ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS

K141618 · Arrow International, Inc (Subsidiary of Teleflex I · OBJ · Jul 8, 2014 · Cardiovascular

Device Facts

• Record ID: K141618
• Device Name: ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
• Applicant: Arrow International, Inc (Subsidiary of Teleflex I
• Product Code: OBJ · Cardiovascular
• Decision Date: Jul 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

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 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.

Device Story

Arrow VPS Stylet PLUS is a 6-foot intravascular stylet used with a VPS Console to guide central venous catheters to the SVC or cavo-atrial junction. The stylet features a distal Doppler transducer and an ivECG sensing wire. It inputs physiological signals (cardiac electrical activity and blood flow) to the console, which processes this data to provide real-time catheter tip location. The system outputs a 'Blue Bullseye' indicator when the tip reaches the target. Used in clinical settings by healthcare providers, the device assists in accurate catheter placement, potentially reducing reliance on fluoroscopy or chest x-rays. The CG+ Arrow PICC version includes an antimicrobial/antithrombogenic coating (Chlorag+ard) and comes preloaded with the stylet.

Clinical Evidence

Bench testing only. Testing included tensile strength, torque, tip flexibility, fracture/corrosion resistance (BS EN ISO 11070), X-ray detectability (ASTM F640-07), electrical performance (Hi-Pot, continuity, Doppler sensitivity), biocompatibility (ISO 10993-1), and electrical safety/EMC (IEC 60601-1-2, IEC 60601-2-37). Simulated use insertion/removal and catheter compatibility testing were also performed.

Technological Characteristics

6 ft polyimide/PTFE stylet; 11.667 MHz Doppler transducer (0.4 mm hexagonal); ivECG stainless steel sensing wire; 7-prong connector. Materials: Polycarbonate, Polypropylene, PTFE, TPE, Santoprene jacket. Sterilization: Ethylene Oxide (10^-6 SAL). Connectivity: Wired to VPS Console. Software: Not specified.

Indications for Use

Indicated for guidance and tip positioning of central venous catheters in adult patients. Provides real-time catheter tip location via cardiac electrical activity (ivECG) and blood flow (Doppler). Used as an alternative to fluoroscopy or chest x-ray when a steady 'Blue Bullseye' indicator is obtained. Contraindicated/limited in patients with cardiac rhythm alterations (atrial flutter, severe tachycardia, pacemaker-driven rhythm) or femoral/saphenous vein access; these require secondary confirmation methods.

Regulatory Classification

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.

Predicate Devices

• Vascular Positioning System (VPS) Stylet (K103255)
• 4.5 French CG+ Arrow PICC powered by Arrow VPS Stylet (K122545)
• 5.5 French CG+ Arrow PICC powered by Arrow VPS Stylet (K123759)
• 6 French CG+ Arrow PICC powered by Arrow VPS Stylet (K130876)

Reference Devices

• VPS Console (K103260)
• VPS Console (K123813)

Submission Summary (Full Text)

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#### K141618 6 510(K) SUMMARY

# JUL 0882014

### Submitter Information

| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|-------------------|--------------------------------------------------------|
| Address: | 2400 Bernville Road<br>Reading, PA 19605-9607 USA |
| Contact Person: | Elizabeth Duncan<br>Sr. Regulatory Affairs Specialist |
| Telephone Number: | [phone] Extension 603220 |
| Fax Number: | [phone]. |
| Email: | [e-mail] |
| 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.)

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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.

### 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 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.

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# Technological Characteristics and Substantial Equivalence

| Characteristic | Predicate Device | Subject Device |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | 6 foot long stylet which contains a<br>Doppler sensor and an intravascular<br>electrocardiogram (ivECG) signal<br>sensing wire at the distal tip | SAME: 6 foot long stylet which<br>contains a Doppler sensor and an<br>intravascular electrocardiogram (ivECG)<br>signal sensing wire at the distal tip |
| Signal Conductor | Two conductor stylet wires (ECG<br>wire and coaxial cable) | SAME: Two conductor stylet wires<br>(ECG wire and coaxial cable) |
| ECG Conductor pathway | Exposed conductive surface at distal<br>end of ECG wire | SAME: Exposed conductive surface at<br>distal end of ECG wire |
| Connector | Single, 7 prong custom | SAME: Single, 7 prong custom |
| Polyimide Tube OD and ID<br>(nominal) | OD: 0.0180"<br>ID: 0.0150" | OD: 0.0154"<br>ID: 0.0134" |
| Coaxial cable OD (nominal) | OD: .0073" | OD: .0063" |
| Stylet Materials | Transducer wire sleeve (stylet<br>body): Polyimide embedded with<br>Fluoropolymer (PTFE) | Transducer wire sleeve (stylet body):<br>Polyimide with Fluoropolymer (PTFE)<br>heat shrink |
| | Tuohy-Borst: Polycarbonate,<br>Polypropylene, silicone. | Tuohy-Borst: Polycarbonate,<br>Polypropylene, PTFE, TPE |
| | Coaxial cable: Encapsulated Silver<br>Plated Copper Wire | Coaxial cable: SAME, Encapsulated<br>Silver Plated Copper Wire |
| | Epoxy: Silver-filled Epoxy | Epoxy: SAME, Silver-filled Epoxy |
| | Stylet jacket: Gray Santoprene, 60-<br>68 shore A (durometer) | Stylet jacket: Black Santoprene, 55<br>shore A (durometer) |
| Stylet Doppler Transducer<br>Operating Frequency | 11.667 MHz | SAME: 11.667 MHz |
| Stylet Doppler Transducer<br>Size | 0.5 mm | 0.4 mm |
| Stylet Doppler Transducer<br>Shape | Cruciform | Hexagonal |
| Marking Accessory | Ink marker | Twist-locking collet |
| PIC Catheters | All characteristics: materials,<br>diameter, lengths, manufacturing<br>processes, conditions and aids | SAME: All characteristics |
| Chlorhexidine Technology | All characteristics: Identity,<br>formulation, concentration (content<br>per surface area), manufacturing<br>processes, conditions and aids,<br>method of application to the device<br>and mechanism by which the agent is<br>released from the device | SAME: All characteristics |
| Stylet Shelf life | 2 years | 1 year |
| Sterilization: All<br>characteristics, including:<br>method, assurance level | All characteristics, including:<br>Method: Ethylene Oxide<br>Assurance Level: 10-6 | SAME: All characteristics, including:<br>Method: Ethylene Oxide<br>Assurance Level: 10-6 |
| Packaging | Standalone kits: PETG tray sealed<br>in a Tyvek header pouch<br>Preloaded kits: PETG tray with a<br>Tyvek lidstock | SAME:<br>Standalone kits: PETG tray sealed in<br>a Tyvek header pouch<br>Preloaded kits: PETG tray with a<br>Tyvek lidstock |

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The Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS is substantially equivalent to the predicate VPS Stylet (K103255) and the CG+ Arrow PICC powered by Arrow VPS Stylet (K122545, K123759, K130876) in terms of intended use, indications for use, patient population, contraindications, operating principle, functional performance, safety, efficacy, sterilization, fundamental scientific technology, material and design. Any differences between the subject device and the predicates do not render the device not-substantially equivalent (NSE), affect safety or effectiveness, or raise different questions of safety and effectiveness as proven through passing verification results.

There are no changes to the catheter or Chlorag+ard Technology portion of the predicate Arrow CG+ PICC catheters preloaded with the VPS Stylet (K122545, K123759, K130876). There are no changes being made to the VPS Consoles (K103260 and K123813), as part of this submission.

### Nonclinical Testing

The following testing was performed on the Arrow VPS Stylet PLUS and the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS after being preconditioned with Et.O sterilization. ISTA simulated environmental conditions and one year accelerated aging:

| Test Device | Test | Results |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|---------|
| Stylet | Tensile | PASS |
| | Torque strength | PASS |
| | Tip Flexibility | PASS |
| | Flexing BS EN ISO 11070 | PASS |
| | Fracture BS EN ISO 11070 | PASS |
| | Corrosion BS EN ISO 11070 | PASS |
| | Component Compatibility: Marking accessory grip strength | PASS |
| | Component Compatibility: Tuohy-Borst Adapter grip strength | PASS |
| | Tuohy-Borst Leak | PASS |
| | Physical characteristics | PASS |
| | X-ray Detectability ASTM F640-07 | PASS |
| | Electrical Performance: Hi-Pot, Continuity, Doppler<br>Bandwidth, Capicitance, Sensitivity, Sensitivity stability | PASS |
| Combined device | Biocompatibility: Cytotoxicity, Irritation, Sensitization, Acute<br>Systemic Toxicity and Hemocompatibility per ISO 10993-1 | PASS |
| Combined device | Electrical Safety and Electromagnetic Compatibility Testing<br>(IEC 60601-1-2, IEC 60601-2-37) | PASS |
| | Catheter Compatibility Simulated Use Insertion/ Removal | PASS |
| | Catheter Compatibility Force to Remove stylet from catheter | PASS |

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### Conclusions

The subject device is substantially equivalent to the predicate device in terms of intended use, indications for use, patient population, contraindications, operating principle, functional performance, safety, efficacy, fundamental scientific technology, design and material. The results of the risk assessment and resultant testing performed have demonstrated that the design and material modifications do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate device, performs as well as and is as safe and effective as the predicate devices.

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Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### July 8, 2014

Arrow International, Inc. (subsidiary Of Teleflex Inc.) Elizabeth Duncan Senor Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605-907 USA

Re: K141618

Trade/Device Name: Arrow VPS stylet PLUS and CG+ Arrow PICC powered by ArrowVPS Stylet PLUS Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: OBJ Dated: June 16, 2014 Received: June 17, 2014

Dear Ms. Duncan:

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 10 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.

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### Page 2 - Ms. Duncan

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 (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K141618 510(k) Number (if known):

Device Name: Arrow VPS Stylet PLUS

Indications for Use:

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.

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)

Digitally signed by Richard C. Chapman -5 Date: 2014.07.08 09:36:33 -04'00'

Page 28 of 67

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Indications for Use

K141618 510(k) Number (if known): _

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

Indications for Use:

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.

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)

Digitally signed by Richard C. Chapman -S Date: 2014.07.08 09:36:54 -04'00'

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