VEIN ENTRY INDICATOR DEVICE (VEID)

K993995 · Vascular Technologies , Ltd. · FMF · Feb 14, 2000 · General Hospital

Device Facts

• Record ID: K993995
• Device Name: VEIN ENTRY INDICATOR DEVICE (VEID)
• Applicant: Vascular Technologies , Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Feb 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

The Vein Entry Indicator Device (VEID) is used to indicate the location of a vein, including indication of vein entry, vein double puncture, vein re-entry and vein exit of an I.V. catheter system needle.

Device Story

Vein Entry Indicator Device (VEID) assists clinicians during I.V. catheterization. Device monitors needle position relative to vein; provides feedback on vein entry, double puncture, re-entry, or exit. Used in clinical settings by healthcare professionals. Output allows clinician to confirm successful venous access or identify complications like through-and-through puncture. Benefits include improved accuracy of catheter placement and reduced risk of failed venipuncture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device functions as an indicator for I.V. catheter needle positioning. Technical specifications, materials, and energy sources are not detailed in the provided documentation.

Indications for Use

Indicated for use as an aid in identifying vein location, vein entry, double puncture, re-entry, and exit during I.V. catheterization procedures.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Vascular Technologies Ltd. c/o Mr. Ahava Stein Regulatory Affairs Consultant for Vascular Technologies Ltd. P.O.B. 454 Ginot Shomron, 44853 ISRAEL

K993995 Re: Vein Entry Indicator Device (VEID) Trade Name: Regulatory Class: II Product Code: FMF Dated: November 16, 1999 Received: November 24, 1999

Dear Mr. Stein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Stein

the Federal_Register. Please note: this response to your ene receet notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

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510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name:

Vein Entry Indicator Device (VEID)

Indications for use:

The Vein Entry Indicator Device (VEID) is used to indicate the location of a vein, including indication of vein entry, vein double puncture, vein re-entry and vein exit of an I.V. catheter system needle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Patricia Cucenile

(Division Sian-Off Division of Dental, Infection Control, and General Hospital De 510(k) Number

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