(213 days)
Not Found
No
The summary describes a standard central venous catheter and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is used for administering fluids, blood products, drugs, and parenteral nutrition, as well as for blood withdrawal and central venous pressure monitoring, all of which are considered therapeutic interventions.
No
The description states the device is "designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media." While it performs "central venous pressure monitoring," this is a measurement and not a diagnosis. The device's primary functions are for access and delivery, not for diagnosing a condition or disease.
No
The device description clearly states it is a family of power injectable central venous catheters constructed of medical grade polyurethane, indicating it is a physical hardware device. The performance studies also focus on physical properties and tests of the catheter itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for accessing the central venous system for administering substances, withdrawing blood, monitoring pressure, and power injecting contrast media. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a catheter designed for insertion into veins. This is a medical device used for direct interaction with the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a tool for accessing the body and delivering or withdrawing substances, not for analyzing samples.
N/A
Intended Use / Indications for Use
Acute central venous catheters are indicated to provide short-term access (: Sizing and Counting Particulate Matter. Testing to ensure that particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes.
MR Safety: Reference Standard: FDA Guidance on Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, 2014. Testing to demonstrate that the subject device is safe for use in an MR environment.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
November 1, 2019
Bard Access Systems, Inc. (Bard has joined BD) % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K190855
Trade/Device Name: BD Acute Central Line Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: October 3, 2019 Received: October 7, 2019
Dear Dave Yungvirt:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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).
Sincerely,
Geeta Pamidimukkala Acting 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
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Indications for Use
510(k) Number (if known) K190855
Device Name BD Acute Central Line
Indications for Use (Describe)
Acute central venous catheters are indicated to provide short-term access ( 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."
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K190855 510(k) Summary for BD Acute Central Line
| General
| Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) | ||
|---|---|---|---|---|
| Submitter Address: | 605 North 5600 West | |||
| Salt Lake City, UT 84116 | ||||
| Contact Person: | Sean Loring | |||
| Regulatory Affairs Specialist | ||||
| Telephone Number: | 801.522.5634 | |||
| Fax Number: | 801.522.5425 | |||
| Date of Preparation: | 10/31/2019 | |||
| Subject | ||||
| Device | Trade Name(s): | BD Acute Central Line | ||
| Common Name: | Acute Central Line | |||
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days | |||
| Class: | 2 | |||
| Regulation Number: | 21 CFR 880.5200 | |||
| Product Code: | FOZ | |||
| Classification Panel | General Hospital | |||
| Predicate | ||||
| Device | Predicate Trade Name: | Arrow Central Venous Catheter | ||
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days | |||
| Class: | 2 | |||
| Product Code: | FOZ | |||
| Regulation Number: | 21 CFR 880.5200 | |||
| Premarket Notification #: | K071538 | |||
| Manufacturer: | Arrow | |||
| Classification Panel | General Hospital | |||
| Device | ||||
| Description | A family of power injectable central venous catheters constructed of medical grade polyurethane and is | |||
| designed for insertion into the central venous system. BD power injectable acute central lines are | ||||
| radiopaque, and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a | ||||
| sterile package with applicable insertion kit accessories. The maximum pressure injector settings and | ||||
| maximum power injection flow rate are specified in the table below: | ||||
| Catheter Length | Lumen(s) | Power Injection | ||
| Flow Rate | Maximum Power | |||
| Injector Pressure | ||||
| Setting | ||||
| 16 cm and 20 cm | Distal | |||
| Medial / Proximal | 10 mL/sec | |||
| 9 mL/sec | 325 psi |
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| | | Catheter Length | Lumen(s) | Power Injection
Flow Rate | Maximum Power
Injector Pressure
Setting |
|----------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | | 16 cm and 20 cm | Distal
Medial / Proximal | 10 mL/sec
9 mL/sec | 325 psi |
| | | 30 cm | Distal
Medial/ Proximal | 9 mL/sec
7 mL/sec | |
| Technological
Characteristics | Attribute | Subject Device – BD Acute Central Line | Predicate Device – Arrow Central Venous Catheter | Discussion of Characteristics
between
subject and predicate | |
| | Owner | Bard Access Systems, Inc. | Arrow | | |
| | Classification | Same | FOZ – 21 CFR 880.5200 | Classification of
subject device is
the same as the
predicate | |
| | 510(k) Status | Subject of this Premarket Notification | K071538 – Concurrence
date August 30, 2007 | | |
| | Indications
for Use | Acute central venous catheters are
indicated to provide short-term access
(ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and
testing within a risk management process | | | |
| | | | Tests to confirm that the catheter is free from biological hazard per testing. A health-
based risk assessment per ISO 10993-1 was performed for determining the
acceptability of the material for the intended purpose. | | | |
| Safety &
Performance
Tests | Biocompatibility Testing | | Testing Performed includes:
• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity
• Subchronic Systemic Toxicity
• Genotoxicity
• Hemocompatibility
• Implantation | | | |
| | | | Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General
requirements | | | |
| | Clamp Engagement | | Test to confirm that the catheter assembly will not leak when the clamp is engaged. | | | |
| | Leak Test | | | Test to confirm that the catheter assembly will not leak when the distal end of the
catheter is occluded. | | |
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| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and lumen area for dual lumen catheters to ensure compliance with dimensional specification. |
|---|---|
| Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensional specification. |
| Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensional specification. |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded. |
| Hydraulic Catheter | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded. |
| Power Injection | |
| Conditioning | Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate. |
| Gravity Flow | Test to measure the gravity flow performance of a full-length catheter. |
| Luer to Extension Leg | |
| Tensile Test | |
| Extension Leg to | |
| Trifurcation Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. |
| Trifurcation to Shaft | |
| Tensile Test | |
| Shaft Tensile Test | |
| Reference Standard: ASTM F640-12 – Standard Test Methods for Radiopacity of Plastics | |
| for Medical Use | |
| Radiopacity | Test to demonstrate catheter radio-detectability |
| Reference Standard: ISO 10555-3:2013 - Intravascular catheters - Sterile and single-use catheters - Part 3: | |
| Central venous catheters | |
| Tip Tensile | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. |
| Reference Guidance: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term | |
| and Long-Term Intravascular Catheters, 1995 | |
| Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum. |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. |
| Suture Wing Integrity | |
| Test | Test to measure the maximum force a catheter junction suture wing can withstand prior to break. |
| Priming Volume | Test to measure the volume required to prime a full-length catheter. |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the size of the labeled OD during power injection. |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation during power injection (tip pointing in direction of venous flow) at the maximum indicated flow rate. |
| Guidewire Drag Test | Test to ensure that the guidewire used to place the catheter can be removed without difficulty. |
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| Reference Standards: ISO 594: Conical Fittings for a 6% (Luer) Taper for Syringes, Needles, and Certain
| Other Medical Equipment - Part 1: General Requirements and Part 2: Lock Fittings | |
|---|---|
| Luer Testing | Testing to ensure that luer connectors meet requirements for: |
| • Leak | |
| • Leak Decay | |
| • Stress Cracking | |
| • Resistance to Separation from Axial Load | |
| • Resistance to Separation from Unscrewing | |
| • Resistance to Overriding | |
| • Gauging | |
| Reference Standard: USP: Sizing and Counting Particulate Matter | |
| Particulate Testing | Testing to ensure that particulate matter on the catheter post-manufacture is not |
| exceeded for prescribed particle sizes. | |
| Reference Standard: FDA Guidance on Establishing Safety and Compatibility of Passive Implants in the | |
| Magnetic Resonance (MR) Environment, 2014 | |
| MR Safety | Testing to demonstrate that the subject device is safe for use in an MR environment. |
| Diagram | Image: Diagram of Catheter with labels: Female Luer Hubs, Thumb Clamp, Trifurcation/Suture Wing, Soft Tip, Catheter Shaft Tubing, Extension Legs |
| Technological | |
| Comparison | |
| to Predicate | |
| Device | Technological characteristics of the subject BD Acute Central Line are substantially equivalent with regard |
| to the basic design and function of the predicate device, Arrow Central Venous Catheter (K071538). Thepriming volumes, differ from the predicate device. However, these differences do not alter the intended use | |
| of the subject device, and do not raise any new or different questions regarding safety or effectiveness | |
| when compared to the predicate device. | |
| Summary of | |
| Substantial | |
| Equivalence | Based on the risk management activities and testing, the subject BD Acute Central Line has been |
| demonstrated to be substantially equivalent to the cited predicate device. |
Based on the indications for use, technological characteristics, and results of performance testing, the Conclusion: subject BD Acute Central Line has been demonstrated to be substantially equivalent to the predicate devices.