(90 days)
The device is intended for the transfer and injection of drugs contained in a vial.
The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use 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 MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.
The provided FDA 510(k) summary for the MixJect® Transfer Device (K230464) describes performance testing, but it does not specify explicit acceptance criteria in a quantitative manner or provide specific performance data points in a table as requested. Instead, it states that testing "confirm[s] the MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and verify conformity to the applicable external and internal standards and demonstrate substantial equivalence to the predicate device."
Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific numerical values based on this document. However, I can infer the types of performance metrics and the general conclusion of the study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific quantitative acceptance criteria and reported performance values are not provided in this document. The document primarily lists the types of performance tests conducted and generally states that the device meets requirements and standards.
Inferred Performance Metrics (from "Performance Testing" section):
| Performance Metric | (Inferred) Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | ||
| Fragmentation | Conforms to ISO 8536-2:2010 section 6.2.2 requirements | Met applicable design and performance requirements. |
| Particulate Matter | Conforms to USP <788> requirements | Met applicable design and performance requirements. |
| Internal Diameter Upper Skirt | Conforms to ISO 8362-6:2010 Section 4.2 requirements and in-house method | Met applicable design and performance requirements. |
| Luer Gauging | Conforms to ISO 594-1:1986 and ISO 594-2:1998 requirements | Met applicable design and performance requirements. |
| Luer Stability & Compliance (ISO 80369-7) | Conforms to ISO 80369-7:2021, ISO 80369-20:2015 Annex B, C, D, E, F, G requirements | Met applicable design and performance requirements. |
| Residual Volume | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Leakage | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Total Penetration Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Vial Adapter Detachment Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Product Retention in Blister | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Flow Rate | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Device Removal Force from Blister | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Tyvek Total Peel Test Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Injection Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Aspiration Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Impact Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Needle Protective Cap Removal Force | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Torque Test | Conforms to in-house test method requirements | Met applicable design and performance requirements. |
| Functional Performance | ||
| Functionality according to IFU | Device operates as described in Instructions For Use (IFU) | Met applicable design and performance requirements. |
| Label Legibility | Labels are clear and legible | Met applicable design and performance requirements. |
| Biocompatibility | ||
| Cytotoxicity | Conforms to ISO 10993-5:2009 standards | Battery of tests conducted; results were acceptable. |
| Hemolysis (ASTM & ISO) | Conforms to ISO 10993-4:2017 and ASTM F756 standards | Battery of tests conducted; results were acceptable. |
| Maximization and Sensitization | Conforms to ISO 10993-10:2010 standards | Battery of tests conducted; results were acceptable. |
| Intracutaneous Reactivity | Conforms to ISO 10993-10:2010 standards | Battery of tests conducted; results were acceptable. |
| Acute Systemic Toxicity | Conforms to ISO 10993-11:2017 standards | Battery of tests conducted; results were acceptable. |
| Material Mediated Pyrogenicity | Conforms to ISO 10993-11:2017 standards | Battery of tests conducted; results were acceptable. |
| Sterilization | ||
| Sterility Assurance Level (SAL) | Achieve SAL of 10-6 | Achieved SAL of 10-6. |
| Bacterial Endotoxin | Acceptable levels per limulus amebocyte lysate (LAL) testing | Passed with acceptable levels. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its requirements is a series of non-clinical bench performance tests and biocompatibility tests as detailed in the "Performance Data" section of the 510(k) submission.
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size (number of devices) used for each individual performance test or biocompatibility test.
- Data Provenance: The document does not explicitly state the country of origin of the data for the performance or biocompatibility tests. It indicates the manufacturer, West Pharma. Services IL, Ltd., is located in Ra'anana, Israel. The studies are retrospective in the sense that they are laboratory and bench studies conducted on the device, not ongoing clinical observations.
3. Number of Experts and Qualifications:
- Not Applicable. For non-clinical bench testing and biocompatibility assessments, the ground truth is established by objective measurements against recognized international and internal standards, rather than expert consensus on medical images or diagnoses. These tests are typically performed by qualified laboratory technicians and overseen by engineers or scientists with expertise in material science, mechanical testing, and biocompatibility, who interpret the results against established regulatory requirements and standards.
4. Adjudication Method:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is required for ground truth labeling, often for diagnostic accuracy studies. This document reports on bench and biocompatibility testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical trials were not performed for the MixJect® Transfer Device." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is applicable or reported.
6. Standalone Performance Study:
- Yes, in the context of a medical device. The entire "Performance Data" section describes standalone performance of the device itself through a variety of engineering, material, and biological safety tests (bench tests, biocompatibility tests). These tests establish the device's inherent properties and functionality without a human-in-the-loop performance assessment (which would be a clinical trial).
7. Type of Ground Truth Used:
- The ground truth for the performance tests and biocompatibility tests is based on:
- International Standards: e.g., ISO 8536-2, USP <788>, ISO 80369-7, ISO 10993 series, BS EN ISO 11137 series.
- In-house test methods: Developed and validated by the manufacturer to assess specific device functions.
- Established biological principles and safety thresholds: For biocompatibility and sterility.
8. Sample Size for Training Set:
- Not Applicable. This device is a physical medical device (an intravascular administration set), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, material science knowledge, and previous device iterations.
9. How Ground Truth for Training Set Was Established:
- Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 23, 2023
West Pharma Services IL, Ltd. % Fred Cowdery Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, Pennsylvania 19341
Re: K230464
Trade/Device Name: MixJect® Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI
Dear Fred Cowdery:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 22, 2023. Specifically, FDA is updating this SE Letter to add the missing clearance date as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-1480, david.wolloscheck(@fda.hhs.gov.
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 Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
West Pharma Services IL, Ltd. % Fred Cowdery Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, Pennsylvania 19341
Re: K230464
Trade/Device Name: MixJect® Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: February 17, 2023 Received: February 21, 2023
Dear Fred Cowdery:
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
{2}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 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 (OS) 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 mediation-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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K230464
Device Name MixJect® Transfer Device
| Indications for Use (Describe) |
|---|
| The device is intended for the transfer and injection of drugs contained in a vial. |
| 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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K230464 - 510(k) SUMMARY
Date Prepared: May 22, 2023
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
Contact Person:
Fred Cowdery Director, Regulatory Affairs, Medical Devices Phone: 267-205-1273 Fax: 610-717-0668 E-mail: fred.cowdery@westpharma.com
SUBJECT DEVICE
| Trade Name: | MixJect® 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
| Predicate Device | MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable VialHolder and Preattached Needle |
|---|---|
| 510(k) Number | K001293 |
| Common/Usual Name | I.V. Fluid Transfer Set |
| Product Code | LHI |
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| Regulation Name / Number / Class | Intravascular Administration Set / 21CFR880.5440 / Class II |
|---|---|
| Panel | General Hospital |
INDICATION FOR USE
The device is intended for the transfer and injection of drugs contained in a vial.
DEVICE DESCRIPTION
Device Overview
The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial.
The MXJ device is intended for use 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 MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life.
The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core.
The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device.
The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body.
A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle.
The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.
In accordance with ISO 10993-1:2018, the subject device MixJect® Transfer Device is classified as an externally communicating device, having limited indirect contact with the patient blood path (< 24 hour). The subject device needle has transient contact (<60 minutes) with the patient body.
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Principle of Operation
The MXJ is operated by a manual process. The subject device connects to a drug vial (supplied by the Drug Manufacturer) having a neck diameter of 13mm via the Vial Adapter portion of the MXJ device.
The vial adapter contains an integral plastic cannulated spike located in the center of the MXJ Vial Adapter component, 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 vial and the syringe.
A prefilled diluent syringe is then connected to the MXJ, interfacing to a female Luer lock port located on the MXJ body.
The diluent is then injected into the drug vial. The reconstituted medicament is then aspirated back into the syringe.
The MXJ body is then manually rotated in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle.
After reconstitution and aspiration, the drug can be administered through the attached syringe / needle.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The MixJect® Transfer Device is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device, MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle, cleared under K001293.
A summary of equivalence and differences between the subject device and the predicate device are provided in the table below.
| Areas forComparison | Subject DeviceMixJect® Transfer Device | Predicate Device(K001293): | Comparison |
|---|---|---|---|
| General Information | |||
| Manufacturer | West Pharma. Services IL, Ltd. | Medimop Medical Projects, Ltd./West Pharma. Services IL., Ltd. | Different; Medimop acquired by West Pharmaceutical Services, Inc. |
| Device Trade Name | MixJect® Transfer Device | MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle | Similar: Changed for marketing purposes only. Change does not impact device intended use. |
| Catalog Number | 970133 | 800405 | Similar: Change does not impact device intended use. |
| Indications for Use | The MixJect® Transfer Device is intended for the transfer and injection of drugs contained in a vial. | Transfer, mixing, and injection of drugs contained in a vial. | Similar – Differences do not raise new or additional concerns regarding device safety profile or clinical effectiveness. |
| Contraindications | None known | None known | Identical |
| Intended UserPopulation | Intended for use by Healthcare Professionals (HCPs) | Intended for use by Healthcare Professionals (HCPs) | Identical |
| Intended UseEnvironment | Intended for use in hospitals, outpatient nursing units and other suitable clinical environments | Intended for use in hospitals, outpatient nursing units and other suitable clinical environments | Identical |
| Device Class &Classification Name | Class II, I.V. Fluid Transfer Set | Class II, I.V. Fluid Transfer Set | Identical |
| Regulation Number / Name | 21CFR 880.5440Intravascular Administration Set | 21CFR 880.5440Intravascular Administration Set | Identical |
| Areas forComparison | Subject DeviceMixJect® Transfer Device | Predicate Device(K001293):MixJect Dispensing Pin /with Detachable Vial Holder/ with Detachable VialHolder and PreattachedNeedle | Comparison |
| Product Code | LHI | rhi | Identical |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Shelf life | 3 years | 3 years | Identical |
| Design | |||
| Operation Principle | Manual | Manual | Identical |
| Design/construction | Featuring a 13mm Vial Adaptorbody with tight grip hold("wings"), intended to beattached to a standard drug vialwith a neck diameter of 13mm.The device contains a piercingspike, a 30Ga Needle and afemale Luer lock fittingcompliant with BS EN ISO80369-7:2016, for attachment toa standard accessory such as asyringe (not supplied). | Featuring a 13mm VialAdaptor body with tight griphold ("wings"), intended tobe attached to a standard drugvial with a neck diameter of13mm. The device containsa piercing spike, a 30GaNeedle and a female Luerlock fitting compliant withISO 594-1 and ISO 594-2,for attachment to a standardaccessory such as a syringe(not supplied). | Similar - Differencesnoted with ISO LuerStandard compliance donot alter device intendeduse, clinical effectiveness,or safety profile. |
| Female Luer LockConnector | Compliant withBS EN ISO 80369-7:2016 | Compliant withISO 594-1 and ISO 594-2 | Similar – Subject deviceupdated for compliancewith latest ISO Luerstandard. No change inintended use. |
| Compatible VialSize | 13mm | 13mm | Identical |
| Body Diameter | 18.5mm to accommodate 13mmstandard vials. | 18.5mm to accommodate13mm standard vials. | Identical |
| Piercing Spike | Single lumen | Single lumen | Identical |
| Vial Adapter Fit | Vial first, snap fit to vial | Vial first, snap fit to vial | Identical |
| Material | MixJect Body: PolycarbonateMixJect Core: High DensityPolyethyleneMixJect Vial Adapter Body:Polycarbonate | MixJect Body: PolycarbonateMixJect Core: High DensityPolyethyleneMixJect Vial Adapter Body:Polycarbonate | Identical |
| Areas forComparison | Subject DeviceMixJect® Transfer Device | Predicate Device(K001293): | Comparison |
| MixJect Dispensing Pin /with Detachable Vial Holder/ with Detachable VialHolder and PreattachedNeedle | |||
| Biocompatibility | ISO 10993-1:2018External Communicating,Transient Contact (<60 min) | ISO 10993-1 and USPBiological ReactivityExternal Communicating,Transient Contact (<60 min) | Identical |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterilization | |||
| Sterility | Sterile | Sterile | Identical |
| Sterilization Method | Gamma | Gamma | Identical |
| Sterility AssuranceLevel | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | |||
| Packaging | Sterile Barrier packagematerials: PETG blister withTyvek® seal | Sterile Barrier packagematerials: PETG blister withTyvek® seal | Identical |
| Sterile Barrier packageorientation: Devices are suppliedin an individual blister, vial firstorientation. | Sterile Barrier packageorientation: Devices aresupplied in an individualblister, vial first orientation. |
Substantial Equivalence Comparison Table
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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 MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and verify conformity to the applicable external and internal standards and demonstrate 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.
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| Test | Test Method/ Standard |
|---|---|
| Fragmentation Test | ISO 8536-2:2010 section 6.2.2 |
| Particulate Testing | USP <788> |
| 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 forthe leakage reference connector (fluidleakage) |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20:2015, Annex D & Annex C forthe leakage reference connector (air leakage) |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex E & Annex C forthe stress cracking reference connector |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex F & Annex C forthe axial load reference connector |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C forthe resistance separation from unscrewingreference connector |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C forthe overriding reference connector |
| Luer Stability and compliance to ISO 80369-7 | ISO 80369-7:2021 Table B.2 and B.5(compliance to dimensions) |
| 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 |
| Flow Rate | In-house test method |
| Device Removal Force from Blister | In-house test method |
| Tyvek Total Peel Test Force | In-house test method |
| Test | Test Method/ Standard |
| Internal Diameter Dimensional Measurements Upper Skirt | In-house test method |
| Functionality according to IFU | In-house test method |
| Injection Force | In-house test method |
| Aspiration Force | In-house test method |
| Label Legibility | In-house test method |
| Impact Force | In-house test method |
| Needle Protective Cap Removal Force | In-house test method |
| Torque Test | In-house test method |
Summary of Performance Testing
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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 MixJect® Transfer Device was conducted in accordance with, 2016 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. The battery of testing included the following tests:
ISO 10993-5:2009: Cytotoxicity ISO 10993-4: 2017: ASTM Hemolysis ASTM F756: Hemolysis Study ISO 10993-10:2010: Maximization and Sensitization ISO 10993-10:2010: Intracutaneous Reactivity ISO 10993-11:2017: Acute Systemic Toxicity ISO 10993-11:2017: Material Mediated Pyrogenicity
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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 VDmaxD. 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. The Sterility Validation and Bacterial Endotoxin Testing are provided within this submission.
CLINICAL DATA
Clinical trials were not performed for the MixJect® Transfer Device.
CONCLUSION
The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The subject device, MixJect® Transfer Device is substantially equivalent to the predicate device, MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle.
§ 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.