(71 days)
Not Found
No
The summary describes a physical medical device (catheter) with antimicrobial and antithrombogenic coatings. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The modifications described are related to the physical design and kit components.
No.
The device provides access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring, but it does not directly treat a disease or condition itself.
No.
The device is a central venous catheter used for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring, which are all therapeutic or interventional functions, not diagnostic ones.
No
The device description clearly details a physical catheter with specific material properties, dimensions, and features like extension lines and a juncture hub. It also mentions a tunneling device as an optional kit component. These are all hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a catheter for accessing the central venous system for various therapeutic and diagnostic purposes within the body (intravenous therapy, blood sampling, infusion, pressure injection, CVP monitoring).
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
The device is a medical device used for direct patient care and intervention, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) has the following characteristics:
- 4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
- 5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
- 6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-lumen and 2-lumen catheters and 6 mL/sec for the 3-lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag-ard technology. There are no modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.
The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.
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)
Risk analysis activities were conducted to assess the impact of the modifications made to the subject device. Appropriate control mechanisms were defined to mitigate the identified risks. Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device. The following testing is summarized in the submission:
- Tunneler Device Testing
- Biocompatibility Cytotoxicity L929 MEM Elution O
- o Corrosion Resistance
- o Tip Penetration
- O Extraneous Matter
- Tunneler device/Catheter Compatibility ●
- Tunneler detachment force from catheter O
- Catheter not damaged by tunnel disconnection O
- Catheter Priming Volume (for labeling purposes only) .
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Arrow International, Inc. (subsidiary of Teleflex Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605
Re: K161765
Trade/Device Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 5, 2016 Received: August 8, 2016
Dear Ms. Lawson:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
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
Indications for Use
510(k) Number (if known) K161765
Device Name
ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC)
Indications for Use (Describe)
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
| 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."
3
510(K) SUMMARY: K161765
Submitter Information
| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 USA | |
| Contact Person: | Julie Lawson |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 603256 |
| Fax Number: | (610) 478-3179 |
| Email: | julie.lawson@teleflex.com |
| Date Prepared: | June 24, 2016 |
Device Name
Device Trade Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Common Name: Central Venous Catheter Classification Regulation: 21 CFR: 880.5970 Classification Name: Percutaneous, implanted, long-term intravascular catheter Product Code: LJS
Predicate Device
K153423: CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet
Device Description
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) has the following characteristics:
- 4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
- 5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
- 6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-lumen and 2-lumen catheters and 6 mL/sec for the 3-lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag-ard technology. There are no
4
modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.
The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.
Indications for Use
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag'arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for shortterm (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
The above Indication for Use is identical to the catheter portion of the predicate Indications for Use. The predicate CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet (K153423) includes a 2-part indications for use statement; the first portion covers the CG+ Arrow JACC and the second portion covers the CG+ Arrow JACC preloaded with the Arrow VPS Stylet. The subject of this submission is the CG+ Arrow JACC portion of the device only. The VPS-preloaded portion of the indications for use is not impacted by the changes described for the proposed CG+ Arrow JACC. Therefore, only the catheter portion of the indications for use statement for the proposed CG+ Arrow JACC is applicable.
Technological Characteristics and Substantial Equivalence
The subject CG+ Arrow JACC is substantially equivalent to the predicate CG+ Arrow JACC / CG+ Arrow JACC powered by VPS (K153423) in terms of indications for use (catheter portion), manufacturing processes, conditions and aids, functional performance, fundamental scientific technology and materials of construction. There is no change to the geometric design of the subject devices with the exception of the catheter tip: the predicate device is constructed with a
5
Blue FlexTip distal tip design and the catheter is trimmable; the proposed device omits the Blue FlexTip distal tip, yielding the same catheter distal tip design as the predicate device when trimmed. The instructions for use are being modified to add detail pertaining to the use of a tunneler; catheter trimming instructions were previously included in the instructions for use and continue to apply to the subject device. The following table reflects a comparison of the subject and predicate device characteristics.
| Characteristic | Predicate:
CG+ Arrow JACC / CG+ Arrow JACC powered
by VPS Stylet (K153423) | Subject:
CG+ Arrow JACC |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Length | 15-35 cm | 35 cm only |
| Catheter OD | 4.5, 5.5, and 6 Fr | SAME |
| Number of
Lumens | 1,2, and 3 Lumen | SAME |
| Internal Lumen
Configuration | 1 Lumen - Round
2 Lumen - Double D
2 Lumen - Round-Crescent
3 Lumen- Round-Split-Crescent | 1 Lumen - Round
2 Lumen - Double D
3 Lumen- Round-Split-Crescent |
| Pressure
Injection
Capabilities | 1 Lumen:
Distal:5 mL/sec. Pressure Injectable | 1 Lumen:
Distal:5 mL/sec. Pressure Injectable |
| | 2 Lumen - Double D:
Distal: 5 mL/sec, Pressure Injectable
Proximal: 5 mL/sec, Pressure Injectable | 2 Lumen - Double D:
Distal: 5 mL/sec, Pressure Injectable
Proximal: 5 mL/sec, Pressure Injectable |
| | 2 Lumen - Round-Crescent:
Distal: 5 mL/sec, Pressure Injectable
Proximal: 4 mL/sec, Pressure Injectable | |
| | 3 Lumen:
Distal: 6 ml/sec, Pressure Injectable
Proximal: No Pressure Injection
Medial: No Pressure Injection | 3 Lumen:
Distal: 6 ml/sec, Pressure Injectable
Proximal: No Pressure Injection
Medial: No Pressure Injection |
| | Note: Lumens that are not indicated for Pressure
Injection have "No CT" printed on the extension
line hubs. | Note: Lumens that are not indicated for Pressure Injection
have "No CT" printed on the extension line hubs. |
| Catheter body
material | Radiopaque polyurethane | SAME |
| Catheter
Juncture Hub
Material | Blue polyurethane | SAME |
| Catheter Tip
Design and
material | Radiopaque, soft blue polyurethane "Blue
FlexTip" | Non Blue FlexTip; blunt tip (integral with and same
material as the catheter body and equivalent to a trimmed
predicate CG+ Arrow JACC) |
| Catheter
trimmable? | Yes | Yes |
| Extension Line
Material | Clear polyurethane | SAME |
| Characteristic | Predicate:
CG+ Arrow JACC / CG+ Arrow JACC powered
by VPS Stylet (K153423) | Subject:
CG+ Arrow JACC |
| Extension Line
Hub Material | Distal - Pink polyurethane
Proximal - White Polyurethane
Medial - Blue Polyurethane | SAME |
| Printing Ink | 2405 Black Ink and White Ink | SAME |
| Sterilization | Provided Sterile. Sterilized by Ethylene Oxide. | SAME |
| Performance
Specifications;
Catheter
treatment
solution
efficacy | Antimicrobial Efficacy
Effective in reducing microbial colonization on
catheter surfaces
Antithrombogenic Efficacy
Effective in reducing thrombus accumulation on
catheter surfaces | SAME |
| Tunneler
Compatibility | N/A | Can accommodate a tunneler accessory which is
specifically designed for use with the catheter to facilitate
the tunneled insertion technique. |
| Indications for
Use | The Arrow® Pressure Injectable JACC with
Chlorag+ard® Antimicrobial and
Antithrombogenic Technology is indicated for
short-term (30 days)
access to the central venous system for intravenous
therapy, blood sampling, infusion, pressure
injection of contrast media and allows for central
venous pressure monitoring. The maximum
pressure of pressure injector equipment used with
the Pressure Injectable JACC may not exceed 300
psi (2068.4 kPa). The maximum pressure injection
flow rate for the specific lumen being used for
pressure injection is printed on the extension line
hub.
Chlorag+ard Technology treatment on the external
surface of the catheter body as well as the entire
fluid pathway of the catheter has been shown to be
effective in reducing microbial colonization on
catheter surfaces. Antimicrobial effectiveness was
evaluated using in vitro and in vivo test methods
and no correlation between these testing methods
and clinical outcome has currently been
ascertained. It is not intended to be used for the
treatment of existing infections.
The VPS Stylet and Console are indicated for
guidance and tip positioning for central venous
catheters. The Stylet provides stiffness for use in
placement of the catheter, intravascular capability
for ECG detection and recording and intravascular
ultrasound for catheter guiding and positioning.
The VPS Stylet, when used with the VPS Console,
provides real-time catheter tip location information
by using the patient's physiological (cardiac
electrical activity and blood flow) information.
When the VPS System guidance indicator shows a
Blue Bullseye, the catheter tip is in the desired
location.
The VPS System is indicated for use as an
alternative method to fluoroscopy or chest x-ray
for central venous catheter tip placement
confirmation in adult patients when a steady Blue | The Arrow® Pressure Injectable JACC with
Chlorag+ard® Antimicrobial and Antithrombogenic
Technology is indicated for short-term (30 days) access to the central venous system for
intravenous therapy, blood sampling, infusion, pressure
injection of contrast media and allows for central venous
pressure monitoring. The maximum pressure of pressure
injector equipment used with the Pressure Injectable
JACC may not exceed 300 psi (2068.4 kPa). The
maximum pressure injection flow rate for the specific
lumen being used for pressure injection is printed on the
extension line hub.
Chlorag+ard Technology treatment on the external surface
of the catheter body as well as the entire fluid pathway of
the catheter has been shown to be effective in reducing
microbial colonization on catheter surfaces.
Antimicrobial effectiveness was evaluated using in vitro
and in vivo test methods and no correlation between these
testing methods and clinical outcome has currently been
ascertained. It is not intended to be used for the treatment
of existing infections. |
| Characteristic | Predicate:
CG+ Arrow JACC / CG+ Arrow JACC powered
by VPS Stylet (K153423) | Subject:
CG+ Arrow JACC |
| | Bullseye is not obtained, standard hospital practice
should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this
technique are in patients where alterations of
cardiac rhythm change the presentation of the P-
wave as in atrial fibrillation, atrial flutter, severe
tachycardia and pacemaker-driven rhythm, and in
central venous catheterization procedures
performed through femoral or saphenous vein
access which change the presentation of the
Pwave. | |
| | In such patients, who are easily identifiable prior
to central venous catheter insertion, the use of an
additional method is required to confirm catheter
tip location. | |
Subject and Predicate Device Comparison
6
7
Nonclinical Testing
Risk analysis activities were conducted to assess the impact of the modifications made to the subject device. Appropriate control mechanisms were defined to mitigate the identified risks. Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device. The following testing is summarized in the submission:
- Tunneler Device Testing
- Biocompatibility Cytotoxicity L929 MEM Elution O
- o Corrosion Resistance
- o Tip Penetration
- O Extraneous Matter
- Tunneler device/Catheter Compatibility ●
- Tunneler detachment force from catheter O
- Catheter not damaged by tunnel disconnection O
- Catheter Priming Volume (for labeling purposes only) .
Conclusions
The predicate and the subject devices have indications for use (catheter portion), intended use, materials (with the exception of the elimination of the material used to form the Blue FlexTip), chlorhexidine formulation, concentration (content per treated surface area), method of application and mechanism of release and are manufactured using the same processes with the exception of the Blue FlexTip formation process, conditions and aids. The results of the verification testing performed support the substantial equivalence of the modified devices to the predicate devices.