VIAVALVE SAFETY IV CATHETER

K113700 · Smiths Medical Asd, Inc. · FOZ · Mar 14, 2012 · General Hospital

Device Facts

• Record ID: K113700
• Device Name: VIAVALVE SAFETY IV CATHETER
• Applicant: Smiths Medical Asd, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Mar 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

Device Story

Peripheral I.V. catheter; provides vascular access for fluid administration, blood sampling, or pressure monitoring. Features internal hub valve to minimize blood exposure during placement; valve opens upon Luer connector attachment. Includes integrated needle guard that locks over needle during catheter threading to prevent accidental needlesticks. Used by clinicians in clinical settings. 18-24 gauge variants support power injection up to 300 PSI. Benefits include reduced blood exposure for clinicians and enhanced sharps injury protection.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing, ISO standard compliance, simulated clinical use studies, and Human Factors Engineering (HFE) and usability testing. Studies confirmed safe and effective operation, including successful needle shielding and user interaction in simulated environments.

Technological Characteristics

Peripheral intravascular catheter with internal hub valve and integral needle guard. Materials and performance specifications comply with applicable ISO standards and FDA Guidance for medical devices with sharps injury prevention features. 18-24 gauge sizes available. Mechanical operation; no electronic or software components.

Indications for Use

Indicated for any patient population requiring venous or arterial access for blood sampling, blood pressure monitoring, or fluid administration. Consideration required for patient size, solution appropriateness, and therapy duration. 18-24 gauge models compatible with power injectors up to 300 PSI.

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

• ProtectIV® and ProtectIV® Plus Safety I.V. Catheter (K990236)
• BD Insyte™ Autoguard™ BC Shielded I.V. Catheter (K110443)

Submission Summary (Full Text)

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# MAR 1 4 2012

KIJ39900

bringing technology to life

Smiths Medical ASD Inc. 10 Bowman Drive Keene, NH 03431, USA T: [phone] F: [phone] www.smiths-medical.com lical

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## SECTION 5, 510(k) Summary

#### Company Information:

Smiths Medical ASD. Inc. 201 West Queen Street Southington, CT 06489 Registration Number: 1219611

Contact: Brian D. Farias Regulatory Affairs Manager [phone], ext 2493

Summary Prepared: December 15, 2011

#### Product Name:

#### Trade Name: ViaValve™ Safety I.V. Catheter

Common Name: Peripheral I.V. Catheter

Classification Name: 880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

#### Predicate Device(s):

K990236 (ProtectIV® and ProtectIV® Plus Safety LV. Catheter) - Marketed by Smiths Medical ASD. Inc.

K110443 {BD Insyte=" Autoguard" BC Shielded I.V. Catheter) - Marketed by Becton Dickinson (BD) & Co.

#### Device Description:

The Via Valve™ Safety I.V. Catheter provides access to a vein or artery. The ViaValve™ Safety I. V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain oven after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve™ Safety.I.V. Catheter is threaded into the vessel to help reduce the risk of accidental rieedlesticks.

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K113700

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### Indications for Use:

A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

### Technological Characteristics:

The ViaValve™ Safety I.V. Catheter is a peripheral intravascular catheter with a valve and integral needlestick protection. The valve inside the ViaValve™ Safety I.V. Catheter hub is designed to reduce blood exposure upon initial catheter placement and is equivalent to the blood control feature of the predicate BD Insyte" Autoguard " BC catheter. The needle guard employs the same technology as the Smiths Medical predicate ProtectIV® Plus Catheter and locks over the needle as the ViaValve™ Safety I.V. Catheter is threaded.

#### Non-Clinical Data:

Bench testing and ISO standard compliance testing confirms that the ViaValve™ Safety I.V. Catheter and the predicate devices have similar performance specifications based on the applicable standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features" August 9, 2005 for medical devices with sharps injury prevention features.

#### Clinical Data:

Simulated clinical use studies were conducted which confirmed that the ViaValve™ Safety I.V. Catheter could be used safely and effectively with the needle shielded by the needle guard after use.

Human Factors Engineering (HFE) and Usability testing was conducted. Analysis of the validation results concluded that the ViaValve™ Safety I.V. Catheter was adequately safe and effective for its intended users, uses and use environments.

#### Conclusion:

The bench testing, standards compliance testing, simulated clinical use, and HFE validation studies conducted demonstrate that the ViaValve™ Safety I.V. Catheter is safe and effective and is Substantially Equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Brian Farias Regulatory Affairs Manager Smiths Medical ASD, Inc. 201 West Queen Street Southington, Connecticut 06489

MAR 1 4 2012

Re: K113700

Trade/Device Name: ViaValve™ Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 15, 2011 Received: December 16, 2011

Dear Mr. Farias:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 2 - Mr. Farias

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anton b. mart

Anthony D. Watson, B.S., M.S., M.B.A. 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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KI1370∅∅

# SECTION 4, Indications for Use Statement

# Indications for Use

510(k) Number (if known):

Device Name: ViaValve™ Safety I.V. Catheter

#### Indications for Use:

A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Chyn 3/12/12
(Division Sign-Off)

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

510(k) Number: K113700

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