SmartSiteTM Vented Vial Access Device

K243486 · Yukon Medical, LLC · LHI · Dec 6, 2024 · General Hospital

Device Facts

• Record ID: K243486
• Device Name: SmartSiteTM Vented Vial Access Device
• Applicant: Yukon Medical, LLC
• Product Code: LHI · General Hospital
• Decision Date: Dec 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The 20mm SmartSite™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite™ Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

Device Story

Device is a sterile, single-use, needle-free vial access system; consists of a vial spike, retention shroud, hydrophobic filter, and SmartSite needle-free valve. User centers spike on vial stopper and pushes down until shroud snaps into place. Dual-lumen spike enables fluid transfer and pressure equalization via filtered air. Hydrophobic filter prevents particulate release, environmental contamination, and liquid leakage during inversion while maintaining internal pressure equilibrium. Used in healthcare and home settings for medication reconstitution or dispensing. Device maintains vial sterility for up to 7 days in USP <797> compliant environments. Healthcare providers or patients access the system via the needle-free luer valve using a syringe. Simplifies medication preparation by eliminating needles and maintaining a microbiologically closed system.

Clinical Evidence

Bench testing only. Includes human factors/usability engineering studies, particulate contamination testing, fragmentation testing, and chemical/biocompatibility testing per ISO 10993-1 and ISO 8536. Sterility maintenance validated for 7 days.

Technological Characteristics

Materials: MABS (main body/filter housing), nylon (filter substrate), acrylic/polyurethane/silicone (SmartSite valve). Principle: Dual-lumen spike for fluid/air exchange with hydrophobic filter. Form factor: Single-use, sterile, needle-free vial access device. Connectivity: None. Sterilization: Radiation. Software: None.

Indications for Use

Indicated for use by healthcare professionals, patients, and caregivers in healthcare and home environments for reconstitution or dispensing of medications from standard 20 mm rubber-stopper vials.

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

• SmartSite® Vented Vial Access Device (K151963)

Reference Devices

• SmartSite™ needle-free valve (K223088)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2024

Yukon Medical, LLC % Prithul Bom Final Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K243486

Trade/Device Name: SmartSite™ Vented Vial Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: November 8, 2024 Received: November 8, 2024

Dear Prithul Bom:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

David Walloschek

David Wolloscheck, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243486

Device Name

20mm SmartSite TM Vented Vial Access Device

ndications for Use (Describe)

The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K243486 - 510(k) Summary

#### 1. Submitter Information

2.

| Company Name: | Yukon Medical, LLC |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 4021 Stirrup Creek Drive<br>Suite 200<br>Durham, NC 27703 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Pam McNulty, Sr. Director QA and Compliance<br>Yukon Medical, LLC<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | Mahima Gupta, Regulatory Affairs & Compliance Specialist<br>Yukon Medical, LLC<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Swapna Khopkar, Regulatory Affairs<br>Yukon Medical, LLC<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary<br>Prepared: | December 6, 2024 |
| Device Identification | |
| Trade/Proprietary Name: | 20mm SmartSite™ Vented Vial Access Device |
| Common Name: | Vial Access Device |
| Classification Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Class: | II |
| Classification Panel | General Hospital |
| Product Code: | LHI |

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#### 3. Predicate Device

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

| Device Name | Manufacturer | 510(k) Number | Date Cleared |
|-----------------------------------------|--------------------|---------------|---------------|
| SmartSite® Vented Vial<br>Access Device | Yukon Medical, LLC | K151963 | July 31, 2015 |

#### 4. 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 vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve.

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 to 7 days.

#### ನ. Intended Use/Indications for Use

| Subject Device: 20mm SmartSite™<br>Vented Vial Access Device | Predicate Device: SmartSite® Vented Vial<br>Access Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The 20mm SmartSite™ Vented Vial Access<br>Device is intended for use by healthcare<br>professionals, patients, and/or caregivers in a<br>wide variety of healthcare and home use<br>environments for reconstitution or<br>dispensing of medication. The SmartSite™<br>Vented Vial Access Device is indicated for<br>use with standard 20 mm rubber-stopper<br>medication vials for reconstitution or<br>dispensing of medications. | The SmartSite® Vented Vial Access Device is<br>intended for use by healthcare professionals in<br>a wide variety of healthcare environments<br>including hospitals, healthcare facilities, and<br>pharmacies for reconstitution or dispensing of<br>medication. The SmartSite® Vented Vial<br>Access Device is indicated for use with<br>rubber-stopper medication vials for<br>reconstitution or dispensing of medications,<br>including chemotherapy agents. |

The 20mm SmartSite™ Vented Vial Access Device's intended use/indications for use is equivalent to that of the predicate device. Both the subject and predicate device are prescription only devices and are intended to be used with rubber-stopper medication vials for reconstitution or dispensing of medication. The subject device, in addition to its use by healthcare professionals in a variety of healthcare environments, is also indicated for use by patients and/or caregivers in home use environments. The subject device does not explicitly claim its use for the reconstitution or dispensing of chemotherapy agents as the home-users are not allowed to infuse or prepare chemotherapy agents by themselves, without the supervision of a healthcare professional.

Further, the subject device is identical to the predicate with no change to the design, construction, materials, technology and principle of operation. The performance specifications are identical between the two devices. The addition of intended users and the home environment does not significantly impact the safety and effectiveness of the device, as supported by the data collected from the human factors engineering/usability engineering studies that have been conducted and discussed in this 510(k) submission. The only difference between the two devices is in the

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Instructions for Use which for the subject device incorporates a more detailed and easier way of interpreting the use of the device, targeting the lay users. No new questions about the safety or effectiveness for the subject device are arising. The device remains the same i.e., use with rubber-stopper medication vials for reconstitution or dispensing of medications.

#### Predicate Device Comparison - Technical Characteristics 6.

The subject device is identical to the predicate. Equivalency of technical characteristics and any differences between the SmartSite™ Vented Vial Access Device and the predicate device is demonstrated below.

| | Device | |
|------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------|
| Technical<br>Characteristics | Subject Device: 20mm<br>SmartSite™ Vented Vial<br>Access Device | Predicate Device: SmartSite®<br>Vented Vial Access Device |
| Spike | Yes | Yes |
| Locking Shroud | Yes | Yes |
| Luer Access | SmartSite™ Needle-free Valve | SmartSite™ Needle-free Valve |
| Hydrophobic Filter | Yes | Yes |

### Design and Technology

Both the subject and the predicate device are designed using plastic and elastomeric materials and consist of a vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite needle-free valve.

- . Vial Spike
The spike is used to penetrate a standard medication vial stopper and provide path for fluid and filtered air.

Both the subject and predicate devices have dual lumen spikes: one lumen for fluid and the other for filtered air that allows for pressure equalization.

- Locking Shroud/Retention 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
Both the subject and predicate device use the same needle-free valve for luer access to the device: the SmartSite™ needle-free 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 the devices:

- 1) Prevents particulates from leaving the devices when air is introduced;
- 2) Prevents contaminants in the surrounding environment from entering the secured drug vial:
- 3) Prevents liquid from leaving the device during misuse conditions, where the devices are inverted when liquid is injected; and

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- 4) Allows the air pressure in the vial to acclimate with ambient air pressure, preventing the build-up of pressure in the vial.
- . SmartSite™ Needle-free Valve The SmartSite valve is manufactured by CareFusion Corporation, a BD (Becton, Dickinson and Company) company. The needle-free valve used in the subject device is identical to the one that was cleared under the predicate submission (K151963). However, the most recent 510(k) cleared for the same needle-free valve manufactured by CareFusion is 510(k)# K223088, the information from which is being leveraged for the review of the subject device.

### Principle of Operation

Both the subject and the predicate device consist of a spike that a user centers on the stopper of a standard medication vial and pushes down, until the spike penetrates the stopper, and the shroud snaps in place. On injecting or withdrawing the fluid using a syringe or mating luer access device, the air and vapor in the vial gets displaced through the filter and into the surrounding environment. The air passes through the filter to maintain drug sterility, while equalizing pressure with the outside environment.

When used and stored in a USP<797> compliant pharmaceutical compounding environment, the device will allow the device to maintain the sterility of the vial contents for up to 7-days.

### Materials

The subject device SmartSite™ Vented Vial Access Device is identical to the predicate and constructed of the same polymeric and elastomeric components. The main body of the device and the filter housing is molded from a Methyl Methacrylate Acrylonitrile Butadiene Styrene Copolymer (MABS), and a filter subassembly. The filter subassembly is comprised of a nonwoven 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 SmartSite™ Vented Vial Access Device materials do not contain natural rubber latex.

Both the subject and the predicate device have been tested to, and meet the biological requirements outlined in ISO 10993-1. More detailed information about the tests is provided in the Biocompatibility section of this submission.

#### 7. Predicate Device Comparison - Performance Characteristics

The subject device is identical to the predicate with no changes to the design, geometry, technology, principle of operation, and materials. There is no change in the basic performance specifications of the subject device when compared to the predicate. Additional testing conducted including the testing to support the use of the device in home-use environments, in addition to its use in healthcare environments, are listed below:

- Human Factors Engineering/Usability Engineering Study
- Particulate Contamination Testing ●
- Fragmentation Testing

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The testing for the following performance specifications were conducted previously for the predicate that apply in-full and are being leveraged for the subject device:

- Attachment force .
- Filter resistant to misuse pressure ●
- Residual fluid volume
- Flow rate ●
- Packaging maintains sterile barrier
- Device packaging opens with gloved hands
- Packaging materials are radiation sterilizable ●
- Device materials are radiation sterilizable
- Vial septum visibility ●
- Device usable with gloved hands
- Priming volume
- SmartSite™ bond strength ●
- . Stopner coring
- . Device locks with >= 2 fingers
- Spike breakage
- Shroud breakage
- Vertical and horizontal detachment force
- Negative pressure leakage
- No leak, crack or rupture of device when subjected to positive misuse pressure
- Filter prevents >=99.9% particulates from exiting the vial
- Shelf life
- Storage temperature ●
- Chemotherapy and hazardous drug compatibility
- Device must maintain sterility of the drug in the vial for 7 days ●

Testing data for the SmartSite™ valve is being leveraged from 510(k) # K223088 application submitted by CareFusion Corporation.

#### Predicate Device Comparison - Chemical Characterization Testing 8.

The predicate device was not tested for the chemical requirements however, the subject device is identical to the predicate with no changes in the chemical properties when compared to the predicate. The chemical requirement testing has been conducted with the subject device as per ISO 8536-4:2019 and ISO 8536-10:2015 at T=0 and T=3 yr timepoints to demonstrate that the acceptance criteria met all the chemical requirements for:

- Reducing Oxidizable Matter ●
- . Metal Ions
- Titration for Acidity or Alkalinity ●
- . Non-Volatile Residue
- . UV Absorption

#### Predicate Device Comparison - Biocompatibility 9.

The subject device is identical to the predicate and hence leverages the biocompatibility testing of the predicate. The predicate (with the exception of the SmartSite® needle-free valve) was assessed and tested for the below listed biological endpoints specified in ISO 10993-1.

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- . Cytoxicity by Elution Test (Cytotoxicity)
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) ●
- Maximization Test for Delayed Hypersensitivity (Sensitization) ●
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) ●
- Evaluation of Hemocompatibility: Interaction with Blood (Hemocompatibility)

The biocompatibility testing data for the SmartSite™ needle-free valve is being leveraged from that submitted under 510(k) # K223088 by CareFusion Corporation, a BD company.

Additional testing has been conducted for the following two biological endpoints for the entire subject device (including the SmartSite™ needle-free valve).

- Sub-acute Toxicity Testing
- Material-mediated Pyrogenicity Testing

#### 10. Conclusion

Based on the comparison of the subject device's intended use, design, principle of operation and performance characteristics to the predicate device, the SmartSite™ Vented Vial Access Device is substantially equivalent to the previously cleared predicate device.