(242 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter) and its performance is evaluated through standard engineering and biocompatibility tests. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is a central venous catheter used for vascular access, fluid administration, blood sampling, and apheresis, but it does not directly treat or cure a disease; it facilitates other therapeutic interventions.
No
The device is a central venous catheter used for administering fluids, blood products, drugs, and for blood withdrawal, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter made of polyurethane with lumens, connectors, and clamps, indicating it is a hardware device. The performance studies also focus on physical properties and biocompatibility of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attaining short term or long term vascular access for intravenous infusion therapy and blood sampling". This describes a device used in vivo (within the body) for delivering substances and withdrawing blood directly from the bloodstream.
- Device Description: The description details a catheter designed for insertion into veins, with lumens for fluid delivery and blood withdrawal. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information about a patient's health. The provided information does not mention any analysis or testing of specimens outside the body.
Therefore, the Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular yein, and subclavian vein. All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheres.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Hickman® TriFusion™ Catheters are open-ended triple lumen radiopague polyurethane . catheters.
The Hickman® TriFusion™ Catheters are 12 Fr triple lumen catheters with up to 27 cm insertion . lenath.
. The Hickman® TriFusion™ Catheters have three equal sized lumens with the distal lumen extending beyond the proximal lumens.
The proximal end of the Hickman® TriFusion™ Catheter consists of three Luer connectors, ● occlusion clamps, and priming volume ID tags.
. Catheters are provided sterile in two kit configurations, an Intermediate Tray and a Microintroducer (MI) Tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, external jugular vein, and subclavian vein
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish the performance of the device: Catheter Assembly Burst Strength, Catheter Assembly Tensile, Catheter Joint Durability Leak Test, Luer Configuration: Luer Gauging, Luer Configuration: Liquid Leak, Luer Configuration: Air Leak, Luer Configuration: Unscrewing Torque, Luer Configuration: Ease of Assembly, Luer Configuration: Resistance to Overriding, Luer Configuration: Stress Cracking, Luer Configuration: Separation Force, Cuff Tensile, Tip Tensile, Gravity Flow, Catheter Stiffness, Priming Volume, Catheter Collapse, Radiopacity. Biocompatibility evaluation and testing was conducted in accordance with ISO10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogencitiy, Subchronic Toxicity, Genotoxicity, Implantation, and Hemocompatibility. The subject Hickman TriFusion Catheter was adopted into the sterilization cycle per AAMI TIR28:2016, Product adoption and process equivalence for ethylene oxide sterilization. The sterilization cycle has been validated by half-cycle over-kill method in accordance with ANSI/AAMI/ISO 11135, Sterilization of Healthcare Products. Ethylene Oxide sterilization testing was conducted per ISO 10993-7:2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Additionally, LAL bacterial endotoxin testing was performed per ANSI/AAMI ST72. Bacterial Endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing, and USP for bacterial endotoxin limits.
Key Results: Based on the indications for use, technological characteristics, and performance testing, the subject Hickman® TriFusion™ Catheter meets the requirements that are considered sufficient for its intended use and demonstrate substantial equivalence to the cited predicate device.
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 shows the logo for 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 in blue. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION".
April 20, 2018
C.R. Bard, Inc Mona Shahrebani Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K172511
Trade/Device Name: Hickman® TriFusion™ Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: March 23, 2018 Received: March 26, 2018
Dear Mona Shahrebani:
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 (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. 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
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K172511
Device Name Hickman® TriFusion™ Catheter
Indications for Use (Describe)
The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular yein, and subclavian vein. All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheres.
| 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)
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3
K172511 Hickman TriFusion Catheter 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information: Bard Access Systems, Inc. (BAS) 605 North 5600 West Salt Lake City, Utah 84116 Phone: (801) 522-5967 Fax: (801) 522-4907 Contact Person: Mona Shahrebani, Regulatory Affairs Specialist April 13, 2018 Date of Submission: Subject Device: Hickman® TriFusion™ Catheter Common or Usual Name: Long-Term Intravascular Catheter Classification Name: Catheter, Intravascular, Therapeutic, Long-Term greater than 30 days Regulatory Class: Class II Requlation Number: 21 CFR 880.5970 FDA Product Code: LIS Hickman® TriFusion™ Catheter Predicate Device: Common or Usual Name: Long-Term Intravascular Catheter Premarket Notification: K041088 Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 days Regulatory Class: Class II Requlation Number: 21 CFR 880.5970 FDA Product Code: പട
4
Device Description:
The device description of the subject Hickman TriFusion Catheter is as follows:
- The Hickman® TriFusion™ Catheters are open-ended triple lumen radiopague polyurethane . catheters.
- The Hickman® TriFusion™ Catheters are 12 Fr triple lumen catheters with up to 27 cm insertion . lenath.
- . The Hickman® TriFusion™ Catheters have three equal sized lumens with the distal lumen extending beyond the proximal lumens.
- The proximal end of the Hickman® TriFusion™ Catheter consists of three Luer connectors, ● occlusion clamps, and priming volume ID tags.
- . Catheters are provided sterile in two kit configurations, an Intermediate Tray and a Microintroducer (MI) Tray.
Indications for Use of Device:
The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.
Technological Comparison to Predicate Devices:
Technological characteristics of the subject Hickman® TriFusion™ Catheter are substantially equivalent with regard to the basic design and function of the predicate device. Hickman® TriFusion™ Catheter (K041088). The subject device differs in technological characteristics when compared to the predicate device in that the Luer connector of the subject devices are manufactured from a different material formulation of the base resin and colorant. These differences do not alter the subject device and do not raise any new questions regarding safety or effectiveness when compared to the predicate device.
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| Subject and Predicate Device Comparison Table | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device- Hickman TriFusion Catheter | Predicate Device- Hickman TriFusion Catheter | |||||||||||||||
| Owner | Same as Predicate | Bard Access Systems, Inc. | ||||||||||||||
| Classification | Same as Predicate | LJS- 21 CFR 880.5970- Long-Term-Intravascular Catheter | ||||||||||||||
| 510(k) Status | Subject of this Premarket Notification | K041088- Concurrence date November 01, 2004 | ||||||||||||||
| Indications for Use | Same as Predicate | The Hickman® TriFusion™ Triple Lumen Long-Term Central | ||||||||||||||
| Venous Catheter is indicated for use in attaining short term or | ||||||||||||||||
| long term vascular access for intravenous infusion therapy and | ||||||||||||||||
| blood sampling via the internal jugular vein, external jugular | ||||||||||||||||
| vein, and subclavian vein. All Hickman® TriFusion™ catheters | ||||||||||||||||
| are designed for apheresis, and the administration of I.V. fluids, | ||||||||||||||||
| blood products, drugs, and parenteral nutrition solutions, as well | ||||||||||||||||
| as blood withdrawal. The Hickman® TriFusion™ catheter | ||||||||||||||||
| incorporates three large, equal size lumens appropriate for | ||||||||||||||||
| apheresis procedures | ||||||||||||||||
| Catheter | ||||||||||||||||
| Configurations | Same as predicate | French Size Length | ||||||||||||||
| (Tip to Cuff) Total | ||||||||||||||||
| Length Insertion | ||||||||||||||||
| Length 12 Fr 19 cm 24 cm 12 Fr 23 cm 28 cm 12 Fr 27 cm 32 cm | ||||||||||||||||
| Catheter Material | Catheter Shaft | Catheter Shaft | ||||||||||||||
| Same as predicate | Polycarbonate Polyurethane | |||||||||||||||
| Catheter Shaft Tip | Catheter Shaft Tip | |||||||||||||||
| Same as predicate | Polycarbonate Polyurethane | |||||||||||||||
| Trifurcation | Trifurcation |
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| Subject and Predicate Device Comparison Table | ||||||||
|---|---|---|---|---|---|---|---|---|
| Subject Device- Hickman TriFusion Catheter | Predicate Device- Hickman TriFusion Catheter | |||||||
| Same as predicate | Polycarbonate Polyurethane | |||||||
| Extension Legs | Extension Legs | |||||||
| Same as predicate | Polyurethane | |||||||
| Luer Connectors | Luer Connectors | |||||||
| Isoplast® 2510 Polyurethane with PolyOne Gray colorant | Isoplast®2530 Polyurethane with Americhem Gray colorant | |||||||
| Proximal | ||||||||
| Configuration | Luer Connectors – same as predicate | |||||||
| Priming Volume ID Tags – same as predicate | ||||||||
| Occlusion Clamps - Small Size and Mini size | ||||||||
| Note: An additional clamp (i.e., "Small Size") was added as an | ||||||||
| option for the subject device with the only difference being a | ||||||||
| proportional dimension change. Please note the "small" size is | ||||||||
| larger than the “mini” size cleared with the predicate device. | Luer Connectors – three Luer connectors | |||||||
| Priming Volume ID Tags | ||||||||
| Occlusion clamps – Mini size | ||||||||
| Distal Configuration | Same as predicate. | Stepped atraumatic tip, a stepped-tip configuration with the | ||||||
| distal lumen extending beyond the two proximal lumens. The | ||||||||
| proximal lumens terminate at the same distance from the | ||||||||
| trifurcation. | ||||||||
| Gravity Flow Rates | Same as predicate | Lumen with White | ||||||
| Clamp Lumen with Blue | ||||||||
| Clamp Lumen with Red | ||||||||
| Clamp 115 ml/min 110 ml/min 114 ml/min |
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Performance Data:
Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish the performance of the device.
| Verification Test | Standard Utilized |
|---|---|
| Catheter Assembly Burst | |
| Strength | Bard internal standards and procedures |
| Catheter Assembly Tensile | ISO 10555-1: 2013, Intravascular catheters -- Sterile and single-use |
| catheters - Part 1: General Requirements | |
| Catheter Joint Durability Leak | |
| Test | |
| Luer Configuration: Luer | |
| Gauging | |
| Luer Configuration: Liquid Leak | |
| Luer Configuration: Air Leak | |
| Luer Configuration: Unscrewing | |
| Torque | ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, |
| needles and certain other medical equipment-Part 1: General | |
| Requirements | |
| Luer Configuration: Ease of | |
| Assembly | |
| Luer Configuration: Resistance | |
| to Overriding | ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, |
| needles and certain other medical equipment- Part 2: Lock Fittings | |
| Luer Configuration: Stress | |
| Cracking | |
| Luer Configuration: Separation | |
| Force | |
| Cuff Tensile | ISO 10555-1: 2013, Intravascular catheters -- Sterile and single-use |
| catheters - Part 1: General Requirements | |
| Tip Tensile | |
| Gravity Flow | |
| Catheter Stiffness | |
| Priming Volume | FDA Guidance 1995, Guidance on Premarket Notification [510(k)] |
| Submission for Short-Term and Long-Term Intravascular Catheters | |
| Catheter Collapse | |
| Radiopacity | ASTM F640: 2012, Standard test methods for determining radiopacity |
| for medical use | |
| ISO 10555-1: 2013, Intravascular catheters -- Sterile and single-use | |
| catheters - Part 1: General Requirements | |
| FDA Guidance 1995, Guidance on Premarket Notification [510(k)] | |
| Submission for Short-Term and Long-Term Intravascular Catheters |
8
Biocompatibility evaluation and testing was conducted in accordance with ISO10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
| The following tests were performed per ISO 10993, Biological evaluation of medical devices: | |||
|---|---|---|---|
| Biocompatibility Test | Standard Utilized |
|---|---|
| Cytotoxicity | ISO 10993-5:2009, Biological evaluation of medical |
| devices -- Part 5: Tests for in vitro cytotoxicity | |
| Sensitization | ISO 10993-10:2010, Biological evaluation of |
| medical devices -- Part 10: Tests for irritation and | |
| skin sensitization | |
| Intracutaneous Reactivity | |
| Acute Systemic Toxicity | ISO 10993-11:2006, Biological evaluation of |
| medical devices -- Part 11: Tests for systemic | |
| toxicity | |
| Material-Mediated Pyrogencitiy | |
| Subchronic Toxicity | ISO 10993-11:2006, Biological evaluation of |
| medical devices -- Part 11: Tests for systemic | |
| toxicity | |
| Genotoxicity | ISO 10993-3:2003, Biological evaluation of medical |
| devices -- Part 3: Tests for genotoxicity, | |
| carcinogenicity and reproductive toxicity | |
| Implantation | ISO 10993-6:2007, Biological evaluation of medical |
| devices -- Part 6: Tests for local effects after | |
| implantation | |
| Hemocompatibility | ISO 10993-4:(2002, amended 2006), Biological |
| evaluation of medical devices -- Part 4: Selection of | |
| tests for interactions with blood |
The subject Hickman TriFusion Catheter was adopted into the sterilization cycle per AAMI TIR28:2016, Product adoption and process equivalence for ethylene oxide sterilization. The sterilization cycle has been validated by half-cycle over-kill method in accordance with ANSI/AAMI/ISO 11135, Sterilization of Healthcare Products. Ethylene Oxide sterilization testing was conducted per ISO 10993-7:2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Additionally, LAL bacterial endotoxin testing was performed per ANSI/AAMI ST72. Bacterial Endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing, and USP for bacterial endotoxin limits.
Conclusions:
Based on the indications for use, technological characteristics, and performance testing, the subject Hickman® TriFusion™ Catheter meets the requirements that are considered sufficient for its intended use and demonstrate substantial equivalence to the cited predicate device.