(12 days)
The Arisure™ Closed Vial Adapter 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 Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The Arisure Closed Vial Adapter 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 Arisure Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The Arisure Closed Vial Adapter is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.
The Arisure™ Closed Vial Adapter's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Arisure™ Closed Vial Adapter Performance | Equivalence to Predicate (Y/N) |
|---|---|---|
| Misuse Test | Tested and meets requirements | Y |
| Detachment Force (Horizontal) | Tested and meets requirements | Y |
| Detachment Force (Vertical) | Tested and meets requirements | Y |
| Flow Rate | Tested and meets requirements | Y |
| Trapped Air Volume | Tested and meets requirements | Y |
| Residual Fluid | Tested and meets requirements | Y |
| Vial attachment force | Tested and meets requirements | Y |
| Vial pressure | Tested and meets requirements | Y |
| Valve Detachment Torque | Tested and meets requirements | Y |
| Biocompatibility (ISO 10993) | Meets biological requirements (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity) | Y |
| Chemical Compatibility | Tested and meets requirements | Y |
| Sterile package integrity testing | Tested and meets requirements | Y |
| Distribution testing | Tested and meets requirements | Y |
| Shelf Life Testing | Tested and meets requirements | Y |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many devices were tested for "Misuse Test" or "Flow Rate"). It generally states that "The following tests were conducted on the Arisure Closed Vial Adapter device to demonstrate equivalency of the performance characteristics to the predicate device(s)."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are lab-based performance tests related to the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a medical accessory (vial adapter), and the tests described are physical, chemical, and biological performance tests, not clinical evaluations requiring human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, as the tests are objective performance metrics rather than assessments requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the Arisure™ Closed Vial Adapter is a medical accessory.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the Arisure™ Closed Vial Adapter. It is a physical medical device, not a software algorithm that operates without human intervention. The performance tests evaluate the device's physical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described are the established scientific and engineering standards and specifications relevant to medical device performance, such as ISO 10993 for biocompatibility and internal specifications for parameters like detachment force, flow rate, trapped air volume, etc.
8. The Sample Size for the Training Set
This information is not applicable. The Arisure™ Closed Vial Adapter is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
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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 consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2017
Yukon Medical, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172884
Trade/Device Name: Arisure™ Closed Vial Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: December 8, 2016 Received: September 21, 2017
Dear Mark 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.
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
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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 devicerelated 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 (DICE) 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. 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
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 (DICE) 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,
Tara A. Ryan -S
for Tina Kiang, PhD Acting 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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Indications for Use
510(k) Number (if known)
Device Name Arisure™ Closed Vial Adapter
Indications for Use (Describe)
The Arisure™ Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthes, and pharmacies for reconstitution or dispensing of medication. The Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
| 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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5.2.
510(k) Summary 5.
5.1. Submitter Information
| Company Name: | Yukon Medical, LLC | ||
|---|---|---|---|
| Company Address: | 4021 Stirrup Creek Drive | ||
| Suite 200 | Durham, NC 27703 | ||
| Company Phone: | (919) 595-8250 | ||
| Company Fax: | (919) 595-8251 | ||
| Contact Person: | Pam McNulty, Director QA and Compliance | ||
| Yukon MedicalPhone: 919-595-8253 | |||
| Fax: 919-595-8251 | |||
| Email: pmcnulty@yukonmedical.com | |||
| Prepared By: | Soorya Kumar, Project Engineer | ||
| Yukon Medical | |||
| Phone: 919-636-6976 | |||
| Fax: 919-595-8251Email: skumar@yukonmedical.com | |||
| Date SummaryPrepared: | 25 August, 2017 | ||
| Device Identification | |||
| Trade/Proprietary Name: | 13mm Arisure™ Closed Vial Adapter | ||
| 20mm Arisure™ Closed Vial Adapter28mm Arisure™ Closed Vial Adapter | |||
| Common Name: | Vial Adapter | ||
| Classification Name: | Intravascular Administration Set | ||
| Regulation Number: | 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 Arisure Closed Vial Adapter is substantially equivalent to the following predicate device:
| Device | Manufacturer | 510(k) | Date Cleared |
|---|---|---|---|
| SmartSite® VialShield | Yukon Medical | K132863 | October 4, 2013 |
5.4. Device Description
The Arisure Closed Vial Adapter 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 Arisure Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The Arisure Closed Vial Adapter is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.
5.5. Intended Use
| Arisure Closed Vial Adapter | Predicate Device |
|---|---|
| The ArisureTM Closed Vial Adapter is intended foruse by healthcare professionals in a wide variety ofhealthcare environments including hospitals,healthcare facilities, and pharmacies forreconstitution or dispensing of medication. TheArisureTM Closed Vial Adapter is indicated for usewith rubber-stopper medication vials forreconstitution or dispensing of medications,including chemotherapy agents. | The SmartSite® VialShield is intended for use byhealthcare professionals in a wide variety ofhealthcare environments including hospitals,healthcare facilities, and pharmacies forreconstitution or dispensing of medication. TheSmartSite® VialShield is indicated for use withrubber-stopper medication vials for reconstitutionor dispensing of medications, includingchemotherapy agents. |
The Arisure Closed Vial Adapter's intended use is equivalent to that of the SmartSite VialShield.
5.6. Indications for Use
| Arisure Closed Vial Adapter | Predicate Device |
|---|---|
| The Arisure™ Closed Vial Adapter is intended for | The SmartSite® VialShield is intended for use by |
| use by healthcare professionals in a wide variety of | healthcare professionals in a wide variety of |
| healthcare environments including hospitals, | healthcare environments including hospitals, |
| healthcare facilities, and pharmacies for | healthcare facilities, and pharmacies for |
| reconstitution or dispensing of medication. The | reconstitution or dispensing of medication. The |
| Arisure™ Closed Vial Adapter is indicated for use | SmartSite® VialShield is indicated for use with |
| with rubber-stopper medication vials for | rubber-stopper medication vials for reconstitution |
| reconstitution or dispensing of medications, | or dispensing of medications, including |
| including chemotherapy agents. | chemotherapy agents. |
The Arisure Closed Vial Adapter's indications for use is equivalent to that of the SmartSite VialShield.
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5.7. Predicate Device Comparison - Technical Characteristics
Equivalency of technical characteristics is demonstrated through a direct comparison of the Arisure Closed Vial Adapter device and the predicate devices listed in the table below.
| TechnicalCharacteristics | Subject Device:Arisure Closed VialAdapter | Predicate Device:SmartSite®VialShield | Equivalence(Y/N) |
|---|---|---|---|
| Hydrophobic Filter | Yes | Yes | Y |
| Spike | Yes | Yes | Y |
| Locking Shroud | Yes | Yes | Y |
| Luer Access | Arisure Neutral Valve(ANV) | SmartSite® NeedleFree Valve | Y |
| Materials(Fluid Contacting) | • Polycarbonate• Silicone• MABS | • Acrylicmultipolymer• Silicone• Polycarbonate | Y |
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 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 a needle free valve for luer access to the device.
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.
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Materials
The subject Arisure Closed Vial Adapter device is constructed of polymeric components, of those components the following are fluid contacting:
- . Arisure Closed Vial Adapter
- Vial Adapter, Membrane Retention Ring, Bell Housing: o Methyl Methacrylate Acrylonitrile Butadiene Styrene
- o Arisure Neutral Valve: Polycarbonate, Silicone, Fluorosilicone
The subject and predicate devices have been tested and meet the biological requirements outlined in ISO 10993-1.
5.8. Predicate Device Comparison - Performance Characteristics
The performance data supplied with this submission demonstrates that the Arisure Closed Vial Adapter meets all specified requirements and is substantially equivalent to the predicate device.
The following tests were conducted on the Arisure Closed Vial Adapter device to demonstrate equivalency of the performance characteristics to the predicate device(s):
- . Misuse Test
- Detachment Force (Horizontal) ●
- Detachment Force (Vertical) ●
- Flow Rate ●
- Trapped Air Volume
- Residual Fluid ●
- Vial attachment force ●
- Vial pressure ●
- Valve Detachment Torque
- . Biocompatibility - ISO 10993
- Cytotoxicity by Elution Test (Cytotoxicity) o
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) o
- Maximization Test for Delayed Hypersensivity (Sensitization) o
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) O
- Evaluation of Hemocompatibility: Interaction with Blood (Hemolysis) o
- o Materials Mediated Pyrogenicity
- Chemical Compatibility ●
- Sterile package integrity testing ●
- . Distribution testing
- Shelf Life Testing
Note:
Both the subject and predicate devices contain needle free valves, which has been previously validated for ISO-594 compliance, microbial ingress, and multiple/extended activation.
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5.9. Conclusion
Test results demonstrate that the Arisure™ Closed Vial Adapter is as safe, as effective, and performs as well as the legally marketed device designated as the predicate device.
Based on comparisons of the device's intended use, technology and performance characteristics, the subject device is substantially equivalent to the indicated predicate device.
§ 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.