The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Device Description

The 20mm SmartSite® Vented Vial Access Device is a stand alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a spike, locking shroud, hydrophobic filter, and SmartSite® needle-free access valve for Luer access.

The SmartSite® Vented Vial Access Device is microbiologically closed. When used in a USP<797> compliant pharmaceutical compounding and storage environment, the SmartSite® Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to7 days.

AI/ML Overview

This document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which is a medical device for accessing medication vials. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML performance evaluation. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the information extracted and categorized based on your request, with "Not Applicable" for sections where the document does not provide the requested AI/ML related details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's AI/ML performance is measured, as this is a traditional medical device submission, not an AI/ML one. However, it lists various tests performed to demonstrate the device's functional and safety characteristics, primarily against a predicate device.

Test Performed (Performance Characteristic)	Device Tested	Result	Note/Interpretation
Attachment Force	Subject & Predicate	Met specified requirements	Demonstrated equivalency during testing.
Filter Misuse Pressure	Subject & Predicate	Met specified requirements	Demonstrated equivalency during testing.
Residual Fluid Volume	Subject & Predicate	Met specified requirements	Demonstrated equivalency during testing.
Flow Rate	Subject & Predicate	Met specified requirements	Demonstrated equivalency during testing.
Tests Performed on Subject Device Only:
Packaging maintains sterile barrier	Subject	Met specified requirements	Performed to establish safety and effectiveness.
Device packaging opens with gloved hands	Subject	Met specified requirements	Performed to establish usability.
Packaging materials are radiation sterilizable	Subject	Met specified requirements	Performed to establish manufacturing compatibility.
Device materials are radiation sterilizable	Subject	Met specified requirements	Performed to establish manufacturing compatibility.
Vial septum visibility	Subject	Met specified requirements	Performed to establish usability.
Device usable with gloved hands	Subject	Met specified requirements	Performed to establish usability.
Priming Volume	Subject	Met specified requirements	Performed to establish functional characteristic.
SmartSite bond strength	Subject	Met specified requirements	Performed to establish structural integrity.
Stopper coring	Subject	Met specified requirements	Performed to establish functional characteristic and prevent contamination.
Device locks with >= 2 fingers	Subject	Met specified requirements	Performed to establish usability and security.
Spike breakage	Subject	Met specified requirements	Performed to establish durability.
Shroud breakage	Subject	Met specified requirements	Performed to establish durability.
Vertical and horizontal detachment force	Subject	Met specified requirements	Performed to establish security of attachment.
Negative pressure leakage	Subject	Met specified requirements	Performed to establish functional integrity.
Filter prevents >=99.9%	Subject	Met specified requirements	Performed to establish filtration effectiveness.
Shelf life (accelerated)	Subject	Met specified requirements	Performed to establish product lifespan.
Storage temperature	Subject	Met specified requirements	Performed to establish storage conditions.
Biocompatibility ISO 10993 (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Hemocompatibility)	Subject	Met specified requirements	Performed to establish biological safety.
Chemotherapy and Hazardous Drug Compatibility	Subject	Met specified requirements	Performed to establish chemical compatibility and safety.
Tests Leveraged from Predicate (SmartSite® needle free valve):
Needle-free Valve Activations >45	Subject & Predicate	Previously evaluated & cleared	Demonstrated robust performance of the shared component.
Needle-free Valve ISO-594 Luer Compatibility	Subject & Predicate	Previously evaluated & cleared	Demonstrated standard compatibility of the shared component.
Microbial ingress	Subject & Predicate	Previously evaluated & cleared	Demonstrated integrity of the shared component.
Leakage	Subject & Predicate	Previously evaluated & cleared	Demonstrated integrity of the shared component.
Additional Test for Subject Device Specifics:
Maintains drug sterility for 7 days	Subject	Met specified requirements	Addresses the "microbiologically closed" characteristic of the subject device.

2. Sample size used for the test set and the data provenance

Not Applicable (This is a traditional medical device; no "test set" in the context of AI/ML data). The document refers to "tests conducted" on the device itself and the predicate device. The specific sample sizes for these engineering and biological tests are not detailed in this summary. Data provenance is not described as it relates to physical device testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (No AI/ML system involved in a clinical study to establish ground truth).

4. Adjudication method for the test set

Not Applicable (No AI/ML system involved in a clinical study requiring adjudication).

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

Not Applicable (This device is a physical medical device, not an AI/ML diagnostic or assistive tool).

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

Not Applicable (No AI/ML algorithm involved).

7. The type of ground truth used

Not Applicable (No AI/ML system requiring a ground truth in the context of expert consensus, pathology, or outcomes data). The "ground truth" for this device would be its adherence to established engineering, safety, and performance specifications as measured by laboratory testing and previous FDA clearances for its components.

8. The sample size for the training set

Not Applicable (No AI/ML model with a training set).

9. How the ground truth for the training set was established

Not Applicable (No AI/ML model with a training set).

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 features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.

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

July 31, 2015

Yukon Medical LLC c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street, NW Buffalo. MN 55313

Re: K151963

Trade/Device Name: SmartSite® Vented Vial Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravenous Administration Set Regulatory Class: II Product Code: LHI Dated: July 15, 2015 Received: July 16, 2015

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.

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Page 2 - Mr. Mark 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 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 vours.

Tina Kiang
-s

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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4.0 Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SmartSite® Vented Vial Access Device

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)

Page 1 of 1

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5. 510(k) Summary

Submitter Information 5.1.

Company Name:	Yukon Medical, LLC
CompanyAddress:	4021 Stirrup Creek DriveSuite 200Durham, NC 27703
Company Phone:	(919) 595-8250
Company Fax:	(919) 595-8251
Contact Person:	Carl Dupper, Director, Technical OperationsYukon MedicalPhone: 919-595-8257Fax: 919-595-8251Email: cdupper@yukonmedical.com
Prepared By:	James Fentress, Director of EngineeringGilero, LLC4022 Stirrup Creek Drive Suite 300Durham, NC 27703Phone: 919-595-8236Fax: 919-595-8221Email: jfentress@gilero.com
Date Summary	February 18, 2015

Prepared:

5.2. Device Identification

Trade/ProprietaryName:	SmartSite® Vented Vial Access Device
Common Name:	Vial Access Device
ClassificationName:	Intravascular Administration Set21 CFR 880.5440, Class II
Classification Panel	General Hospital
Product Code:	LHI, I.V. Fluid Transfer Set

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5.3. Predicate Device

The SmartSite® Vented Vial Access Device (SSVVAD) is substantially equivalent to the following predicate device:

Device	Manufacturer	510(k)	Date Cleared
SmartSite® Vented VialAccess Device	Cardinal Health,Alaris Products	K052790	December, 23,2005

5.4. Device Description

5.5. Intended Use

The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with standard rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

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 device listed in the table below.

The indications statement for the SmartSite® Vented Vial Access Device [Yukon Medical] is the same as its predicate device, Cardinal Health (Now CareFusion) SmartSite® Vented Vial Access Device (K052790).

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Technical Characteristic	Device
	Subject Device:	Predicate Device:
	[Yukon Medical]SmartSite® VentedVial Access Device	[CareFusion] SmartSite®Vented Vial AccessDevice
Spike	Yes	Yes
Locking Shroud	Yes	Yes
Luer Access	SmartSite® NeedleFree Valve	SmartSite® Needle FreeValve
Hydrophobic Filter	Yes	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 ([CareFusion] SmartSite® Vented Vial Access Device) both have equivalent dual lumen spikes; one lumen for fluid transfer and the other which allows for pressure equalization with vented air.

Locking Shroud

The purpose of the locking shroud is to secure the device to a standard medication vial after the stopper is penetrated. Both the subject and predicate device utilize a locking shroud with retention tabs to ensure device security atop a vial.

Luer Access

All configurations of the subject device and predicate device use the same needle free valve for Luer access to the device: the SmartSite® needle-free access valve.

Hydrophobic Filter

Both the subject and predicate device use a hydrophobic filter membrane in their respective designs. This filter serves four purposes in both devices: 1) The filter prevents particulates from leaving the devices when air is introduced; 2) The filter prevents contaminants in the surrounding environment from entering the secured drug vial; 3) The filter prevents liquid from leaving the device during misuse conditions, where the devices are inverted when liquid is injected; 4) The filter allows the air pressure in the vial to acclimate with ambient air pressure, preventing the build-up of pressure in the vial.

Materials

The subject SmartSite® Vented Vial Access Device is constructed of polymeric Components. The main body of the device and the filter housing is molded

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from a methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS), and a filter subassembly. The filter subassembly is comprised of a non-woven nylon substrate secured to a MABS housing. The filter housing is glued into the main body of the device using a Loctite medical grade UV adhesive.

A SmartSite® needle-free access valve is bonded to the top of the main body using a Loctite medical grade UV adhesive. The SmartSite® valve itself is comprised of a clear main body molded from Acrylic, a cap molded from polyurethane, and a piston, molded from silicone. The piston is lubricated with silicone oil.

The subject SmartSite® VVAD materials do not contain natural rubber latex.

The subject SmartSite® VVAD has been tested and meets the biological requirements outlined in ISO 10993-1.

5.7. Predicate Device Comparison - Performance Characteristics

The performance data supplied with this submission demonstrates that the subject SmartSite® VVAD meets all specified requirements and is substantially equivalent to the predicate device.

Since limited performance data for the predicate [CareFusion] SmartSite® Vented Vial Access Device was available, some performance characteristics of the predicate device were tested along with the subject SmartSite® VVAD.

The following tests were conducted on the predicate and subject SmartSite® Vented Vial Access Devices to demonstrate equivalency of the performance characteristics to the predicate device(s):

Tests Performed on Subject and Predicate Devices:

Attachment Force ●
Filter Misuse Pressure ●
Residual Fluid Volume ●
Flow Rate

Tests Performed on Subject Device:

Packaging maintains sterile barrier .
· Device packaging opens with gloved hands
Packaging materials are radiation sterilizable ●
Device materials are radiation sterilizable ●
Vial septum visibility

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Device usable with gloved hands ●
Priming Volume ●
SmartSite bond strength .
Stopper coring
Device locks with >= 2 fingers ●
Spike breakage ●
Shroud breakage
Vertical and horizontal detachment force
Negative pressure leakage
Filter prevents >=99.9% ●
Shelf life (accelerated)
Storage temperature ●
Biocompatibility ISO 10993 ●
- o Cytotoxicity by Elution Test (Cytotoxicity)
- Intracutaneous Reactivity (Irritation or Intracutaneous o Reactivity)
- Maximization Test for Delayed Hypersensivity (Sensitization) o
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) O
- Evaluation of Hemocompatibility: Interaction with Blood o (Hemolysis)
. Chemotherapy and Hazardous Drug Compatibility

Tests leveraged from Carefusion MAF-1918:

Needle-free Valve Activations >45 ●
Needle-free Valve ISO-594 Luer Compatibility ●
Microbial ingress
Leakage

Both the subject and predicate devices contain the SmartSite® needle free valve, which has been previously evaluated and cleared by the FDA for ISO-594 compliance, microbial ingress, leakage, and multiple/extended activation.

Additional testing on the subject SmartSite® VVAD has been done to ensure that the mechanically closed and microbiologically closed technical characteristics of the subject SmartSite® VVAD, not present on the predicate device, raise no new types of safety or effectiveness questions when compared to the predicate device.

Maintains drug sterility for 7 days

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5.8. Conclusion

Test results demonstrate that the SmartSite® Vented Vial Access Device is as safe and effective, and performs as well as the legally marketed device designated as the predicate device per 807.92 (b)(3).

Based on comparisons of the device's intended use, technology and performance characteristics, the subject SmartSite® VVAD is substantially equivalent to the indicated predicate device.

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.