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 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.

AI/ML Overview

The provided text describes the ViaValve™ Safety I.V. Catheter, an intravascular catheter designed to reduce blood exposure during placement and prevent accidental needlesticks.

Here's an analysis of the acceptance criteria and supporting studies based on the provided information, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Similar Performance to Predicates	Equivalence to predicate devices based on applicable standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features".	Confirmed through bench testing and ISO standard compliance testing.
Blood Exposure Reduction	Valve inside the catheter hub designed to reduce blood exposure during initial catheter placement.	"Equivalent to the blood control feature of the predicate BD Insyte" Autoguard " BC catheter."
Accidental Needlestick Prevention	Needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks.	"Employs the same technology as the Smiths Medical predicate ProtectIV® Plus Catheter" and confirmed in "simulated clinical use studies" that the needle was shielded after use.
Safe and Effective Use	Device can be used safely and effectively.	Confirmed through "simulated clinical use studies" and "Human Factors Engineering (HFE) and Usability testing," which concluded the device was "adequately safe and effective for its intended users, uses and use environments."

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

The document does not explicitly state the numerical sample size for any specific "test set" in terms of how many devices were tested or how many participants were involved in the usability studies.

Bench Testing & ISO Standard Compliance Testing: No sample size or specific data provenance (e.g., country of origin) is mentioned. This testing is inherently retrospective in nature, as it evaluates the manufactured product.
Simulated Clinical Use Studies: No specific sample size is provided. The nature of "simulated clinical use" implies prospective data collection in a controlled environment, likely within the manufacturing country (USA, given the company information).
Human Factors Engineering (HFE) and Usability Testing: No specific sample size is provided. This is typically prospective data collection involving human participants. The provenance is not explicitly stated but would likely be within the USA.

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

The document does not mention the use of "experts" to establish ground truth in the context of the device's technical or clinical performance. The evaluation relies on:

Bench testing: Against established ISO standards and FDA guidance.
Simulated clinical use: To confirm operational aspects like needle shielding.
Human Factors/Usability testing: To assess user interaction for safety and effectiveness.

Therefore, there is no information provided about a specific number of experts or their qualifications for establishing a "ground truth" as it might be understood in an AI/diagnostic context (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned. This type of method is typically used in studies involving expert interpretation of data (like medical images) where there might be inter-reader variability, which is not the primary focus of the described device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not reported. The information describes testing to demonstrate substantial equivalence to predicate devices and confirm safety and effectiveness, not to compare the performance of human readers with and without AI assistance.

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

This question is not applicable to the described medical device. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in its function as a physical catheter, evaluated through bench and simulated clinical tests.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Compliance with validated standards: ISO standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features."
Engineering specifications and design intent: For features like blood control and needle-stick prevention, confirmed through testing.
Usability metrics: Derived from Human Factors and Usability testing to ensure the device is "adequately safe and effective for its intended users, uses and use environments."

There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for the device's fundamental function.

8. The Sample Size for the Training Set

This question is not applicable. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable, as there is no "training set" for this physical device.

Summary

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

MAR 1 4 2012

KIJ39900

bringing technology to life

Smiths Medical ASD Inc. 10 Bowman Drive Keene, NH 03431, USA T: +1 603 352 3812 F: +1 603 355 8157 www.smiths-medical.com lical

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 (603) 352-3812, 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:

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

K113700

Page 2 of 2

Indications for Use:

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.

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

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.

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

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 (800) 638-2041 or (301) 796-7100 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

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

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:

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

Page l of l

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).