ViaValve Safety I.V. Catheter

K160235 · Smiths Medical Asd, Inc. · FOZ · Jun 30, 2016 · General Hospital

Device Facts

• Record ID: K160235
• Device Name: ViaValve Safety I.V. Catheter
• Applicant: Smiths Medical Asd, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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 providing venous or arterial access for fluid administration, blood sampling, or pressure monitoring. Features internal blood control valve to reduce blood exposure during placement; valve opens upon Luer connection. Includes integrated needle guard for sharps injury prevention; guard locks over needle during catheter threading. Used in clinical settings by healthcare providers. Device facilitates safe vascular access; reduces accidental needlestick risk; enables power injection (18-24G) up to 300 PSI.

Clinical Evidence

Bench testing only. No clinical data required. Performance verified via biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility) and mechanical testing (leakage, tensile force, flow rate, power injection, sharps protection activation) per ISO standards.

Technological Characteristics

Peripheral I.V. catheter; 16G-24G. Materials: 304 stainless steel needle, Techrilon® polyurethane tube, silicone rubber valve, polypropylene hub, polycarbonate end cap. Features: integrated needle guard, blood control valve, radiopaque, single-use. Sterilization: Ethylene Oxide. Connectivity: None. Standards: ISO 594-1/2 (Luer fittings), ISO 10555-1/5 (catheter requirements), ISO 23908 (sharps protection).

Indications for Use

Indicated for any patient population requiring venous or arterial access for blood sampling, blood pressure monitoring, or fluid administration. Contraindications include patient size or therapy duration incompatibility with catheter specifications.

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

• ViaValve® Safety I.V. Catheter (K113700)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human figure with outstretched arms, resembling an eagle or bird in flight.

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

June 30, 2016

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

Re: K160235

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: May 31, 2016 Received: June 1, 2016

### 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.

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang". The signature is complex and illegible. There is a number "-s" below the name, which may be part of the signature.

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K160235

Device Name ViaValve® Safety I.V. Catheter

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# K160235

## 510(k) Summary

# I Submitter:

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

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

Summary Prepared: 27 May 2016

# II Device Name:

Trade Name: ViaValve® Safety I.V. Catheter Common Name: Peripheral I.V. Catheter Classification Name: 880.5200 Intravascular catheter Regulatory Class II Product Code FOZ

## III Predicate Device(s):

K113700 ViaValve® Safety I.V. Catheter - Smiths Medical ASD, Inc.

## IV Device Description:

The ViaValve® 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 open 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 needlesticks.

## V 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.

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

# VI Comparison of Technological Characteristics with the Predicate Device:

The intended use and the technological characteristics of the proposed and predicate devices are the same. The difference is that the proposed device is manufactured with a different polyurethane catheter tubing material. The following table provides a comparison between the subject and predicate device:

| | Subject Device<br>ViaValve® Safety I.V.<br>Catheter | Predicate Device<br>ViaValve® Safety I.V.<br>Catheter |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| CHARACTERISTIC | | |
| Peripheral I.V. Catheter | Yes | Yes |
| Intended Use | Same | Same |
| Target population | Same | Same |
| Integral sharps prevention<br>feature | Yes | Yes |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Single Use | Yes | Yes |
| Prescription Device | Yes | Yes |
| Packaging | Form/Fill/Seal Blister Pack | Form/Fill/Seal Blister Pack |
| One-handed safety activation | Yes | Yes |
| Use with Power Injectors up to<br>300 PSI | Yes | Yes |
| Nonpyrogenic | Yes | Yes |
| Radiopaque | Yes | Yes |
| Made with natural rubber latex | No | No |
| Gauge sizes offered | 16G to 24G | 14G to 24G |
| COMPONENTS | | |
| Needle Point Type | V-point | V-point |
| "Ribbed" Catheter Hub | Yes | Yes |
| Notched needle cannula for<br>flashback detection | Yes, 20 to 24 gauge sizes | Yes, 20 to 24 gauge sizes |
| End Cap | Yes | Yes |
| Has a blood control valve or<br>septum to reduce blood flow<br>during initial catheter placement | Yes | Yes |
| Blood control valve is<br>permanently open after initial<br>Luer connection is made | Yes | Yes |
| MATERIALS | | |
| Needle Cannula | 304 Stainless Steel | 304 Stainless Steel |
| Catheter Valve or Septum | Silicone Rubber | Silicone Rubber |
| Catheter Hub | Polypropylene | Polypropylene |
| Catheter Tube | Techrilon® Polyurethane | Ocrilon® Polyurethane |
| End Cap | Polycarbonate | Polycarbonate |

{5}------------------------------------------------

# VII Non-Clinical Performance Data:

Bench testing, biocompatibility testing and ISO standard compliance testing as listed below confirms that the ViaValve® Safety I.V. Catheter with Techrilon® polyurethane tubing is substantially equivalent to the Smiths Medical predicate device. Clinical data was not required to demonstrate substantial equivalence.

| E N ISO 10993-5 | Cytotoxicity |
|------------------|-----------------------------------------|
| EN ISO 10993-10 | Sensitization |
| E N ISO 10993-10 | Irritation or Intracutaneous reactivity |
| E N ISO 10993-11 | Systemic Toxicity (acute) |
| EN ISO 10993-11 | Subacute and subchronic toxicity |
| E N ISO 10993-3 | Genotoxicity |
| E N ISO 10993-6 | Implantation |
| EN ISO 10993-4 | Hemocompatibility |
| E N ISO 10993-7 | Ethylene Oxide Sterilization Residuals |
| EN ISO 10993-17 | Risk Assessment |
| EN ISO 10993-18 | Chemical Characterization of Materials |

Biological Testing was conducted as listed below:

Bench Testing was conducted to the following Standards:

| Standard | Title |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 594-1:1986 | Conical fittings with a 6% (Luer) taper for syringes, needles<br>and certain other medical equipment. General requirements<br>Tests:<br>•Gauging<br>•Liquid and Air Leakage<br>•Separation Force<br>• Stress Cracking |
| ISO 594-2:1998(E) | Conical fittings with a 6% (Luer) taper for syringes, needles<br>and certain other medical equipment –Part2:Lock Fittings<br>Tests:<br>•Gauging<br>•Liquid and Air Leakage<br>•Separation and Unscrewing Force<br>•Ease of Assembly<br>•Resistance to Overriding<br>•Stress Cracking |
| ISO 10555-1:2013<br>(Corrected version 2013-07-01) | Intravascular catheters-Sterile and single- use catheters-<br>Part 1: General requirements<br>Tests:<br>•Radio-detectability<br>•Biocompatibility<br>•Surface<br>•Corrosion resistance |

{6}------------------------------------------------

| | •Peak tensile force |
|------------------|----------------------------------------------------------------|
| | •Hub connections |
| | •Flowrate |
| | •Power injection |
| | •Distal tip |
| ISO 10555-5:2013 | Intravascular catheters-Sterile and single- use catheters- |
| | Part5: Over-needle peripheral catheters |
| | Tests: |
| | •Cather tip conformance |
| | •Needle point and hub |
| | •Strength of Union |
| | •Vent Fitting |
| | •Flowrate |
| ISO 23908:2011 | Sharps Injury protection-Requirements and test methods- |
| | Sharps protection features for single-use hypodermic needles. |
| | Introducers for catheters and needles used for blood sampling. |
| | Tests: |
| | •Sharps activation |
| | •Security of safe mode |
| | • Challenging device in safe mode |
| | •Testing access of the device in safe mode |
| | •Testing simulated clinical use |

# VIII Conclusions:

Based on the indications for use, technological characteristics, and performance testing, the subject ViaValve® Safety I.V. Catheter is demonstrated to be substantially equivalent to the predicate device.