(265 days)
Not Found
No
The summary describes a physical catheter device and its accessories. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on physical and biological properties.
Yes
The device is indicated for administration of fluids and nutrients, sampling of blood, and monitoring blood pressure and temperature, all of which are considered therapeutic or diagnostic interventions.
No
Explanation: The "Intended Use / Indications for Use" section states the device is used for "administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously." While "sampling of blood" and "monitoring blood pressure and temperature intravenously" involve collecting data, the primary purpose of the device (a catheter) is for access and administration, not for interpreting medical conditions or making diagnoses. It facilitates the collection of information that could be used for diagnosis, but it does not perform the diagnostic function itself.
No
The device description clearly outlines physical components like catheters, stylets, and introducers, and the performance studies focus on physical properties and biological compatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously." This describes a device used in vivo (within the body) for therapeutic and monitoring purposes, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details a catheter and its accessories, which are used to access the circulatory system directly. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process that involves testing biological samples outside of the body to provide diagnostic information. The "sampling of blood" is for collection, not for the device itself to perform a diagnostic test on the sample.
Therefore, based on the provided information, the L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are medical devices used for accessing the central venous system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJS, FOZ
Device Description
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:
• 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 or Splittable Introducer
- Stylet (include in the final catheter assembly as applicable)
- Trim Tool
- Tourniquet
- Tape measure
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system, lower one third of the superior vena cava to the junction of the superior vena cava and the right atrium, thoracic inferior vena cava above the level of the diaphragm, basilic, cephalic, or brachial vein at or below the axillary level and distal to the shoulder.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For proper use, clinicians must be familiar with and trained in the placement, maintenance, and use of PICC and/or midline catheters. Their use should be preceded by an established institutional protocol and accepted professional standards and guidelines and performed by persons trained in the procedure and knowledgeable of the inherent risks.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Catheter – Joint Leak Test
Catheter – Dimensional
Catheter – Pressure Burst
Catheter – Durometer
Catheter – Radiopacity
Stylet – Retaining force
Luer Functional Mechanical Bonds – Pull force
Particulates Material Durability
Supplemental testing to support the design change were Report 2023-039-RPT Luer Integrity (Functional), Report 2023-042-RPT ISO 80369-7 Compliance Testing and Report 2023-134-RPT Luer Integrity (Functional); Functional Leak Test.
Biological Comparison:
Pyrogenicity (ISO 10993-11)
Cytotoxicity (ISO 10993-5)
Hemocompatibility (ISO 10993-4)
Irritation/Sensitization (ISO 10993-10)
Systemic Toxicity (ISO 10993-11)
Ethylene oxide Residuals (ISO 10993-7)
Local effects after implantation (ISO 10993-7)
Supplemental testing to support the material change were Report 2022-026-RPT Systemic Toxicity (10993-17) and Genotoxicity (10993-3).
Sterilization:
100% EtO
SAL 10-6
ISO 11135:2014
AAMI TIR28:2016
The subject device met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device. This included evaluation of biocompatibility endpoints and assessment of impact of the design changes on the SAL.
Clinical Testing was not required for the determination of substantial equivalence.
Animal Testing was not required for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular 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)
| 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 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.
1445 Flat Creek Road
Athens, Texas 75751 USA
Facility Registration number: 1625425 |
|----------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott Bishop
Director, Regulatory Affairs
Phone: 469.430.0546
Email: Scott.Bishop@argonmedical.com |
| Device Trade Name: | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline
Catheters |
|-------------------------|-------------------------------------------------------------------------|
| Device Common Name: | Catheter, Intravascular, Therapeutic, Long-Term Greater Than
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
BD Cath™ Single Lumen
BD Cath™ Dual Lumen
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:
• Trim Tool
• Tape measure
• Stylet (include in the final catheter assembly as applicable)
• 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
L-Cath™ Single and Dual Lumen and L-
Cath™ Midline Catheter | Modified Proposed Device
(Subject of This Submission) &
Discussion |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Argon Medical Devices, Inc | SAME |
| FDA Clearance | K091670 | K230669 |
| Class | II | SAME |
| Device Classification Name | Percutaneous, implanted, long-term
intravascular catheter. | SAME |
| Regulation | 21 CFR 880.5970 | SAME |
| Product Code | LJS/FOZ | SAME |
| Technological Characteristics:
Technological characteristics of the Subject device are substantially equivalent to those of the cited predicate
device with respect to intended use, indications for use, target patient population, operating principle,
fundamental scientific technology, packaging configurations, sterility assurance level and method of sterilization.
The differences of the Subject device from the Predicate device are limited to the materials used in the Luer Lock
assembly. Additionally, contraindications have been added based on review of similar devices.
The following table provides a summary comparison between the subject and predicate device. | | |
| Intended Use | 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 administration of fluids,
medications, and nutrients; the sampling of
blood; and monitoring blood pressure and
temperature intravenously. | SAME |
| Principle of Operation | The L-Cath Single and Dual Lumen
Catheters and the L-Cath Midline Catheters
are a family of surgically Invasive, long-
term, polyurethane catheters that are in
direct contact with the central circulatory
system.
• For proper use, clinicians must be familiar
with and trained in the placement,
maintenance, and use of PICC and/or
midline catheters. Their use should be
preceded by an established institutional
protocol and accepted professional
standards and guidelines and performed by
persons trained in the procedure and
knowledgeable of the inherent risks.
• PICC catheters shall have the distal tip
dwelling in the lower one third of the
superior vena cava to the junction of the
superior vena cava and the right atrium.
Lower extremity placement shall have the
distal tip dwelling in the thoracic inferior
vena cava above the level of the
diaphragm.
• Midline catheters shall have the distal tip
residing in the basilic, cephalic, or brachial
vein at or below the axillary level and distal
to the shoulder. Infusates should be at or
near normal serum osmolality.
• Follow sterile technique per institutional
policy. Sterile technique and proper skin
preparation are essential for proper use.
The use of maximal barrier precautions
during catheter insertion is recommended
to help reduce the risk of catheter-related
infection, including the use of sterile gown,
mask, cap, sterile gloves, and large sterile
drapes to cover the body. Observe
Standard/Universal precautions for all
patients to reduce the potential exposure
to bloodborne pathogens. | SAME |
| Mechanism of Action | The polyurethane PICC and Midline
Catheter Systems transport medicines and
nutritional therapies into the bloodstream
of the patient by providing an enclosed
fluid pathway that connects other
catheters and then creates a seal at the
connections and junctions with the other
enclosed fluid pathways (catheters). | SAME |
| Indication for Use | The L-Cath Single and Dual Lumen
Catheters and the L-Cath Midline Catheters
intended use shall be for the administration
of fluids, medications, and nutrients; the
sampling of blood; and monitoring blood
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
Outer Diameter | Single Lumen: 16, 18, or 20-gauge
Dual Lumen: 16, 18, and 20-gauge
Small vein access (SVA) Single Lumen: 26 and 28-gauge
Midline: 18 and 20-gauge | SAME |
| PICC & Midline Catheter
Length | Single Lumen: 60 cm
Dual Lumen: 60 cm
SVA Single Lumen: 25 and 30 cm
Midline: 20 cm | SAME |
| Luer Lock Material | Gamma Stable Polycarbonate | PEBAX 7433 SA01 MED
NATURAL/CLEAR
• Biocompatibility and
performance testing
demonstrated that the difference
between the subject and
predicate devices does not raise
new or different questions to
safety and effectiveness |
| Catheter Material | Polyurethane | SAME |
| Strain Relief Material | Silicon | SAME |
| Tubing Material | Polyurethane | SAME |
| Stylet Material | 304V Stainless Steel
ABS | SAME |
| Y Site Assembly Material | Makrolon | SAME |
| Performance Testing: | | |
| In accordance with the Design Failure Modes and Effects Analysis, supplemental verification testing was identified | | |
| to support the substantial equivalence of the Subject Device. | | |
| Performance Testing | Catheter – Joint Leak Test Catheter – Dimensional Catheter – Pressure Burst Catheter – Durometer Catheter – Radiopacity Stylet – Retaining force Luer Functional Mechanical Bonds – Pull force Particulates Material Durability | SAME as K091670
Supplemental testing to support
the design change:
Report 2023-039-RPT
Luer Integrity (Functional) Report 2023-042-RPT
ISO 80369-7 Compliance
Testing Report 2023-134-RPT
Luer Integrity (Functional);
Functional Leak Test |
| Biological Comparison | Pyrogenicity (ISO 10993-11) Cytotoxicity (ISO 10993-5) Hemocompatibility (ISO 10993-4) Irritation/Sensitization (ISO 10993-10) Systemic Toxicity (ISO 10993-11) Ethylene oxide Residuals (ISO 10993-7) Local effects after implantation (ISO 10993-7) | Supplemental testing to support
the material change:
Report 2022-026-RPT Systemic Toxicity (10993-17) Genotoxicity (10993-3) |
| Sterilization | 100% EtO
SAL 10-6 | ISO 11135:2014
AAMI TIR28:2016
SAME |
| The subject device met all the predetermined acceptance criteria derived from the above listed reference
standards and internal test protocols and demonstrated substantially equivalent performance compared to the
predicate device. This included evaluation of biocompatibility endpoints and assessment of impact of the design
changes on the SAL. | | |
| Clinical Testing | Clinical testing was not required for the determination of substantial
equivalence. | |
| Animal Testing | Animal testing was not required for the determination of substantial
equivalence. | |
6
7
8
standards and as determined in the risk assessment. The technological differences between the subject and predicate device do not raise new or different questions of safety or effectiveness.
9
The proposed device modifications to the L-Cath™ Single and Dual Lumen and L-Conclusion: Cath™ Midline Catheters do not change its intended use or principles of operation. Based on the Indication for Use, design, and safety and performance testing, L-Cath Single-Lumen and Dual-Lumen Catheters and the L-Cath Midline Catheters, K230669 meet the requirements for its intended use, the differences do not raise new or different questions of safety and effectiveness and is therefore substantially equivalent to the predicate device, K091670.