SmartSite Vented Vial Access Device

K151963 · Yukon Medical, LLC · LHI · Jul 31, 2015 · General Hospital

Device Facts

• Record ID: K151963
• Device Name: SmartSite Vented Vial Access Device
• Applicant: Yukon Medical, LLC
• Product Code: LHI · General Hospital
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for 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 rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Device Story

The SmartSite® Vented Vial Access Device is a sterile, single-use, needle-free accessory for medication vials. It features a dual-lumen spike for fluid transfer and pressure equalization, a locking shroud for vial attachment, and a hydrophobic filter to prevent contamination and particulate release. The device incorporates a SmartSite® needle-free access valve for Luer connections. Used by healthcare professionals in clinical and pharmacy settings, it enables needle-free reconstitution and dispensing of drugs, including chemotherapy agents. By maintaining a microbiologically closed system, it allows for the sterility of vial contents to be maintained for up to 7 days when used in USP <797> compliant environments. The device simplifies medication handling, reduces needle-stick risks, and supports safe drug preparation.

Clinical Evidence

Bench testing only. Testing included attachment force, filter misuse pressure, residual fluid volume, flow rate, packaging integrity, sterilization validation, vial septum visibility, bond strength, stopper coring, detachment force, leakage, and biocompatibility per ISO 10993. Microbial ingress and valve performance were leveraged from existing data (Carefusion MAF-1918). The device demonstrated the ability to maintain drug sterility for 7 days.

Technological Characteristics

Constructed of MABS (methyl methacrylate acrylonitrile butadiene styrene copolymer), nylon filter substrate, and SmartSite® valve (acrylic body, polyurethane cap, silicone piston). Features dual-lumen spike, locking shroud, and hydrophobic filter. Sterile, single-use, disposable. Luer-compatible needle-free valve. Biocompatibility per ISO 10993-1. No natural rubber latex.

Indications for Use

Indicated for healthcare professionals in hospitals, facilities, and pharmacies for reconstitution or dispensing of medications, including chemotherapy agents, using rubber-stopper medication 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 (K052790)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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)

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## 5. 510(k) Summary

## Submitter Information 5.1.

| Company Name: | Yukon Medical, LLC |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>Address: | 4021 Stirrup Creek Drive<br>Suite 200<br>Durham, NC 27703 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Carl Dupper, Director, Technical Operations<br>Yukon Medical<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | James Fentress, Director of Engineering<br>Gilero, LLC<br>4022 Stirrup Creek Drive Suite 300<br>Durham, NC 27703<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary | February 18, 2015 |

# Prepared:

## 5.2. Device Identification

| Trade/Proprietary<br>Name: | SmartSite® Vented Vial Access Device |
|----------------------------|---------------------------------------------------------------|
| Common Name: | Vial Access Device |
| Classification<br>Name: | Intravascular Administration Set<br>21 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 Vial<br>Access Device | Cardinal Health,<br>Alaris Products | K052790 | December, 23,<br>2005 |

#### 5.4. 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 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.

#### 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]<br>SmartSite® Vented<br>Vial Access Device | [CareFusion] SmartSite®<br>Vented Vial Access<br>Device |
| Spike | Yes | Yes |
| Locking Shroud | Yes | Yes |
| Luer Access | SmartSite® Needle<br>Free Valve | SmartSite® Needle Free<br>Valve |
| 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.