume test | Likely "Meets specified prime volume" or "Comparable to predicate device's prime volume." | Results demonstrated the device is safe and as effective as the legally marketed predicate device. (Specific values not provided) |
| Hemodialysis Efficiency | Recirculation test | Likely "Achieves acceptable recirculation rates for effective hemodialysis." | Results demonstrated the device is safe and as effective as the legally marketed predicate device. (Specific values not provided) |
Important Note: The document states, "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. These would typically be detailed in the full submission, not necessarily in the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The tests are described as "laboratory tests," suggesting in-vitro testing. The number of units tested for each specific performance test (tensile, flow rate, etc.) is not provided.
- Data Provenance: Not explicitly stated, but it's generated by the manufacturer (ARROW International, Inc.) through internal "laboratory tests." This would be prospective testing on the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a performance testing submission for a physical medical device, not an AI/diagnostic software. Ground truth in this context refers to engineering and performance specifications, not clinical diagnoses by experts.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this applies to clinical or diagnostic studies, not engineering performance tests.
5. 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. This is not an AI-assisted diagnostic device. It is a physical medical device (catheterization kit).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- For the performance tests, the ground truth would be defined by pre-established engineering specifications and performance requirements derived from regulatory standards, internal product design specifications, and comparison data from the predicate device. For example, "tensile strength must exceed X Newtons" or "flow rate must be Y ml/min at Z pressure."
8. The Sample Size for the Training Set
- Not Applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, there is no training set.
§ 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.