(30 days)
The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.
The device is a dual-lumen, polyurethane catheter, 14 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. The catheter is available in a length of 16cm and is identical in appearance and function to the other manufactured catheter products aforementioned in section 3b. Moreover, the ARROW 14 Fr Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size.
An ARROW 14 Fr Hemodialysis Two-Lumen 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 guides, 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 tray and wrapped with in an absorbent cloth. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in shipping containers, labeled and sterilized.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ARROW 14 Fr Hemodialysis Two-Lumen Catheterization Kit:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list numerical acceptance criteria for each test. Instead, it states that "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." This implies a comparison to a predicate device and meeting equivalent performance.
| Test | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Tensile tests (Blue tip to catheter body, Catheter body to juncture hub, Extension lines to juncture hub) | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Flow rate test | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Prime volume test | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Flex fatigue | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Recirculation | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Kink test | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Shelf-Life; mechanical age testing | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
| Mechanical hemolysis | Equivalent to predicate device | Demonstrated safety and effectiveness equivalent to predicate | No specific numerical values provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide the specific sample sizes used for each of the performance tests. It only lists the types of tests conducted.
The data provenance is not explicitly stated as 'country of origin' or 'retrospective/prospective'. However, since these are laboratory performance tests for a medical device seeking FDA clearance, they would typically be conducted in a controlled, prospective manner by the manufacturer (ARROW International, Inc., based in the USA).
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 "ground truth" for a medical device's physical and functional performance tests (like tensile strength, flow rate) is established through standardized engineering and laboratory testing protocols, not through expert human review of data in the same way, for example, a diagnostic imaging device might require expert radiologist review. The document focuses on objective physical and functional characteristics.
4. Adjudication Method for the Test Set
This is not applicable to the type of performance testing described. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessments, such as clinical trials or diagnostic imagery reviews, where multiple readers might have differing opinions. For physical device performance tests, the results are typically quantitative and objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device described is a hemodialysis catheter, which is a physical medical device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable for the reasons stated in point 5. The device itself is not an algorithm. The performance tests are for the physical integrity and function of the catheter.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests listed (tensile, flow rate, prime volume, flex fatigue, recirculation, kink, shelf-life, mechanical hemolysis) would be objective laboratory measurements based on established engineering and materials science principles, and comparison to the performance of the legally marketed predicate device.
8. The Sample Size for the Training Set
There is no "training set" in the context of this device's performance testing. The listed tests are for verification and validation of the device's physical and functional properties, not for training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/algorithm in this context, this point is not applicable.
§ 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.