(280 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
No.
The device is a drug transfer device and does not provide therapeutic benefit or treatment to a patient.
No
The device is described as a transfer device for mixing drugs and diluents, and its primary function is to facilitate the transfer and reconstitution of medication, not to diagnose a condition or disease.
No
The device description clearly outlines a physical, single-use, gamma sterilized, nonpyrogenic device consisting of vial adapter bodies, piercing spikes, wings, a Luer connection, and an in-line filter. It is a hardware device for transferring drugs between vials.
Based on the provided information, the Mix2Vial® Transfer Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "transferring drugs contained in two vials." This is a drug delivery or preparation function, not a diagnostic function.
- Device Description: The description details a device for reconstituting and transferring medications. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's purpose is purely mechanical transfer and filtration of a drug solution.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device for drug transfer (leakage, force, flow, etc.), not on diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mix2Vial® Transfer Device does not fit this definition.
N/A
Intended Use / Indications for Use
The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter.
The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial.
The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter.
Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port.
After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm.
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
adolescents and adults
Intended User / Care Setting
The M2V device is intended for use by a patient (adolescents and adults) or caregivers for Home Use (HU) and by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment.
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)
Performance testing was conducted to confirm the Mix2Vial® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life, conforms to the applicable external and internal standards, and demonstrates substantial equivalence to the predicate device. Non-clinical bench performance tests included: Fragmentation Test, Particulate Testing, Internal Diameter Upper Skirt, Luer Gauging Test, Luer Stability and compliance to ISO 80369-7 (fluid leakage, air leakage, stress cracking, axial load, resistance separation from unscrewing, overriding, dimensions), Residual Volume, Device Leakage, Device Total Penetration Force, Vial Adapter Detachment Force, Product Retention in Blister, Vacuum Test, Device Removal Force from Blister, Tyvek Total Peel Test Force, Functionality according to IFU, Leakage under Normal Use, Product Skirt Position on Vial, Injection Force, Aspiration Force, Label Legibility, Opening Torque Test.
The results of performance, biocompatibility, and sterility testing for the subject device, demonstrate that the differences between the subject device and the predicate device do not raise new or different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
January 19, 2024
% Lauren Tiller Senior Regulatory Affairs Specialist West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton, Pennsylvania 19341
Re: K231071
Trade/Device Name: Mix2Vial® Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: December 21, 2023 Received: December 21, 2023
Dear Lauren Tiller:
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/cdrb/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.
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).
1
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 820.70) 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.
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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations. please see Device (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.
Porsche Bennett
Porsche Bennett For 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 Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231071
Device Name Mix2Vial® Transfer Device
Indications for Use (Describe) The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K231071 - 510(K) SUMMARY
SUBMITTER
Applicant:
West Pharma. Services IL, Ltd. 4 Hasheizaf St. Ra'anana, Israel 4366411 Facility Establishment Registration Number: 3000223297
Manufacturer:
West Pharma. Services IL, Ltd. 4 Hasheizaf St. Ra'anana, Israel 4366411 Facility Establishment Registration Number: 3000223297
Applicant & Correspondent Contact Person:
Lauren Tiller Senior Regulatory Affairs Specialist Phone: 484-753-6859 Fax: 610-717-0668 E-mail: Lauren.Tiller@westpharma.com
Date Prepared: January 19, 2024
DEVICE
Trade Name: Mix2Vial® Transfer Device Common/Usual Name: I.V. Fluid Transfer Set Regulation Name: Intravascular Administration Set Product Code: LHI Regulation No.: 880.5440 Class: II Panel Identification: General Hospital Panel Predicate Device: Mix2vial Transfer Device – K031861
4
DEVICE DESCRIPTION
Device Overview
The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter.
The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial.
The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter.
Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port.
After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm. The figure below depicts the components of the device.
5
Image /page/5/Figure/14 description: The image shows a diagram of a vial adapter component with labels. The diagram shows two main parts, a male vial adapter component (VA) labeled as '1' and a female VA labeled as '3'. The in-line filter is labeled as '2', the spike is labeled as '4', and the other parts are labeled as '5' and '6'.
Mix2Vial® Transfer Device
-
- Spike
-
- Luer Connector
- Skirt Wings 6.
The M2V has a 5-year shelf life.
The M2V device is intended for use by a patient (adolescents and adults) or caregivers for Home Use (HU) and by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications.
The M2V primary packaging consists of a polyethylene terephthalate glycol (PETG) blister that is sealed with a Tyvek® lid on top of the blister pack.
Principle of Operation
The M2V is operated by a manual process. The device is connected to a diluent vial (supplied by the Drug Manufacturer) having a neck diameter of 20mm via the male Vial Adapter portion of the device. Then, the device is connected to a drug vial (supplied by the Drug Manufacturer) having a neck diameter of 20mm via the female Vial Adapter portion of the device.
The vial adapters contain an integral plastic cannulated spike located in the center of the Vial Adapter components, intended to puncture the vial stopper membrane allowing access to the vial contents. This piercing cannulated spike then facilitates the transfer of the drug between the diluent vial and the drug vial.
6
The device is swirled to mix the drug per the Drug Manufacturer's package insert.
The male Vial Adapter (with diluent bottle still attached) is unscrewed from the female Vial Adapter and discarded.
An empty syringe is pressurized then connected to the female Luer Lock (port on female Adapter). Once connection is secure, the air from the syringe is injected into the vial.
The device is then flipped, and the plunger of the syringe is pulled downward to withdraw the desired amount of the reconstituted drug. The device is flipped back with the vial side down, and the syringe is removed.
The drug can now be administered through the syringe.
INDICATION FOR USE
The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Mix2Vial® Transfer Device is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device Mix2vial Transfer Device, cleared under K031861.
A summary of equivalence and differences between the subject device and the predicate device are provided in the table below.
| Areas for
Comparison | Subject Device
Mix2Vial® Transfer Device | Predicate Device (K031861)
Mix2vial Transfer Device | Comparison |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Transferring drugs contained in
two vials | Transferring and mixing of
drugs contained in two vials | Difference #1: The subject
device has had a reduction
of "mixing" from the
indications for use. |
| Contraindications | None known | None known | Identical |
| Intended User
Population | Intended for use by patients
(adolescents and adults),
caregivers, and by Healthcare
Professionals (HCPs) | Intended for use by Healthcare
Professionals (HCPs) | Difference #2: The subject
device is intended to be
used by Healthcare
Professionals (HCPs) and
by patients / lay users
(adolescents and adults)
and caregivers for Home
Use. |
| Areas for
Comparison | Subject Device
Mix2Vial® Transfer Device | Predicate Device (K031861)
Mix2vial Transfer Device | Comparison |
| Intended Use
Environment | Intended for Home Use and in
hospitals, outpatient nursing
units and other suitable clinical
environments | Intended for use in hospitals,
outpatient nursing units and
other suitable clinical
environments | Difference #3: The subject
device is intended to be
used for Home Use and in
hospitals, outpatient
nursing units and other
suitable clinical
environments. |
| Device Class &
Classification
Name | Class II, I.V. Fluid Transfer
Set | Class II, I.V. Fluid Transfer
Set | Identical |
| Regulation
Number / Name | 21CFR 880.5440
Intravascular Administration
Set | 21CFR 880.5440
Intravascular Administration
Set | Identical |
| Product Code | LHI | LHI | Identical |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Design | | | |
| Operation
Principle | Manual | Manual | Identical |
| Direction of Flow | Two-way | Two-way | Identical |
| Design/
Construction | Female 20mm Vial Adapter
with wings and piercing short
spike, containing an in-line
filter intended to be attached to
a standard drug vial with a
neck diameter of 20mm.
Female Luer Lock fitting is
compliant with ISO 80369-7
for attachment to a standard
accessory such as a syringe
(not supplied).
Male 20mm Vial Adapter with
"tight grip" wings and piercing
short spike intended to be
attached to a standard diluent
vial with a neck diameter of
20mm. | Female 20mm Vial Adapter
with wings and piercing spike,
containing an in-line filter
intended to be attached to a
standard drug vial with a neck
diameter of 20mm. Female
Luer Lock fitting is compliant
with ISO 594-1 and ISO 594-2
for attachment to a standard
accessory such as a syringe
(not supplied).
Male 20mm Vial Adapter with
wings and piercing spike
intended to be attached to a
standard diluent vial with a
neck diameter of 20mm. | Difference #4: The subject
device female vial adapter
is compliant with ISO
80369-7, both vial adapters
have a 1.5mm shorter
spike, and the male vial
adapter has "tight grip"
wings. |
| Female Luer Lock
Connector | Compliant with
ISO 80369-7:2021 | Compliant with
ISO 594-1 and ISO 594-2 | Difference #5: The subject
device complies with the
most current Luer standard
revision. |
| Compatible Vial
Size | 20mm | 20mm | Identical |
| Areas for
Comparison | Subject Device
Mix2Vial® Transfer Device | Predicate Device (K031861)
Mix2vial Transfer Device | Comparison |
| Female Vial
Adapter Wing
Diameter | 30.4mm to accommodate
20mm standard vials | 30.4mm to accommodate
20mm standard vials | Identical |
| Male Vial Adapter
Wing Diameter | 30.1mm to accommodate
20mm standard vials | 30.4mm to accommodate
20mm standard vials | Difference #6: The male
vial adapter of the subject
device has a Tight Grip
(TG) 30.1mm external
body diameter, a .3mm
reduction. |
| Piercing Spike | Single lumen
11.25mm short spike | Single lumen
12.75mm standard spike | Difference #7: The subject
device has a 11.25mm
short spike, a 1.5mm
reduction. |
| Vial Adapter Fit | Snap fit to vial | Snap fit to vial | Identical |
| Material | Vial Adapters: Polycarbonate
In-Filter: Polyethylene +
Hydrophilic Mesh | Vial Adapters: Polycarbonate
In-Filter: Polyethylene +
Hydrophilic Mesh | Identical |
| Biocompatibility | ISO 10993-1:2018
External Communicating,
Prolonged Indirect Contact
with Patient Blood Path
(24 hours to 30 days) | USP Biological Reactivity
External Communicating,
Transient Indirect Contact with
Patient Blood Path
(≤ 24 hours) | Difference #8: The subject
device is compliant with
the latest biocompatibility
standard and has Prolonged
Indirect Contact with
Patient Blood Path (24
hours to 30 days). |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterilization | | | |
| Sterility | Sterile | Sterile | Identical |
| Sterilization
Method | Gamma | Gamma or ETO | Difference #9: The subject
device is gamma sterilized. |
| Sterility Assurance
Level | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | | | |
| Packaging | Sterile Barrier package
materials: PETG blister with
Tyvek® seal | Sterile Barrier package
materials: PETG blister with
Tyvek® seal | Identical |
Substantial Equivalence Comparison Table
7
8
The results of performance, biocompatibility, and sterility testing for the subject device, demonstrate that the differences between the subject device and the predicate device do not raise new or different questions of safety and effectiveness. See details as follows:
- Difference #1: The "mixing" claim has been removed from the device labeling, including ● the Indications for Use statement as the drug mixing requirements are defined by the Drug
9
Manufacturer, as indicated in the device Instructions for Use. Therefore, West Pharmaceutical Services, Inc does not maintain verification or validation data within the device Design History File to substantiate the mixing claim.
This change does not raise new or different questions of safety and effectiveness.
- Difference #2: The subject device is intended to be used by Healthcare Professionals . (HCPs) which is identical to the predicate: however, the subject device is also intended for use by patients / lay users (adolescents and adults) and caregivers for Home Use. This change does not raise new or different questions of safety and effectiveness.
- Difference #3: The subject device is intended to be used in hospitals, outpatient nursing . units, and other suitable clinical environments, identical to the predicate; however, the subject device is also intended for Home Use. This change does not raise new or different questions of safety and effectiveness.
- Difference #4: The subject device female vial adapter is compliant with ISO 80369-7, both ● vial adapters have a 1.5mm shorter spike, and the male vial adapter has "tight grin" wings. The predicate device Luer fitting is compliant with ISO 594-1 and ISO 594-2. Both ISO 594-1 and ISO 594-2 were superseded with ISO 80369-7.
This change does not raise new or different questions of safety and effectiveness.
- Difference #5: The subject device complies with the most current Luer standard revision. . This change does not raise new or different questions of safety and effectiveness, as demonstrated by bench testing.
- . Difference #6: The subject device male Vial Adapter has "Tight Grip" which is a .3mm diameter reduction from the predicate, while still accommodating a standard 20mm drug vial. This change does not raise new or different questions of safety and effectiveness, as demonstrated by bench testing.
- Difference #7: The subject device has 11.25mm "short spikes," which is a 1.5mm . reduction from the predicate. This change does not raise new or different questions of safety and effectiveness, as demonstrated by bench testing.
- . Difference #8: The subject device contact duration has been extended to prolonged (24 hours to 30 days) and complies with the most current biocompatibility standards. This change does not raise new or different questions of safety and effectiveness, as demonstrated by biocompatibility testing.
- . Difference #9: The subject device is only sterilized by Gamma Irradiation, while the predicate device had the option to be either EtO or Gamma sterilized. This change does not raise new or different questions of safety and effectiveness, as demonstrated by sterilization validation.
For these reasons, the Mix2Vial® Transfer Device, subject of this Traditional 510(k), is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device, Mix2vial Transfer Device, which is cleared under K031861.
10
PERFORMANCE DATA
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Performance Testing
Performance testing was conducted to confirm the Mix2Vial® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life, conforms to the applicable external and internal standards, and demonstrates substantial equivalence to the predicate device. The table below provides a list of non-clinical bench performance tests that were completed on the device and provided within this submission.
| Test | Test Method/ Standard |
|---|---|
| Fragmentation Test | ISO 8536-2:2010 section 6.2.2 |
| Particulate Testing | USP |
| Internal Diameter Upper Skirt | ISO 8362-6:2010 Section 4.2 |
| Luer Gauging Test | ISO 594-1:1986 and ISO 594-2:1998 |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-7:2021 |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20:2015, Annex B & Annex C for |
| the leakage reference connector (fluid | |
| leakage) | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20:2015, Annex D & Annex C for |
| the leakage reference connector (air leakage) | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex E & Annex C for |
| the stress cracking reference connector | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex F & Annex C for |
| the axial load reference connector | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C for |
| the resistance separation from unscrewing | |
| reference connector | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C for |
| the overriding reference connector | |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-7:2021 Table B.2 and B.5 |
| (compliance to dimensions) |
Summary of Performance Testing
11
| Test | Test Method/ Standard |
|---|---|
| Residual Volume | In-house test method |
| Device Leakage | In-house test method |
| Device Total Penetration Force | In-house test method |
| Vial Adapter Detachment Force | In-house test method |
| Product Retention in Blister | In-house test method |
| Vacuum Test | In-house test method |
| Device Removal Force from Blister | In-house test method |
| Tyvek Total Peel Test Force | In-house test method |
| Functionality according to IFU | In-house test method |
| Leakage under Normal Use | In-house test method |
| Product Skirt Position on Vial | In-house test method |
| Injection Force | In-house test method |
| Aspiration Force | In-house test method |
| Label Legibility | In-house test method |
| Opening Torque Test | In-house test method |
Performance testing and risk management review indicate all product design requirements are verified and the residual risk level is acceptable based on the test results. Together, objective evidence satisfies the product requirements for performance, safety, and effectiveness, and the results support a determination of substantial equivalence to the predicate device.
Biocompatibility Testing
The biocompatibility evaluation for the Mix2Vial® Transfer Device was conducted in accordance with, 2020 FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
In accordance with ISO 10993-1:2018, the subject device Mix2Vial® Transfer Device is classified as an externally communicating device, having prolonged indirect contact with the patient blood path (24 hours to 30 days).
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Sterilization
The subject device is terminally sterilized using a Gamma irradiation sterilization method, validated in accordance with standard BS EN ISO 11137-1:2015 & A2:2019 Sterilization of health care products – Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and BS EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and ISO 13004 -Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose: Method VDmaxSD. The sterilization method of Gamma irradiation provides a sterility assurance level (SAL) of 10-6.
Bacterial Endotoxin Testing by limulus amebocyte lysate (LAL) was also performed on the same batch of product used for sterility dose verification, which passed with acceptable levels, further ensuring the safety of the device.
CLINICAL DATA
Clinical trials were not performed for the Mix2Vial® Transfer Device.
CONCLUSION
In summary, the subject device, Mix2Vial® Transfer Device is determined to be substantially equivalent to the predicate device (K031861) in technology, principle of operation, materials, and performance in comparison to the predicate device, when used as intended use environment by the intended users.