The Arisure™ Neutral Valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or artery. The Arisure™ Neutral Valve may be used with low-pressure power injectors up to 300 psi.

Device Description

The Arisure™ Neutral Valve is a sterile, single-use, swab-able, normally closed, luer-activated, valved connector. The Arisure™ Neutral Valve consists of five primary components: lower housing, upper housing, retention ring, pre-slit silicone piston, and lubricating silicone oil. The lower housing, made of polycarbonate, consists of a male luer and a long feature that provides support for the silicone piston to move upon. The pre-slit silicone piston attaches to the lower housing. A series of round protrusions on the inside of the silicone piston provides sliding seals over the long feature on the lower housing. These sliding seals allow fluid to travel through the silicone piston when the piston is accessed with a male luer. The retention ring, made of polycarbonate, fits over the silicone piston and provides extra rigidity. The silicone piston and top housing together comprise the female end of the needle-free valve. The top housing, made of polycarbonate, fits over the top of the piston and is permanently affixed to the bottom housing. When pressed downward by a male luer, the slit in the piston opens, and the sliding seal on the inside of the piston opens a fluid pathway through the device. Silicone oil is used to lubricate the silicone piston. The Arisure™ Neutral Valve does not contain any natural rubber latex.

AI/ML Overview

The provide text is a 510(k) summary for the Arisure™ Neutral Valve. As such, it describes the device's intended use, comparison to predicate devices, and a list of non-clinical tests conducted. The document demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with the detailed parameters requested in the prompt. While non-clinical tests are mentioned, the document does not provide the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert-related details required in the prompt.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document lists non-clinical tests performed (e.g., Microbial Ingress Testing, Liquid Leak, Flow Rate) but does not provide the specific acceptance criteria for each test or the reported performance values. It only states that the testing met "pre-determined acceptance criteria."
Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic study with a "ground truth" derived from expert consensus.
Adjudication method for the test set: Not applicable.
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: Not applicable, as this is a medical device, not an AI system being evaluated for diagnostic accuracy or human-in-the-loop performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the device, "ground truth" would relate to its physical performance meeting specifications, rather than a diagnostic accuracy truth. The document mentions "hemolytic testing" where "hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00)" as a general threshold, but this is a standard, not internally established ground truth from experts.
The sample size for the training set: Not applicable; this device does not use a training set as it is not an AI/machine learning product.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (MicroCLAVE® Connector and CLAVE® Connector) by comparing technical and performance characteristics and conducting non-clinical tests to ensure safety and effectiveness.

The only specific performance data mentioned related to criteria is about hemolysis:

Acceptance Criteria for Hemolysis (General Threshold): Hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00).
Reported Device Performance (Hemolysis): Both the 21GA needle (comparator) and the Arisure™ Neutral Valve had hemolytic percentages below 2%. The Arisure™ Neutral Valve had less hemolysis compared to blood withdrawn using a 21GA needle.
Study Details for Hemolysis (Limited): It was an "additional testing" conducted on the Arisure™ Neutral Valve. Compared to blood withdrawn using a 21GA needle. No sample size, data provenance, ground truth establishment, or expert involvement details are provided for this specific test, beyond the standard mentioned.

Summary

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

510(K) Notification
Yukon Medical, LLC
Arisure™ Nestral Valve

5.0 510(k) Summary

MAR 3 0 2012

ﺮ ":"

5.1. Submitter

Submitter's Nameand Address	Todd Korogi, President
	Yukon Medical, LLC
	4819-400 Emperor Blvd.
	Durham, NC 27703
	Phone: 919-595-8250
	Email: tkorogi@yukonmedical.com
Contact Person	Carl Dupper, Director of Engineering and Quality
	Yukon Medical
	4819-400 Emperor Blvd.
	Durham, NC 27703
	Phone: 919-595-8257
	Email: cdupper@yukonmedical.com
Prepared By	James Fentress, Product Development Engineer
	Gilero Biomedical
	4022-300 Stirrup Creek Dr.
	Durham, NC 27703
	Phone: 919-595-8236
	Email: jfentress@gilero.com
Date Prepared	01 November 2011

5.2. Device Identification

Trade Name	Arisure™ Neutral Valve
Common Name	Needle-free access device, needle-free connector, lueraccess device
Classification	Intravascular Administration SetProduct Code - FPARegulation 21 CFR 880.5440

5.3. Predicate Devices

Device	Manufacturer	510(k)
B3300MicroCLAVE®Connector; C1000CLAVE® Connector	ICU Medical, Inc.	K970855

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

5.4. Device Description

5.5. Intended Use

The indications statement for the Arisure™ Neutral Valve differs from the indications statement of the predicate device (presented in 510(k) K970855) in that it additionally states that the Arisure™ Neutral Valve can be used to withdraw fluid from a patient, rather than just administer fluid. This difference is not critical to the intended therapeutic use of the device, and the difference does not affect the safety and effectiveness of the device when used as indicated.

The primary concern with the withdrawal of fluids from a patient through an cannula placed in the vein or artery of a patient is damage that can occur to the withdrawn fluid sample; damage to blood. In addition to the traditional tests for material hemocompatibility presented in the biocompatibility section (section 15), additional testing was also conducted on the Arisure™ Neutral Valve to determine whether the withdrawal of blood using the Arisure™ Neutral Valve caused damage to the blood. Section 15 details this test, which shows that when compared to blood withdrawn using a 21GA needle, the Arisure™ Neutral Valve has less hemolysis. A general threshold for assessing the hemolytic property of a given material is that hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00). Both the 21GA needle and the Arisure™ Neutral Valve had hemolytic percentages below 2%.

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

In addition to the hemolytic testing conducted on the Arisure™ Neutral Valve, the predicate CLAVE® device is also used for the withdrawal of fluid. ICU Medical Instructions M1-1053 Rev01 illustrates the use of the CLAVE® device for withdrawing blood from a patient.

5.6. Predicate Device Comparison (Technological Characteristics)

A direct comparison of the technical and performance characteristics of the Arisure™ Neutral Valve and the technical and performance characteristics of the predicate device demonstrates equivalency. Minor differences in subject and predicate device characteristics do not introduce any new safety or efficacy concerns.

Table 5.6: Device Technological Comparison
Subject Device Arisure™ NeutralValve	Predicate Device MicroCLAVE®B3300 Connector and CLAVE®C1000 Connector(510(k):K970855)
Materials
Neutral Valve Materials:Lower Housing (Internal Conduit) -Polycarbonate	Materials per 510(k): K970855Internal Conduit- Polycarbonate
Pre-slit Silicone Piston: silicone rubber	Silicone Seal[Silicone Piston] - SiliconeRubber
Lubricant - Fluorosilicone	Lubricant - Fluorosilicone
Upper Housing - Polycarbonate	[upper]Housing - Polyester
Retention Ring- Polycarbonate
Principles ofOperation	The female Luer valve opens to permit theintroduction or withdrawal of fluids whenaccessed by a male Luer tip. This accessdeforms a compressible element that returnsto its original shape through the mechanicalproperties of the deformable element.	The female Luer valve opens to permit theintroduction or withdrawal of fluids whenaccessed by a male Luer tip. This accessdeforms a compressible element that returnsto its original shape through the mechanicalproperties of the deformable element.
Technologyand Design	When activated by a male Luer, a pre-slitelastomeric sleeve advances over an internalpost, opening a fluid pathway that connectsthe female and male ends of the device.	When activated by a male Luer, a pre-slitelastomeric sleeve advances over an internalpost, opening a fluid pathway that connectsthe female and male ends of the device.

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

5.7. Discussion of Non-clinical tests

The following non-clinical tests have been done in support of the substantial equivalence of the Arisure™ Neutral Valve to the Predicate CLAVE® devices:

Microbial Ingress Testing .
Biocompatibility Testing .
Liquid Leak (open position) .
Liquid Leak (closed position) .
Vacuum Leak (open position) .
Vacuum Leak (closed position) .
Flow Rate .
Tensile Strength .
Disconnection Bolus .

Results from non-clinical testing indicate that the Arisure™ Neutral valve is as safe and effective as the predicate device. Testing conducted that reference the design verification and validation testing of the Arisure™ Neutral valve meet pre-determined acceptance criteria for the device. Testing conducted as a direct comparison of the Arisure™ Neutral valve and predicate device demonstrate that the equivalence of the devices.

5.8. Conclusion

The Arisure™ Neutral Valve is equivalent to the predicate device and is safe and effective for its intended use.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Yukon Medical, LLC C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25TH Street N.W. Buffalo, Minnesota 55313

MAR 3 0 2012

Re: K120799

Trade/Device Name: Arisure™ Neutral Valve Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set. Regulatory Class: II Product Code: FPA Dated: March 15, 2012 Received: March 16, 2012

Dear Mr. Job:

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.

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

Page 2 - Mr. Job

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,

Anthony Dimon

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

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

4.0 Indications for Use Statement

510(k) Number (if known): K120799

Device Name: Arisure™ Neutral Valve

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruld C. Chign 3/29/2012
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

120799 510(k) Number:

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.