(28 days)
The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size.
The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with the coil reinforcement, designed based on the FDA cleared 5.2F dELC via K041791, provides kinking resistance and ensures consistent flow. Depth markings are provided in 0.5cm increments along the insertable length of the catheter shaft. The proximal end of the catheter shaft and clear polyurethane extension tubes are over-molded into a polyurethane hub, which has suture wings for securement to the skin.
Additionally, the catheter has female ISO 80369-compliant luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. When the catheter is not in use, two yellow male locking caps can be placed on the female luer connectors for reducing the risk of infection. Each extension tube has a clamp: blue on the blood withdrawal tube (marked by the withdrawal ID ring) and white on the blood infusion tube (marked by the infusion ID ring). The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.
An attached MRI tag indicates the device is MR unsafe.
The provided FDA 510(k) clearance letter (K252226) describes a medical device, the Dual Lumen Extended Length Catheter (dELC), and details the rationale for its substantial equivalence to a predicate device. This submission focuses on a material change to an existing cleared device, rather than a de novo submission for a novel AI/software device. Therefore, the information typically requested regarding acceptance criteria and study proving performance for an AI/software device (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment) is not applicable in this context.
The acceptance criteria here pertain to the safety and effectiveness equivalency of the modified medical device (specifically, the change in material for the Female Luer Lock Connector) compared to its predicate. The study conducted is non-clinical performance testing rather than a clinical trial or AI model validation.
Here's a breakdown of the available information relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific 510(k) submission:
Acceptance Criteria and Reported Device Performance (for a Material Change)
The core acceptance criterion for this 510(k) submission is to demonstrate that the change in material for the Female Luer Lock Connector does not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to the predicate device.
| Acceptance Criterion (for a Material Change) | Reported Device Performance/Conclusion |
|---|---|
| Biocompatibility: No increased adverse tissue reactions from new material. | "The new material has a similar biocompatibility profile to the predicate." |
| Sterilization: No increased patient harm from Ethylene Oxide (EO) residuals. | "Safety testing established that the new Female Luer Lock Connector material did not introduce new risks related to... increased patient harm from EO residuals." |
| Shelf-Life: No reduced shelf-life. | "Safety testing established that the new Female Luer Lock Connector material did not introduce new risks related to... reduced shelf-life." |
| Functional Integrity (Connector/Extension Tube Bond): Maintained mechanical integrity and bond strength. | "Functionality testing focused mainly on the integrity of the junction of the connector to the extension tubes." |
| "Functionality testing established that the new Female Luer Lock Connector material did not impact device effectiveness." | |
| "This was determined by visual inspection of the caps for damage following IPA conditioning, the absence of catheter leakage, and suitable peak tensile force of the connector/extension tube bond." | |
| Overall Safety & Effectiveness: No new or increased risks. | "Risk analysis and, where applicable, verification and validation activities confirm that the change does not introduce new or increased risks." |
| "The modified device is substantially equivalent to the predicate device (K233515) in terms of safety and effectiveness." |
Information NOT APPLICABLE to this 510(k) (as it's a material change, not an AI/software device):
The following points are standard for AI/software device clearances but are not relevant to this specific 510(k) for a material change in a physical medical device.
- Sample sizes used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing non-clinical bench testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is typically for patient data used in AI validation.
- Number of experts used to establish ground truth for the test set and qualifications: Not applicable. There is no "ground truth" to establish in the context of an algorithmic output. The performance tests are specific to the mechanical and chemical properties of the device.
- Adjudication method for the test set: Not applicable. No human interpretation or adjudication of an algorithm's output.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, which doesn't apply to this physical device change.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable. Ground truth typically refers to a verified diagnosis or measurement used to evaluate an AI model's accuracy. For this device, "ground truth" would be established through calibrated instruments measuring physical properties.
- The sample size for the training set: Not applicable. There is no AI model or training set involved.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) demonstrates substantial equivalence through non-clinical bench testing to affirm that a material change to a connector on a physical medical device does not compromise its safety or effectiveness when compared to the previously cleared predicate device. It specifically avoids the need for clinical studies by establishing this equivalence.
§ 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.