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K Number
K141618
Device Name
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
Manufacturer
ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I
Date Cleared
2014-07-08

(21 days)

Product Code
OBJ
Regulation Number
870.1200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the cather , intravascular capability for ECG delection and intravascular ultrasound for catheter guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catherer in location information by using the patient's physiological (cardiae 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 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 Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraincied situations for this technique are in patients where allerations of cardias the presentation of the P-waye 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 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. The Pressure Intectable PICC with Chlorag+ard Aniithombogenic Technology is indicated for short-lerm or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of 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 entire fluid patiway of the catheler has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheler surfaces. Antimicrobial and antitlersmoogenic effectiveness were evaluated using in viro and in vive test methods and no correlation between these test methods and clinical outcome has currently been asseriained. It is not intented 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 stiffess for use in placement of the catheter, intravascular capability for ECG detection and intravascular ultrasound for catherer guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catheter ip location information by using the patient's physiological (cardial 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 allemative 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 patientions of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachyeardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change 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.
Device Description
The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.) The subject device, the Arrow VPS Stylet PLUS has the following characteristics: - 6 ft overall length . - < 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene . (PTFE) heat shrink - Intravascular electrocardiogram (ivECG) signal sensing stainless steel wire with exposed . portion at the distal end - Doppler transducer connected to coaxial cable at the distal end . - Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in . to VPS Console or extension cable (that in turn connects to the VPS Console) - Tuohy-Borst adapter ● - Marking accessory . The Arrow VPS Stylet PLUS is the stylet portion of a vascular positioning system designed to be used with the VPS Console and a market-available catheter. The Arrow VPS Stylet PLUS is a polyimide tube with a fluoropolymer (PTFE) heat shrink. The tubing contains a Doppler sensor on a coaxial cable and an intravascular electrocardiogram (ivECC) 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 CG+ Arrow PICC Powered by Arrow VPS Stylet PLUS is the Arrow VPS Stylet PLUS preloaded into a 4.5 Fr 1-Lumen, 5.5 Fr 2-Lumen, and 6 Fr 3-Lumen, 40-55 cm pressure injectable antimicrobial and antithrombogenic Peripherally Inserted Central Catheter (PICC). The CG+ Arrow PICC 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 external catheter body and the internal fluid path of the device are treated with Chlorag+ard, a Chlorhexidine-based coating technology.
More Information

K 103255, K122545, K 123759, K130876

Not Found

No
The document describes a system that uses physiological signals (ECG and blood flow) and intravascular ultrasound to guide catheter placement and confirm tip location. It does not mention any AI or ML algorithms being used for analysis or decision-making. The "Blue Bullseye" indicator appears to be based on direct interpretation of these signals, not on a learned model.

Yes
The device is used to guide central catheters to a desired location for central venous therapy and pressure injection, and its antimicrobial/antithrombogenic coating helps reduce microbial colonization and thrombus accumulation.

Yes

The device aids in guiding and confirming the placement of central venous catheters, which involves real-time physiological information (cardiac electrical activity and blood flow) to determine the catheter tip location. This process involves assessing the patient's internal state to assist a medical procedure, aligning with the definition of a diagnostic device.

No

The device description clearly outlines hardware components including a stylet, Doppler transducer, coaxial cable, and connector, in addition to the VPS Console. While software is involved in analyzing the physiological data, the device is not solely software.

Based on the provided text, the Arrow VPS Stylet PLUS and VPS Console (VPS System) is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This testing is performed outside of the living body.
  • VPS System Function: The VPS System, as described, is used to guide and position a central venous catheter within the patient's body. It utilizes physiological signals (cardiac electrical activity and blood flow) detected intravascularly to determine the catheter tip location.
  • No Specimen Analysis: The device does not analyze any specimens taken from the patient. It directly interacts with and monitors physiological signals within the circulatory system.

Therefore, the VPS System falls under the category of a medical device used for a procedural guidance and positioning, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction.

The CG+ Arrow PIC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system.

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 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 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 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.

The Pressure Injectable PICC with Chlorag+ard Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of 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 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 of existing infections or vein thrombosis.

Product codes (comma separated list FDA assigned to the subject device)

OBJ

Device Description

The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS already loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.)

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

  • 6 ft overall length

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).

0

K141618 6 510(K) SUMMARY

JUL 0882014

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:June 16, 2014

Device Name

Device Trade Name: Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS

Common Name, Stylet: Catheter, Ultrasound, Intravascular

Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200

Predicate Devices

  • K 103255: Vascular Positioning System (VPS) Stylet ●
  • K122545: 4.5 French CG+ Arrow PICC powered by Arrow VPS Stylet .
  • K 123759: 5.5 French CG+ Arrow PICC powered by Arrow VPS Stylet ●
  • K130876: 6 French CG+ Arrow PICC powered by Arrow VPS Stylet ●

Device Description

The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.)

1

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

  • 6 ft overall length .