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.

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or the details of a study that proves the device meets them. It is a 510(k) summary, which states that "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices," but it does not elaborate on these tests, their criteria, or the results.

Therefore, I cannot populate the requested table or answer most of the questions.

Here's a breakdown of what can be inferred from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified with quantitative metrics in the provided text. The statement "Performance test results support the performance characteristics of the device" is qualitative and lacks detail.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The device is a "Console" that provides "user feedback and guiding indicators," suggesting human interaction, but no MRMC study details are given.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but the nature of the device ("Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify...") implies it's an assisted device, not a standalone diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

In summary, the provided document is a high-level regulatory submission summary and does not contain the detailed performance study information, acceptance criteria, or experimental setup details that would be found in a full scientific study report.

Summary

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OCT 1 5 2008

K081626

510(k) SUMMARY

Date Prepared	September 3, 2008
Submitted by	VasoNova, Inc.1368 Bordeaux Drive, Ste 100Sunnyvale, CA 94089Tel: 650.269.8444
Contact	Sorin Grunwald, Ph.D., MBA, Chief Technology Officer
Proprietary Name	FlowPICCTM Console
Classification	870.1200 Class II880.5970 Class II
Predicates	ComboMap (Volcano K041134 SE 6/2/04)Sherlock (Bard K063240 SE 11/21/06)

Device Description

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.

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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

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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:

(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

Regulation Number and Section

§ 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).