(90 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No.
The device is indicated for the transfer of drugs, not for treatment or diagnosis of a disease or condition.
No
The device is described as a "Vial Adapter" for the transfer of drugs, and its intended use is for drug transfer, not for diagnosing any condition or disease.
No
The device description clearly states it is a physical, single-use, molded polycarbonate part with a Luer port and integral plastic spike, 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 is "for the transfer of drugs contained in a vial." This describes a device used for handling and administering medications, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical device for accessing and transferring liquid from a vial. It does not mention any components or functions related to analyzing biological specimens (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents
- Assays
- Measurement of analytes
- Diagnostic or monitoring purposes
The device is clearly intended for drug preparation and administration, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vial Adapter is indicated for the transfer of drugs contained in a vial.
Product codes
LHI
Device Description
The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having 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
Not Found
Intended User / Care Setting
Intended for use in hospitals, outpatient nursing units and other suitable clinical environments by Healthcare Professionals (HCPs).
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 conducted confirms the Vial Adapter 20mm meets all applicable design and performance requirements throughout its defined shelf life, conforms to applicable external and internal standards, and demonstrates substantial equivalence to the predicate device. The following non-clinical bench performance tests were completed: Fragmentation Test, Particulate Testing, Internal Diameter Upper Skirt Test, Luer Gauging Test, Luer Stability and compliance to ISO 80369-7 (fluid leakage, air leakage, stress cracking, axial load, resistance separation from unscrewing, overriding reference connector, and dimensions), Residual Volume, Device Leakage, Device Leakage under normal use, Device Total Penetration Force, Vial Adapter Detachment Force, Product Retention in Blister, Device Removal Force from Blister, Tyvek Total Peel Test, Functionality according to IFU, Filter Efficiency, Syringe First Orientation, Product Skirt Position on Vial, Injection Force, Aspiration Force, Label Legibility, and Packaging Integrity.
Biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018 and the 2020 FDA Guidance: Use of International Standard ISO 10993-1. Tests successfully conducted include: 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, and ISO 10993-12:2012: Solvent and Extraction Condition.
Sterilization validation was performed in accordance with ISO 11137-1:2015 & A2:2019, ISO 11137-2:2015, and ISO 13004. Bacterial Endotoxin Testing by Limulus Amebocyte Lysate (LAL) was also performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 14, 2023
West Pharma Services IL, Ltd. David Ceretti Principal Regulatory Affairs Specialist 4 Hasheizaf St Ra'anana. 4366411 Israel
Re: K232875
Trade/Device Name: Vial Adapter 20mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: September 14, 2023 Received: September 15, 2023
Dear David Ceretti:
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/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.
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).
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Page
2
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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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-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).
2
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
Enclosure
3
Indications for Use
510(k) Number (if known) K232875
Device Name Vial Adapter 20mm
Indications for Use (Describe) The Vial Adapter is indicated for the transfer of drugs contained in a vial.
| 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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4
K232875- 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
Contact Person:
David Ceretti Principal Regulatory Affairs Specialist Phone: 484-757-0426 Fax: 610-717-0668 E-mail: Dave.Ceretti@westpharma.com
Date Prepared: December 14, 2023
DEVICE
| Trade Name: | Vial Adapter 20mm |
|---|---|
| Common/Usual Name: | I.V. Fluid Transfer Set |
| Regulation Name: | Intravascular Administration Set |
| Product Code: | LHI |
| Regulation Number: | 880.5440 |
| Class: | II |
| Panel Identification: | General Hospital Panel |
5
PREDICATE DEVICE
MixJect Dispensing Pin – K001293.
No reference devices were used in this submission.
DEVICE DESCRIPTION
Device Overview
The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial.
The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number.
The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation, which function as follows:
The VF packaging orientation allows the VA 20mm device to be attached to a vial immediately after the removal of the packaging Tyvek® lid stock, while still cradled by the blister pack. The blister package is then removed leaving the VA 20mm attached to the vial.
The SF packaging orientation allows the VA 20mm device to be attached to a syringe immediately after the removal of the packaging Tyvek® lid stock, while still cradled by the blister pack. Using the syringe, the VA 20mm device is then removed from the blister packaging.
The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.
6
Principle of Operation
The VA 20mm device is operated by a manual process. The subject device connects to a drug vial (supplied by the Drug Manufacturer) having a neck diameter of 20mm, along with a female Luer Lock. The VA 20mm contains an integral plastic cannulated spike located in the center of the VA, 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 syringe. Depending on the catalog number ordered, the VA 20mm cannulated spike may be provided lubricated with a sterile silicone compound.
For the Syringe First (SF) Female Luer Lock (FLL) Vial Adapter, a prefilled slip syringe is connected to the female Luer Lock port located on the SF FLL VA by turning the syringe clockwise until secure. Once the vial and syringe are firmly attached to the SF FLL VA, the diluent is then injected into the vial. The drug is then aspirated back into the syringe by means of inverting SF FLL VA with the vial up and pulling the plunger downward. The vial and device are then inverted with the vial down and the syringe is then manually rotated in a counterclockwise direction, allowing the syringe to be removed from the SF FLL VA. The drug is then ready for administration per the instructions in the drug manufacturer's packaging insert.
For the Vial First (VF) Female Luer Lock (FLL) Vial Adapter, the VF FLL VA is firmly attached to the vial. A prefilled slip syringe is connected to the VF FLL VA, interfacing with the female Luer Lock port located on the top of the VF FLL VA, by turning the syringe clockwise until a secure connection is obtained. The diluent is then injected into the vial. The drug is then aspirated back into the syringe by means of inverting VF VA with the vial up (vertical) and pulling the plunger downward. The vial and subject device are then inverted with the vial down and the Syringe is then manually rotated in a counterclockwise direction, allowing the syringe to be removed from the VF FLL VA. The drug is then ready for administration per the instructions in the drug manufacturer's packaging insert.
INDICATION FOR USE
The Vial Adapter is indicated for the transfer of drugs contained in a vial.
7
SUBSTANTIAL EQUIVALENCE COMPARISON
The Vial Adapter 20mm is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device MixJect Dispensing Pin, cleared under K001293.
Indications for Use Comparison Summary
The Indications for Use statement for the Vial Adapter is not identical to the predicate device. However, the differences do not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate.
The subject device is indicated for the transfer of drugs contained in a vial.
The predicate device is indicated for the transfer and mixing of drugs contained in a vial.
The mixing claim has been removed from the subject device labeling, including the Indications for Use statement. As indicated in the device Instructions for Use, the mixing operation is defined by the Drug manufacturer. Therefore, West Pharmaceutical Services, Inc does not maintain verification or validation data within the device Design History File to substantiate the mixing claim.
The subject device, Vial Adapter, and predicate device, MixJect Dispensing Pin, have identical regulation number / code, product code, and device classification.
Both devices are intended for use by Health Care Professionals (HCP) in hospitals or healthcare facilities.
Technological Characteristics Comparison Summary
The subject device is identical to the predicate device in its operation principles, compatible vial size, body diameter, piercing spike (with a siliconization option), vial adapter fit, material, sterility method, and packaging.
Similarities can be found in the packaging design as both the subject and predicate device are packaged in vial first configuration, while the subject device also has a syringe first configuration option. Additionally, the subject device can withstand a shelf life of 5 years, while the predicate had been cleared for 3-vear shelf-life.
The differences between the subject and the predicate device consist of a new tight grip and an optional inline mesh filter in the subject device, not previously available for the predicate device. Further, the Luer connector design construction in the subject device has been redesigned to be compliant with ISO 80369-7:2021 vs. the predicate device being compliant with ISO 594-1 and ISO 594-2.
8
A comparison of equivalence and differences between the subject device and the predicate device is provided in the table below.
| Areas for
Comparison | Subject Device
Vial Adapter 20mm | Predicate Device (K001293):
MixJect Dispensing Pin | Comparison |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Device Trade Name | Vial Adapter | MixJect Dispensing Pin | Different: A business
decision was made to
change the name of the
MixJect Dispensing
Pin to Vial Adapter
20mm for marketing
purposes. |
| Indications for Use | Transfer of drugs contained
in a vial | Transfer and mixing of drugs
contained in a vial. | Different: Removal of
"mixing" claim since
drug mixing
instructions are
provided by the
customer, not West
Pharmaceutical
Services (WPS).
Therefore, WPS does
not have Verification /
Validation data on file
to substantiate this
claim and consequently
has removed this
claim. This claim
removal does not raise
new or additional
concerns regarding
device safety profile or
clinical effectiveness. |
| Intended User
Population | Intended for use by Healthcare
Professionals (HCPs) | Intended for use by Healthcare
Professionals (HCPs) | Identical |
| Intended Use
Environment | 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 |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Areas for
Comparison | Subject Device
Vial Adapter 20mm | Predicate Device (K001293):
MixJect Dispensing Pin | Comparison |
| Shelf life | 5 years | 3 years | Different: The subject
device packaging and
performance has been
tested and determined
to withstand a shelf life
of 5 years, per ASTM
F1886, in comparison
to the predicate device
withstanding a shelf
life of 3 years. These
changes do not raise
new or additional
concerns regarding
device safety profile or
clinical effectiveness. |
| Design | | | |
| Operation Principle | Manual | Manual | Identical |
| Design/construction | Featuring a 20mm Vial
Adaptor, with and without
tight grip hold (“wings”) and
filter intended to be attached to
a standard drug vial with a
neck diameter of 20mm. The
device contains either a silicon
or non-silicone piercing spike,
and a female Luer Lock fitting
compliant with ISO 80369-
7:2021, for attachment to a
standard accessory such as a
syringe (not supplied) | Featuring a 20mm Vial
Adaptor intended to be
attached to a standard drug vial
with a neck diameter of 20mm.
The device contains a silicone
and non-silicone piercing
spike, and a female Luer Lock
fitting compliant with ISO
594-1 and ISO 594-2, for
attachment to a standard
accessory such as a syringe
(not supplied). | Different -The
differences noted with
ISO Luer Standard
compliance, and
additional tight grip
and filter options do
not alter the device
intended use, clinical
effectiveness, or safety
profile. These changes
do not raise new or
additional concerns
regarding the device's
safety profile or
clinical effectiveness. |
| Female and Male
Luer Lock Connector | Compliant with
ISO 80369-7:2021 | Compliant with
ISO 594-1 and ISO 594-2 | Different - Subject
device updated for
compliance with latest
ISO Luer standard. No
change in the intended
use or device
performance. |
| Compatible Vial Size | 20mm | 20mm | Identical |
| Areas for
Comparison | Subject Device
Vial Adapter 20mm | Predicate Device (K001293):
MixJect Dispensing Pin | Comparison |
| Body Diameter | 17.4mm (TG) and 23.6mm to
accommodate 20mm standard
vials | 23.6mm to accommodate
20mm standard vials | Identical - standard
23.6mm for 20mm
standard vials
Different - Additional
Tight Grip (TG)
17.4mm body diameter
as the subject device is
not offered in the
predicate device.
The addition does not
raise new or additional
concerns regarding
device safety profile or
clinical effectiveness. |
| Piercing Spike | Single lumen | Single lumen | Identical |
| Vial Adapter Fit | snap fit to vial | snap fit to vial | Identical |
| Material | Vial Adapter Body/Vial
Holder: Polycarbonate
Lubricant (optional):
DOWSIL 360 Medical Fluid
In-Line Filter (optional):
Polyethylene Mesh | MixJect Body / Vial Holder:
Polycarbonate
Lubricant:
DOWSIL 360, Medical Grade | Identical - The
Body/Vial Holder and
lubricant material is
identical.
Different - The subject
device also has an
optional in-line filter,
not offered with the
predicate device.
These additions do not
raise new or additional
concerns regarding the
device's safety profile
or clinical
effectiveness. |
| Biocompatibility | ISO 10993-1:2018
External Communicating,
Limited Contact (