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.

Device Description

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.

AI/ML Overview

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.

Summary

FDA 510(k) Clearance Letter - K252226

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 13, 2025

Nuwellis, Inc.
℅ Sydney Wiggins
Sr. Regulatory Affairs Specialist
Avio Medtech Consulting
2300 Myrtle Avenue
Suite 200
St Paul, MN 55114

Re: K252226
Trade/Device Name: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Regulation Number: 21 CFR§ 876.5540
Regulation Name: Blood access device and accessories
Regulatory Class: II
Product Code: NQJ, MPB
Dated: July 16, 2025
Received: July 16, 2025

Dear Sydney Wiggins:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K252226 - Sydney Wiggins
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K252226 - Sydney Wiggins
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Maura Rooney -S

Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252226

Device Name: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

510(k) #: K252226
Prepared on: 2025-07-16

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Nuwellis, Inc.
Applicant Address	12988 Valley View Road Eden Prairie MN 55344 United States
Applicant Contact Telephone	9523454200
Applicant Contact	Mr. Neil Ayotte
Applicant Contact Email	Neil.Ayotte@nuwellis.com
Correspondent Name	Avio Medtech Consulting
Correspondent Address	2300 Myrtle Avenue Suite 200 St Paul MN 55114 United States
Correspondent Contact Telephone	4794593337
Correspondent Contact	Mrs. Sydney Wiggins
Correspondent Contact Email	syd@aviomedtech.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Common Name	Blood access device and accessories
Classification Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Regulation Number	876.5540
Product Code(s)	NQJ, MPB

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K233515	Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	NQJ

Device Description Summary

21 CFR 807.92(a)(4)

Page 6

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.

An attached MRI tag indicates the device is MR unsafe.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use for the subject device and the predicate device are the same.

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has nearly identical technological characteristics to the predicate device. The only modification made to the dELC device was the change of the Female Luer Lock Connector's material from Cryolite G-20 acrylic to the Tritan™ copolyester MX731 (polyester of dimethyl terephthalate, 1,4-cyclohexanedimethanol, 2,2,4,4-tetremethyl-1,3-cyclobutanediol, mold release additive) made by Eastman. The geometry of the Female Luer Lock connector component has remained identical.

The change in the Female Luer Lock Connector component material from an acrylic multipolymer to a copolyester does not raise different questions of safety and effectiveness. The new material has a similar biocompatibility profile to the predicate and an identical mechanism of action/mode of operation. The intended use, technological characteristics, and patient-contact profile remain unchanged. Risk analysis and, where applicable, verification and validation activities confirm that the change does not introduce new or increased risks. Of note, evaluation of the updated Female Luer Lock Connector was conducted using well-established methods and no new types of performance or safety testing was required beyond what was already established for the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Nonclinical testing of the 6F dELC device with the updated, copolyester Female Luer Lock Connector demonstrated that the modified device is substantially equivalent to the predicate device (K233515) in terms of safety and effectiveness. Safety testing established that the new Female Luer Lock Connector material did not introduce new risks related to increased adverse tissue reactions (biocompatibility), increased patient harm from EO residuals, and reduced shelf-life. 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.

Regulation Number and Section

§ 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.