The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm DLX® 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® DLX Device, indicated for visual navigation of a peripherally inserted catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.

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® DLX Device with 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® DLX 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 Tip TipTracker™ Technology includes the software algorithms and accessory components (the non-sterile, reusable TipTracker™ T-piece and sterile, single-use TipTracker™ and proposed NaviCurve™ Stylet) which facilitate the real-time visualization of a Peripherally Inserted Central Catheter's (PICC) track and direction as it is inserted by the clinician through the vasculature. The TipTracker™ T-piece consists of a magnetic emitter array that is connected to the VPS Rhythm® DLX Device monitor. In use, the TipTracker™ T-piece is placed externally on the patient's chest. When the sterile, single-use TipTracker™ Stylet or NaviCurve Stylet is assembled with the peripherally inserted central catheter (PICC) and inserted by the clinician, the VPS Rhythm® DLX Device with TipTracker™ Technology facilitates the visualization of the PICC'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 catheter tip location.

The proposed VPS Rhythm® DLX Device introduces the ability to pair a commercially available Ultrasound probe (Interson Corporation: K163443) with the VPS Rhythm® DLX monitor to permit ultrasound visualization during the initial central catheter insertion procedure for vessel assessment and visualization on the display of the VPS Rhythm® DLX system. An optional catheter to vessel ratio tool can be used during vessel assessment.

As a new optional feature related to P-wave morphology changes, the DLX Software uses a time detected reference based on the R-Peak to show where the P-wave should exist in a patient with a normal sinus rhythm.

AI/ML Overview

The provided text, a 510(k) summary for the VPS Rhythm® DLX Device with TipTracker™ Technology, describes the device and its demonstrated equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly a table of acceptance criteria with reported performance, or details about patient sample sizes, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to an existing predicate device (VPS Rhythm® Device with TipTracker™ Technology, K160925) by highlighting non-clinical performance data and the absence of new safety or effectiveness concerns due to the modifications.

Here's a breakdown of what can be extracted from the document regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states that "testing verifying the performance requirements of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted and included in this premarket notification and the results support substantial equivalence."

The types of testing performed can be inferred as fulfilling the acceptance criteria, as the document concludes that the testing "has passed all acceptance criteria to verify that the proposed VPS Rhythm® DLX Device with TipTracker™ Technology meets its design, physical integrity, functional, software, and safety requirements."

Inferred "Acceptance Criteria" based on tests mentioned:

Acceptance Criteria Category (Inferred)	Reported Device Performance (Summary)
Electrical Safety	Passed IEC 60601-1, 3rd Edition Electrical Safety.
Electromagnetic Compatibility	Passed IEC 60601-1-2, 4th Edition Electromagnetic Compatibility.
Software Verification & Validation	Passed Software Verification and Validation Testing.
Cybersecurity	Passed Cybersecurity assessments in accordance with FDA Guidance.
Accessory Compatibility	Demonstrated compatibility.
Essential Performance	Demonstrated acceptable performance for: Distortion, Screen Freezing, ECG Impedance, ECG Waveform Performance.
ECG Display	Acceptable display of ECG waveforms.
Tracking Display	Acceptable display of tracking information.
Ultrasound Display	Acceptable display of ultrasound images (with optional probe).
Chemical Resistance	Demonstrated chemical resistance.
Cleaning and Disinfection	Demonstrated capability for cleaning and disinfection.
Cable Connector Flex Life	Passed ANSI/AAMI EC53 flex life tests.
Cable Connection Tensile Strength	Passed ANSI/AAMI EC53 tensile strength tests.
Shock Resistance (Monitor, T-piece, Remote Control)	Passed IEC 60068-2-27 shock tests.
Sinusoidal Vibration (Monitor, T-piece, Remote Control)	Passed IEC 60068-2-6 sinusoidal vibration tests.
Random Vibration (Monitor, T-piece, Remote Control)	Passed IEC 60068-2-64 random vibration tests.
Dielectric Withstand Voltage (T-piece, Remote Control, ECG Patient Cable)	Passed ANSI/AAMI EC53 dielectric withstand voltage tests.
Navigation Stylet Tensile Strength	Passed tensile strength tests per FDA Guidance.
Navigation Stylet Flexural Integrity	Passed ISO 11070 flexural integrity tests.
Navigation Stylet Insertion & Withdrawal Force	Passed insertion and withdrawal force tests.
Navigation Stylet Corrosion	Passed ISO 11070 corrosion tests.
Navigation Stylet Particulate Evaluation	Passed particulate evaluation.
Navigation Stylet Coating Integrity	Passed coating integrity tests.
Navigation Stylet Torque	Passed torque tests.
Navigation Stylet Radiopacity	Demonstrated radiopacity.
Navigation Stylet Kink Resistance	Demonstrated kink resistance.
Navigation Stylet Holding Force & Leak Resistance	Demonstrated holding force and leak resistance.
Navigation Stylet Electrical Impedance & Voltage Feedback	Passed electrical impedance and voltage feedback tests.
Biocompatibility (Cytotoxicity)	Passed ISO 10993-5 cytotoxicity assessment.
Biocompatibility (Sensitization & Irritation)	Passed ISO 10993-10 sensitization and irritation assessment.
Biocompatibility (Hemocompatibility)	Passed ISO 10993-4 hemocompatibility (for blood-contacting).
Biocompatibility (Systemic Toxicity)	Passed ISO 10993-11 systemic toxicity (for blood-contacting).
Human Factors/Usability	Met predetermined usability criteria as assessed by independent clinician participants.

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not specify a sample size for the test set for any of the non-clinical performance tests. It refers to "Human Factors: A human factors and usability report assessing the usability of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted. The studies conducted utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria." However, it does not state the number of participants.
Data Provenance: The document explicitly states: "No human clinical data was provided to support substantial equivalence." The data described is "Non-Clinical Performance Data," implying in-vitro and bench testing, as well as a human factors study which involves users, not patients. Therefore, information regarding "country of origin of the data," "retrospective or prospective," or "patient samples" is not applicable based on what is provided.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable, as no human clinical data was provided and the human factors study involves participants for usability assessment, not for establishing medical ground truth for device accuracy.
Qualifications of Experts: The human factors study used "independent clinician participants," but no specific qualifications (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical ground truth was established by experts for medical performance. The human factors study assessed usability against "predetermined usability criteria," implying internal validation, but no multi-expert adjudication process is described for device performance accuracy.

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." Therefore, there is no information on human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document describes the device's overall performance in various non-clinical tests (e.g., "ECG Waveform Performance," "Tracking Display," "Ultrasound Display"). Since no human clinical data was presented, the "performance" described is effectively the "algorithm's" or device's inherent capability as measured in bench and engineering tests. However, it does not isolate "algorithm-only" performance as a separate study component distinct from the integrated device. The device itself uses the cardiac electrical activity and magnetic field technology for its functions.

7. Type of Ground Truth Used:

For the non-clinical performance data, the ground truth is implicitly defined by the standards and specifications against which the device was tested (e.g., IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC53, ISO 11070, ISO 10993-1). These standards represent established engineering and safety benchmarks for medical devices.
For the human factors study, the "ground truth" was predetermined usability criteria.

8. Sample Size for the Training Set:

The document describes a 510(k) submission for a device that uses cardiac electrical activity and magnetic field technology, and mentions "software algorithms." However, it does not state that the device uses machine learning or AI that requires a "training set" in the typical sense of supervised learning. The software V&V refers to traditional software testing. Therefore, information on a training set size is not provided and likely not applicable in the context of this traditional medical device clearance.

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

As a "training set" for AI/machine learning is not mentioned as part of the device's development or clearance, this information is not applicable and not provided. The device's functionality is based on known physiological principles (ECG changes to detect catheter tip location) and magnetic field-based tracking, rather than data-driven "learning" from a large dataset.

Summary

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August 22, 2022

Arrow International, LLC (a subsidiary of Teleflex, Inc.) Elizabeth Duncan Principal Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K220363

Trade/Device Name: VPS Rhythm® DLX Device with TipTracker™ Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: August 12, 2022 Received: August 12, 2022

Dear Elizabeth 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220363

Device Name

VPS Rhythm® DLX Device with TipTracker™ Technology

Indications for Use (Describe)

For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.

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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K220363 - 510(k) SUMMARY (per CFR 807.92)

VPS Rhythm® DLX Device with TipTracker™ Technology

1.	Applicant Information:	Arrow International LLC (a subsidiary of Teleflex Incorporated)
		3015 Carrington Mill Blvd.
		Morrisville, NC 27560
	Contact Person:	Elizabeth Duncan or Frank Pelc
	Telephone Number:	(610) 781-6455 or 484-209-2172
	Email:	elizabeth.duncan@teleflex.com or frank.pelc@teleflex.com
	Date Prepared:	August 22, 2022
2.	Device Name:
	Trade/Proprietary Name:	VPS Rhythm® DLX Device with 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 Device(s):

Predicate Device Name	510(k)	Original ApplicantName
VPS Rhythm® Device with TipTracker™Technology	K160925	Arrow InternationalLLC

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Reference Device(s):

Reference Device Name	510(k)	Original ApplicantName
Interson USB Ultrasound System	K163443	Interson Corporation

The reference device is used to specify the ultrasound probe that is optionally intended to attach to the proposed VPS Rhythm® DLX Device. The VPS Rhythm® DLX Device introduces the ability to pair the commercially available ultrasound probe (Interson Corporation, K163443) to permit ultrasound visualization during the initial central catheter insertion procedure for vessel assessment and visualization on the display of the VPS Rhythm® DLX system. No changes are being introduced to the Interson USB Ultrasound System.

Device Description: 4.

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Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final catheter tip location.

1. Indications for Use:
  Indications for Use:

The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm® DLX Device is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of central venous catheter tip placement in adult patients.

The TipTracker™ Technology is an optional accessory for use with the VPS Rhythm® DLX Device, indicated for visual navigation of a peripherally inserted central catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.

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)

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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.

Comparison of Intended Use / Indications for Use:

The subject device has the same intended use and technology as the predicate device, VPS Rhythm® Device with TipTracker™ Technology (K160925). The subject and predicate devices 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 addition of the optional use of Ultrasound for vessel assessment does not change the intended use or technology of the device as compared to the predicate. As demonstrated by the data included in this 510(k) submission, this difference is not critical to the intended use of the VPS Rhythm® DLX Device with TipTracker™ Technology and does not introduce any new safety or effectiveness concerns.

Comparison of Technological Characteristics with the Predicate Device: 6.

The subject VPS Rhythm® DLX Device with TipTracker™ Technology incorporates the same fundamental technology as the predicate device. The subject device as well as the predicate (K160925) incorporate the same 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 to radiographic confirmation.

The subject VPS Rhythm® DLX Device with TipTracker™ Technology and the predicate device include touch-screen graphical user interface displays; include remote control capability, and reusable components which facilitate the display of the patient ECG information. The subject VPS Rhythm® DLX Device with TipTracker™ Technology also includes the same 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 subject and the predicate device utilize a reusable accessory component (T-Piece) 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.

With respect to the external and intravascular ECG waveform display functionality, the VPS Rhythm® DLX Device with TipTracker™ Technology is identical to the predicate VPS Rhythm® Device (K160925). The purpose of this premarket notification is for the introduction of an additional sterile, single-use navigation stylet for use with the optional TipTracker™ Technology and associated

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components, new monitor, software and cybersecurity upgrades, workflow modifications to allow for fewer system interactions and a pairing with a commercially available ultrasound probe (K163443), upgraded ECG Patient Cable to function with the DLX device.

Table 6.1 summarizes the substantial equivalence comparison of the subject VPS Rhythm® Device with TipTracker™ Technology with the predicate devices.

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TechnologicalCharacteristic	Proposed Device	Predicate Device	Substantial Equivalence Assessment ofModifications
	VPS Rhythm® DLX Device with TipTrackerTMTechnology	VPS Rhythm® Device with OptionalTipTrackerTM Technology(K160925)
SystemDescription	Displays the patient's surface (external) ECGwaveform to the monitor via three (3) electrodeleads. Displays the patient's intravascular ECGwaveform to the monitor through the RemoteControl cable via connection of an ECG clip cableto the central catheter's placement wire/stylet, orto the saline column in a central catheter's distallumen via the commercially available ARROW-Johans ECG adapter. Intravascular ECGwaveform is also transmitted through thenavigation stylets.Includes TipTrackerTM Technology whichfacilitates display of a PICC's tip insertion trackand direction relative to the T-piece magneticemitter array. The sterile, single-use navigationstylet is assembled with a PICC. A signal ispassively induced in the stylet's inner distal coilwhen the stylet's tip enters the T-piece magneticfield. Device software triangulates the passivelyinduced signal with respect to the T-piece magneticarray to derive the catheter tip's insertion track anddirection.Includes a connection that provides the ability toattach/pair an Ultrasound transducer for use inassessing the vasculature during a CVADplacement procedure.	Same as predicate with the exception of theability to connect an Ultrasound transducer	Justification for no S&E impact: theability to attach a commercially availableultrasound probe to has no impact on thesafety and effectiveness of the VPSRhythm DLX device since theUltrasound feature/display isindependent of the primary functionalityof the VPS Rhythm DLX device, whichis placement of a central catheter usingTipTrackerTM Technology fornavigation and ECG technology for finaltip placement and confirmation, which isthe same as the predicate. Compatibilitytesting of the ultrasound probe with theVPS Rhythm DLX system demonstratedthere are no new safety or efficacyconcerns.
Monitor	- DLX Monitor- Off-the-shelf single boardcomputer with custom main board electroniccircuitry and software with a 12" touch screengraphical user interface to display surface(external) and intravascular patient ECGwaveforms, catheter insertion track and directionrelative to the T-piece magnetic emitter arrayaccessory. Includes a connection port for the	- Rhythm Monitor Off-the-shelf singleboard computer with custom main boardelectronic circuitry and software with 8"touch screen graphical user interface todisplay surface (external) and intravascularpatient ECG waveforms as well as catheterinsertion track and direction relative to the	Justification for no S&E impact: Thelarger screen and ultrasound probeconnection port modifications have noimpact on the use or functionality of theVPS Rhythm® DLX device per itsintended use as demonstrated byappropriate system testing of the VPSRhythm® DLX system with these

Table 6.1 - Substantial Equivalence Comparison Summary

Traditional 510(k) – VPS Rhythm® DLX Device with TipTracker™ Technology
Arrow International LLC (A subsidiary of Teleflex Incorporated)

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TechnologicalCharacteristic	Proposed DeviceVPS Rhythm® DLX Device with TipTracker™Technology	Predicate DeviceVPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)	Substantial Equivalence Assessment ofModifications
	- attachment of an Ultrasound probe to provide theability to display ultrasound images when thecommercially available ultrasound probe isconnected.- A custom LEMO USB port allows connectionof a USB ultrasound probe and two standardUSB ports for a USB printer and USB memorystick to facilitate printing and PDF export of storedcase information.• Standard Lemo Ports customized to aidcustomers in determining which accessoryconnects to which port/socket for theconnection of Remote Control, ECGPatient Cable and T-piece to the DLXmonitor.	- T-piece magnetic emitter array accessory.- Standard USB ports allow connection ofUSB printer and USB memory stick tofacilitate printing and PDF export of storedcase information.• Standard Lemo Ports allowconnection of Remote Control, ECGPatient Cable and T-piece to theRhythm monitor.	modifications which supports that thereare no new safety or efficacy concerns.
RemoteControl	- Remote Control Non-sterile, reusable componentfor connection to monitor allows clinician-inserterselection of display options. Remote controlconnector to the monitor has been modified toconnect to the DLX monitor.	- Remote Control SAME as the proposeddevice with the exception of the connector.	Justification for no S&E impact: sameas described under Monitor.
ECGcomponents	- ECG Patient cable: Non-sterile provides aconnection to the monitor on one end, and to theECG snap leads at the other - Connector hasbeen modified to connect to the DLX monitor- ECG snap leads Non-sterile (1.5mm DIN- styleconnectors) for surface (external) ECG.- ECG clip cable Sterile for connection to centralcatheter placement wire or placement stylet to	- ECG patient cable SAME as the proposeddevice with the exception of the connector- ECG snap leads SAME as the proposeddevice- ECG clip cable SAME as the proposeddevice	Justification for no S&E impact: same asdescribed under Monitor.
TechnologicalCharacteristic	Proposed Device	Predicate Device	Substantial Equivalence Assessment ofModifications
	VPS Rhythm® DLX Device with TipTracker™Technology	VPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)
	obtain intravascular ECG.
	- ECG Electrode Pads - Non-sterile, disposable,commercially-available, off the shelf ECG padsfor snap leads to connect to transmit signal.	- ECG Electrode Pads SAME as theproposed device
NavigationStylets	-TipTracker™ Stylet (cleared under K160925—no changes presented in this submission):Provided: Sterile and for single useElectrical Output: When inserted into a PICC,allows visualization of the catheter's insertiontrack and direction relative to the TipTracker™ T-piece magnetic emitter array accessory. Transmitsintravascular electrocardiogram (ECG) informationduring insertion.- Stylet Outside Diameter Spec: 0.015”- Stylet Overall Length: 30.58”- Contains Curve Profile: No- Contains Flexible Tip: No- NaviCurve™ StyletProvided: Sterile and for single useElectrical Output: When inserted into an ArrowPICC, allows visualization of the catheter'sinsertion track and direction relative to the	TipTracker™ Stylet: SAME as proposeddevice	Justification for no S&E impact for theNaviCurve Stylet: The NaviCurve stylethas the same intended use andfunctionality as the predicateTipTracker™ stylet for use with theTipTracker™ Technology to allowvisualization of the catheter as itadvances through the vessel during aninsertion procedure. Neither stylet isindicated for use in final catheter tipplacement confirmation. The minimalspecification changes described do notintroduce new concerns of safety andeffectiveness as demonstrated by theV&V testing performed, includingHuman Factors/ Usability testing.
TechnologicalCharacteristic	Proposed DeviceVPS Rhythm® DLX Device with TipTracker™Technology	Predicate DeviceVPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)	Substantial Equivalence Assessment ofModifications
	TipTracker™ T-piece magnetic emitter arrayaccessory. Transmits intravascularelectrocardiogram (ECG) information duringinsertion.- Stylet Outside Diameter Spec: 0.018"- Stylet Overall Length: 32-13/32"- Contains Curve Profile: Yes- Contains Flexible Tip: Yes
T-piece	DLX T-piece magnetic emitter array placed onpatient's chest during catheter insertion. Facilitatespassively induced signal in navigation stylet'scoiled tip when stylet (assembled with insertedPICC) enters the low-power magnetic field.Connector has been modified from the predicate toconnect to the DLX monitor.	- Rhythm T-piece SAME as PROPOSEDDEVICE except for connector.	Justification for no S&E impact: sameas described under Monitor
ECG RegionFeature	- P-wave region highlight feature-optional featurerelated to P-wave morphology changes capturedthrough a snapshot, the DLX Software uses a timedetected reference based on the R-Peak to showwhere the P-wave should exist in a patient with anormal sinus rhythm.	-NA	Justification for no S&E impact: The P-wave region highlight feature is anoptional tool for clinician use that mustbe turned on to be functional if theclinician chooses to use it. This featuredoes not indicate the presence of a P-wave. It only identifies the region wherethe P-wave should exist for a patientwith normal sinus rhythm. It remains theclinician's responsibility to use theirjudgement to identify P-wavemorphology changes when determiningfinal catheter tip location, which is the
TechnologicalCharacteristic	Proposed DeviceVPS Rhythm® DLX Device with TipTracker™Technology	Predicate DeviceVPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)	Substantial Equivalence Assessment ofModifications
			same as that required for the predicatedevice.
UltrasoundConnectionCapability	The VPS Rhythm® DLX provides the abilityto optionally pair/attach a commerciallyavailable ultrasound probe (IntersonCorporation, K163443) to permit ultrasoundvisualization during the initial central catheterinsertion procedure for vessel assessment andneedle insertion on the display of the VPSRhythm® DLX system. In ultrasound mode, an optional catheter-to-vessel ratio tool is provided.	-NA	Justification for no S&E impact: The useof the commercially available IntersonUltrasound probe (K163443) is anoptional tool for clinician use. There areno modifications to the Interson probefunctionality associated with this VPSRhythm® DLX 510(k). Use ofUltrasound is independent of the ECG annavigational features of the proposeddevice and is not a required step forsuccessful tip placement.Compatibility testing of the ultrasoundprobe with the VPS Rhythm® DLXsystem demonstrated there are no newsafety or efficacy concerns.The catheter-to-vessel ratio tool is anoptional feature the clinician chooses touse if desired. The tool does notdetermine the size of catheter to use; itprovides a visual display for the clinicianto consider when determining the cathetersize for the patient, and calculates catheterocclusion area based on the vessel sizeand catheter size selected by the clinicianwhen viewing the catheter-to-vessel ratiotool overlay on the ultrasound display (thedevice does not make any decisions onsize). It remains the clinician'sresponsibility to use their judgement tochoose the right catheter for the patient,which is the same as that required for thepredicate device.
TechnologicalCharacteristic	Proposed Device	Predicate Device	Substantial Equivalence Assessment ofModifications
	VPS Rhythm® DLX Device with TipTracker™Technology	VPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)
Energy Source	- Energy Source: AC/DC power supply [18V 40W]with removable hospital grade mains power cord.- Rechargeable internal Lithium-ion battery [11V74W-hr].	Similar AC/DC power supply [12V 20W]with SAME AS PROPOSED DEVICEremovable hospital grade mains powercord.Similar rechargeable Lithium-ion battery[7.2V 63 W-hr].	Justification for no S&E impact: Thepower supply and battery modificationswere tested as part of the system testing(IEC 60601-1 safety testing) anddemonstrated acceptable results,supporting that there are no differentconcerns of safety or efficacy as a resultof these modifications.
Software	Programming environment: Windows-based hostdevelopment system comprised of:a) Visual Studio 2017 running on Windows 10PCb) Advantech SOM-6869 single board computer.c) Azure DevOps cloud-based developmentservices; including code repository, defecttracking, code review, continuous integration,build/configuration management.Operating Environment: The DLX systemsoftware runs on the Windows 10 IoT Enterprise2019 LTSC operating system for an X64-basedsingle board computer. It utilizes the WindowsPresentation Foundation (WPF), .Net and C# tocreate the graphical user interface (GUI),application program interface (API) and both aremote and a touchscreen interface as the basis forits human machine interface.Workflow modifications to minimize the numberof system interactions	Programming environment:a) QNX 6.4.1 Momentics DevelopmentPlatform running on Windows XP orLinux.b) Advantech PCM-3353 single boardcomputer.c) Perforce P4V source code controlmanagement system.d) Configuration Management, IssueTracking, and Collaboration Systembased on Atlassian softwaredevelopment tools.Operating Environment: The Rhythmsystem software runs on the QNX 6.4.1real-time operating system for an X86	Justification for no S&E impact: Allsoftware changes were tested andevaluated through V&V and HumanFactors testing and demonstratedacceptable results, supporting that thereare no different concerns of safety orefficacy as a result of thesemodifications.
TechnologicalCharacteristic	Proposed DeviceVPS Rhythm® DLX Device with TipTracker™Technology	Predicate DeviceVPS Rhythm® Device with OptionalTipTracker™ Technology(K160925)	Substantial Equivalence Assessment ofModifications
Notifications/Alerts	Alerts may occur in ECG and Tracking modes, onthe Case Manager screen, during device startup,and when battery is low.New alerts:-Replace coin cell battery-Ultrasound probe not connected	Some alerts have different visualnotification of these alerts from the proposeddevice.	Justification for no S&E impact:Although the visual notification mayappear slightly different, all alertsprovided in the predicate device are alsopresent in the proposed device withidentical functionality and with nochange in procedural workflow toaddress the alert messages.The added Replace coin cell battery alertwould appear only when the system isinitially powered on, resulting in nodifference to procedural workflow andno change to safety or performance ofthe device.The Ultrasound probe not connectedalert was added only due to the additionof the optional ultrasound probeconnection and is a simple notice that theUS probe must be connected to use theUltrasound feature. There is no differentissue of safety and effectiveness relatedto this alert since the use of Ultrasound isoptional. Even if it was not possible touse the Ultrasound, the catheterplacement procedure using the VPSRhythm® DLX device could still befully conducted using TipTrackerTMTechnology for catheter tracking andECG technology for final tipplacement-same as for the predicate.

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7. Non-Clinical Performance Data

Testing verifying the performance requirements of the subject VPS Rhythm® DLX Device with 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, 4th Edition Electromagnetic Compatibility .
Software Verification and Validation Testing ●
Cybersecurity assessments conducted in accordance with the ● FDA Guidance for Industry and Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff, Draft Guidance, 2018
VPS Rhythm® DLX device performance and physical integrity ● testing:
- Accessory Compatibility
- Essential Performance: Distortion, Screen Freezing, ECG Impedance, ECG Waveform Performance
- ECG Display
- Tracking Display
- Ultrasound Display
- Chemical Resistance
- Cleaning and Disinfection
- Flex life of cable connectors (ANSI/AAMI EC53)
- Tensile strength of cable connections (ANSI/AAMI EC53)
- Shock Testing of Monitor, T-piece, Remote Control (IEC 60068-2-27)
- Sinusoidal Vibration of Monitor, T-piece and Remote Control (IEC 60068-2-6)
- Random Vibration of Monitor, T-piece and Remote Control (IEC 60068-2-64)
- Dielectric withstand voltage of T-piece, Remote Control and ECG Patient Cable (ANSI/AAMI EC53)
Navigation Stylet performance and physical integrity testing per . FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, Guidance for Industry and Food and Drug Administration Staff, 2019:
- Tensile Strength
- Flexural Integrity (ISO 11070)
- Insertion and Withdrawal Force

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Corrosion (ISO 11070)
Particulate Evaluation
Coating Integrity
Torque
Radiopacity
Kink Resistance
Holding Force and Leak Resistance
Electrical Impedance and Voltage Feedback Testing
Biocompatibility according to the requirements identified in ISO 10993-1. . and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a Risk Management Process: Guidance for Industry and Food and Drug Administration Staff, 2020. Biocompatibility testing on the patient contacting devices subject to this premarket notification is included. For skin contacting devices, testing was conducted for the assessment of cytotoxicity (ISO 10993-5) and sensitization and irritation (ISO 10993-10); for circulating blood contacting devices, those tests as well as hemocompatibility (ISO 10993-4) and systemic toxicity (ISO 10993-11) were conducted. The patient contacting materials as part of the subject device are intended for a duration of less than 24 hours.
Human Factors: A human factors and usability report assessing the usability of ● the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted. The studies conducted 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, 2016; as well as with IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices.

Clinical Performance Data

No human clinical data was provided to support substantial equivalence.

1. Conclusion
  The information included in this premarket notification supports the substantial equivalence of the subject VPS Rhythm® DLX Device with TipTracker™ Technology to the stated predicate device. The subject device has the same intended use and technology as the legally marketed predicate device to which it was compared.

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Performance, Human Factors/Usability, Biocompatibility, and safety testing has been conducted and has passed all acceptance criteria to verify that the proposed VPS Rhythm® DLX Device with TipTracker™ Technology meets its design, physical integrity, functional, software, and safety requirements and that any dimensional or material differences between it and the predicate devices do not raise new issues of safety and effectiveness. The results of the testing included in this premarket notification support a determination of substantial equivalence.

It is concluded that the information provided in this discussion supports a conclusion of Substantial Equivalence of the proposed VPS Rhythm® DLX Device with TipTracker™ Technology to the VPS Rhythm® Device with TipTracker™ Technology.

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.”