(108 days)
Not Found
No
The description focuses on real-time physiological signal processing (ECG and ultrasound) for tip location, without mentioning any learning or adaptive algorithms characteristic of AI/ML.
No.
The device is indicated for use as a supplemental aid in PICC placement and provides real-time catheter tip location information, assisting in the procedure rather than directly treating a condition or disease.
No
The device is indicated as a "supplemental aid in PICC placement" and provides "real-time catheter tip location information," which are functionalities for guiding a medical procedure rather than diagnosing a disease or condition. While it uses physiological information, its primary purpose is procedural assistance, not diagnosis.
No
The device description explicitly details hardware components (Console and Stylet) which are integral to the device's function, including a Doppler sensor and ivECG signal sensing wire within the Stylet.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- FlowPICC System Function: The FlowPICC System is used during a medical procedure (PICC placement) to provide real-time information about the catheter tip location within the patient's vasculature. It uses physiological signals (cardiac electrical activity and blood flow) and intravascular ultrasound.
- No Specimen Examination: The device does not collect, prepare, or examine specimens taken from the body. It interacts directly with the patient's internal environment during the procedure.
Therefore, the FlowPICC System falls under the category of a medical device used for guiding a procedure, rather than an in vitro diagnostic device used for analyzing specimens.
N/A
Intended Use / Indications for Use
The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.
Product codes
OBJ
Device Description
The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound
Anatomical Site
Patient's vasculature
Indicated Patient Age Range
Not Found
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)
Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 6 2008
510(k) Summarv K081625
| Date Prepared | September 26, 2008 |
|---|---|
| Submitted by | VasoNova, Inc. |
| 1368 Bordeaux Drive, Ste 100 | |
| Sunnyvale, CA 94089 | |
| Contact | Sorin Grunwald, Ph.D., MBA, Chief Technology Officer |
| Proprietary Name | |
| Classification | FlowPICCT™ Stylet, name subject to change |
| 870.1200 Class II/880.5970 Class II | |
| Predicates | ComboMap (Volcano K041134 SE 6/2/04) |
| Sherlock (Bard K063240 SE 11/21/06) |
Device Description
The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.
Intended Use
The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICCTM Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.
1
Performance Data
Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices.
Conclusion
The FlowPICC Stylet has the same intended use and utilizes the same fundamental scientific technology as that of the referenced predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VasoNova, Inc. c/o Sorin Grunwald, PhD, MBA Chief Technology Officer 1368 Bordeaux Drive, Ste. 100 Sunnyvale, CA 94089
Re: K081625
Trade/Device Name: FlowPICCTM Stylet Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: August 29, 2008 Received: September 2, 2008
Dear Dr. Grunwald:
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 such 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
3
Page 2 - Sorin Grunwald, PhD, MBA
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Indications for Use
Page 1 of 1
510(k) Number (if known): K081625
Device Name:
FlowPICC Stylet
Indications for use:
The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
(Division 56)
Division of Cardiovascular Devices
510(k) Number K081675