(55 days)
No
The description focuses on the physical characteristics and performance of a catheter, with no mention of AI or ML capabilities.
No.
The device (dELC) is an access catheter used with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not the therapeutic device itself; it is a component that facilitates the therapy.
No
This device is a catheter used for vascular access in ultrafiltration therapy. Its purpose is to provide a pathway for blood in and out of the body for treatment, not to diagnose a condition.
No
The device description clearly describes a physical catheter with specific dimensions, materials (polyurethane, stainless steel), and features (lumens, tip design, connectors, clamps). The performance studies also focus on physical properties and interactions with the body and other hardware (Aquadex systems). There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy." This describes a device used in vivo (within the body) for a therapeutic procedure (ultrafiltration).
- Device Description: The description details a catheter designed for insertion into the peripheral venous circulation. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. IVDs typically involve analyzing blood, urine, tissue, etc., in a laboratory setting.
Therefore, the Dual Lumen Extended Length Catheter (dELC) is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NOJ, NQJ
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 short-term 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 effective (insertable) 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 reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular venous circulation (peripheral venous circulation)
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Verification and Validation testing: Bench testing was conducted in accordance with FDA guidance on Premarket Notification[510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, and ISO 10555-1 to evaluate the performance of the subject device through its shelf life on: Dimensional Analysis, Shaft Stiffness, Air Leakage into hub during aspiration, Liquid Leakage under pressure, Peak Tensile Force, Pressure Drop, Gravity Flow Rate, Priming Volume, Kink Resistance, Repeated Clamping on extension tubes, Marking adhesion, Chemical Tolerance, Recirculation Rate, Cyclic Fatigue, Aquadex System Compatibility. ISO 11135 and ISO 11607-1 were followed to evaluate sterilization and packaging of the subject device.
Biocompatibility testing: The biocompatibility evaluation was conducted in accordance with the FDA Biocompatibility Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, September 2020 and International Standard ISO10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." The battery of tests included: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Subacute Systemic Toxicity, Material Mediated Pyrogenicity, Genotoxicity (Bacterial Reverse Mutation Assay), Genotoxicity (Mouse Lymphoma Assay), Implantation, Hemocompatibility (ASTM Hemolysis), Hemocompatibility (Complement Activation), Hemocompatibility (Blood Platelet and Leukocyte Count), Hemocompatibility (PTT), Chemical Characterization with Toxicological Risk Assessment, Mechanical Hemolysis, Thrombogenicity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 26, 2023
Nuwellis Inc. Dawn Li Principal RA Specialist 12988 Valley View Road Eden Prairie, Minnesota 55344
Re: K233515
Trade/Device Name: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (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: NOJ. MPB Dated: October 31, 2023 Received: November 1, 2023
Dear Dawn Li:
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.
1
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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Image /page/1/Picture/8 description: The image shows a digital signature. The signature is from Maura Rooney -S. The date of the signature is 2023.12.26. The time of the signature is 10:43:06 -05'00'.
Maura Rooney Assistant Director
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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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Indications for Use (Describe)
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.
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.
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510(k) Summary
I. SUBMITTER
Nuwellis, Inc. 12988 Valley View Road Eden Prairie, MN 55344
Primary Contact: Mrs. Dawn Li Phone: 612-644-9452 Email: dawn.li@nuwellis.com
Date Prepared: October 31, 2023
II. DEVICE
Name of Device: Dual Lumen Extended Length Catheter (dELC), Model# 320101&320102
Common or Usual Name: Short-term/non-implanted blood access device
Classification Name: Blood Access Device and Accessories (21 CFR 876.5540)
Regulatory Class: II
Product Code: NQJ
III. PREDICATE DEVICE
Primary Predicate Device: 6F Dual Lumen Extended Length Catheter (dELC), K031689 Secondary Predicate: 5.2F Dual Lumen Extended Length Catheter (dELC), K041791 Reference Device: medCOMP PRO-LINE® CT Pressure Injectable CVC catheter, K093309 Reference Device: ArrowG+ard Blue Advance Midline 5.5F catheter, K161313 Reference Device: 14.5F x 24cm Hemo-Flow Double Lumen Catheter Set, K994105
The primary and secondary predicates have not been subject to a design-related recall.
IV. 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
5
venous circulation by way of a peel away introducer. The catheter is intended for short-term 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 effective (insertable) 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 reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. 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.
V. INDICATIONS FOR USE
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.
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Dual Lumen Extended Length Catheter (dELC) is identical in terms of indications for use and principles of operation to the primary predicate device (6F Dual Lumen Extended Length Catheter) and the secondary device (5.2 F Dual Lumen Extended Length Catheter). The subject Dual Lumen External Length Catheter (dELC) has the similar design and is manufactured from similar materials as the predicate devices. The minor design changes do not raise new questions regarding safety and effectiveness.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Verification and Validation testing
The subject Dual Lumen Extended Length Catheter followed verification and validation activities in accordance with Design Controls as per 21 CFR Section 820.30. Bench testing was conducted in accordance with FDA guidance on Premarket Notification[510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, and ISO 10555-1 to evaluate the performance of the subject device through its shelf life on:
- Dimensional Analysis ●
- Shaft Stiffness ●
- Air Leakage into hub during aspiration
- Liquid Leakage under pressure ●
- Peak Tensile Force ●
- Pressure Drop ●
- Gravity Flow Rate ●
- Priming Volume
- Kink Resistance
- Repeated Clamping on extension tubes
- Marking adhesion ●
- Chemical Tolerance ●
- Recirculation Rate ●
- . Cyclic Fatigue
- Aquadex System Compatibility .
ISO 11135 and ISO 11607-1 were followed to evaluate sterilization and packaging of the subject device.
7
Biocompatibility testing
The biocompatibility evaluation for the subject Dual Lumen Extended Length Catheter was conducted in accordance with the FDA Biocompatibility Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, September 2020 and International Standard ISO10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of tests included the following:
- . Cytotoxicity
- Sensitization ●
- Intracutaneous Irritation
- Acute Systemic Toxicity ●
- Subacute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Genotoxicity (Bacterial Reverse Mutation Assay) ●
- Genotoxicity (Mouse Lymphoma Assay) ●
- Implantation
- Hemocompatibility (ASTM Hemolysis) ●
- Hemocompatibility (Complement Activation)
- Hemocompatibility (Blood Platelet and Leukocyte Count)
- Hemocompatibility (PTT) ●
- Chemical Characterization with Toxicological Risk Assessment ●
- Mechanical Hemolysis
- Thrombogenicity
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VIII. CONCLUSIONS
In accordance with FDA 21 CFR Section 807.92 and based on the indications for use, technological characteristics, and safety and performance testing, the subject Dual Lumen Extended Length Catheters have the same indications for use, same operating principles, and similar performance characteristics to the predicate devices. The safety and performance of the dELC devices were evaluated through rigorous verification and validation activities. The changes in design and materials do not impact the safety and effectiveness of the subject devices. The subject dELC devices are substantially equivalent to the predicate devices.