(127 days)
Not Found
No
The description focuses on using physiological signals (blood velocity profile and heart electrical activity) and proprietary software to provide real-time feedback and guiding indicators. There is no mention of AI, ML, deep learning, or any related concepts. The system appears to rely on signal processing and rule-based logic rather than learned patterns from data.
No
The device is described as a "supplemental aid in PICC placement" and provides "real-time catheter tip location information" but does not independently diagnose, treat, or prevent a disease or condition, which are characteristics of a therapeutic device.
No
The device is indicated for "assistance in tip placement of the PICC catheter" and "provides real-time catheter tip location information," which are functions related to guiding a medical procedure rather than diagnosing a condition or disease.
No
The device description explicitly states that the FlowPICC System consists of a Console and a Stylet, and the Console integrates hardware components like a data acquisition system, DAQ cards, and an isolation transformer, in addition to the software.
Based on the provided information, the FlowPICC System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The FlowPICC System is used in vivo (within the living body) to guide the placement of a catheter.
- The intended use is for guiding a medical procedure. The system uses physiological information (blood velocity and heart electrical activity) from the patient during the procedure to assist with catheter tip placement.
- There is no mention of analyzing samples or specimens. The device interacts directly with the patient's body.
The FlowPICC System is a medical device used for real-time guidance during a medical procedure, not for the diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The FlowPICC System 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 information.
Product codes
OBJ
Device Description
The FlowPICC™ 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 Console integrates a data acquisition system, two DAQ cards, an isolation transformer and a PC pre-loaded with proprietary software. The Console, when used as intended, uses a blood velocity profile and heart electrical activity to provide user feedback and guiding indicators for proper PICC catheter tip placement in the caval-atrial junction. The Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify when the catheter is moving towards the heard, moving away from the heart, in the proper location or should be adjusted because there isn't enough information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
caval-atrial junction, 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)
ComboMap (Volcano K041134 SE 6/2/04), Sherlock (Bard K063240 SE 11/21/06)
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
OCT 1 5 2008
510(k) SUMMARY
| Date Prepared | September 3, 2008 |
|---|---|
| Submitted by | VasoNova, Inc. |
| 1368 Bordeaux Drive, Ste 100 | |
| Sunnyvale, CA 94089 | |
| Tel: 650.269.8444 | |
| Contact | Sorin Grunwald, Ph.D., MBA, Chief Technology Officer |
| Proprietary Name | FlowPICCTM Console |
| Classification | 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 FlowPICC™ 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 Console integrates a data acquisition system, two DAQ cards, an isolation transformer and a PC pre-loaded with proprietary software. The Console, when used as intended, uses a blood velocity profile and heart electrical activity to provide user feedback and guiding indicators for proper PICC catheter tip placement in the caval-atrial junction. The Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify when the catheter is moving towards the heard, moving away from the heart, in the proper location or should be adjusted because there isn't enough information.
Intended Use/Indications for Use
The FlowPICC System 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 information.
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 Console has the same intended use and utilizes the same fundamental scientific technology as that of the referenced predicate devices.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
OCT 1 5 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: K081626
Trade/Device Name: FlowPICCTM Console Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 23, 2008 Received: September 24, 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
2
Page 2 - Dr. Sorin Grunwald
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 predicate 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
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Page _ 1 _ of _ 1
510(k) Number (if known): K081626
Device Name:
FlowPICC Console
Indications for use:
The FlowPICC System 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 a 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 information.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the-Counter Use
(per 21 CFR 801.109)
(Division Sign-Off) for BZuckermaa
10/15/08
Division of Cardiovascular Devices
510(k) Number_ K00(626