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.

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.

AI/ML Overview

This FDA 510(k) summary for the FlowPICC™ Stylet (K081625) does not provide details of specific acceptance criteria or a dedicated study demonstrating the device meets those criteria.

The document states: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a general statement and does not include the detailed information requested in your prompt regarding acceptance criteria and a specific study plan.

Based on the provided text, here's what can be inferred and what is not present:

Table of acceptance criteria and reported device performance:
- Not provided. The document does not list any specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) or acceptance thresholds for them.
Sample size used for the test set and data provenance:
- Not provided. The document states "Performance test results" but does not specify the sample size, type of data (e.g., in-vitro, ex-vivo, in-vivo), patients included, or their country of origin. It also doesn't mention if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and qualifications:
- Not provided. There is no mention of a ground truth establishment process, experts, or their qualifications.
Adjudication method for the test set:
- Not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study:
- Not done/reported. The document does not mention any MRMC study or evaluation of human readers with or without AI assistance. The FlowPICC System is described as providing "real-time catheter tip location information" to assist in placement, implying it's a tool for a clinician, but no study is described to quantify this assistance.
Standalone (algorithm only without human-in-the-loop performance) study:
- Not explicitly reported as a separate study with specific metrics. The device's function is to provide real-time information. While this implies a standalone measurement capability, the document doesn't detail a separate "standalone" performance study. The statement about "performance characteristics" is general.
Type of ground truth used:
- Not provided. Since no specific study is detailed, the method for establishing ground truth (e.g., pathology, surgical confirmation, independent imaging) is not mentioned.
Sample size for the training set:
- Not applicable / Not provided. The device is described as using "physiological (cardiac electrical activity and blood flow) information" and "intravascular ultrasound." This suggests a sensor-based system and signal processing, rather than a machine learning model that would typically have a "training set" in the common sense of AI/ML. There's no indication of a training set as would be relevant for an AI model.
How the ground truth for the training set was established:
- Not applicable / Not provided. (See point 8).

Summary of what is present:

Device Description: The FlowPICC System uses a Stylet with a Doppler sensor and an intravascular ECG (ivECG) signal sensing wire connected to a Console to provide real-time catheter tip location information using cardiac electrical activity and blood flow information.
Intended Use: Supplemental aid in PICC placement to assist in tip placement of the PICC catheter.
Performance Data Statement: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a generalized statement of sufficiency for 510(k) clearance, not a detailed study report.
Predicate Devices: ComboMap (Volcano K041134) and Sherlock (Bard K063240) are cited, implying that the "performance test results" likely demonstrated equivalence to these devices based on their established performance.

In conclusion, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study with defined acceptance criteria and its outcomes. It does not contain the specific information requested in your prompt regarding detailed performance studies, ground truth, expert involvement, or sample sizes.

Summary

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SEP 2 6 2008

510(k) Summarv K081625

Date Prepared	September 26, 2008
Submitted by	VasoNova, Inc.1368 Bordeaux Drive, Ste 100Sunnyvale, CA 94089
Contact	Sorin Grunwald, Ph.D., MBA, Chief Technology Officer
Proprietary NameClassification	FlowPICCT™ Stylet, name subject to change870.1200 Class II/880.5970 Class II
Predicates	ComboMap (Volcano K041134 SE 6/2/04)Sherlock (Bard K063240 SE 11/21/06)

Device Description

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.

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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.

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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

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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

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510(k) Indications for Use

Page 1 of 1

510(k) Number (if known): K081625

Device Name:

FlowPICC Stylet

Indications for use:

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)

K081625

(Division 56)
Division of Cardiovascular Devices

510(k) Number K081675

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).