(277 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is a Closed System Drug Transfer Device (CSTD) designed to prevent the release of drugs and contaminants, primarily functioning to ensure safety during drug handling, not directly treating a medical condition.
No
The device is a Closed System Drug Transfer Device (CSTD) designed to prevent the release of drugs and the introduction of contaminants during drug preparation and administration. It does not diagnose any medical condition.
No
The device description clearly outlines physical components (Closed Vial Adapter, Closed Male Luer, Dry Spike) and their mechanical functions, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Arisure® is a "Closed System Drug Transfer Device (CSTD)" used for the preparation and administration of drugs. It focuses on preventing the release of hazardous drugs and the introduction of contaminants during these processes. This is a drug delivery and safety function, not a diagnostic function.
- Device Description: The description details the mechanical components (Vial Adapter, Male Luer, Dry Spike) and how they work together to create a closed system for transferring fluids (drugs) between vials, IV containers, and syringes. This aligns with a drug transfer device, not a device used to perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
The device's purpose is to ensure the safe handling and transfer of drugs, which falls under the category of medical devices used in the administration of treatment, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
ONB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
individuals, healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
- 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 24)
- 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 with nitrile gloved hands)
- Valve Removal Torque and Bond Strength (N/A, >4.5 in-lbs)
- Vial Pressure (N/A)
- Attachment Force (N/A,
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 919-595-8250 Fax: 919-595-8251 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.
4
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.
5
| | Subject Device
(K201422) | Predicate Device
(K141448) | Discussion |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | TEVADAPTOR is a
Closed System Drug
Transfer Device (CSTD)
that mechanically
prohibits the release of
the drug 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 | Same |
| Design | Designed using plastic
and elastomeric materials,
has normally closed fluid
path which closes off
flow when the device is
not attached to mating
component. Includes anti-
unwinding feature. | Designed using plastic,
elastomeric, and metal
materials, has normally
closed fluid path which
closes off flow when the
device is not attached to
mating component. | Minor differences in materials
do not raise different questions
of safety or effectiveness as all
materials contain inherent
properties to achieve their
intended use and have been
demonstrated to be
biocompatible. |
| External
Dimensions
(LxW) (inches) | Closed Male Luer: 1.1 x
0.6
Closed Vial Adapter: 2.5
x 2.25
Dry Spike: 4.0 x 0.5 | Syringe Adaptor: 2.2 x
0.6
Vial Adaptor: 2.2 x 0.9
Spike Port Adaptor: 8.5
x 0.8 | External dimensions have no
impact on performance and do
not raise different questions of
safety or effectiveness. |
| Packaging | Form, fill, seal packaging
with top web material
sealed to bottom web
material | Form, fill, seal packaging
with top web material
sealed to bottom web
material | Same |
| Sterilization | Gamma Irradiation | EO | Both sterilization methods are
considered traditional by FDA
and both achieve a SAL of 10-6,
no different questions of safety
or effectiveness. |
| Latex | Not made with natural
rubber latex | Not made with natural
rubber latex | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Reuse | Single use | Single use | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Externally
communicating Blood
contact, indirect
Prolonged duration (>24
hours to 30 d) | Externally
communicating Blood
contact, indirect
Prolonged duration (>24
hours to 30 d) | Same |
| Flow Rate | ≥76 mL/min | 125 mL/min | This discrepancy is due to the
fact that the subject device is
limited by the CML which was
designed to have the flow rate
of an 18-gauge needle. This was
based upon clinical input prior
to the device design and this
difference is not anticipated to
have any impact on safety and
efficacy. |
| Residual Fluid | |
| 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
with nitrile gloved hands |
| Valve Removal Torque and Bond Strength | N/A, >4.5 in-lbs |
| Vial Pressure | N/A |
| Attachment Force | N/A,