VPS Catheters are indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring and contrast studies. For blood or hyperalimentation delivery, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. Each VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console).

Device Description

The VPS Catheter is designed for use with or without the VPS Console. When sold together, the VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter is sterile, single use, non-pyrogenic and non-toxic.

VPS Catheters are single lumen (3F and 4F) or dual lumen (5F) open-ended central venous access catheters fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 or 55 cm and catheter markings at 1 cm intervals and 5 cm increments. VPS Catheters are packaged sterile with the VPS Stylet in a tray with accessories necessary for a percutaneous micro-introducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper design.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static, burst and dynamic pressure	Not specified	Device "meets all acceptance criteria"
Physical characteristics	Not specified	Device "meets all acceptance criteria"
Flexural fatigue and flexibility	Not specified	Device "meets all acceptance criteria"
Flow rate	Not specified	Device "meets all acceptance criteria"
Tensile and torque strength	Not specified	Device "meets all acceptance criteria"
Freedom from air leakage	Not specified	Device "meets all acceptance criteria"
Priming volume	Not specified	Device "meets all acceptance criteria"
Mechanical hemolysis	Not specified	Device "meets all acceptance criteria"
Collapsibility and elongation	Not specified	Device "meets all acceptance criteria"

Note: The document states that "Previously provided in vivo and in vivo testing demonstrated that the subject device meets all acceptance criteria." However, the specific quantitative acceptance criteria for each test are not detailed in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "in vivo and in vitro testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The performance data section refers to "in vivo and in vitro testing" results, but there is no mention of expert-established ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The performance data focuses on device and material characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the performance tests described (e.g., static pressure, flow rate, tensile strength) would be the objective measurements obtained during the actual physical and mechanical testing of the catheter. This is not explicitly detailed but implied by the nature of the tests. There is no mention of expert consensus, pathology, or outcomes data as a form of ground truth for these specific performance criteria.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical catheter and not an AI/ML algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical catheter and not an AI/ML algorithm.

Summary

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5. 510(k) Summary

Sponsor:	VasoNova Inc.1368 Bordeaux DriveSunnyvale, CA 94089	NOV 1 8 2009
Contact Person:	Kim Tompkins
Phone Number:	408.738.7006
Fax Number:	650.644.2456
Prepared:	June 26, 2009
Trade Name:	VPS Catheter, name subject to change
Common Name:	Percutaneous, implanted, long-term intravascular catheter
Classification:	II
Product Code:	LJS 21 CFR 880.5970
Advisory Panel:	General Hospital
Predicate Devices:	VasoNova VPS Catheter
	Bard Catheter
	Medcomp Catheter

Device Description

Intended Use

VPS catheters are indicated for short or long-term central or peripheral access to the central venous system for intravenous fluid and blood infusions, contrast studies with and without a power injector, central venous pressure monitoring, and blood sampling.

Performance Data

Previously provided in vivo and in vivo testing demonstrated that the subject device meces all acceptance criteria. Completed testing included:

Static, burst and dynamic pressure .
Physical characteristics .
. Flexural fatigue and flexibility
. Flow rate
. Flexural fatigue and flexibility
Tensile and torque strength .
Freedom from air leakage .
. Priming volume
Mechanical hemolysis .
Collapsibility and elongation .

Substantial Equivalence

VasoNova VPS Catheters have the same intended use, technological characteristics and principles of operation as its predicate devices. The subject and predicate catheters are similar in that they are labeled for central or peripheral access, deliver fluid and blood infusions, can be used for contrast studies, are appropriate for CVP monitoring and blood sampling. Previously provided performance data demonstrate that the subject device is as safe and effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Kim Tompkins, RN, MBA Vice President, Regulatory/Quality/Clinical VasoNova Incorporated 1368 Bordeaux Drive, Suite 100 Sunnyvale, California 94089

NOV 1 8 2009

Re: K091924

Trade/Device Name: VasoNova VPS Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 29, 2009 Received: October 30, 2009

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.

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Page - Ms. Tompkins

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 listing (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.htm 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Susan Tanner

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. 510(k) Indications for Use

Page 1 of _1

510(k) Number (if known):

Device Name:

VasoNova VPS Catheter

Indications for use:

X Prescription Use (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antren D. Owen

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Kag 1934 510(k) Number:

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”