(107 days)
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, 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 bullseye, 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.
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 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. 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 VSP Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.
Here's a breakdown of the acceptance criteria and study information for the VasoNova™ Vascular Positioning System™ (VPS™ System) Stylet, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy of PICC Tip Placement | Correct indication of proper PICC tip placement for a high percentage of procedures (implied by "alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation"). | 98.4% of placement procedures correctly indicated proper PICC tip placement. |
Note: The document explicitly states "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures". While not framed as a 'pre-defined' acceptance criterion with a specific numerical threshold like ">= 95%", the achievement of 98.4% is presented as the performance demonstrating effectiveness for its intended use as an alternative to imaging.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 77 patients
- Data Provenance: The study was a "prospective, single-armed, open design study clinical study." The country of origin of the data is not explicitly stated, but the submission is to the US FDA, implying it could be US-based or an international study accepted by the FDA. Given the company's address is in Menlo Park, CA, a US origin is likely.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. The document does not detail how the ground truth for "proper PICC tip placement" was established for the 77 patients in the clinical study. It is implied that post-procedure confirmation (likely via chest x-ray or fluoroscopy, which the device aims to replace) would serve as ground truth, but the specifics of who performed this assessment are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text. As the method for establishing ground truth isn't detailed, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical study described is a "single-armed" study, focusing on the performance of the VPS System itself, not a comparison involving multiple human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical study performed appears to be a standalone performance study of the device. The text states, "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures," implying the system's output (the "blue bullseye" guidance indicator) was assessed against the actual tip placement. While a human uses the device, the 98.4% figure reflects the system's ability to accurately guide/indicate.
7. The Type of Ground Truth Used
The type of ground truth used is not explicitly stated but is strongly implied to be the actual physical location of the catheter tip as determined by a "gold standard" method after the procedure. The device is intended as "an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation." Therefore, the ground truth for assessing the device's accuracy would logically be derived from these post-placement imaging modalities.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is typical for a device like this, which likely relies on physiological signal processing and established anatomical/physiological principles rather than machine learning models trained on vast datasets in the same way an AI imaging algorithm would.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As no training set is discussed, the method for establishing its ground truth is also not mentioned.
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KIP3522 6/14
5.0 Traditional 510(k) Summary
FEB 18 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | VasoNova, Inc. |
| Address | 155 Jefferson Drive, Suite 100Menlo Park, CA 94025 |
| Phone number | 650.388.5605 |
| Fax number | 650.388.5611 |
| EstablishmentRegistrationNumber | 3006795936 |
| Name of contactperson | Kim Tompkins, RN, MBA |
| Date prepared | October 27, 2010 |
| Name of device | |
| Trade or proprietaryname | Vascular Positioning System™ (VPS™ System) Stylet |
| Common or usualname | Catheter, Ultrasound, Intravascular |
| Classification name | Class II |
| Classification panel | Cardiovascular |
| Regulation | 21 CFR §870.1200 |
| Product Code(s) | OBJ |
| Legally marketeddevice(s) to whichequivalence is claimed | FlowPICC Stylet (K081625)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 integratedsoftware-driven components: a data acquisition module;and a PC with processing and display capabilities. | |
| The VPS Stylet is a polyimide tube containing a Dopplersensor on a coax cable and an intravascularelectrocardiogram (ivECG) signal sensing stainless steelwire. The Doppler sensor and the exposed portion of theivECG are located at the distal end of the stylet and areused to detect and transmit physiological information tothe VPS Console for analysis. The proximal endcontains a connector to the VPS Console or to anextension cable that in turn connects to the VPSConsole. The stylet can be inserted and removed fromany catheter with a luminal diameter of at least 0.021inches. | |
| The data acquisition module of the console transmitsand receives ultrasound data while receiving electricalsignals from the heart through sensors mounted at thetip of the VSP Stylet. Using signals gathered by the dataacquisition module, the graphical user interface of thePC provides the user with guidance for tip positioning. | |
| Intended use of thedevice | The intended use of the VPS Stylet and Console (VPSSystem) is to quickly and accurately guide marketavailable peripherally inserted central catheters (PICCs)to the goal location which is the cavo-atrial junction nearthe sino-atrial node. |
| Indications for use | The VPS Stylet and Console are indicated for guidance andtip positioning for central venous catheters. The Styletprovides stiffness for use in placement of the catheter,intravascular capability for ECG detection and recordingand intravascular ultrasound for catheter guiding andpositioning. The VPS Stylet, when used with the VPSConsole, provides real-time catheter tip location informationby using the patient's physiological (cardiac electricalactivity and blood flow) information. When the VPS Systemguidance indicator shows a blue bullseye, the catheter tip isin the desired location. The VPS System is indicated foruse as an alternative method to fluoroscopy or chest x-rayfor central venous catheter tip placement confirmation inadult patients. |
| Limiting but not contraindicated situations for this techniqueare in patients where alterations of cardiac rhythm changethe presentation of the P-wave as in atrial fibrillation, atrialflutter, severe tachycardia and pacemaker-driven rhythm,and in central venous catheterization procedures performedthrough femoral or saphenous vein access which changethe presentation of the P-wave. In such patients, who areeasily identifiable prior to central venous catheter insertion,the use of an additional method is required to confirmcatheter tip location. | |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICECOMPARED TO THE PREDICATE DEVICE | ||
|---|---|---|
| Characteristic | New Device | Predicate |
| Materials, design | 6 foot long polymeric tubewhich contains a Dopplersensor at the distal tip and anintravascularelectrocardiogram (ivECG)signal sensing wire. | Identical (FlowPICC,K081625) |
| Intended Use | When the VPS Systemguidance indicator shows ablue bull's-eye, the catheter tipis in the desired location. TheVPS System is indicated foruse as an alternative methodto fluoroscopy or chest x-rayfor central venous catheter tipplacement confirmation in adultpatients. | Sapiens™ TLS isindicated for use as analternative method tochest X-ray or fluoroscopyfor central venouscatheter tip placementconfirmation in adultpatients. (Sapiens TLS,K093775) |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATIONOF SUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Performance Testing: | Tensile strength, torque strength,tip flexibility, cathetercompatibility and electrical safetytesting were performed on theVPS Stylet | Met allspecifications |
| Biocompatibility Testing | Cytotoxicity: ISO Elution Test(MEM extract), Cytotoxicity: ISODirect Contact, Cytotoxicity: ISOAgar Diffusion Test, Murine LocalLymph Node Assay, Hemolysis,Partial Thromboplastin Test,Intracutaneous (intradermal)Reactivity Test (ISO), Acutesystemic toxicity test, AmesMutagenicity Test, ProthrombinTime Test, Thrombogenicitystudy in Dogs (ISO), ISO implanttest (7 days), ISO implant test(90 days) | Compliant with ISO10993-1:2003 |
| Sterilization and Shelf-lifeTesting: | Sterilization validation and EtOResiduals testing per ANSI-AAMI-ISO 11135-1:1994 -Sterilization Validation. Shelf-lifetesting to 24 months has beenperformed. | Passed |
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| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | New Device | PredicateDevice(s) |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | Same | ||
| ECG | Same | ||
| Ultrasound | Same (FlowPICC,only) |
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 study clinical study of 77 patients.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The VPS Stylet is identical in design and materials to the FlowPICC Stylet (K081625) and has been clinically demonstrated to be substantially equivalent to the Sapiens™ TLS Tip Location System (K093775) with regard to intended use.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 18 201
Re: K103255
Trade/Device Name: Vascular Positioning System™ (VPSTM) Stylet 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 2, 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 country of the county of the county of the county of
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Page 2 – Ms. Kim Tompkins
Enclosure
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 lisung (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/ucm115809.hypn1 for 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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.
Sincerely vours.
W. Mcd
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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4.0 Indications for Use Statement
| 510(k) Number: | To be determined |
|---|---|
| Device Name: | VasoNova™ Vascular Positioning System™ (VPS™ System)Stylet |
| Intended Use: | The VPS Stylet and Console are indicated for guidance and tippositioning for central venous catheters. The Stylet provides stiffness foruse in placement of the catheter, intravascular capability for ECGdetection and recording and intravascular ultrasound for catheter guidingand positioning. The VPS Stylet, when used with the VPS Console,provides real-time catheter tip location information by using the patient'sphysiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, 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 andpacemaker-driven rhythm, and in central venous catheterizationprocedures performed through femoral or saphenous vein access whichchange the presentation of the P-wave. In such patients, who are easilyidentifiable 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.M.D.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103253
§ 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).