(262 days)
No
The device description focuses on using the patient's cardiac electrical waveform (ECG) and magnetic tracking for navigation, with interpretation performed by the clinician. There is no mention of AI or ML algorithms for analysis or decision-making.
No
This device is indicated for positioning and confirming the tip placement of central venous catheters, not for treating any specific disease or condition. While it aids in a medical procedure, its primary function is diagnostic/guidance, not therapeutic.
Yes
The device provides catheter tip location information by using the patient's cardiac electrical activity, specifically through the interpretation of changes in the patient's intravascular cardiac ECG waveform morphology. This information is used for confirmation of the final position of the catheter tip, serving as an alternative to radiographic confirmation, which is a diagnostic function.
No
The device description explicitly states it is a "medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components." It also mentions an "electronic monitor with graphical user interface display," "connection cables and accessories," and physical components like the "TipTracker T-piece" and "TipTracker Stylet." Furthermore, the performance studies include testing for electrical safety, electromagnetic compatibility, and physical integrity of components, indicating it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The VPS Rhythm Device works by analyzing the patient's in vivo cardiac electrical activity (ECG) to determine the position of a catheter tip. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for positioning and confirming the placement of central venous catheters using the patient's cardiac electrical activity.
- Device Description: The description focuses on electronic components, cables, and accessories used to display and interpret real-time in vivo ECG waveforms. The optional TipTracker technology uses magnetic fields for navigation, not analysis of biological specimens.
Therefore, the VPS Rhythm Device falls under the category of a medical device used for procedural guidance and confirmation based on physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
Product codes
LJS
Device Description
The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.
With respect to the external and intravascular ECG waveform display functionality, the VPS Rhythm Device with Optional TipTracker Technology is identical to the predicate PICC Tip Positioning Aid (K152261). The subject VPS Rhythm Device incorporates the same monitor with graphical user interface, ECG Patient Cable, ECG snap leads, and ECG Clip Cable accessories as those cleared with the predicate PICC Tip Positioning Aid (K152261). The purpose of this premarket notification is for the introduction of the optional TipTracker Technology and associated components for PICC navigation as well as a clarification of the indications for use from the originally indicated use of ECG for final tip confirmation with PICCs only to use with central venous catheters in general for final catheter tip positioning.
The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.
The TipTracker Stylet is to be provided sterile in a convenience kit for use with PICCs that are geometrically compatible. The TipTracker stylet may be used with PICCs that have a minimum internal distal lumen diameter of 0.018" or catheter sizes from 3-6 French. The TipTracker stylet may also be provided pre-loaded with ARROW PICC in ARROW convenience kits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous catheters (including PICCs) vasculature
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 Device with Optional TipTracker Technology was conducted and included in this premarket notification and the results support substantial equivalence. Testing included:
- IEC 60601-1, 3rd Edition Electrical Safety .
- IEC 60601-1-2, 3rd Edition Electromagnetic Compatibility .
- Software Verification and Validation Testing
- · TipTracker Stylet Performance and Physical Integrity (after 1 year aging)
- Tensile Strength
- Flexural Integrity (ISO 11070)
- Insertion and Withdrawal Force
- Holding Force and Leak Resistance
- Electrical Impedance and Voltage Feedback Testing
- Corrosion Testing (ISO 11070)
- PICC compatibility with TipTracker Stylet
- TipTracker Stylet particulate Testing
- . Sterile barrier package testing per ASTM F2096
- · Sterilization residuals per ISO 10993-7
- · Biocompatibility: According to the requirements identified in ISO 10993-1, biocompatibility testing on the patient contacting devices subject to this premarket notification is included. Testing was conducted for the assessment of cvtotoxicity (ISO 10993-5), hemocompatibility (ISO 10993-4), sensitization and irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11).
- · Human Factors: A human factors study assessing the usability of the subject VPS Rhythm Device with Optional TipTracker Technology was conducted. The study utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria.
The results of the human factors study were compiled and assessed in accordance with CDRH guidance, Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff (February 3, 2016) as well as with IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices.
Clinical Performance Data:
No human clinical data was provided to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Arrow International, Inc. (a Subsidiary of Teleflex, Inc.) Christine Ford Senior Regulatory Affairs Manager 2400 Bernville Rd. Reading, Pennsylvania 19605
Re: K160925
Trade/Device Name: VPS Rhythm™ Device with Optional TipTracker™ Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 22, 2016 Received: November 28, 2016
Dear Christine Ford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image contains a signature of a person named Tina Kiang. The signature is written in black ink and is located in the upper right corner of the image. There is also a symbol that looks like an infinity sign to the left of the name. The text "-s" is located below the name.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160925
Device Name
VPS Rhythm™ Device with Optional TipTracker™ Technology
Indications for Use (Describe)
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 6. 510(k) SUMMARY VPS Rhythm Device with Optional TipTracker Technology
- Applicant Information:
Arrow International (a subsidiary of Teleflex, Inc.) 2400 Bernville Rd. Reading, PA 19605
Contact Person: Christine Ford Telephone Number: (610) 378-0131, ext. 603338 Fax Number: (610) 478-3179 Date Prepared: 22-NOV-2016
-
- Device Name:
- Proprietary Name: VPS Rhythm Device with Optional TipTracker Technology
- Common Name: Central catheter placement accessory ●
- Classification Name: Percutaneous, implanted long-term intravascular catheter. ●
- CFR Number: 21 CFR 880.5970 ●
- Device Class: II
- Product Code: LJS (Catheter, Intravascular, long-term greater than 30 Days) ●
3. Predicate and Reference Device(s):
| Predicate or Reference Device Name | 510(k) | Original Applicant Name |
|---|---|---|
| PICC Tip Positioning Aid | K152261 | Nostix LLC |
| Sherlock 3CG™ Tip Confirmation System | K140345 | Bard Access Systems, Inc. |
| Nautilus Delta | K141634 | Romedex |
4. Description of Device:
The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.
4
With respect to the external and intravascular ECG waveform display functionality, the VPS Rhythm Device with Optional TipTracker Technology is identical to the predicate PICC Tip Positioning Aid (K152261). The subject VPS Rhythm Device incorporates the same monitor with graphical user interface, ECG Patient Cable, ECG snap leads, and ECG Clip Cable accessories as those cleared with the predicate PICC Tip Positioning Aid (K152261). The purpose of this premarket notification is for the introduction of the optional TipTracker Technology and associated components for PICC navigation as well as a clarification of the indications for use from the originally indicated use of ECG for final tip confirmation with PICCs only to use with central venous catheters in general for final catheter tip positioning.
The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.
The TipTracker Stylet is to be provided sterile in a convenience kit for use with PICCs that are geometrically compatible. The TipTracker stylet may be used with PICCs that have a minimum internal distal lumen diameter of 0.018" or catheter sizes from 3-6 French. The TipTracker stylet may also be provided pre-loaded with ARROW PICC in ARROW convenience kits.
5. Indications for Use:
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the Pwave including:
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
5
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
6. Substantial Equivalence
Intended Use / Indications for Use:
The subject VPS Rhythm Device with Optional TipTracker Technology has the same intended use as the predicate device. The subject and predicate device are intended to display the patient's external and intravascular ECG waveforms in order to allow the clinician to interpret changes in the patient's intravascular P-wave morphology as a central catheter is inserted through the vasculature towards the heart.
The indications for use of the subject device are identical (with the exception of the reference to central catheter type) to those of the predicate PICC Tip Positioning Aid (K152261) and similar to the reference device Sherlock 3CGTM Tip Confirmation System (K140345). The indications for use are similar to the Romedex Nautilus Delta (K141634) reference device in regards to placement of central venous access devices. All of the devices are indicated for providing real-time central catheter tip location information by using the patient's cardiac electrical activity as well as for use as an alternative method to chest x-ray or fluoroscopy confirmation of catheter tip placement.
Technological Characteristics:
The subject VPS Rhythm Device with Optional TipTracker Technology incorporates the fundamental technology as the predicate and reference devices. The subject same device as well as the predicate PICC Tip Positioning Aid (K152261) and the reference Sherlock 3CGTM Tip Confirmation System (K140345) incorporate electronic circuitry and software algorithms to acquire and display the patient's intravascular and external ECG waveforms in order to facilitate the confirmation of final central catheter tip placement as an alternative method to chest x-ray or fluoroscopy. Similarly, the reference Romedex Nautilus Delta (K141634) includes a patient module with integrated remote control for ECG data acquisition and processing; data is sent to a mobile platform via wireless (Bluetooth) technology for visualization of the patient's ECG information.
The subject VPS Rhythm Device with Optional TipTracker Technology and the predicate PICC Tip Positioning Aid (K152261) and the reference Sherlock 3CG Tip Confirmation System (K140345) include touch-screen graphical user interface displays; include remote control capability, and reusable components which facilitate the display of the patient ECG information. Similarly, the reference Romedex Nautilus Delta (K141634) includes an integrated remote control for ECG data acquisition and processing; the ECG data is sent to a mobile platform via wireless (Bluetooth) technology where it is displayed.
The subject VPS Rhythm Device with Optional TipTracker Technology and the reference Sherlock 3CG Tip Confirmation System (K140345) also include catheter insertion visualization in which magnetic field-based technology is utilized to allow the display of the relative position of the catheter's tip as it is inserted by the clinician. Both the
6
subject device and the reference Sherlock 3CG device (K140345) utilize a reusable accessory component which is placed on the patient's chest and a sterile, single-use stylet which is assembled with the catheter in order to facilitate the catheter tracking feature.
Table 6.1 summarizes the substantial equivalence comparison of the subject VPS Rhythm Device with Optional TipTracker Technology with the predicate and reference devices.
7
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| VPS Rhythm Device with | |||
| Optional TipTracker | |||
| Technology | PICC Tip Positioning Aid | ||
| (K152261) | Sherlock 3CGTM | ||
| Tip Confirmation System | |||
| (K140345) | |||
| Indications for Use: | Indications for Use: | Indications for Use: | Indications for Use: |
| The VPS Rhythm Device is | |||
| indicated for the positioning of | |||
| central venous catheters | |||
| including PICCs. It provides | |||
| catheter tip location information | |||
| by using the patient's cardiac | |||
| electrical activity. The VPS | |||
| Rhythm Device is indicated for | |||
| use as an alternative method to | |||
| chest x-ray or fluoroscopy for | The PICC Tip Positioning Aid | ||
| is indicated for the positioning | |||
| of peripherally inserted central | |||
| catheters (PICCs) in adult | |||
| patients. It provides real-time | |||
| catheter tip location | |||
| information by using the | |||
| patient's cardiac electrical | |||
| activity. The PICC Tip | |||
| Positioning Aid is indicated for | The Sherlock 3CG Tip | ||
| Confirmation System (TCS) is | |||
| indicated for guidance and | |||
| positioning of Peripherally | |||
| Inserted Central Catheters | |||
| (PICCs). The Sherlock 3CG | |||
| TCS provides real-time PICC tip | |||
| location information by using | |||
| passive magnet tracking and the | |||
| patient's cardiac electrical | Indications for Use: | ||
| Navigational guidance for | |||
| navigating the peripheral | |||
| venous system and for | |||
| leasing the catheter tip. It | |||
| provides real-time PICC tip | |||
| information by using the | |||
| cardiac electrical signal as an | |||
| indicator. It is an alternative | |||
| method to chest x-ray or | |||
| for |
Table 6.1 – Substantial Equivalence Comparison Summary
| Indications for Use: | Indications for Use: | Indications for Use: | Indications for Use: |
|---|---|---|---|
| The VPS Rhythm Device is | |||
| indicated for the positioning of | |||
| central venous catheters | |||
| including PICCs. It provides | |||
| catheter tip location information | |||
| by using the patient's cardiac | |||
| electrical activity. The VPS | |||
| Rhythm Device is indicated for | |||
| use as an alternative method to | |||
| chest x-ray or fluoroscopy for | |||
| confirmation of central venous | |||
| catheter tip placement in adult | |||
| patients. The TipTracker | |||
| Technology is an optional | |||
| accessory for use with the VPS | |||
| Rhythm Device, indicated for | |||
| visual navigation of a | |||
| peripherally-inserted central | |||
| catheter (PICC) as it is inserted | |||
| through the vasculature. The | |||
| TipTracker technology is used | |||
| for catheter tip navigation | |||
| purposes only; it is not used to | |||
| determine final catheter tip | |||
| placement. Note: In general, | |||
| devices that utilize ECG | |||
| technique to | The PICC Tip Positioning Aid | ||
| is indicated for the positioning | |||
| of peripherally inserted central | |||
| catheters (PICCs) in adult | |||
| patients. It provides real-time | |||
| catheter tip location | |||
| information by using the | |||
| patient's cardiac electrical | |||
| activity. The PICC Tip | |||
| Positioning Aid is indicated for | |||
| use as an alternative method to | |||
| chest x-ray or fluoroscopy | |||
| confirmation of PICC tip | |||
| placement in adult patients. | |||
| 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 | The Sherlock 3CG Tip
Confirmation System (TCS) is
indicated for guidance and
positioning of Peripherally
Inserted Central Catheters
(PICCs). The Sherlock 3CG
TCS provides real-time PICC tip
location information by using
passive magnet tracking and the
patient's cardiac electrical
activity (ECG). When relying on
patient's ECG signal, the
Sherlock 3CG TCS is indicated
for use as an alternative method
to chest X-ray and fluoroscopy
for PICC tip placement
confirmation in adult patients.
Limiting, but not contraindicated
situations for this technique are
in patients where alterations of
cardiac rhythm change the
presentation of the P-wave as in
atrial fibrillation, atrial flutter,
severe tachycardia, and
pacemaker driven rhythm. In
such patients, who are easily | Nautilus Delta is indicated for
navigation and positioning of central
venous access devices (CVADs) of at
least 3 Fr in size. Nautilus Delta
provides real-time catheter tip location
information by using the patient's
cardiac electrical activity and is
indicated for use as an alternative
method to chest X-ray and fluoroscopy
for CVAD tip placement confirmation.
In adult patients and in adolescents
(greater than 12 through 21 years of
age), Nautilus Delta can be used with
CVADs such as peripherally inserted
central catheters (PICCs), central
venous catheters (CVCs), implantable
ports, and hemodialysis catheters; in
children (greater than 2 to 12 years of
age), Nautilus Delta can be used with
PICCs and with centrally inserted
central catheters (CICCs); in infants
(greater than 1 month to 2 years of
age) and in neonates (from birth to 1
month of age), Nautilus Delta can be
used with CICCs.
In each specific age group, the CVAD |
Reference Device
Romedex Nautilus Delta (K141634)
8
| Proposed Device | Predicate Device | Reference Device | Reference Device |
|---|---|---|---|
| VPS Rhythm Device with | PICC Tip Positioning Aid | ||
| (K152261) | Sherlock 3CGTM | ||
| Tip Confirmation System | |||
| (K140345) | Romedex Nautilus | ||
| Delta (K141634) | |||
| observe P-wave are limited, but | |||
| not contraindicated, for patients | |||
| where cardiac rhythms may | |||
| change presentation of the P- | |||
| wave; including |
- Atrial flutter
- Atrial fibrillation
- 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. | pulmonary disease (COPD)
Such patients are easily
identified prior to central
catheter insertion. Use of an
additional confirmation method
is necessary to confirm catheter
tip location. | identifiable prior to catheter
insertion, the use of an
additional method is required
to confirm PICC tip location. | type and size must be chosen and the
CVAD must be used according to the
CVAD's indications and instructions
for use.
Limiting but not contraindicated
situations for this method are in
patients where alterations of cardiac
rhythm change the presentation of the
P wave as in atrial fibrillation, atrial
flutter, severe tachycardia, and
pacemaker driven rhythm. In such
patients, who are easily identifiable
prior to central venous catheter
insertion, the use of an additional
method is required to confirm catheter
tip location. |
| System Features and Components | | | |
| Monitor with touch screen
graphical user interface. | Monitor with touch screen
graphical user interface. | Monitor with touch screen
graphical user interface. | Mobile medical software
application running on a mobile
platform which is used for display of
surface and intracavitary ECG |
| Functionality for storage of
insertion case information and
subsequent printing by a USB
printer. | Functionality for storage of
insertion case information and
subsequent printing by a USB
printer. | Functionality for storage of
insertion case information and
subsequent printing by a USB
printer. | Storage of data is on the on the mobile
platform. The mobile application can
send the data to a user-supplied
Bluetooth printer. |
| Remote Control for clinician-
inserter input and selection of
display options. | Remote Control for clinician-
inserter input and selection of
display options. | Remote control for clinician
input and selection of display
options. | Patient module (ECG data acquisition
and processing with integrated remote
control); data is sent to a mobile
platform via wireless (Bluetooth) |
| Proposed Device | Predicate Device | Reference Device | Reference Device |
| VPS Rhythm Device with
Optional TipTracker
Technology | PICC Tip Positioning Aid
(K152261) | Sherlock 3CGTM
Tip Confirmation
System (K140345) | Romedex Nautilus
Delta (K141634) |
| | | | technology. |
| TipTracker stylet for assembly
with central venous catheter to
allow visualization of
catheter's insertion track and
direction relative to the
TipTracker T-piece magnetic
emitter array.
Stylet Design:
Stylet Outer diameter: 0.015"
Stylet Overall length : 29.5"
(75 cm)
Min. catheter lumen diameter
compatibility: .018" (3-6
French catheters
Sterile, single-use. | N/A | Sherlock 3CG stylet for
assembly with central catheter to
allow visualization of catheter's
tip location and direction
relative to the Sherlock 3CG
magnetic field sensor.
Stylet Design:
Stylet Outer diameter: 0.019"
Stylet Overall length : 78.5 cm
Min. catheter lumen diameter
compatibility: .020"
Sterile, single-use. | N/A |
| TipTracker T-piece magnetic
emitter array placed on
patient's chest during catheter
insertion.
Facilitates passively-induced
signal in TipTracker stylet's
coiled tip when stylet
(assembled with inserted
catheter) enters the low power
magnetic field. | N/A | 3CG magnetic sensor placed on
patient's chest during catheter
insertion. Senses the permanent
magnet in the 3CGTM stylet's tip
(assembled with inserted
catheter) when the inserted
catheter is within sensing range. | N/A
(this predicate supports only the use of
the device's ECG technology for
placement of CVADs, not catheter
navigation) |
| Energy Source:
-AC/DC power supply with
removable hospital grade
mains power cord - Rechargeable internal | Energy Source:
-AC/DC power supply with
removable hospital grade mains
power cord - Rechargeable internal | Energy Source:
-AC/DC power supply with
hospital grade mains power cord - Rechargeable internal battery | Energy Source:
- patient module: lithium polymer
battery with USB cable for charging
As determined by host device (mobile |
| Proposed Device | Predicate Device | Reference Device | Reference Device |
| VPS Rhythm Device with
Optional TipTracker
Technology | PICC Tip Positioning Aid
(K152261) | Sherlock 3CGTM
Tip Confirmation
System (K140345) | Romedex Nautilus
Delta (K141634) |
| Lithium-ion battery | Lithium-ion battery | | platform) such as tablet/smartphone” |
| Sterile accessory convenience
kits:
Will include sterile
convenience kits.
• VPS Rhythm ECG
Accessory Pack: Contains
ECG clip cable, Remote
Control cover, and
commercially available
ARROW-Johans ECG
adapter.
VPS TipTracker Stylet
Accessory kit: Contains
TipTracker stylet and Remote
Control cover in sterile portion
of kit. Contains T-piece cover
and commercially available
ECG surface electrodes in
non-sterile portion of kit. | N/A | N/A | N/A |
9
10
11
7. Non-Clinical Performance Data
Testing verifying the performance requirements of the subject VPS Rhythm Device with Optional TipTracker Technology was conducted and included in this premarket notification and the results support substantial equivalence. Testing included:
- IEC 60601-1, 3rd Edition Electrical Safety .
- IEC 60601-1-2, 3rd Edition Electromagnetic Compatibility .
- Software Verification and Validation Testing
- · TipTracker Stylet Performance and Physical Integrity (after 1 year aging)
- Tensile Strength
- Flexural Integrity (ISO 11070)
- Insertion and Withdrawal Force
- Holding Force and Leak Resistance
- Electrical Impedance and Voltage Feedback Testing
- Corrosion Testing (ISO 11070)
- PICC compatibility with TipTracker Stylet
- TipTracker Stylet particulate Testing
- . Sterile barrier package testing per ASTM F2096
- · Sterilization residuals per ISO 10993-7
- · Biocompatibility: According to the requirements identified in ISO 10993-1, biocompatibility testing on the patient contacting devices subject to this premarket notification is included. Testing was conducted for the assessment of cvtotoxicity (ISO 10993-5), hemocompatibility (ISO 10993-4), sensitization and irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11).
- · Human Factors: A human factors study assessing the usability of the subject VPS Rhythm Device with Optional TipTracker Technology was conducted. The study utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria.
The results of the human factors study were compiled and assessed in accordance with CDRH guidance, Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff (February 3, 2016) as well as with IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices.
8. Clinical Performance Data
No human clinical data was provided to support substantial equivalence.
9. Conclusion Regarding Substantial Equivalence
The information included in this premarket notification supports the substantial equivalence of the subject VPS Rhythm Device with Optional TipTracker Technology to the stated predicate device. The listed reference devices provided substantial equivalence support for the catheter tracking portion of the device and the indications for use with central venous catheters for final tip confirmation using ECG technology. The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate device and the reference devices to which it was compared.
12
Performance and biocompatibility data were included to verify the performance of the subject device against its physical design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.