The SmartSite® VialShield 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® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Device Description

The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

The SmartSite® VialShield is microbiologically closed. When used in a USP <797> compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days.

The subject SmartSite® Vialshield device is constructed of polymeric components:

Upper and Lower Housings: Polycarbonate
Check Valves: Silicone
Lubricant: Silicone
Hydrophobic Filter Membrane: PTFE, Polyester
Loctite 3341: UV adhesive
Barrier Film: Polyether Polyurethane
SmartSite® valve, including:
- Body: Acrylic
- Cap: Polyurethane
- Piston: Silicone
- Lubricants: Silicone

The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene.

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

AI/ML Overview

This document describes Yukon Medical's SmartSite® VialShield, a vial access device, and its successful 510(k) submission to the FDA. The submission demonstrates substantial equivalence to a predicate device through a comparison of technical and performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as a separate table with quantified values. Instead, it describes performance tests conducted and states that the device "meets all specified requirements" and "is as safe and effective as the legally marketed devices designated as predicate device."

However, we can infer some of the performance criteria based on the tests conducted. The table below outlines the tests and the general reported outcome:

Performance Characteristic (Test)	Reported Device Performance
Misuse Leak Test	Met requirements
Filter Recovery Test	Verified hydrophobicity
Priming Volume	Met requirements
Detachment Force (Horizontal)	Met requirements
Detachment Force (Vertical)	Met requirements
Filter Integrity	Met requirements
Biocompatibility (ISO 10993)	Met biological requirements
--- Cytotoxicity by Elution Test	Met requirements
--- Intracutaneous Reactivity	Met requirements
--- Maximization Test for Delayed Hypersensitivity	Met requirements
--- Acute Systemic Toxicity	Met requirements
--- Evaluation of Hemocompatibility	Met requirements
Chemotherapy and Hazardous Drug Compatibility	Met requirements
ISO-594 compliance (Luer valve)	Validated
Microbial ingress (Luer valve)	Validated
Leakage (Luer valve)	Validated
Multiple/extended activation (Luer valve)	Validated
Expansion chamber air capture	Met requirements (vapor retention verified)
Maintains drug sterility for 7 days	Met approved protocol and acceptance criteria

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

Sample Size for Test Set: The document does not specify the exact sample size used for each individual performance test. It mentions that "some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield device," implying comparative testing was done.
Data Provenance: The studies were conducted by Yukon Medical, LLC, and Gilero, LLC for regulatory submission in the USA. The studies are prospective as they were specifically conducted to demonstrate the device's performance for this 510(k) application.

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

The document does not explicitly state that experts were used to establish "ground truth" for the performance tests in the way it might be for a diagnostic AI device. The tests described are laboratory-based performance and safety tests (e.g., leak tests, filter integrity, biocompatibility). The "ground truth" in this context would be the objective measurement against established standards (e.g., ISO, USP guidelines) rather than expert consensus on diagnostic interpretations. Therefore, this question is not directly applicable in the same manner as it would be for AI-driven diagnostic imaging.

4. Adjudication Method for the Test Set

Given the nature of the performance tests (e.g., physical integrity, biological compatibility), an "adjudication method" in the sense of resolving discrepancies between expert opinions is not applicable or detailed in the document. The tests involve objective measurements and adherence to pre-defined protocols and acceptance criteria, likely performed and verified by trained technical personnel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices, especially those incorporating AI to assess human reader performance with and without AI assistance. The SmartSite® VialShield is a mechanical medical device for drug preparation and administration, not a diagnostic imaging or AI-driven diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This question is also primarily relevant for AI-driven diagnostic devices. The SmartSite® VialShield is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established by:

Objective Measurements against Established Standards: For tests like Biocompatibility (ISO 10993), ISO-594 compliance for the Luer valve, and other physical performance tests, the "ground truth" is adherence to predefined specifications, industry standards, and regulatory requirements.
Approved Protocols and Acceptance Criteria: For some tests, like "maintains drug sterility for 7 days," the document explicitly mentions "Approved protocol and acceptance criteria."

8. Sample Size for the Training Set

Not applicable. The SmartSite® VialShield is a mechanical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for this mechanical device, the concept of establishing ground truth for a training set does not apply.

Summary

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5.2.

Product Code:

510(k) Summary ડ.

5.1. Submitter Information

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, Technical OperationsYukon MedicalPhone: 919-595-8257Fax: 919-595-8251Email: cdupper@yukonmedical.com
Prepared By:	James Fentress, Product Development EngineerGilero, LLC4022 Stirrup Creek Drive Suite 300Durham, NC 27703Phone: 919-595-8236Fax: 919-595-8221Email: jfentress@gilero.com
Date Summary Prepared:	August 1, 2013
Device Identification
Trade/Proprietary Name:	SmartSite® VialShield
Common Name:	Vial Access Device
Classification Name:	Intravascular Administration Set21 CFR 880.5440, Class II
Classification Panel	General Hospital

LHI, I.V. Fluid Transfer Set

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5.3. Predicate Device

The Closed Vial Access Device 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

The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

ર્ડ. Intended Use

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

Predicate Device Comparison - Technical Characteristics 5.6.

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.

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Technical Characteristic	Device
	Subject Device:	Predicate Device:
	SmartSite®VialShield	SmartSite® Vented VialAccess Device
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 (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® Vialshield device is constructed of polymeric components:

. Upper and Lower Housings: Polycarbonate

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0 Check Valves: Silicone
. Lubricant: Silicone
Hydrophobic Filter Membrane: PTFE, Polyester .
Loctite 3341: UV adhesive ●
Barrier Film: Polyether Polyurethane .
SmartSite® valve, including: .
- O Body: Acrylic
- 0 Cap: Polyurethane
- o Piston: Silicone
- o Lubricants: Silicone

The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene.

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

The subject SmartSite® VialShield has been tested and meets the biological requirements outlined in ISO 10993-1. 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 SmartSite® Vialshield meets all specified requirements and is substantially equivalent to the predicate device.

Since limited performance data for the predicate SmartSite® Vented Vial Access Device was available, some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield 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):

o Misuse Leak Test
o Filter Recovery Test (verification of hydrophobicity)
Priming Volume .
Detachment Force (Horizontal) .
Detachment Force (Vertical) o
. Priming Volume
. Filter Integrity
Biocompatibility ISO 10993 (SmartSite® VialShield tested only) . O Cytotoxicity by Elution Test (Cytotoxicity)

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Intracutaneous Reactivity (Irritation or Intracutaneous O Reactivity)
Maximization Test for Delayed Hypersensivity (Sensitization) o
O Acute Systemic Toxicity (Systemic Toxicity (Acute))
Evaluation of Hemocompatibility: Interaction with Blood o (Hemocompatibility)
Chemotherapy and Hazardous Drug Compatibility .

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

Additional testing on the subject SmartSite® Vialshield has been done to ensure that the mechanically closed and microbiologically closed technical characteristics of the subject SmartSite® Vialshield, not present on the predicate device, raise no new concerns about the safety and efficacy when compared to the predicate device

Expansion chamber air capture .
. [device] retains introduced vapors
Maintains drug sterility for 7 days (Approved protocol and acceptance . criteria for the subject SmartSite® Vialshield only)

Test results demonstrate that the subject SmartSite® Vialshield is as safe and effective as the legally marketed devices designated as predicate device.

ર.8. Conclusion

Test results demonstrate that the SmartSite® Vialshield 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 SmartSite® Vialshield is substantially equivalent to the indicated predicate devices.

Any differences between the SmartSite® Vialshield and the equivalent predicate devices have no significant influence on safety or effectiveness.

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Image /page/5/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 wavy lines extending from its body, representing the department's commitment to health, services, and people. 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 Center - WO66-G609 Silver Spring, MD 20993-0002

October 4, 2013

Yukon Medical. LLC Mr. Todd Korogi President 2200 Gateway Centre Boulevard, Suite 208 MORRISVILLE NC 27560

Re: K132863

Trade/Device Name: SmartSite® VialShield Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sct Regulatory Class: II Product Code: LHI Dated: September 18, 2013 Received: September 19, 2013

Dear Mr. Korogi:

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. Iisting 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 vour 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. Korogi

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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510{k} Notification Yukon Medical, LLC SmartSite® ViaiShield

4.0 Indications for Use Statement

510(k) Number (if known): __K132863

Device Name: SmartSite® VialShield

Indications for Use:

Prescription Use × (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)

FDA

Richard C. Chapman 2013.10.03 13:52:58 -04'00'

Page 1 of _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.