The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-driven rhythm
Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

Device Description

The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "VPS Rhythm™ Device with Optional TipTracker™ Technology." It indicates that no human clinical data was provided to support substantial equivalence (Section 8). Therefore, it is not possible to describe a study that proves the device meets acceptance criteria based on clinical performance.

However, the document does list non-clinical performance data that was submitted. This non-clinical data focuses on verifying the device's technical performance, electrical safety, electromagnetic compatibility, software, material properties, sterilization, biocompatibility, and usability.

Based on the provided information, I can address the available non-clinical performance data and the usability study.

Here's a breakdown of the requested information based on the non-clinical data and the usability study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and no clinical studies are reported, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) for the device are not described in the document. The non-clinical testing, however, implies meeting industry standards and internal design requirements.

Acceptance Criteria Category (Implied from testing)	Reported Device Performance (Summary from doc)
Electrical Safety (per IEC 60601-1, 3rd Ed.)	Testing conducted and results support substantial equivalence.
Electromagnetic Compatibility (EMC) (per IEC 60601-1-2, 3rd Ed.)	Testing conducted and results support substantial equivalence.
Software Verification and Validation	Testing conducted and results support substantial equivalence.
TipTracker Stylet Performance & Physical Integrity (including tensile strength, flexural integrity, insertion/withdrawal force, holding force, leak resistance, electrical impedance/voltage feedback, corrosion, PICC compatibility, particulate testing)	Testing conducted (after 1 year aging) and results support substantial equivalence.
Sterile Barrier Package Integrity (per ASTM F2096)	Testing conducted and results support substantial equivalence.
Sterilization Residuals (per ISO 10993-7)	Testing conducted and results support substantial equivalence.
Biocompatibility (cytotoxicity, hemocompatibility, sensitization, irritation, systemic toxicity per ISO 10993-1, -4, -5, -10, -11)	Testing conducted and results support substantial equivalence.
Usability (per CDRH guidance & IEC 62366-1)	A human factors study was conducted, assessing primary operating functions against predetermined usability criteria. Results were compiled and assessed, supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Human Factors Study Test Set (Usability): The document mentions "independent clinician participants" but does not specify the sample size for this test set.
Data Provenance for Human Factors Study: This was a prospective study conducted with clinicians. The country of origin is not explicitly stated, but given the context of a US FDA submission, it can be inferred to be a US-based study or following US regulatory guidelines.
Other Non-Clinical Testing: Sample sizes for material integrity, electrical, EMC, and software testing are not specified. These are typically lab-based tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For the Usability Study (Human Factors): The "ground truth" here would be the predefined usability criteria and the assessment of whether clinicians could successfully perform tasks. The "experts" would be the independent clinician participants, but their specific qualifications (e.g., years of experience) are not detailed. The study assessed the device's functions against predetermined usability criteria.
For other non-clinical tests: Ground truth is established by engineering specifications, international standards (IEC, ISO, ASTM), and internal design requirements.

4. Adjudication Method for the Test Set

For the Usability Study (Human Factors): An explicit adjudication method (e.g., 2+1) is not described. The document states that "The results of the human factors study were compiled and assessed," suggesting an analysis against predefined usability criteria rather than an expert consensus on a subjective outcome.
For other non-clinical tests: Adjudication is typically against established engineering specifications and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states "No human clinical data was provided to support substantial equivalence." An MRMC study would fall under clinical data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, in the context of the device's ECG technology and TipTracker navigation:
- The "VPS Rhythm Device" as a standalone component uses software algorithms to acquire, process, and display ECG waveforms for catheter tip location. Its performance in this function relies on the algorithm interpreting cardiac electrical activity.
- The "TipTracker Technology" also involves "software algorithms" to facilitate real-time visualization of the catheter's track and direction using magnetic field-based technology. This is also a standalone algorithmic function.
The non-clinical testing, particularly "Software Verification and Validation Testing" and "TipTracker Stylet Performance," would evaluate these standalone algorithmic and system performances against specified requirements.

7. Type of Ground Truth Used

For the Human Factors Study (Usability): "Predetermined usability criteria" established prior to the study, likely by device designers and regulatory/human factors experts.
For TipTracker Stylet Performance and Physical Integrity: Engineering specifications, material science standards (e.g., ISO 11070), and internal design requirements.
For Electrical Safety, EMC, Sterilization Residuals, Biocompatibility: International and national standards (e.g., IEC 60601 series, ISO 10993 series, ASTM F2096).

8. Sample Size for the Training Set

The document does not mention a training set for any AI/machine learning models. The description of the device's technology points to signal processing and magnetic tracking algorithms rather than learnable AI models in the modern sense. Therefore, "training set" is not applicable in the context described.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), this information is not applicable/provided.

Summary

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

December 22, 2016

Arrow International, Inc. (a Subsidiary of Teleflex, Inc.) Christine Ford Senior Regulatory Affairs Manager 2400 Bernville Rd. Reading, Pennsylvania 19605

Re: K160925

Trade/Device Name: VPS Rhythm™ Device with Optional TipTracker™ Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 22, 2016 Received: November 28, 2016

Dear Christine Ford:

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.

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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 devicerelated 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 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.

Sincerely yours,

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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

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Indications for Use

510(k) Number (if known) K160925

Device Name

VPS Rhythm™ Device with Optional TipTracker™ Technology

Indications for Use (Describe)

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-driven rhythm
Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

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)

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SECTION 6. 510(k) SUMMARY VPS Rhythm Device with Optional TipTracker Technology

Applicant Information:

Arrow International (a subsidiary of Teleflex, Inc.) 2400 Bernville Rd. Reading, PA 19605

Contact Person: Christine Ford Telephone Number: (610) 378-0131, ext. 603338 Fax Number: (610) 478-3179 Date Prepared: 22-NOV-2016

1. Device Name:
- Proprietary Name: VPS Rhythm Device with Optional TipTracker Technology
- Common Name: Central catheter placement accessory ●
- Classification Name: Percutaneous, implanted long-term intravascular catheter. ●
- CFR Number: 21 CFR 880.5970 ●
- Device Class: II
- Product Code: LJS (Catheter, Intravascular, long-term greater than 30 Days) ●

3. Predicate and Reference Device(s):

Predicate or Reference Device Name	510(k)	Original Applicant Name
PICC Tip Positioning Aid	K152261	Nostix LLC
Sherlock 3CG™ Tip Confirmation System	K140345	Bard Access Systems, Inc.
Nautilus Delta	K141634	Romedex

4. Description of Device:

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With respect to the external and intravascular ECG waveform display functionality, the VPS Rhythm Device with Optional TipTracker Technology is identical to the predicate PICC Tip Positioning Aid (K152261). The subject VPS Rhythm Device incorporates the same monitor with graphical user interface, ECG Patient Cable, ECG snap leads, and ECG Clip Cable accessories as those cleared with the predicate PICC Tip Positioning Aid (K152261). The purpose of this premarket notification is for the introduction of the optional TipTracker Technology and associated components for PICC navigation as well as a clarification of the indications for use from the originally indicated use of ECG for final tip confirmation with PICCs only to use with central venous catheters in general for final catheter tip positioning.

The TipTracker Stylet is to be provided sterile in a convenience kit for use with PICCs that are geometrically compatible. The TipTracker stylet may be used with PICCs that have a minimum internal distal lumen diameter of 0.018" or catheter sizes from 3-6 French. The TipTracker stylet may also be provided pre-loaded with ARROW PICC in ARROW convenience kits.

5. Indications for Use:

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the Pwave including:

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-driven rhythm
Chronic obstructive pulmonary disease (COPD)

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Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

6. Substantial Equivalence

Intended Use / Indications for Use:

The subject VPS Rhythm Device with Optional TipTracker Technology has the same intended use as the predicate device. The subject and predicate device are intended to display the patient's external and intravascular ECG waveforms in order to allow the clinician to interpret changes in the patient's intravascular P-wave morphology as a central catheter is inserted through the vasculature towards the heart.

The indications for use of the subject device are identical (with the exception of the reference to central catheter type) to those of the predicate PICC Tip Positioning Aid (K152261) and similar to the reference device Sherlock 3CGTM Tip Confirmation System (K140345). The indications for use are similar to the Romedex Nautilus Delta (K141634) reference device in regards to placement of central venous access devices. All of the devices are indicated for providing real-time central catheter tip location information by using the patient's cardiac electrical activity as well as for use as an alternative method to chest x-ray or fluoroscopy confirmation of catheter tip placement.

Technological Characteristics:

The subject VPS Rhythm Device with Optional TipTracker Technology incorporates the fundamental technology as the predicate and reference devices. The subject same device as well as the predicate PICC Tip Positioning Aid (K152261) and the reference Sherlock 3CGTM Tip Confirmation System (K140345) incorporate electronic circuitry and software algorithms to acquire and display the patient's intravascular and external ECG waveforms in order to facilitate the confirmation of final central catheter tip placement as an alternative method to chest x-ray or fluoroscopy. Similarly, the reference Romedex Nautilus Delta (K141634) includes a patient module with integrated remote control for ECG data acquisition and processing; data is sent to a mobile platform via wireless (Bluetooth) technology for visualization of the patient's ECG information.

The subject VPS Rhythm Device with Optional TipTracker Technology and the predicate PICC Tip Positioning Aid (K152261) and the reference Sherlock 3CG Tip Confirmation System (K140345) include touch-screen graphical user interface displays; include remote control capability, and reusable components which facilitate the display of the patient ECG information. Similarly, the reference Romedex Nautilus Delta (K141634) includes an integrated remote control for ECG data acquisition and processing; the ECG data is sent to a mobile platform via wireless (Bluetooth) technology where it is displayed.

The subject VPS Rhythm Device with Optional TipTracker Technology and the reference Sherlock 3CG Tip Confirmation System (K140345) also include catheter insertion visualization in which magnetic field-based technology is utilized to allow the display of the relative position of the catheter's tip as it is inserted by the clinician. Both the

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subject device and the reference Sherlock 3CG device (K140345) utilize a reusable accessory component which is placed on the patient's chest and a sterile, single-use stylet which is assembled with the catheter in order to facilitate the catheter tracking feature.

Table 6.1 summarizes the substantial equivalence comparison of the subject VPS Rhythm Device with Optional TipTracker Technology with the predicate and reference devices.

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Proposed Device	Predicate Device	Reference Device
VPS Rhythm Device withOptional TipTrackerTechnology	PICC Tip Positioning Aid(K152261)	Sherlock 3CGTMTip Confirmation System(K140345)
Indications for Use:	Indications for Use:	Indications for Use:	Indications for Use:
The VPS Rhythm Device isindicated for the positioning ofcentral venous cathetersincluding PICCs. It providescatheter tip location informationby using the patient's cardiacelectrical activity. The VPSRhythm Device is indicated foruse as an alternative method tochest x-ray or fluoroscopy for	The PICC Tip Positioning Aidis indicated for the positioningof peripherally inserted centralcatheters (PICCs) in adultpatients. It provides real-timecatheter tip locationinformation by using thepatient's cardiac electricalactivity. The PICC TipPositioning Aid is indicated for	The Sherlock 3CG TipConfirmation System (TCS) isindicated for guidance andpositioning of PeripherallyInserted Central Catheters(PICCs). The Sherlock 3CGTCS provides real-time PICC tiplocation information by usingpassive magnet tracking and thepatient's cardiac electrical	Indications for Use:Navigational guidance fornavigating the peripheralvenous system and forleasing the catheter tip. Itprovides real-time PICC tipinformation by using thecardiac electrical signal as anindicator. It is an alternativemethod to chest x-ray orfor

Table 6.1 – Substantial Equivalence Comparison Summary

Indications for Use:	Indications for Use:	Indications for Use:	Indications for Use:
The VPS Rhythm Device isindicated for the positioning ofcentral venous cathetersincluding PICCs. It providescatheter tip location informationby using the patient's cardiacelectrical activity. The VPSRhythm Device is indicated foruse as an alternative method tochest x-ray or fluoroscopy forconfirmation of central venouscatheter tip placement in adultpatients. The TipTrackerTechnology is an optionalaccessory for use with the VPSRhythm Device, indicated forvisual navigation of aperipherally-inserted centralcatheter (PICC) as it is insertedthrough the vasculature. TheTipTracker technology is usedfor catheter tip navigationpurposes only; it is not used todetermine final catheter tipplacement. Note: In general,devices that utilize ECGtechnique to	The PICC Tip Positioning Aidis indicated for the positioningof peripherally inserted centralcatheters (PICCs) in adultpatients. It provides real-timecatheter tip locationinformation by using thepatient's cardiac electricalactivity. The PICC TipPositioning Aid is indicated foruse as an alternative method tochest x-ray or fluoroscopyconfirmation of PICC tipplacement in adult patients.Note: In general, devices thatutilize ECG technique toobserve P-wave are limited, butnot contraindicated, for patientswhere cardiac rhythms maychange presentation of the P-wave; including- Atrial fibrillation- Atrial flutter- Severe tachycardia- Pacemaker-driven rhythm- Chronic obstructive	The Sherlock 3CG TipConfirmation System (TCS) isindicated for guidance andpositioning of PeripherallyInserted Central Catheters(PICCs). The Sherlock 3CGTCS provides real-time PICC tiplocation information by usingpassive magnet tracking and thepatient's cardiac electricalactivity (ECG). When relying onpatient's ECG signal, theSherlock 3CG TCS is indicatedfor use as an alternative methodto chest X-ray and fluoroscopyfor PICC tip placementconfirmation in adult patients.Limiting, but not contraindicatedsituations for this technique arein patients where alterations ofcardiac rhythm change thepresentation of the P-wave as inatrial fibrillation, atrial flutter,severe tachycardia, andpacemaker driven rhythm. Insuch patients, who are easily	Nautilus Delta is indicated fornavigation and positioning of centralvenous access devices (CVADs) of atleast 3 Fr in size. Nautilus Deltaprovides real-time catheter tip locationinformation by using the patient'scardiac electrical activity and isindicated for use as an alternativemethod to chest X-ray and fluoroscopyfor CVAD tip placement confirmation.In adult patients and in adolescents(greater than 12 through 21 years ofage), Nautilus Delta can be used withCVADs such as peripherally insertedcentral catheters (PICCs), centralvenous catheters (CVCs), implantableports, and hemodialysis catheters; inchildren (greater than 2 to 12 years ofage), Nautilus Delta can be used withPICCs and with centrally insertedcentral catheters (CICCs); in infants(greater than 1 month to 2 years ofage) and in neonates (from birth to 1month of age), Nautilus Delta can beused with CICCs.In each specific age group, the CVAD

Reference Device

Romedex Nautilus Delta (K141634)

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Proposed Device	Predicate Device	Reference Device	Reference Device
VPS Rhythm Device with	PICC Tip Positioning Aid(K152261)	Sherlock 3CGTMTip Confirmation System(K140345)	Romedex NautilusDelta (K141634)
observe P-wave are limited, butnot contraindicated, for patientswhere cardiac rhythms maychange presentation of the P-wave; including- Atrial flutter- Atrial fibrillation- Severe tachycardia- Pacemaker-driven rhythm- Chronic obstructive pulmonarydisease (COPD). Such patientsare easily identified prior tocentral catheter insertion. Inthese specific cases, use of anadditional confirmation methodis necessary to confirm cathetertip location.	pulmonary disease (COPD)Such patients are easilyidentified prior to centralcatheter insertion. Use of anadditional confirmation methodis necessary to confirm cathetertip location.	identifiable prior to catheterinsertion, the use of anadditional method is requiredto confirm PICC tip location.	type and size must be chosen and theCVAD must be used according to theCVAD's indications and instructionsfor use.Limiting but not contraindicatedsituations for this method are inpatients where alterations of cardiacrhythm change the presentation of theP wave as in atrial fibrillation, atrialflutter, severe tachycardia, andpacemaker driven rhythm. In suchpatients, who are easily identifiableprior to central venous catheterinsertion, the use of an additionalmethod is required to confirm cathetertip location.
System Features and Components
Monitor with touch screengraphical user interface.	Monitor with touch screengraphical user interface.	Monitor with touch screengraphical user interface.	Mobile medical softwareapplication running on a mobileplatform which is used for display ofsurface and intracavitary ECG
Functionality for storage ofinsertion case information andsubsequent printing by a USBprinter.	Functionality for storage ofinsertion case information andsubsequent printing by a USBprinter.	Functionality for storage ofinsertion case information andsubsequent printing by a USBprinter.	Storage of data is on the on the mobileplatform. The mobile application cansend the data to a user-suppliedBluetooth printer.
Remote Control for clinician-inserter input and selection ofdisplay options.	Remote Control for clinician-inserter input and selection ofdisplay options.	Remote control for clinicianinput and selection of displayoptions.	Patient module (ECG data acquisitionand processing with integrated remotecontrol); data is sent to a mobileplatform via wireless (Bluetooth)
Proposed Device	Predicate Device	Reference Device	Reference Device
VPS Rhythm Device withOptional TipTrackerTechnology	PICC Tip Positioning Aid(K152261)	Sherlock 3CGTMTip ConfirmationSystem (K140345)	Romedex NautilusDelta (K141634)
			technology.
TipTracker stylet for assemblywith central venous catheter toallow visualization ofcatheter's insertion track anddirection relative to theTipTracker T-piece magneticemitter array.Stylet Design:Stylet Outer diameter: 0.015"Stylet Overall length : 29.5"(75 cm)Min. catheter lumen diametercompatibility: .018" (3-6French cathetersSterile, single-use.	N/A	Sherlock 3CG stylet forassembly with central catheter toallow visualization of catheter'stip location and directionrelative to the Sherlock 3CGmagnetic field sensor.Stylet Design:Stylet Outer diameter: 0.019"Stylet Overall length : 78.5 cmMin. catheter lumen diametercompatibility: .020"Sterile, single-use.	N/A
TipTracker T-piece magneticemitter array placed onpatient's chest during catheterinsertion.Facilitates passively-inducedsignal in TipTracker stylet'scoiled tip when stylet(assembled with insertedcatheter) enters the low powermagnetic field.	N/A	3CG magnetic sensor placed onpatient's chest during catheterinsertion. Senses the permanentmagnet in the 3CGTM stylet's tip(assembled with insertedcatheter) when the insertedcatheter is within sensing range.	N/A(this predicate supports only the use ofthe device's ECG technology forplacement of CVADs, not catheternavigation)
Energy Source:-AC/DC power supply withremovable hospital grademains power cord- Rechargeable internal	Energy Source:-AC/DC power supply withremovable hospital grade mainspower cord- Rechargeable internal	Energy Source:-AC/DC power supply withhospital grade mains power cord- Rechargeable internal battery	Energy Source:- patient module: lithium polymerbattery with USB cable for chargingAs determined by host device (mobile
Proposed Device	Predicate Device	Reference Device	Reference Device
VPS Rhythm Device withOptional TipTrackerTechnology	PICC Tip Positioning Aid(K152261)	Sherlock 3CGTMTip ConfirmationSystem (K140345)	Romedex NautilusDelta (K141634)
Lithium-ion battery	Lithium-ion battery		platform) such as tablet/smartphone”
Sterile accessory conveniencekits:Will include sterileconvenience kits.• VPS Rhythm ECGAccessory Pack: ContainsECG clip cable, RemoteControl cover, andcommercially availableARROW-Johans ECGadapter.VPS TipTracker StyletAccessory kit: ContainsTipTracker stylet and RemoteControl cover in sterile portionof kit. Contains T-piece coverand commercially availableECG surface electrodes innon-sterile portion of kit.	N/A	N/A	N/A

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7. Non-Clinical Performance Data

Testing verifying the performance requirements of the subject VPS Rhythm Device with Optional TipTracker Technology was conducted and included in this premarket notification and the results support substantial equivalence. Testing included:

IEC 60601-1, 3rd Edition Electrical Safety .
IEC 60601-1-2, 3rd Edition Electromagnetic Compatibility .
Software Verification and Validation Testing
· TipTracker Stylet Performance and Physical Integrity (after 1 year aging)
- Tensile Strength
- Flexural Integrity (ISO 11070)
- Insertion and Withdrawal Force
- Holding Force and Leak Resistance
- Electrical Impedance and Voltage Feedback Testing
- Corrosion Testing (ISO 11070)
- PICC compatibility with TipTracker Stylet
- TipTracker Stylet particulate Testing
. Sterile barrier package testing per ASTM F2096
· Sterilization residuals per ISO 10993-7
· Biocompatibility: According to the requirements identified in ISO 10993-1, biocompatibility testing on the patient contacting devices subject to this premarket notification is included. Testing was conducted for the assessment of cvtotoxicity (ISO 10993-5), hemocompatibility (ISO 10993-4), sensitization and irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11).
· Human Factors: A human factors study assessing the usability of the subject VPS Rhythm Device with Optional TipTracker Technology was conducted. The study utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria.

The results of the human factors study were compiled and assessed in accordance with CDRH guidance, Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff (February 3, 2016) as well as with IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices.

8. Clinical Performance Data

No human clinical data was provided to support substantial equivalence.

9. Conclusion Regarding Substantial Equivalence

The information included in this premarket notification supports the substantial equivalence of the subject VPS Rhythm Device with Optional TipTracker Technology to the stated predicate device. The listed reference devices provided substantial equivalence support for the catheter tracking portion of the device and the indications for use with central venous catheters for final tip confirmation using ECG technology. The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate device and the reference devices to which it was compared.

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Performance and biocompatibility data were included to verify the performance of the subject device against its physical design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.

Regulation Number and Section

§ 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.”