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 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.

AI/ML Overview

The provided documentation describes the ViaValve® Safety I.V. Catheter (K160235), which is a peripheral intravenous catheter. This submission is a 510(k) premarket notification, meaning it seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the device itself (e.g., specific sensitivity/specificity thresholds, or mean values with standard deviations). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various ISO standards and showing that the subject device's performance is equivalent to the predicate device in relevant non-clinical tests. The "reported device performance" is largely framed as "passes" or "complies" with the specified standards.

Implicit Acceptance Criteria and Reported Device Performance

Characteristic / Test	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Intended Use	Same as predicate device (ViaValve® Safety I.V. Catheter K113700)	Same as predicate; provides access to vein/artery, enables blood sampling, pressure monitoring, fluid administration; needle guard reduces needlesticks.
Technological Characteristics	Same as predicate device (e.g., integral sharps prevention, sterilization, single use, materials, etc.)	All listed characteristics are "Same" or "Yes" as the predicate device, except for the catheter tube material.
Biocompatibility (ISO 10993 series)	Compliance with ISO 10993 standards for various biological effects	Confirms compliance for Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Systemic Toxicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility, Ethylene Oxide Sterilization Residuals, Risk Assessment, Chemical Characterization.
Conical fittings (ISO 594-1 & 594-2)	Compliance with ISO 594-1 and 594-2 requirements	Confirms compliance for Gauging, Liquid and Air Leakage, Separation Force, Stress Cracking, Separation and Unscrewing Force, Ease of Assembly, Resistance to Overriding.
Intravascular catheters - General requirements (ISO 10555-1)	Compliance with ISO 10555-1 requirements	Confirms compliance for Radio-detectability, Biocompatibility, Surface, Corrosion resistance, Peak tensile force, Hub connections, Flowrate, Power injection, Distal tip.
Intravascular catheters - Over-needle peripheral catheters (ISO 10555-5)	Compliance with ISO 10555-5 requirements	Confirms compliance for Catheter tip conformance, Needle point and hub, Strength of Union, Vent Fitting, Flowrate.
Sharps Injury protection (ISO 23908)	Compliance with ISO 23908 requirements	Confirms compliance for Sharps activation, Security of safe mode, Challenging device in safe mode, Testing access of the device in safe mode, Testing simulated clinical use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to a medical device (catheter) and the "study" is a set of non-clinical, bench and biological tests, not a clinical trial with patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) in the context of clinical data do not directly apply.

Sample Size for Testing: The specific sample sizes for each bench or biological test (e.g., number of catheters tested for flow rate, or number of units for biocompatibility) are not detailed in this summary. The summary only lists the standards to which the tests were conducted.
Data Provenance: The data provenance is from non-clinical laboratory testing performed to comply with international (ISO) standards. The location of the testing laboratories or country of origin of the data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is hardware, and the 'ground truth' for its performance is established through compliance with engineering and biological standards, not through expert consensus on interpretation of medical images or patient outcomes. The testing involves standardized procedures and measurements (e.g., flow rate, material strength, biocompatibility), not expert judgment on diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to arbitration processes used when multiple human readers (e.g., radiologists) provide conflicting interpretations of diagnostic data. Since these are non-clinical, objective bench and biological tests, there is no "adjudication method" in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a physical medical instrument (an IV catheter), not an AI algorithm or a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance of this device is established by:

Compliance with recognized international standards (ISO): These standards define acceptable performance limits and test methodologies for various aspects of the device (e.g., material safety, physical integrity, functional performance).
Comparison to a predicate device: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed device. Thus, the performance of the predicate device, as established by its clearance and adherence to standards, serves as a de facto ground truth for the subject device.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument and does not involve AI or machine learning models that require 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 device.

Summary

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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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

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Indications for Use

510(k) Number (if known) K160235

Device Name ViaValve® Safety I.V. Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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 (603) 352-3812, 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:

V Indications for Use:

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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 DeviceViaValve® Safety I.V.Catheter	Predicate DeviceViaValve® Safety I.V.Catheter
CHARACTERISTIC
Peripheral I.V. Catheter	Yes	Yes
Intended Use	Same	Same
Target population	Same	Same
Integral sharps preventionfeature	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 to300 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 forflashback detection	Yes, 20 to 24 gauge sizes	Yes, 20 to 24 gauge sizes
End Cap	Yes	Yes
Has a blood control valve orseptum to reduce blood flowduring initial catheter placement	Yes	Yes
Blood control valve ispermanently open after initialLuer 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

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

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	•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.

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).