(106 days)
Not Found
No
The description focuses on processing physiological signals (cardiac electrical activity and blood flow) using a data acquisition module and PC with processing and display capabilities. There is no mention of AI, ML, or related concepts like training/test sets, which would be expected if such technologies were used for signal analysis or guidance.
No
The device is used for guiding and positioning central venous catheters, which is a diagnostic or procedural aid function, not a therapeutic intervention itself.
Yes
The device provides real-time catheter tip location information using the patient's physiological data and is intended for use as an alternative method to confirm central venous catheter tip placement, which is a diagnostic function.
No
The device description explicitly states that the VPS System consists of both a VPS Console and a VPS Stylet, which are hardware components. The console includes a data acquisition module and a PC, and the stylet contains a Doppler sensor and an ivECG wire.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- This Device's Function: The VPS System works by using sensors inside the patient's body (intravascular) to detect physiological signals (cardiac electrical activity and blood flow). It provides real-time guidance for catheter placement during a medical procedure.
The device is used in vivo (within the living body) to guide a medical procedure, not to perform diagnostic testing on a sample taken from the body.
N/A
Intended Use / Indications for Use
The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately.guide market available peripherally inserted central catheters (PICCs) to the goal location which is the lower third of the SVC or at the cavo-atrial junction.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter 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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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.
Product codes (comma separated list FDA assigned to the subject device)
OBJ
Device Description
The VPS System consists of a VPS Console and VPS Stylet.
The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.
The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
SVC or at the cavo-atrial junction (for PICC placement). Central venous catheters.
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
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)
Clinical Performance Data/Information.
The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures in a prospective, single-armed, open design clinical study of 77 patients.
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.
FlowPICC Console (K081626), Sapiens™ Tip Location System (TLS) (K093775)
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.
Not Found
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K103260 P1/3
FEB 1 8 2011
Traditional 510(k) Summary 5.0
| Submitter Information | |
|---|---|
| Name | VasoNova, Incorporated |
| Address | 155 Jefferson Drive, Suite 100 |
| Menlo Park, CA 94025 | |
| Phone number | (650) 388-5605 |
| Fax number | (650) 388-5611 |
| Establishment | |
| Registration | |
| Number | 3006795936 |
| Name of contact | |
| person | Kim Tompkins, RN, MBA |
| Date prepared | October 29, 2010 |
| Name of device | |
| Trade or | |
| proprietary name | Vascular Positioning System™ (VPS™ System) Console |
| Common or usual | |
| name | Catheter, Ultrasound, Intravascular |
| Classification name | Diagnostic intravascular catheter, Class II |
| Classification panel | Cardiovascular |
| Regulation | 21 CFR §870.1200 |
| Product Code(s) | OBJ |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | FlowPICC Console (K081626) |
| Sapiens™ Tip Location System (TLS) (K093775) | |
| Reason for 510(k) | |
| submission | Expanded labeling |
| Device description | The VPS System consists of a VPS Console and VPS Stylet. |
| The VPS Console consists of two key integrated software-driven | |
| components: a data acquisition module; and a PC with processing | |
| and display capabilities. The data acquisition module of the console | |
| transmits and receives ultrasound data while receiving electrical | |
| signals from the heart through sensors mounted at the tip of the VPS | |
| Stylet. Using signals gathered by the data acquisition module, the | |
| graphical user interface of the PC provides the user with guidance for | |
| tip positioning. | |
| The VPS Stylet is a polyimide tube containing a Doppler sensor on a | |
| coax cable and an intravascular electrocardiogram (ivECG) signal | |
| sensing stainless steel wire. The Doppler sensor and the exposed | |
| portion of the ivECG are located at the distal end of the stylet and are | |
| used to detect and transmit physiological information to the VPS | |
| Console for analysis. The proximal end contains a connector to the | |
| VPS Console or to an extension cable that in turn connects to the | |
| VPS Console. The stylet can be inserted and removed from any | |
| catheter with a luminal diameter of at least 0.021 inches. |
1
| Intended use of the device | The intended use of the VPS Stylet and Console (VPS System) is to
quickly and accurately.guide market available peripherally inserted
central catheters (PICCs) to the goal location which is the lower third
of the SVC or at the cavo-atrial junction. | | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The VPS Stylet and Console are indicated for guidance and tip
positioning for central venous catheters. The Console is intended
for use with the stylet supplied by VasoNova. The VPS System
consists of a Console and associated power supply and cabling and
a stylet. The VPS Console, when used with the VPS Stylet, provides
real-time catheter tip location information by using the patient's
physiological (cardiac electrical activity and blood flow) information.
When the VPS System guidance indicator shows a blue bull's-eye,
the catheter tip is in the desired location. The VPS System is
indicated for use as an alternative method to fluoroscopy or chest x-
ray for central venous catheter 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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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. | | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE
DEVICE | | | |
| Characteristic | VPS Console | FlowPICC Console
(K081626) | Sapiens TLS
(K093775) |
| Guidance indicator | Colored icons, waveform
data | Colored icons, waveform
data | Waveform data |
| Guidance signal type(s) | ivECG, Doppler
ultrasound | ivECG, Doppler
ultrasound | ivECG |
| Signal Conductor | Two conductor stylet
wires | Two conductor stylet
wires | Saline column via saline
adapter or
commercially-available
(unspecified)
conducting stylet or
guidewire via electrical
adapter |
| Acoustic Output | One setting; not
controlled by the user | One setting; not
controlled by the user | N/A |
| Method of Use | Percutaneous
Intravascular | Percutaneous
Intravascular | Percutaneous
Intravascular |
| User Interface | PC-based system with
keyboard and touch
screen and mouse | PC-based system with
keyboard and touch
screen and mouse | PC-based system with
keyboard and mouse |
2
| PERFORMANCE DATA | ||
|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device: | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Electromagnetic | ||
| Compatibility | IEC 60601-2:2007 | Compliant |
| Electrical Safety and | ||
| Acoustic Safety | IEC 60601-1:1988 + A1:1991; A2:1995 | |
| IEC 60601-1-4:1996 + A1:1999 (Cons. Ed 1.1) | ||
| IEC 60601-2-37:2001 +A1:2004; A2:2005 | ||
| VasoNova SOP | Compliant | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR | ||
| OF CLINICAL INFORMATION | ||
| Clinical Performance Data/Information. | ||
| The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement | ||
| procedures in a prospective, single-armed, open design clinical study of 77 patients. | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
The vast similarities of the VPS Console to the VasoNova FlowPICC Console predicate device support the substantial equivalence in intended use, function, and basic composition. The nonclinical testing to voluntary standards and applicable FDA guidance documents provide additional evidence the VPS Console is substantially equivalent to the VasoNova FlowPICC Console predicate device in terms of safety, efficacy, and performance.
The clinical testing of the VPS Console supports the substantial equivalence in indications for use to the Romedex Sapiens™ TLS predicate device.
The minor differences between the VPS Console and the predicate devices do not raise new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized graphic of three wavy lines above the text. The text is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
VasoNova. Incorporated c/o Ms. Kim Tompkins VP, Regulatory/Clinical Corporate Compliance Officer 155 Jefferson Drive. Suite 100 Menlo Park, CA 94025
FEB 1 8 201
Re: K103260
Trade/Device Name: Vascular Positioning System™ (VPSTM) Console Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: February 1, 2011 Received: February 3, 2011
Dear Ms. Tompkins:
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.
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.
and the country of the country of the county of the county of the county of the county of the county of the count
:
4
Page 2 - Ms. Kim Tompkins
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 lisuing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001 http://www.faor. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 4.0
510(k) Number: To be determined
Device Name: VasoNova™ Vascular Positioning System™ (VPS™ System) Console
- The VPS Stylet and Console are indicated for guidance and tip Intended Use: positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter 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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.W.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103260