(195 days)
No
The document describes the device's functionality based on interpreting ECG waveforms and magnetic tracking, with a new feature using an R-Peak reference for P-wave location. There is no mention of AI or ML algorithms being used for interpretation, tracking, or any other function. The interpretation is explicitly stated as being done by the clinician.
No
Explanation: The device is indicated for positioning and confirming the tip placement of central venous catheters, and for navigating PICC catheters. It does not treat or cure a disease or condition. While essential for a medical procedure, its function is diagnostic/guidance-oriented rather than therapeutic.
Yes
The device provides real-time catheter tip location information using the patient's cardiac electrical activity and is indicated for confirmation of central venous catheter tip placement as an alternative to radiographic methods, which are diagnostic functions.
No
The device description explicitly states that the system consists of "nonsterile, reusable electronic components and accessories, as well as single-use, sterile components," including an "electronic monitor with graphical user interface display," "connection cables and accessories," and a "magnetic emitter array." This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The VPS Rhythm® DLX Device with TipTracker™ Technology operates by using the patient's cardiac electrical activity (ECG) and optionally ultrasound to guide and confirm the placement of a central venous catheter within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for positioning and confirming the placement of a medical device (a catheter) within the patient's vascular system. This is an in vivo procedure, not an in vitro diagnostic test.
The device is a medical device used for a procedural application, not for analyzing biological samples for diagnostic purposes.
N/A
Intended 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Central venous catheters including PICCs
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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.
No human clinical data was provided to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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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
1
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
2
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) | |
|---|---|
| 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 Applicant
Name |
|---------------------------------------------------|---------|----------------------------|
| VPS Rhythm® Device with TipTracker™
Technology | K160925 | Arrow International
LLC |
4
Reference Device(s):
| Reference Device Name | 510(k) | Original Applicant
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™
5
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.
-
- Indications for Use:
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)
6
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
7
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
Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of
Modifications |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VPS Rhythm® DLX Device with TipTrackerTM
Technology | VPS Rhythm® Device with Optional
TipTrackerTM Technology
(K160925) | |
| System
Description | Displays the patient's surface (external) ECG
waveform to the monitor via three (3) electrode
leads. Displays the patient's intravascular ECG
waveform to the monitor through the Remote
Control cable via connection of an ECG clip cable
to the central catheter's placement wire/stylet, or
to the saline column in a central catheter's distal
lumen via the commercially available ARROW-Johans ECG adapter. Intravascular ECG
waveform is also transmitted through the
navigation stylets.
Includes TipTrackerTM Technology which
facilitates display of a PICC's tip insertion track
and direction relative to the T-piece magnetic
emitter array. The sterile, single-use navigation
stylet is assembled with a PICC. A signal is
passively induced in the stylet's inner distal coil
when the stylet's tip enters the T-piece magnetic
field. Device software triangulates the passively
induced signal with respect to the T-piece magnetic
array to derive the catheter tip's insertion track and
direction.
Includes a connection that provides the ability to
attach/pair an Ultrasound transducer for use in
assessing the vasculature during a CVAD
placement procedure. | Same as predicate with the exception of the
ability to connect an Ultrasound transducer | Justification for no S&E impact: the
ability to attach a commercially available
ultrasound probe to has no impact on the
safety and effectiveness of the VPS
Rhythm DLX device since the
Ultrasound feature/display is
independent of the primary functionality
of the VPS Rhythm DLX device, which
is placement of a central catheter using
TipTrackerTM Technology for
navigation and ECG technology for final
tip placement and confirmation, which is
the same as the predicate. Compatibility
testing of the ultrasound probe with the
VPS Rhythm DLX system demonstrated
there are no new safety or efficacy
concerns. |
| Monitor | - DLX Monitor- Off-the-shelf single board
computer with custom main board electronic
circuitry and software with a 12" touch screen
graphical user interface to display surface
(external) and intravascular patient ECG
waveforms, catheter insertion track and direction
relative to the T-piece magnetic emitter array
accessory. Includes a connection port for the | - Rhythm Monitor Off-the-shelf single
board computer with custom main board
electronic circuitry and software with 8"
touch screen graphical user interface to
display surface (external) and intravascular
patient ECG waveforms as well as catheter
insertion track and direction relative to the | Justification for no S&E impact: The
larger screen and ultrasound probe
connection port modifications have no
impact on the use or functionality of the
VPS Rhythm® DLX device per its
intended use as demonstrated by
appropriate system testing of the VPS
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)
9
| Technological
Characteristic | Proposed Device
VPS Rhythm® DLX Device with TipTracker™
Technology | Predicate Device
VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | Substantial Equivalence Assessment of
Modifications |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - attachment of an Ultrasound probe to provide the
ability to display ultrasound images when the
commercially available ultrasound probe is
connected.
-
A custom LEMO USB port allows connection
of a USB ultrasound probe and two standard
USB ports for a USB printer and USB memory
stick to facilitate printing and PDF export of stored
case information.
• Standard Lemo Ports customized to aid
customers in determining which accessory
connects to which port/socket for the
connection of Remote Control, ECG
Patient Cable and T-piece to the DLX
monitor. | - T-piece magnetic emitter array accessory. -
Standard USB ports allow connection of
USB printer and USB memory stick to
facilitate printing and PDF export of stored
case information.
• Standard Lemo Ports allow
connection of Remote Control, ECG
Patient Cable and T-piece to the
Rhythm monitor. | modifications which supports that there
are no new safety or efficacy concerns. |
| Remote
Control | - Remote Control Non-sterile, reusable component
for connection to monitor allows clinician-inserter
selection of display options. Remote control
connector to the monitor has been modified to
connect to the DLX monitor. | - Remote Control SAME as the proposed
device with the exception of the connector. | Justification for no S&E impact: same
as described under Monitor. |
| ECG
components | - ECG Patient cable: Non-sterile provides a
connection to the monitor on one end, and to the
ECG snap leads at the other - Connector has
been modified to connect to the DLX monitor
- ECG snap leads Non-sterile (1.5mm DIN- style
connectors) for surface (external) ECG. - ECG clip cable Sterile for connection to central
catheter placement wire or placement stylet to | - ECG patient cable SAME as the proposed
device with the exception of the connector - ECG snap leads SAME as the proposed
device - ECG clip cable SAME as the proposed
device | Justification for no S&E impact: same as
described under Monitor. |
| Technological
Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of
Modifications |
| | VPS Rhythm® DLX Device with TipTracker™
Technology | VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | |
| | obtain intravascular ECG. | | |
| | - ECG Electrode Pads - Non-sterile, disposable,
commercially-available, off the shelf ECG pads
for snap leads to connect to transmit signal. | - ECG Electrode Pads SAME as the
proposed device | |
| Navigation
Stylets | -TipTracker™ Stylet (cleared under K160925—
no changes presented in this submission):
Provided: Sterile and for single use
Electrical Output: When inserted into a PICC,
allows visualization of the catheter's insertion
track and direction relative to the TipTracker™ T-
piece magnetic emitter array accessory. Transmits
intravascular electrocardiogram (ECG) information
during insertion.
-
Stylet Outside Diameter Spec: 0.015”
-
Stylet Overall Length: 30.58”
-
Contains Curve Profile: No
-
Contains Flexible Tip: No
-
NaviCurve™ Stylet
Provided: Sterile and for single use
Electrical Output: When inserted into an Arrow
PICC, allows visualization of the catheter's
insertion track and direction relative to the | TipTracker™ Stylet: SAME as proposed
device | Justification for no S&E impact for the
NaviCurve Stylet: The NaviCurve stylet
has the same intended use and
functionality as the predicate
TipTracker™ stylet for use with the
TipTracker™ Technology to allow
visualization of the catheter as it
advances through the vessel during an
insertion procedure. Neither stylet is
indicated for use in final catheter tip
placement confirmation. The minimal
specification changes described do not
introduce new concerns of safety and
effectiveness as demonstrated by the
V&V testing performed, including
Human Factors/ Usability testing. |
| Technological
Characteristic | Proposed Device
VPS Rhythm® DLX Device with TipTracker™
Technology | Predicate Device
VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | Substantial Equivalence Assessment of
Modifications |
| | TipTracker™ T-piece magnetic emitter array
accessory. Transmits intravascular
electrocardiogram (ECG) information during
insertion.
- 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 on
patient's chest during catheter insertion. Facilitates
passively induced signal in navigation stylet's
coiled tip when stylet (assembled with inserted
PICC) enters the low-power magnetic field.
Connector has been modified from the predicate to
connect to the DLX monitor. | - Rhythm T-piece SAME as PROPOSED
DEVICE except for connector. | Justification for no S&E impact: same
as described under Monitor |
| ECG Region
Feature | - P-wave region highlight feature-optional feature
related to P-wave morphology changes captured
through a snapshot, 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. | -NA | Justification for no S&E impact: The P-
wave region highlight feature is an
optional tool for clinician use that must
be turned on to be functional if the
clinician chooses to use it. This feature
does not indicate the presence of a P-
wave. It only identifies the region where
the P-wave should exist for a patient
with normal sinus rhythm. It remains the
clinician's responsibility to use their
judgement to identify P-wave
morphology changes when determining
final catheter tip location, which is the |
| Technological
Characteristic | Proposed Device
VPS Rhythm® DLX Device with TipTracker™
Technology | Predicate Device
VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | Substantial Equivalence Assessment of
Modifications |
| | | | same as that required for the predicate
device. |
| Ultrasound
Connection
Capability | The VPS Rhythm® DLX provides the ability
to optionally pair/attach a commercially
available ultrasound probe (Interson
Corporation, K163443) to permit ultrasound
visualization during the initial central catheter
insertion procedure for vessel assessment and
needle insertion on the display of the VPS
Rhythm® DLX system. In ultrasound mode, an optional catheter-to-
vessel ratio tool is provided. | -NA | Justification for no S&E impact: The use
of the commercially available Interson
Ultrasound probe (K163443) is an
optional tool for clinician use. There are
no modifications to the Interson probe
functionality associated with this VPS
Rhythm® DLX 510(k). Use of
Ultrasound is independent of the ECG an
navigational features of the proposed
device and is not a required step for
successful tip placement.
Compatibility testing of the ultrasound
probe with the VPS Rhythm® DLX
system demonstrated there are no new
safety or efficacy concerns.
The catheter-to-vessel ratio tool is an
optional feature the clinician chooses to
use if desired. The tool does not
determine the size of catheter to use; it
provides a visual display for the clinician
to consider when determining the catheter
size for the patient, and calculates catheter
occlusion area based on the vessel size
and catheter size selected by the clinician
when viewing the catheter-to-vessel ratio
tool overlay on the ultrasound display (the
device does not make any decisions on
size). It remains the clinician's
responsibility to use their judgement to
choose the right catheter for the patient,
which is the same as that required for the
predicate device. |
| Technological
Characteristic | Proposed Device | Predicate Device | Substantial Equivalence Assessment of
Modifications |
| | VPS Rhythm® DLX Device with TipTracker™
Technology | VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | |
| Energy Source | - Energy Source: AC/DC power supply [18V 40W]
with removable hospital grade mains power cord.
- Rechargeable internal Lithium-ion battery [11V
74W-hr]. | Similar AC/DC power supply [12V 20W]
with SAME AS PROPOSED DEVICE
removable hospital grade mains power
cord.
Similar rechargeable Lithium-ion battery
[7.2V 63 W-hr]. | Justification for no S&E impact: The
power supply and battery modifications
were tested as part of the system testing
(IEC 60601-1 safety testing) and
demonstrated acceptable results,
supporting that there are no different
concerns of safety or efficacy as a result
of these modifications. |
| Software | Programming environment: Windows-based host
development system comprised of:
a) Visual Studio 2017 running on Windows 10
PC
b) Advantech SOM-6869 single board computer.
c) Azure DevOps cloud-based development
services; including code repository, defect
tracking, code review, continuous integration,
build/configuration management.
Operating Environment: The DLX system
software runs on the Windows 10 IoT Enterprise
2019 LTSC operating system for an X64-based
single board computer. It utilizes the Windows
Presentation Foundation (WPF), .Net and C# to
create the graphical user interface (GUI),
application program interface (API) and both a
remote and a touchscreen interface as the basis for
its human machine interface.
Workflow modifications to minimize the number
of system interactions | Programming environment:
a) QNX 6.4.1 Momentics Development
Platform running on Windows XP or
Linux.
b) Advantech PCM-3353 single board
computer.
c) Perforce P4V source code control
management system.
d) Configuration Management, Issue
Tracking, and Collaboration System
based on Atlassian software
development tools.
Operating Environment: The Rhythm
system software runs on the QNX 6.4.1
real-time operating system for an X86 | Justification for no S&E impact: All
software changes were tested and
evaluated through V&V and Human
Factors testing and demonstrated
acceptable results, supporting that there
are no different concerns of safety or
efficacy as a result of these
modifications. |
| Technological
Characteristic | Proposed Device
VPS Rhythm® DLX Device with TipTracker™
Technology | Predicate Device
VPS Rhythm® Device with Optional
TipTracker™ Technology
(K160925) | Substantial Equivalence Assessment of
Modifications |
| Notifications/
Alerts | Alerts may occur in ECG and Tracking modes, on
the 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 visual
notification of these alerts from the proposed
device. | Justification for no S&E impact:
Although the visual notification may
appear slightly different, all alerts
provided in the predicate device are also
present in the proposed device with
identical functionality and with no
change in procedural workflow to
address the alert messages.
The added Replace coin cell battery alert
would appear only when the system is
initially powered on, resulting in no
difference to procedural workflow and
no change to safety or performance of
the device.
The Ultrasound probe not connected
alert was added only due to the addition
of the optional ultrasound probe
connection and is a simple notice that the
US probe must be connected to use the
Ultrasound feature. There is no different
issue of safety and effectiveness related
to this alert since the use of Ultrasound is
optional. Even if it was not possible to
use the Ultrasound, the catheter
placement procedure using the VPS
Rhythm® DLX device could still be
fully conducted using TipTrackerTM
Technology for catheter tracking and
ECG technology for final tip
placement-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
17
- 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.
-
- 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.
- Conclusion
18
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.