Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a purely mechanical drug transfer and injection system with no mention of computational or data-driven components.

Therapeutic

No
The device is described as a transfer and injection device for drugs, not as a device that provides therapy itself. It facilitates drug administration, but doesn't have a direct therapeutic effect on the patient.

Diagnostic

No

Explanation: The device description clearly states its intended use is for "the transfer and injection of drugs contained in a vial." There is no mention of it being used to diagnose conditions or collect diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical device with multiple hardware components (needle, vial adapter, body, core) intended for the transfer and injection of drugs. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "for the transfer and injection of drugs contained in a vial." This describes a device used for administering medication, not for performing diagnostic tests on biological samples.
Device Description: The description details a mechanical device for reconstituting and injecting drugs. It does not mention any components or processes related to analyzing biological specimens (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state.
Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical methods typically associated with IVD devices.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is solely related to the preparation and administration of a drug.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for the transfer and injection of drugs contained in a vial.

Product codes (comma separated list FDA assigned to the subject device)

LHI

Device Description

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 (), 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, ISO 80369-20:2015 Annex B, D, E, F, G, and ISO 80369-7:2021 Table B.2 and B.5). In-house test methods were used for Residual Volume, Device Leakage, Device Total Penetration Force, Vial Adapter Detachment Force, Product Retention in Blister, Flow Rate, Device Removal Force from Blister, Tyvek Total Peel Test Force, Internal Diameter Dimensional Measurements Upper Skirt, Functionality according to IFU, Injection Force, Aspiration Force, Label Legibility, Impact Force, Needle Protective Cap Removal Force, and Torque Test.

Biocompatibility evaluation was performed in accordance with ISO 10993-1:2018, including ISO 10993-5:2009 (Cytotoxicity), ISO 10993-4:2017 and ASTM F756 (Hemolysis), ISO 10993-10:2010 (Maximization and Sensitization, Intracutaneous Reactivity), and ISO 10993-11:2017 (Acute Systemic Toxicity, Material Mediated Pyrogenicity).

Sterilization was validated using Gamma irradiation in accordance with BS EN ISO 11137-1:2015 & A2:2019, BS EN ISO 11137-2:2015, and ISO 13004, achieving a SAL of 10-6. Bacterial Endotoxin Testing by limulus amebocyte lysate (LAL) was also performed.

Key results: Performance testing and risk management review indicate all product design requirements are verified and the residual risk level is acceptable. The results support a determination of substantial equivalence to the predicate device. Clinical trials were not performed.

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.

K001293

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

Regulation Number and Section

§ 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.

Summary

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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

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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 Vial
Holder 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