L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. November 30, 2023 Argon Medical Devices Scott Bishop Director, Regulatory Affairs 1445 Flat Creek Road Athens. Texas 75751 Re: K230669 Trade/Device Name: L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, FOZ Dated: October 31, 2023 Received: October 31, 2023 Dear Scott Bishop: 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. 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). {1}------------------------------------------------ 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 OS 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 medical devices and radiation-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). {2}------------------------------------------------ Sincerely, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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 510(k) Number (if known) K230669 Device Name L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters Indications for Use (Describe) The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {4}------------------------------------------------ ## K230669 510(k) Summary November 30, 2023 Date Prepared: | Company: | Argon Medical Devices, Inc.<br>1445 Flat Creek Road<br>Athens, Texas 75751 USA<br>Facility Registration number: 1625425 | |----------|-------------------------------------------------------------------------------------------------------------------------| | Contact: | Scott Bishop<br>Director, Regulatory Affairs<br>Phone: 469.430.0546<br>Email: Scott.Bishop@argonmedical.com | | Device Trade Name: | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline<br>Catheters | |-------------------------|-------------------------------------------------------------------------| | Device Common Name: | Catheter, Intravascular, Therapeutic, Long-Term Greater Than<br>30 Days | | Regulation Name: | Percutaneous, implanted, long-term intravascular catheter | | Primary Product Code: | LJS | | Secondary Product Code: | FOZ | | Regulation: | 21 CFR 880.5970 | | Classification: | Class II | | Review Panel: | General Hospital | | Predicate Device(s): K091670 | BD L-Cath™ Midline Catheter<br>BD Cath™ Single Lumen<br>BD Cath™ Dual Lumen<br>Peripherally Inserted Central Catheters PICC | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description of the Device: | The L-Cath™ Single and Dual Lumen and L-Cath™ Midline Catheters are sterile, single use devices, sold as standalone devices which includes the following accessories:<br>• Trim Tool<br>• Tape measure<br>• Stylet (include in the final catheter assembly as applicable)<br>• Polyurethane catheter | {5}------------------------------------------------ These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following: - BD Introsyte Autoguard Introducer or Splittable Introducer ● - Stylet (include in the final catheter assembly as applicable) - Trim Tool - Tourniquet - Tape measure #### Indication for The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are Use: indicated for short or long term peripheral access to the central venous system for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously. ### Substantial Equivalence: There is no change of intended use or fundamental scientific technology between the proposed modified and predicate device. The proposed modified device has the same indication for use as the predicate, K091670. | | Predicate Device<br>L-Cath™ Single and Dual Lumen and L-<br>Cath™ Midline Catheter | Modified Proposed Device<br>(Subject of This Submission) &<br>Discussion | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Argon Medical Devices, Inc | SAME | | FDA Clearance | K091670 | K230669 | | Class | II | SAME | | Device Classification Name | Percutaneous, implanted, long-term<br>intravascular catheter. | SAME | | Regulation | 21 CFR 880.5970 | SAME | | Product Code | LJS/FOZ | SAME | | Technological Characteristics:<br>Technological characteristics of the Subject device are substantially equivalent to those of the cited predicate<br>device with respect to intended use, indications for use, target patient population, operating principle,<br>fundamental scientific technology, packaging configurations, sterility assurance level and method of sterilization.<br>The differences of the Subject device from the Predicate device are limited to the materials used in the Luer Lock<br>assembly. Additionally, contraindications have been added based on review of similar devices.<br>The following table provides a summary comparison between the subject and predicate device. | | | | Intended Use | The L-Cath Single and Dual Lumen<br>Catheters and the L-Cath Midline Catheters<br>are indicated for short or long term<br>peripheral access to the central venous<br>system for the administration of fluids,<br>medications, and nutrients; the sampling of<br>blood; and monitoring blood pressure and<br>temperature intravenously. | SAME | | Principle of Operation | The L-Cath Single and Dual Lumen<br>Catheters and the L-Cath Midline Catheters<br>are a family of surgically Invasive, long-<br>term, polyurethane catheters that are in<br>direct contact with the central circulatory<br>system.<br>• For proper use, clinicians must be familiar<br>with and trained in the placement,<br>maintenance, and use of PICC and/or<br>midline catheters. Their use should be<br>preceded by an established institutional<br>protocol and accepted professional<br>standards and guidelines and performed by<br>persons trained in the procedure and<br>knowledgeable of the inherent risks.<br>• PICC catheters shall have the distal tip<br>dwelling in the lower one third of the<br>superior vena cava to the junction of the<br>superior vena cava and the right atrium.<br>Lower extremity placement shall have the<br>distal tip dwelling in the thoracic inferior<br>vena cava above the level of the<br>diaphragm.<br>• Midline catheters shall have the distal tip<br>residing in the basilic, cephalic, or brachial<br>vein at or below the axillary level and distal<br>to the shoulder. Infusates should be at or<br>near normal serum osmolality.<br>• Follow sterile technique per institutional<br>policy. Sterile technique and proper skin<br>preparation are essential for proper use.<br>The use of maximal barrier precautions<br>during catheter insertion is recommended<br>to help reduce the risk of catheter-related<br>infection, including the use of sterile gown,<br>mask, cap, sterile gloves, and large sterile<br>drapes to cover the body. Observe<br>Standard/Universal precautions for all<br>patients to reduce the potential exposure<br>to bloodborne pathogens. | SAME | | Mechanism of Action | The polyurethane PICC and Midline<br>Catheter Systems transport medicines and<br>nutritional therapies into the bloodstream<br>of the patient by providing an enclosed<br>fluid pathway that connects other<br>catheters and then creates a seal at the<br>connections and junctions with the other<br>enclosed fluid pathways (catheters). | SAME | | Indication for Use | The L-Cath Single and Dual Lumen<br>Catheters and the L-Cath Midline Catheters<br>intended use shall be for the administration<br>of fluids, medications, and nutrients; the<br>sampling of blood; and monitoring blood<br>pressure and temperature intravenously. | SAME | | Contraindication | There are no Contraindications | The devices are contraindicated whenever there is presence of device related infections or presence of thrombosis in the intended insertion vessel or catheter pathway. The devices are contraindicated when the patient's body size is insufficient to accommodate the size of the device. The patient is known or is suggested to be allergic to materials contained in the device. Clinical assessment of the patient must be completed to ensure no contraindications exist. | | Single Use | Yes | SAME | | Supplied Sterile | Yes, EO | SAME | | Device Description | All Argon L-Cath PICC and Midline polyurethane catheters are sold as standalone devices which includes the following accessories: Trim Tool Tape measure Stylet (include in the final catheter assembly as applicable) Polyurethane catheter These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following: BD Introsyte Autoguard Introducer Stylet (include in the final catheter assembly as applicable) Trim Tool Tourniquet Tape measure | SAME | | PICC & Midline Catheter<br>Outer Diameter | Single Lumen: 16, 18, or 20-gauge<br>Dual Lumen: 16, 18, and 20-gauge<br>Small vein access (SVA) Single Lumen: 26 and 28-gauge<br>Midline: 18 and 20-gauge | SAME | | PICC & Midline Catheter<br>Length | Single Lumen: 60 cm<br>Dual Lumen: 60 cm<br>SVA Single Lumen: 25 and 30 cm<br>Midline: 20 cm | SAME | | Luer Lock Material | Gamma Stable Polycarbonate | PEBAX 7433 SA01 MED<br>NATURAL/CLEAR<br><br>• Biocompatibility and<br>performance testing<br>demonstrated that the difference<br>between the subject and<br>predicate devices does not raise<br>new or different questions to<br>safety and effectiveness | | Catheter Material | Polyurethane | SAME | | Strain Relief Material | Silicon | SAME | | Tubing Material | Polyurethane | SAME | | Stylet Material | 304V Stainless Steel<br>ABS | SAME | | Y Site Assembly Material | Makrolon…