VPS Rhythm DLX Device with TipTracker Technology

K220363 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · LJS · Aug 22, 2022 · General Hospital

Device Facts

• Record ID: K220363
• Device Name: VPS Rhythm DLX Device with TipTracker Technology
• Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
• Product Code: LJS · General Hospital
• Decision Date: Aug 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended 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 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.

Device Story

System facilitates central venous catheter (CVC/PICC) tip placement and navigation. Inputs: patient surface ECG (via 3 leads), intravascular ECG (via catheter stylet/saline column), and magnetic field signals (via TipTracker T-piece). Optional input: ultrasound transducer for vessel assessment. Operation: clinician inserts catheter; device displays real-time ECG waveforms and catheter track/direction relative to chest-mounted magnetic T-piece. Software provides P-wave morphology monitoring and optional catheter-to-vessel ratio tool. Output: visual display on 12-inch touchscreen monitor. Used in clinical settings by physicians/nurses. Benefits: real-time guidance, reduced reliance on radiographic confirmation (x-ray/fluoroscopy), and improved vessel assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V, cybersecurity assessment, physical integrity (vibration, shock, tensile strength), biocompatibility (ISO 10993), and human factors/usability testing.

Technological Characteristics

System includes 12-inch touchscreen monitor, magnetic emitter array (T-piece), and sterile single-use navigation stylets. Connectivity: USB ports for ultrasound probe, printer, and memory. Power: AC/DC supply and internal Li-ion battery. Software: Windows 10 IoT Enterprise-based. Biocompatibility: ISO 10993-1 compliant. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC53, ISO 11070.

Indications for Use

Indicated for adult patients requiring central venous catheter (including PICC) placement. Contraindicated/limited for patients with cardiac rhythms affecting P-wave presentation: atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm, or COPD; these patients require additional confirmation methods.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• VPS Rhythm® Device with TipTracker™ Technology (K160925)

Reference Devices

• Interson USB Ultrasound System (K163443)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>Prescription Use (Part 21 CFR 801 Subpart D)</b></span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

# #

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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: | [phone] or 484-209-2172 |
| | Email: | [e-mail] or [e-mail] |
| | 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 Applicant<br>Name |
|---------------------------------------------------|---------|----------------------------|
| VPS Rhythm® Device with TipTracker™<br>Technology | K160925 | Arrow International<br>LLC |

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### Reference Device(s):

| Reference Device Name | 510(k) | Original Applicant<br>Name |
|--------------------------------|---------|----------------------------|
| 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.

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™

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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.

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.

- 5. 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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| Technological<br>Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of<br>Modifications |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VPS Rhythm® DLX Device with TipTrackerTM<br>Technology | VPS Rhythm® Device with Optional<br>TipTrackerTM Technology<br>(K160925) | |
| System<br>Description | Displays the patient's surface (external) ECG<br>waveform to the monitor via three (3) electrode<br>leads. Displays the patient's intravascular ECG<br>waveform to the monitor through the Remote<br>Control cable via connection of an ECG clip cable<br>to the central catheter's placement wire/stylet, or<br>to the saline column in a central catheter's distal<br>lumen via the commercially available ARROW-Johans ECG adapter. Intravascular ECG<br>waveform is also transmitted through the<br>navigation stylets.<br><br>Includes TipTrackerTM Technology which<br>facilitates display of a PICC's tip insertion track<br>and direction relative to the T-piece magnetic<br>emitter array. The sterile, single-use navigation<br>stylet is assembled with a PICC. A signal is<br>passively induced in the stylet's inner distal coil<br>when the stylet's tip enters the T-piece magnetic<br>field. Device software triangulates the passively<br>induced signal with respect to the T-piece magnetic<br>array to derive the catheter tip's insertion track and<br>direction.<br>Includes a connection that provides the ability to<br>attach/pair an Ultrasound transducer for use in<br>assessing the vasculature during a CVAD<br>placement procedure. | Same as predicate with the exception of the<br>ability to connect an Ultrasound transducer | Justification for no S&E impact: the<br>ability to attach a commercially available<br>ultrasound probe to has no impact on the<br>safety and effectiveness of the VPS<br>Rhythm DLX device since the<br>Ultrasound feature/display is<br>independent of the primary functionality<br>of the VPS Rhythm DLX device, which<br>is placement of a central catheter using<br>TipTrackerTM Technology for<br>navigation and ECG technology for final<br>tip placement and confirmation, which is<br>the same as the predicate. Compatibility<br>testing of the ultrasound probe with the<br>VPS Rhythm DLX system demonstrated<br>there are no new safety or efficacy<br>concerns. |
| Monitor | - DLX Monitor- Off-the-shelf single board<br>computer with custom main board electronic<br>circuitry and software with a 12" touch screen<br>graphical user interface to display surface<br>(external) and intravascular patient ECG<br>waveforms, catheter insertion track and direction<br>relative to the T-piece magnetic emitter array<br>accessory. Includes a connection port for the | - Rhythm Monitor Off-the-shelf single<br>board computer with custom main board<br>electronic circuitry and software with 8"<br>touch screen graphical user interface to<br>display surface (external) and intravascular<br>patient ECG waveforms as well as catheter<br>insertion track and direction relative to the | Justification for no S&E impact: The<br>larger screen and ultrasound probe<br>connection port modifications have no<br>impact on the use or functionality of the<br>VPS Rhythm® DLX device per its<br>intended use as demonstrated by<br>appropriate system testing of the VPS<br>Rhythm® 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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| Technological<br>Characteristic | Proposed Device<br>VPS Rhythm® DLX Device with TipTracker™<br>Technology | Predicate Device<br>VPS Rhythm® Device with Optional<br>TipTracker™ Technology<br>(K160925) | Substantial Equivalence Assessment of<br>Modifications |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - attachment of an Ultrasound probe to provide the<br>ability to display ultrasound images when the<br>commercially available ultrasound probe is<br>connected.<br>- A custom LEMO USB port allows connection<br>of a USB ultrasound probe and two standard<br>USB ports for a USB printer and USB memory<br>stick to facilitate printing and PDF export of stored<br>case information.<br>• Standard Lemo Ports customized to aid<br>customers in determining which accessory<br>connects to which port/socket for the<br>connection of Remote Control, ECG<br>Patient Cable and T-piece to the DLX<br>monitor. | - T-piece magnetic emitter array accessory.<br><br>- Standard USB ports allow connection of<br>USB printer and USB memory stick to<br>facilitate printing and PDF export of stored<br>case information.<br><br>• Standard Lemo Ports allow<br>connection of Remote Control, ECG<br>Patient Cable and T-piece to the<br>Rhythm monitor. | modifications which supports that there<br>are no new safety or efficacy concerns. |
| Remote<br>Control | - Remote Control Non-sterile, reusable component<br>for connection to monitor allows clinician-inserter<br>selection of display options. Remote control<br>connector to the monitor has been modified to<br>connect to the DLX monitor. | - Remote Control SAME as the proposed<br>device with the exception of the connector. | Justification for no S&E impact: same<br>as described under Monitor. |
| ECG<br>components | - ECG Patient cable: Non-sterile provides a<br>connection to the monitor on one end, and to the<br>ECG snap leads at the other - Connector has<br>been modified to connect to the DLX monitor<br>- ECG snap leads Non-sterile (1.5mm DIN- style<br>connectors) for surface (external) ECG.<br>- ECG clip cable Sterile for connection to central<br>catheter placement wire or placement stylet to | - ECG patient cable SAME as the proposed<br>device with the exception of the connector<br>- ECG snap leads SAME as the proposed<br>device<br>- ECG clip cable SAME as the proposed<br>device | Justification for no S&E impact: same as<br>described under Monitor. |
| Technological<br>Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of<br>Modifications |
| | VPS Rhythm® DLX Device with TipTracker™<br>Technology | VPS Rhythm® Device with Optional<br>TipTracker™ Technology<br>(K160925) | |
| | obtain intravascular ECG. | | |
| | - ECG Electrode Pads - Non-sterile, disposable,<br>commercially-available, off the shelf ECG pads<br>for snap leads to connect to transmit signal. | - ECG Electrode Pads SAME as the<br>proposed device | |
| Navigation<br>Stylets | -TipTracker™ Stylet (cleared under K160925—<br>no changes presented in this submission):<br><br>Provided: Sterile and for single use<br><br>Electrical Output: When inserted into a PICC,<br>allows visualization of the catheter's insertion<br>track and direction relative to the TipTracker™ T-<br>piece magnetic emitter array accessory. Transmits<br>intravascular electrocardiogram (ECG) information<br>during insertion.<br><br>- Stylet Outside Diameter Spec: 0.015”<br><br>- Stylet Overall Length: 30.58”<br><br>- Contains Curve Profile: No<br><br>- Contains Flexible Tip: No<br><br>- NaviCurve™ Stylet<br><br>Provided: Sterile and for single use<br><br>Electrical Output: When inserted into an Arrow<br>PICC, allows visualization of the catheter's<br>insertion track and direction relative to the | TipTracker™ Stylet: SAME as proposed<br>device | Justification for no S&E impact for the<br>NaviCurve Stylet: The NaviCurve stylet<br>has the same intended use and<br>functionality as the predicate<br>TipTracker™ stylet for use with the<br>TipTracker™ Technology to allow<br>visualization of the catheter as it<br>advances through the vessel during an<br>insertion procedure. Neither stylet is<br>indicated for use in final catheter tip<br>placement confirmation. The minimal<br>specification changes described do not<br>introduce new concerns of safety and<br>effectiveness as demonstrated by the<br>V&V testing performed, including<br>Human Factors/ Usability testing. |
| Technological<br>Characteristic | Proposed Device<br>VPS Rhythm® DLX Device with TipTracker™<br>Technology | Predicate Device<br>VPS Rhythm® Device with Optional<br>TipTracker™ Technology<br>(K160925) | Substantial Equivalence Assessment of<br>Modifications |
| | TipTracker™ T-piece magnetic emitter array<br>accessory. Transmits intravascular<br>electrocardiogram (ECG) information during<br>insertion.<br>- Stylet Outside Diameter Spec: 0.018"<br>- Stylet Overall Length: 32-13/32"<br>- Contains Curve Profile: Yes<br>- Contains Flexible Tip: Yes | | |
| T-piece | DLX T-piece magnetic emitter array placed on<br>patient's chest during catheter insertion. Facilitates<br>passively induced signal in navigation stylet's<br>coiled tip when stylet (assembled with inserted<br>PICC) enters the low-power magnetic field.<br><br>Connector has been modified from the predicate to<br>connect to the DLX monitor. | - Rhythm T-piece SAME as PROPOSED<br>DEVICE except for connector. | Justification for no S&E impact: same<br>as described under Monitor |
| ECG Region<br>Feature | - P-wave region highlight feature-optional feature<br>related to P-wave morphology changes captured<br>through a snapshot, the DLX Software uses a time<br>detected reference based on the R-Peak to show<br>where the P-wave should exist in a patient with a<br>normal sinus rhythm. | -NA | Justification for no S&E impact: The P-<br>wave region highlight feature is an<br>optional tool for clinician use that must<br>be turned on to be functional if the<br>clinician chooses to use it. This feature<br>does not indicate the presence of a P-<br>wave. It only identifies the region where<br>the P-wave should exist for a patient<br>with normal sinus rhythm. It remains the<br>clinician's responsibility to use their<br>judgement to identify P-wave<br>morphology changes when determining<br>final catheter tip location, which is the |
| Technological<br>Characteristic | Proposed Device<br>VPS Rhythm® DLX Device with TipTracker™<br>Technology | Predicate Device<br>VPS Rhythm® Device with Optional<br>TipTracker™ Technology<br>(K160925) | Substantial Equivalence Assessment of<br>Modifications |
| | | | same as that required for the predicate<br>device. |
| Ultrasound<br>Connection<br>Capability | The VPS Rhythm® DLX provides the ability<br>to optionally pair/attach a commercially<br>available ultrasound probe (Interson<br>Corporation, K163443) to permit ultrasound<br>visualization during the initial central catheter<br>insertion procedure for vessel assessment and<br>needle insertion on the display of the VPS<br>Rhythm® DLX system. In ultrasound mode, an optional catheter-to-<br>vessel ratio tool is provided. | -NA | Justification for no S&E impact: The use<br>of the commercially available Interson<br>Ultrasound probe (K163443) is an<br>optional tool for clinician use. There are<br>no modifications to the Interson probe<br>functionality associated with this VPS<br>Rhythm® DLX 510(k). Use of<br>Ultrasound is independent of the ECG an<br>navigational features of the proposed<br>device and is not a required step for<br>successful tip placement.<br><br>Compatibility testing of the ultrasound<br>probe with the VPS Rhythm® DLX<br>system demonstrated there are no new<br>safety or efficacy concerns.<br><br>The catheter-to-vessel ratio tool is an<br>optional feature the clinician chooses to<br>use if desired. The tool does not<br>determine the size of catheter to use; it<br>provides a visual display for the clinician<br>to consider when determining the catheter<br>size for the patient, and calculates catheter<br>occlusion area based on the vessel size<br>and catheter size selected by the clinician<br>when viewing the catheter-to-vessel ratio<br>tool overlay on the ultrasound display (the<br>device does not make any decisions on<br>size). It remains the clinician's<br>responsibility to use their judgement to<br>choose the right catheter for the patient,<br>which is the same as that required for the<br>predicate device. |
| Technological<br>Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of<br>Modifications |
| | VPS Rhythm® DLX Device with TipTracker™<br>Technology…