(30 days)
Not Found
No
The description focuses on the device's physical components, antimicrobial/antithrombogenic technology, and the use of physiological signals (ECG and ultrasound) for tip positioning. There is no mention of AI or ML algorithms being used for analysis or decision-making.
Yes
This device is a therapeutic device because it provides access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring, which are all therapeutic interventions or enable therapeutic interventions.
Yes
The device, specifically the VPS System and VPS Stylet, provides real-time catheter tip location information using physiological data (cardiac electrical activity and blood flow) and is indicated for central venous catheter tip placement confirmation, serving a diagnostic function.
No
The device description clearly outlines physical components including a catheter, stylet with sensors (Doppler and ivECG), and a console. While the console likely contains software for analysis, the device system includes significant hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this device is a catheter and a stylet used for accessing the central venous system within the patient's body for therapy, blood sampling, infusion, and positioning. It does not involve the examination of samples taken from the body.
- The technology described is for in-vivo use. The Chlorag+ard technology is applied to the catheter surfaces that are in contact with the patient's blood and tissues. The VPS Stylet uses intravascular ultrasound and ECG signals obtained directly from within the patient's bloodstream.
- The performance studies mentioned are related to device function and placement within the body. The nonclinical testing focuses on catheter and stylet performance during insertion and use in a simulated environment, not on the analysis of biological samples.
Therefore, this device falls under the category of an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral 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 injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.
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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
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 Bullseye is obtained. NOTE: If a steady Blue 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 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 P-wave. 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS, OBJ
Device Description
The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:
- 4.5 Fr, 1-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.
The Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.
The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.
For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
central venous system, lower third of the SVC or at the cavo-atrial junction, peripheral vein
Indicated Patient Age Range
adult patients
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)
The following testing was performed on the CG+ Arrow PICC powered by Arrow VPS Stylet: catheter performance testing: air and liquid leakage, stylet performance testing: tensile, electrical function and removal testing and the combined device performance testing: simulated use insertion/removal test.
The results of the testing performed have demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness and therefore the combination is considered substantially equivalent to the cited predicate devices.
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
K.122545
SEP 20 2012
510(K) SUMMARY 6
Submitter Information
| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road Reading, PA 19605-9607 USA |
| Contact Person: | Elizabeth Duncan Sr. Regulatory Affairs Specialist |
| Telephone Number: | (610) 378-0131 Extension 603220 |
| Fax Number: | (610) 478-3179 |
| Email: | elizabeth.duncan@teleflex.com |
| Date Prepared: | August 20, 2012 |
Device Name
Device Trade Name: CG+ Arrow PICC powered by Arrow VPS Stylet Common Name, Catheter: Peripherally Inserted Central Catheter (PICC) Common Name, Stylet: Catheter, Ultrasound, Intravascular
Classification Name, Catheter: Percutaneous, implanted, long-term intravascular catheter per 21 CFR: 880.5970 Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200
Predicate Devices
- . K103255: Vascular Positioning System (VPS System) Stylet
- K112896: Pressure Injectable PICC with Chlorag+ard Antimicrobial and . Antithrombogenic Technology
Device Description
The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:
- 4.5 Fr, 1-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet
The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.
The Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of
Page 22 of 118
page 1 of 3
6
1
contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.
The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.
For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet.
Intended Use
A PICC permits venous access to the central circulation through a peripheral vein.
The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction.
Technological Characteristics and Substantial Equivalence
The CG+ Arrow PICC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS System) Stylet (K103255) and the Pressure Injectable Peripherally Inserted Central Catheter (PICC) with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) in terms of indications for use, design, manufacturing process, functional performance, and materials of construction. The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology; there is no change to the previously cleared devices or their indications for use.
Nonclinical Testing
The following testing was performed on the CG+ Arrow PICC powered by Arrow VPS Stylet: catheter performance testing: air and liquid leakage, stylet performance testing: tensile, electrical function and removal testing and the combined device performance testing: simulated use insertion/removal test.
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page 2 of 3
2
Conclusions
The predicate and the subject devices have the same indications for use, intended use, design, materials, and are manufactured using the same processes. The results of the testing performed have demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness and therefore the combination is considered substantially equivalent to the cited predicate devices.
Page 24 of 118
page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Arrow International, Inc. c/o Ms. Elizabeth Duncan Sr. Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605
Re: K122545
K122343
Trade/Device Name: CG+ Arrow PICC powered by Arrow VPS Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, OBJ Dated: August 20, 2012 Received: August 21, 2012
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 310(x) prematics is substantially equivalent (for the indications referenced above and nave uctchined the arrow as a society of the started in interstate for use stated in the encrosury manated position of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior in May 28, 1970, the chacinent care of the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, sucject to urements for annual registration, listing of
general controls provisions of the Act include requirements wishrending and general controls provisions of the Act mendo requirements misbranding and adulteration. Please note: CDRH does not evaluate information related to contract fiability adulteration. Please note: CDNT docs not evaluate international of truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and be If your device is classified (see above) mio energentions affecting your device can be
may be subject to additional controls. Existed on addition, EDA may may be subject to addinonal confrois: "Existing migral" - "Edecal Register found in the Code of Federal Rogarations, Frins Boys, In the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device and or and of excepcies. You mus that FDA has made a determilation in an your arrived by other Federal agencies. You must
or and Federal statutes and regulations administered by registration and listing or any Federal statures and regulations administered by Callery of Childred to: registration and listing (21
4
Page 2 – Ms. Elizabeth Duncan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122545
Device Name: CG+ Arrow PICC powered by Arrow VPS Stylet
Indications for Use:
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral 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 injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.
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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
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 Bullseye is obtained. NOTE: If a steady Blue 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 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 P-wave. 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.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K122545 |
| Page | 21 of 118 |