VANTAGECATH INTRAVASCULAR CATHETER

K073471 · Advantage Medical Device · FOZ · Apr 30, 2008 · General Hospital

Device Facts

• Record ID: K073471
• Device Name: VANTAGECATH INTRAVASCULAR CATHETER
• Applicant: Advantage Medical Device
• Product Code: FOZ · General Hospital
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The VantageCath™ is an intravascular catheter that allows the health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy. The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle- shielding barrel, the catheter hub and needle assembly components are automatically separated.

Device Story

VantageCath is short-term intravascular catheter; used by healthcare practitioners for blood sampling and IV administration of fluids/medications. Device features integrated needle-shielding mechanism; upon catheter insertion, needle retracts into cylindrical shield; catheter hub and needle assembly automatically separate. Safety feature minimizes accidental needle sticks. Supplied sterile for single use. Clinical benefit includes reduced risk of sharps injury to practitioners.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 and FDA General Program Memorandum #G95-1 to establish safety.

Technological Characteristics

Short-term intravascular catheter; manufactured with conventional medical-grade, biocompatible materials. Features integrated needle-shielding barrel and automatic hub/needle separation mechanism. Supplied sterile for single use.

Indications for Use

Indicated for any patient population requiring intravenous blood sampling or fluid/medication administration, subject to vascular anatomy, infusion solution appropriateness, and therapy duration. Contraindicated if vascular anatomy is inadequate or infusion solution is inappropriate.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• BD Nexiva™ Closed IV Catheter System (K032843)
• BD Insyte™ Autoguard Intravascular Catheter (K971339)

Submission Summary (Full Text)

{0}------------------------------------------------

K073471/
APR 30 2008

Image /page/0/Picture/1 description: The image shows a symmetrical design inside an octagon. There are five circles arranged around a central point, each connected to the center by a line. The circles are filled in black, creating a stark contrast with the background.

ADVANTAGE MEDICAL DEVICES Today's Innovation for Tomorrow's Healthcare Advantage

## 510(k) SUMMARY

| Submitted by: | Gaylene Fisch<br>Advantage Medical Devices<br>740 Lomas SantaFe Drive, Suite 210<br>Solana Beach, CA 92075<br>858-436-8543 (phone)<br>848-436-8545 (fax)<br>E-mail: [e-mail] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Smith, Ph.D., RAC<br>Bentley Biomedical Consulting, LLC<br>28241 Crown Valley Parkway, Suite 510<br>Laguna Niguel, CA 92677<br>949-340-7261 (phone)<br>949-340-7141 (fax)<br>E-mail: [e-mail] |
| Date Prepared: | November 26, 2007 |
| Device Trade Name: | VantageCath™ |
| Device Common Name: | Intravascular Catheter |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than<br>30 days |
| Device Class: | II |
| Procode: | FOZ |
| CFR Reference: | 880.5200 |
| Predicate Device: | BD Nexiva™ Closed IV Catheter System<br>BD Insyte™ Autoguard Intravascular Catheter |
| Predicate 510(k) #: | K032843 (BD Nexiva)/K971339 (BD Insyte Autoguard) |
| Device Description: | The VantageCath™ is a short-term intravascular catheter that includes a needle-shielding feature. After threading the catheter into the vein, the sharps safety feature is activated and the needle is retracted into the cylindrical needle shield. The catheter hub and needle assembly components are automatically separated.<br>It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by providing a sharps safety feature, thus minimizing the opportunity for accidental needle sticks.<br>It is supplied sterile for single use only. |

Corporate Office
711 S. Carson St. Suite 4 Carson City, NV 89701 775-881-3489

Sales Office: 740 LOMAS SANT FE DR., SUITE 210

WWW.ADVMEDDEVICES.COM

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a symbol with a geometric design. The design consists of an octagon shape with a pattern inside. The pattern inside the octagon consists of six circles connected by lines to a central point.

ADVANTAGE MEDICAL DEVICES TODAY'S INNOVATION FOR TOMORROW'S HEALTHCARE ADVANTAGE

| Intended Use: | The VantageCath™ is an intravascular catheter that allows the health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy. The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle- shielding barrel, the catheter hub and needle assembly components are automatically separated. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology Comparison: | The VantageCath™ is substantially equivalent to the predicate devices. The new device and predicate devices are similar in function, composition, and intended use. |
| Nonclinical Testing: | Standard biocompatibility tests were performed on the VantageCath™ to establish device safety. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part- 10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by Edwards Lifesciences LLC Quality Laboratory. The studies indicate that the VantageCath™ is biocompatible and safe for its intended use. |

Conclusion of Comparison: The VantageCath™ is substantially equivalent to the currently-marketed predicate devices.

> Corporate Office 711 S. Carson St. Suite 4 Carson City, NV 89701

WWW.ADVMEDDEVICES.COM

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advantage Medical Devices C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747

APR 3 0 2008

Re: K073471

Trade/Device Name: VantageCathTM Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 15, 2008 Received: April 17, 2008

Dear Mr. Conry:

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 vour 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.

{3}------------------------------------------------

## Page 2 - Mr. Conry

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); 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Saute Y. Michae Oms.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a symbol inside of an octagon. The symbol is composed of five circles connected to a central point by lines. The circles are arranged in a pentagonal pattern around the central point.

ADVANTAGE MEDICAL DEVICES Today's Innovation for Tomorrow's Healthcare Advantage

## INDICATIONS FOR USE

510(k) Number (if known):

VantageCath™ Device Name:

Indications for Use:

The VantageCath™ is a short-term intravascular catheter which allows health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy.

The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated.

Prescription Use X

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Page 1 of 1

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

Antun

Coneurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K073471

Corporate Office 711 S. Carson St. Suite 4 CARSON CITY, NV 89701 775-881-3489

Sales Office: 740 Lomas Sant FE DR., Suite 210 SOLANA BEACH, CA. 92075 858-436-8543

WWW.ADVMEDDEVICES.COM