The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

Device Description

The Vented Single Vial Access Device (ViaLokTM / Universal) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. These devices are inserted into a stopper of a medication vial. The healthcare provider uses the Vented Single Vial Access Device to transfer and mix drugs contained in standard medication vials. The Vented Single Vial Access Device includes three product configurations in this submission:

ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer .
. ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer
. Universal Single Vial Access Device, Vented, Female Luer

The 20mm and 13mm product configurations are intended to mate with standard medication vial enclosure sizes (20mm and 13mm, respectively). The Universal device does not contain a shroud and can be used independent of enclosure size. Each Vented Single Vial Access Device configuration is offered with a female luer.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with pass/fail values. Instead, it lists various performance tests conducted to demonstrate equivalency to predicate devices. The reported device performance for each test is generally stated as "meets all specified requirements" or "is as safe and effective as the legally marketed devices."

Performance Characteristic	Acceptance Criteria (Implicit from Equivalency)	Reported Device Performance
Attachment Force	Equivalent to predicate devices	Meets all specified requirements
Flow Rate	Equivalent to predicate devices	Meets all specified requirements
Pressurization Leak Test	Equivalent to predicate devices	Meets all specified requirements
Vacuum Leak Test	Equivalent to predicate devices	Meets all specified requirements
Priming Volume	Equivalent to predicate devices	Meets all specified requirements
Detachment Force	Equivalent to predicate devices	Meets all specified requirements
Filter Integrity	Provides equivalent air filtration to predicate	Meets all specified requirements
Septum Coring	Equivalent to predicate devices	Meets all specified requirements
Multiple Access	Equivalent to predicate devices	Meets all specified requirements
ISO 594-2 Test Methods	Compliance with ISO 594-2 standards	Meets all specified requirements
- Luer Leakage (Air Ingress)	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Luer Leakage (Fluid Ingress)	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Luer Attachment	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Luer Separation Force	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Unscrewing Torque	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Resistance to Overriding	(Implicitly tested against ISO 594-2)	Meets all specified requirements
- Stress Cracking	(Implicitly tested against ISO 594-2)	Meets all specified requirements
Biocompatibility (ISO 10993)	Compliance with ISO 10993 standards	Meets all biological requirements
- Cytotoxicity by Elution Test	(Implicitly tested against ISO 10993)	Meets all biological requirements
- Intracutaneous Reactivity	(Implicitly tested against ISO 10993)	Meets all biological requirements
- Maximization Test for Delayed Hypersensitivity	(Implicitly tested against ISO 10993)	Meets all biological requirements
- Acute Systemic Toxicity	(Implicitly tested against ISO 10993)	Meets all biological requirements
- Evaluation of Hemocompatibility	(Implicitly tested against ISO 10993)	Meets all biological requirements

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

The document does not explicitly state the specific sample sizes used for each performance test. It only mentions that "samples of the predicate device were tested along with the Vented Single Vial Access Device" where performance data for a predicate was unavailable.

The data provenance is from Yukon Medical, LLC's internal testing as part of their 510(k) submission. It is a prospective study in the sense that the new device was manufactured and then subjected to these performance tests. The country of origin of the data is not specified, but the submission is to the US FDA, implying US regulatory standards and potentially US-based testing.

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

This information is not applicable as the device is a physical medical device (Vented Single Vial Access Device), not an AI/software-based diagnostic tool. Ground truth in this context refers to objective physical and chemical properties and performance, not expert interpretation of data. The "ground truth" is established by the specifications and standards for medical device performance.

4. Adjudication Method for the Test Set

This is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation (e.g., of medical images) needs consensus. For device performance, the results are objectively measured against established standards.

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 is not applicable. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI to improve their performance. The Vented Single Vial Access Device is a physical, non-AI medical device.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The Vented Single Vial Access Device is a physical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Vented Single Vial Access Device is primarily based on:

Established industry standards: Such as ISO 594-2 for luer connections and ISO 10993 series for biocompatibility.
Performance characteristics of legally marketed predicate devices: The new device's performance is compared to that of existing, cleared predicate devices (Yukon Medical's ViaLok™ Non-vented and Medimop Medical Projects' Vented Vial Adapter Transfer Device). The implicit ground truth is that the predicate devices are safe and effective.
Engineering specifications and design requirements: While not explicitly detailed in the summary, underlying the tests are specific engineering targets for flow rates, leak resistance, etc., which define acceptable performance.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an AI algorithm. The Vented Single Vial Access Device is a physical medical device and does not involve AI.

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

This is not applicable for the reasons stated in point 8.

Summary

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K 12 2265

510(k) Notification
Yukon Medical, LLC
Vented Single Vial Access Device

5. 510(k) Summary

5.2.

5.1. Submitter Information

AUG 1 4 2012

Company Name:	Yukon Medical, LLC
Company Address:	2200 Gateway Centre BlvdSuite 208Morrisville, NC 27560
Company Phone:	(919) 595-8250
Company Fax:	(919) 595-8251
Contact Person:	Carl Dupper, Director of Engineering and QualityYukon MedicalPhone: 919-595-8257Fax: 919-595-8251Email: cdupper@yukonmedical.com
Prepared By:	Kristin Benokraitis, Director of Programs and QualityManagementGilero, LLC4022 Stirrup Creek Drive Suite 300Durham, NC 27703Phone: 919-595-8223Fax: 919-595-8221Email: kristinb@gilero.com
Date Summary Prepared:	June 29, 2012
Device Identification
Trade/ProprietaryName:	ViaLokTM 20 mm Single Vial Access Device,Vented, Female Luer
	ViaLokTM 13 mm Single Vial Access Device,Vented, Female Luer
	Universal Single Vial Access Device, Vented,Female Luer
Common Name:	Vial Access Device

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Classification	Intravascular Administration Set
Name:	21 CFR 880.5440, Class II
Classification Panel	General Hospital
Product Code:	LHI, I.V. Fluid Transfer Set

5.3. Predicate Device

The Vented Single Vial Access Device is substantially equivalent to the following predicate device:

Device	Manufacturer	510(k)	Date Cleared
ViaLokTMNon-vented	Yukon Medical	K121182	May 3, 2012
Vented VialAdapter TransferDevice	Medimop MedicalProjects, LTD.	K062482	November 3, 2006

Device Description 5.4.

ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer .
. ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer
. Universal Single Vial Access Device, Vented, Female Luer

5.5. Intended Use

The Vented Single Vial Access Device is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

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The Vented Single Vial Access Device is indicated for use with standard " medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The indications statement for the Vented Single Vial Access Device is the same as its predicate device, Yukon Medical's ViaLok™ Non-vented (K121182).

5.6. Predicate Device Comparison - Technical Characteristics Equivalency of technical characteristics is demonstrated through a direct comparison of the Vented Single Vial Access Device and the predicate devices listed in the table below.

	Device
TechnicalCharacteristic	Subject Device:Vented Single VialAccess Device	Predicate: ViaLok™Non-vented(K121182)	Predicate:Vented Vial AdapterTransfer Device(K062482)
Spike	Yes	Yes	Yes
Shroud	20mm and 13mm - YesUniversal - No	Yes	Yes
Luer Access	Yes	Yes	Yes
Filter	Yes	No	Yes

Spike

The spike is used to penetrate a standard medication vial stopper and provide fluid and filtered air paths.

The subject device and the predicate (Vented Vial Adapter Transfer Device) both have equivalent dual lumen spikes; one lumen for fluid transfer and the other which allows for pressure equalization with vented air.

Shroud

The purpose of the shroud is to secure the device to a standard medication vial after the stopper is penetrated. The 20mm and 13mm product configurations contain this feature which is equivalent to that of the ViaLokTM Non-vented design.

Luer Access

All configurations of the subject device facilitate connection of mating luer access devices. This is equivalent to referenced predicate devices.

Filter

Air flows into and out of the vial through a filter during drug transfer/withdrawal.

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The subject device and the predicate (Vented Vial Adapter Transfer Device) both provide equivalent means of air filtration.

Materials

The Vented Single Vial Access Device is an assembly of a molded methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS) body and filter sub-assembly. The filter sub-assembly is comprised of a non-woven nylon substrate secured to a molded polyethylene housing.

The Vented Single Vial Access Device may be provided with a molded polyethylene cap and/or a molded polyethylene spike cover.

The subject device's spike may also be lubricated with a fluorosilicone polymer.

The Vented Single Vial Access Device materials do not contain natural rubber latex.

The Vented Single Vial Access Device has been tested and meets the biological requirements outlined in ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-9, ISO 10993-10, and ISO 10993-11. A summary of these test results is provided in Section 15 - Biocompatibility.

5.7. Predicate Device Comparison - Performance Characteristics

The performance data supplied with this submission demonstrates that the Vented Single Vial Access Device meets all specified requirements and is substantially equivalent to the predicate device(s).

Performance data for the Vented Vial Adapter Transfer Device was not available. Therefore, samples of the predicate device were tested along with the Vented Single Vial Access Device.

The following tests were conducted on the Vented Single Vial Access Device to demonstrate equivalency of the performance characteristics to the predicate device(s):

Attachment Force .
Flow Rate .
Pressurization Leak Test .
Vacuum Leak Test .
Priming Volume .
Detachment Force ●
Filter Integrity .
Septum Coring .
Multiple Access .

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510(k) Notification Yukon Medical, LLC Vented Single Vial Access Device

ISO 594-2 Test Methods (Vented Single Vial Access Device tested . only)
- Luer Leakage (Air Ingress) o
- Luer Leakage (Fluid Ingress) ্ত
- Luer Attachment o
- Luer Separation Force o
- o Unscrewing Torque
- Resistance to Overriding ্
- O Stress Cracking
Biocompatibility ISO 10993 (Vented Single Vial Access Device . tested only)
- o Cytotoxicity by Elution Test (Cytotoxicity)
- Intracutaneous Reactivity (Irritation or Intracutaneous ০ Reactivity)
- Maximization Test for Delayed Hypersensivity (Sensitization) ୍
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) ୍
- Evaluation of Hemocompatibility: Interaction with Blood o (Hemocompatibility)

Test results demonstrate that the Vented Single Vial Access Device is as safe and effective as the legally marketed devices designated as predicate device(s).

5.8. Conclusion

Test results demonstrate that the Vented Single Vial Access Device is as effective, and performs at least as safely and effectively as the legally marketed devices designated as predicate devices.

Based on comparisons of the device's intended use, technology and performance characteristics, the Vented Single Vial Access Device is substantially equivalent to the indicated predicate devices.

Any differences between the Vented Single Vial Access Device and the equivalent predicate devices have no significant influence on safety or effectiveness.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is a stylized design, with simple lines and curves.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Yukon Medical, Limited Liability Company AUG 1 4 2012 C/O Mark Job Responsible Third Party Official Regulatory Technology Services, Limited Liability Company 1394 250 Street, North West Buffalo, Minnesota 55313 Re: K12265 Trade/Device Name: ViaLok13 20 mm Single Vial Access Device, Vented, Female Luer ViaLok1M 13 mm Single Vial Access Device, Vented, Female Luer Universal Single Vial Access Device, Vented, Female Luer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 27, 2012 Received: July 30, 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

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Page 2- Mr. Job

addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

th for

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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Indications for Use Statement 4.

510(k) Number (if known):

Device Name:

ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer ●
ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer .
. Universal Single Vial Access Device, Vented, Female Luer

Indications for Use: The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

hild C. Chapman 8/13/12

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

510(k) Number: K122265

4-1

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.