Arisure Closed System Drug Transfer Device (CSTD)

K201422 · Yukon Medical, LLC · ONB · Mar 2, 2021 · General Hospital

Device Facts

• Record ID: K201422
• Device Name: Arisure Closed System Drug Transfer Device (CSTD)
• Applicant: Yukon Medical, LLC
• Product Code: ONB · General Hospital
• Decision Date: Mar 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Device Story

Arisure CSTD is a mechanical system for safe drug preparation and administration. Components include a Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to drug vials, preventing pressurization by capturing vapors and filtering air. The Dry Spike connects to IV containers; the Closed Male Luer facilitates fluid transfer between the vial and IV container. The fluid path remains closed, opening only upon connection to the neutral valve. Used in clinical settings by healthcare personnel. The device minimizes hazardous drug exposure to clinicians and the environment, and prevents microbial ingress into the fluid path. It functions as a physical barrier system.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (ISO 10993), Luer access, liquid leakage, stress cracking, separation force, vial pressure, attachment force, coring, microbial ingress, particulate (USP 788), vapor containment (NIOSH-288:2015), and chemical characterization/toxicological risk assessment.

Technological Characteristics

Materials: Polycarbonate, silicone, COC, ePTFE, polyester, acrylic adhesive. Components: Closed Vial Adapter, Closed Male Luer, Dry Spike. Energy: None (mechanical). Connectivity: None. Sterilization: Gamma irradiation. Fluid path: Normally closed, neutral valve interface. Dimensions: CML (1.1x0.6 in), CVA (2.5x2.25 in), Dry Spike (4.0x0.5 in).

Indications for Use

Indicated for use by healthcare personnel to minimize exposure to hazardous drugs during preparation and administration by mechanically prohibiting the release of drugs in vapor, aerosol, or liquid form and preventing microbial/airborne contamination of the drug or fluid path.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TEVADAPTOR® Closed Drug Reconstitution and Transfer System (K141448)

Submission Summary (Full Text)

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March 2, 2021

Yukon Medical, LLC Pamela Mcnulty Sr. Director QA and Compliance 4021 Stirrup Creek Dr Ste 200 Durham, North Carolina 27703

Re: K201422

Trade/Device Name: Arisure Closed System Drug Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: November 25, 2020 Received: December 2, 2020

Dear Pamela Mcnulty:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201422

Device Name Arisure Closed System Drug Transfer Device (CSTD)

Indications for Use (Describe)

Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <b> </b> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image is a logo for Yukon Medical. The logo consists of a stylized figure in teal and gray, with the letters "Y" and "M" incorporated into the design. To the right of the figure is the word "YUKON" in dark gray, with the word "MEDICAL" in teal underneath.

#### 510(k) Summary

#### I. SUBMITTER

Yukon Medical, LLC 4021 Stirrup Creek Drive, Suite 200 Durham, NC 27703 Phone: [phone] Fax: [phone] Contact Person: Pam McNulty Sr. Director QA and Compliance

Date Prepared: March 2nd, 2020

#### II. DEVICE

Name of Device: Arisure® Closed System Drug Transfer Device (CSTD) Common Name: Drug Reconstitution and Transfer System Classification Name: Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulatory Class: II Product Code: ONB

#### III. PREDICATE DEVICE

Name of Predicate: TEVADAPTOR® Closed Drug Reconstitution and Transfer System Predicate 510(k) Number: K141448 Regulation Number: 21 CFR 880.5440 Product Code: ONB This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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## IV. DEVICE DESCRIPTION

Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.

## V. INDICATIONS FOR USE

Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A direct comparison of the indications for use and technical characteristics between the subject and predicate devices demonstrates equivalency. Minor differences between subject and predicate device characteristics do not introduce different questions of safety or effectiveness, the subject device is substantially equivalent to the predicate device.

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| | Subject Device<br>(K201422) | Predicate Device<br>(K141448) | Discussion |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Arisure® is a Closed<br>System Drug Transfer<br>Device (CSTD) that<br>mechanically prohibits<br>the release of drugs in<br>vapor, aerosol or liquid<br>form during preparation<br>and administration, and<br>prevents the introduction<br>of microbial and airborne<br>contaminants into the<br>drug or fluid path,<br>allowing the system to<br>minimize exposure of<br>individuals, healthcare<br>personnel, and the<br>environment to hazardous<br>drugs. | TEVADAPTOR is a<br>Closed System Drug<br>Transfer Device (CSTD)<br>that mechanically<br>prohibits the release of<br>the drug in vapor, aerosol<br>or liquid form during<br>preparation and<br>administration, and<br>prevents the introduction<br>of microbial and airborne<br>contaminants into the<br>drug or fluid path,<br>allowing the system to<br>minimize exposure of<br>individuals, healthcare<br>personnel, and the<br>environment to hazardous<br>drugs | Same |
| Design | Designed using plastic<br>and elastomeric materials,<br>has normally closed fluid<br>path which closes off<br>flow when the device is<br>not attached to mating<br>component. Includes anti-<br>unwinding feature. | Designed using plastic,<br>elastomeric, and metal<br>materials, has normally<br>closed fluid path which<br>closes off flow when the<br>device is not attached to<br>mating component. | Minor differences in materials<br>do not raise different questions<br>of safety or effectiveness as all<br>materials contain inherent<br>properties to achieve their<br>intended use and have been<br>demonstrated to be<br>biocompatible. |
| External<br>Dimensions<br>(LxW) (inches) | Closed Male Luer: 1.1 x<br>0.6<br>Closed Vial Adapter: 2.5<br>x 2.25<br>Dry Spike: 4.0 x 0.5 | Syringe Adaptor: 2.2 x<br>0.6<br>Vial Adaptor: 2.2 x 0.9<br>Spike Port Adaptor: 8.5<br>x 0.8 | External dimensions have no<br>impact on performance and do<br>not raise different questions of<br>safety or effectiveness. |
| Packaging | Form, fill, seal packaging<br>with top web material<br>sealed to bottom web<br>material | Form, fill, seal packaging<br>with top web material<br>sealed to bottom web<br>material | Same |
| Sterilization | Gamma Irradiation | EO | Both sterilization methods are<br>considered traditional by FDA<br>and both achieve a SAL of 10-6,<br>no different questions of safety<br>or effectiveness. |
| Latex | Not made with natural<br>rubber latex | Not made with natural<br>rubber latex | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Reuse | Single use | Single use | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Externally<br>communicating Blood<br>contact, indirect<br>Prolonged duration (>24<br>hours to 30 d) | Externally<br>communicating Blood<br>contact, indirect<br>Prolonged duration (>24<br>hours to 30 d) | Same |
| Flow Rate | ≥76 mL/min | 125 mL/min | This discrepancy is due to the<br>fact that the subject device is<br>limited by the CML which was<br>designed to have the flow rate<br>of an 18-gauge needle. This was<br>based upon clinical input prior<br>to the device design and this<br>difference is not anticipated to<br>have any impact on safety and<br>efficacy. |
| Residual Fluid | <0.05mL for 13 mm and<br>20mm<br><1mL for 28 mm | 0.37mL for 20mm | The residual fluid is less than<br>the predicate, no different<br>questions of safety or<br>effectiveness |
| Priming Volume | 0.12 mL for Dry Spike,<br>0.11mL for 13mm,<br>0.10mL for 20mm<br>0.12mL for 28mm ACVA | 0.15mL | The priming volume is less than<br>the predicate, no different<br>questions of safety or<br>effectiveness |
| | Subject Device<br>(K201422)<br>Closed Male Luer | Predicate Device<br>(K141448)<br>Syringe Adaptor | Discussion |
| Connector Type | Luer Lock | Luer Lock | |
| Septum/Seal Type | Flat, Split Septum | Double Seal | |
| Upper Housing | Polycarbonate | ABS | |
| Lower Housing | Polycarbonate | Polycarbonate | |
| Cannula | Polycarbonate | Stainless Steel | |
| Anti-Unwinding<br>Housing | Polycarbonate | N/A | Minor differences in materials<br>due to different components<br>achieving the same intended<br>use. |
| Piston | Silicone | Stainless Steel | |
| Actuator | COC | N/A | |
| Lubrication | Fluorosilicone | N/A | |
| Adhesive | Acrylic Adhesive | Acrylic Adhesive | |
| | Subject Device<br>(K201422)<br>Closed Vial Adapter<br>with Neutral Valve | Predicate Device<br>(K141448)<br>Vial Adaptor / Luer<br>Lock Adaptor | Discussion |
| Vial Adapter | Terlux 2802 | ABS | |
| Bell Base | Cyrolite CG97 | N/A | |
| Bell Labyrinth<br>Ring | Cyrolite CG97 | N/A | |
| Bell Housing | Terlux 2822 | N/A | |
| Bell Membrane | Medalist MD145 | N/A | |
| Bell Membrane<br>UV Tracer | SC-5 | N/A | |
| Membrane<br>Retention Ring | Terlux 2802 | N/A | Minor differences in materials |
| Vent Filter<br>Membrane | ePTFE Membrane with<br>polyester support | Charcoal | |
| Bell Filter<br>Membrane | ePTFE Membrane with<br>polyester support | N/A | |
| Vent Check Valve | Elastosil LR3043 60 | N/A | due to different components |
| Bell Check Valve | Silicone | N/A | |
| Adhesive | Acrylic Adhesive | N/A | |
| Check Valve<br>Lubrication | Silicone | N/A | use. |
| Neutral<br>Valve/Luer Lock<br>Adaptor Housing | Polycarbonate | ABS | |
| Neutral<br>Valve/Luer Lock<br>Adaptor Piston | Silicone | Polyisoprene | |
| Neutral<br>Valve/Luer Lock<br>Adaptor<br>Retention Ring | Polycarbonate | Polyisoprene | |
| Neutral<br>Valve/Luer Lock<br>Adaptor<br>Lubrication | Fluorosilicone,<br>Trifluoroprophyl-<br>methylsiloxane | N/A | |

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## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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| Test Name | Standard # |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5 |
| Hemocompatibility | ISO 10993-4 |
| Sensitization | ISO 10993-10 |
| Systemic Toxicity (Acute) | ISO 10993-11 |
| Irritation | ISO 10993-10 |
| Material-Mediated Pyrogenicity | ISO 10993-11 |
| LAL Endotoxin | ANSI/AAMI ST72:2002, USP<br>24<161> |
| Luer Access | ISO 594-2 |
| Liquid Leakage (back pressure) | ISO 594-2 |
| Liquid Leakage (connected pressure) | ISO 594-2 |
| Ease of Assembly | ISO 594-2 |
| Resistance to Overriding | ISO 594-2 |
| Stress Cracking | ISO 594-2 |
| Separation Force | ISO 594-2 |
| Gloved Hands | N/A, to verify the device is usable<br>with nitrile gloved hands |
| Valve Removal Torque and Bond Strength | N/A, >4.5 in-lbs |
| Vial Pressure | N/A |
| Attachment Force | N/A, <40 lbf |
| Horizontal / Vertical Detachment | N/A, remain attached with a 15N<br>force attached for 15 seconds |
| Misuse Leakage | N/A, no leakage with 7.5PSI for 15<br>seconds |
| Coring | N/A, coring of the drug vial septum<br>to have particulates does not occur |
| Security of Attachment | N/A, remain attached without leak<br>with a 15N load for 15 seconds |
| Drug/Device Compatibility | N/A |
| Dry Disconnection | N/A |
| Microbial Ingress | N/A |
| Particulate | USP 788 |
| Vapor Study | CDC-2015-0075, NIOSH -288:2015<br>(draft) |
| Chemical Characterization | ISO 10993-18 |
| Toxicological Risk Assessment | ISO 10993-17 |
| Sub-Acute Toxicity | ISO 10993-11 |
| Partial Simulation Performance Tests | ISTA P2A (2011) |
| Standard Practice for Performance Testing of Shipping Containers and<br>Systems | ASTM D4169-14 |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ASTM F88M-09 |
| Standard Test Method for Detecting Gross Leaks in Packaging by<br>Internal Pressurization (Bubble Test) | ASTM F2096-11 |
| Standard Test Method for Determining Integrity of Seals for Flexible<br>Packaging by Visual Inspection | ASTM F1886 |

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## VIII. CONCLUSIONS

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device currently marketed with some minor differences. These differences do not impact the intended use or the fundamental scientific technology of the device. Through the comprehensive performance testing performed the subject device has demonstrated substantial equivalence to the predicate.