(28 days)
No
The description focuses on a mechanical fluid transfer device and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is described as an "admixture device" for reconstituting and transferring fluids from drug vials into IV bags. It facilitates drug preparation but does not directly administer therapy or perform a therapeutic function on a patient.
No
This device is described as an "admixture device" for reconstituting and admixing drugs into an IV bag for administration to a patient. Its function is to facilitate fluid transfer and preparation of medications, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, single-use, sterile, needle-less fluid transfer device with specific components (body, Protector, IV Port, integrated vial adapter). It is designed to connect physical objects (IV bag, vial, IV administration set). There is no mention of software as a component or function of the device.
Based on the provided information, the Vial2Bag Advanced® 20mm Admixture Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for connecting an IV bag, vial, and administration set to reconstitute and/or admix drugs prior to administration to the patient. This describes a process related to drug preparation and delivery, not the examination of specimens taken from the human body.
- Device Description: The description details a fluid transfer device for moving substances between a vial and an IV bag. This aligns with drug preparation and administration, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Vial2Bag Advanced® 20mm Admixture Device does not fit this description.
N/A
Intended Use / Indications for Use
The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.
Product codes
LHI
Device Description
The Vial2Bag Advanced® 20mm Admixture Device is a single-use, sterile, needle-less, non-pyrogenic, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is intended to be used with standard drug vials with a 20mm closure and an elastomeric stopper. The Vial2Bag Advanced® 20mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set.
Users should not attach a Vial2Bag Advanced® device to another Vial2Bag Advanced® Device.
The device does not contain any medicinal substances and no additional accessories are required nor provided with the Vial2Bag Advanced® 20mm Device to meet its intended purpose.
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
adolescent and adult patients only
Intended User / Care Setting
Intended for use by Healthcare Professionals (HCPs)
Intended for use in hospitals, outpatient nursing units and other suitable clinical environments
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
Performance Testing was conducted to ensure that the Vial2Bag Advanced® 20mm Admixture Device met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
Test types include: Vial Adaptor Tensile Detachment Force, Vial Adaptor Torque Test, Detachment Force of Vial Adapter from Vial, Attachment Force of Vial Adapter to the Vial, Leakage Testing, Internal Diameter of the Upper Skirt for Vial Adapter, 1m Drop Durability, Fragmentation, Mass Transfer, Residual Volume, Dose Concentration.
Biocompatibility Testing: In accordance with ISO 10993-1, the subject device, Vial2Bag Advanced® 20mm Admixture Device, is classified as an externally communicating device with prolonged contact duration (>24 hours to 30 days) and blood path indirect contact. The reference device (K201415) biocompatibility test reports are deemed applicable and are being leveraged for the subject device to demonstrate biological safety.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2024
West Pharmaceutical Services, Inc. % Fred Cowdery Director Regulatory Affairs 530 Herman O. West Drive Exton, Pennsylvania 19431
Re: K240940
Trade/Device Name: Vial2Bag Advanced® 20mm Admixture Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: March 19, 2024 Received: April 5, 2024
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 (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).
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 820.30 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 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, Pasane 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
2
Indications for Use
510(k) Number (if known) K240940
Device Name
Vial2bag Advanced® 20mm Admixture device
Indications for Use (Describe)
The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.
| 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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3
K240940 - 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:
Fred Cowdery Director, Regulatory Affairs Phone: 267-205-1273 Fax: 610-717-0668 E-mail: fred.cowdery@westpharma.com
Date Prepared: 05-Apr-2024
DEVICE
| Trade Name: | Vial2Bag Advanced® 20mm Admixture 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 |
4
PREDICATE DEVICE
Vial2Bag Advanced® 13mm Admixture Device (K230988).
A reference device, Vial2Bag Advanced® 20mm Admixture Device; K201415 is also included in this submission.
DEVICE DESCRIPTION
Device Design and Operation
The Vial2Bag Advanced® 20mm Admixture Device is a single-use, sterile, needle-less, nonpyrogenic, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is intended to be used with standard drug vials with a 20mm closure and an elastomeric stopper. The Vial2Bag Advanced® 20mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set.
Users should not attach a Vial2Bag Advanced® device to another Vial2Bag Advanced® Device.
The device does not contain any medicinal substances and no additional accessories are required nor provided with the Vial2Bag Advanced® 20mm Device to meet its intended purpose.
Principle of Operation
The Vial2Bag Advanced® 20mm Admixture Device is operated by manual process. The Vial Adapter is first attached to the drug vial, and after removing the Protector, the IV spike is then connected to the administration port of the IV bag. Fluid is transferred from the IV bag to the drug vial to reconstitute/dilute the drug prior to being transferred back to the IV bag. The IV administration set is then connected to the device's IV Port followed by administration to the patient.
INDICATION FOR USE
The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.
Both the subject and predicate devices have the same intended use except for the specified vial closure diameter. While the predicate device is interface with vials having a 13mm closure, the subject device is intended to interface with vials having a 20mm closure.
5
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALAENCE
The Vial2Bag Advanced® 20mm Admixture Device, subject of this Special 510(k), is substantially equivalent in its intended use, design, technology, principles of operation, materials (with exception of Vial Adapter colorant additive), and performance to the predicate device, Vial2Bag Advanced® 13mm Admixture Device, cleared under K230988.
A summary comparing the subject device and the predicate device are provided in the table below.
| Areas for
Comparison | Subject Device
Vial2Bag Advanced®
20mm Admixture Device | Predicate Device
(K230988)
Vial2Bag Advanced®
13mm Admixture Device | Comparison |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | To serve as a connection
between a 50, 100, or
250ml IV bag, vial with
20mm closure, and an
external IV administration
set. The integrated Vial
Adapter makes it possible
to reconstitute and/or
admix drugs. Indicated for
adolescent and adult
patients only. | To serve as a connection
between a 50, 100, or
250ml IV bag, vial with
13mm closure, and an
external IV administration
set. The integrated Vial
Adapter makes it possible
to reconstitute and/or
admix drugs. Indicated for
adolescent and adult
patients only. | Difference #1: Although the
subject device Vial Adapter
size differs from the predicate
device, the reference device
performance test results
confirm the vial adapter size
does not raise new or different
questions of safety and
effectiveness. |
| Contraindications | None known | None known | Identical |
| 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 |
| Device Product
Code, Class &
Classification Name | LHI, Class II, I.V. Fluid
Transfer Set | LHI, Class II, I.V. Fluid
Transfer Set | Identical |
| Regulation Number
/ Name | 21CFR 880.5440
Intravascular
Administration Set | 21CFR 880.5440
Intravascular
Administration Set | Identical |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Operation Principle | Manual | Manual | Identical |
| Design | Made of plastic material,
featuring a Vial Adapter
to access the drug content | Made of plastic material,
featuring a Vial Adapter to
access the drug content in a | Difference #1:
Although the subject device
Vial Adapter size differs from |
| Areas for
Comparison | Subject Device
Vial2Bag Advanced®
20mm Admixture Device | Predicate Device
(K230988)
Vial2Bag Advanced®
13mm Admixture Device | Comparison |
| | in a 20mm vial, an IV
Spike integrated for
connection to an IV bag,
and a twist off which,
after removal, opens the
IV port for connection to
the IV administration set. | 13mm vial, an IV Spike
integrated for connection
to an IV bag, and a twist
off which, after removal,
opens the IV port for
connection to the IV
administration set. | the predicate device, the
reference device performance
test results confirm the vial
adapter size difference does not
raise new or different questions
of safety and effectiveness. |
| Materials of
Construction | 20mm Vial Adapter:
Polycarbonate (PC) +
Blue colorant masterbatch | 13mm Vial Adapter:
Polycarbonate (PC) +
Orange colorant
masterbatch | Difference #2: Although the
subject device Vial Adapter
colorant differs from the
predicate device, the reference
device Biocompatibility test
reports confirm subject device
colorant does not impact device
intended use, clinical
effectiveness, or safety profile. |
| | IV Port Twist Off: PC +
Polyvinyl Chloride (PVC)
3224 (non-DEHP) | IV Port Twist Off: PC +
Polyvinyl Chloride (PVC)
3224 (non-DEHP) | Identical |
| | Spike Protector: Low
Density Polyethylene
(LDPE) | Spike Protector: Low
Density Polyethylene
(LDPE) | Identical |
| Compatible Vial
Size | 20mm | 13mm | Difference #1: Although the
subject device Vial Adapter
size differs from the predicate
device, the reference device
performance test results
confirm the vial adapter size
does not raise new or different
questions of safety and
effectiveness. |
| Bag Size | 50, 100, 250mL | 50, 100, 250mL | Identical |
| Dose Concentration | 200% | 200% | Identical |
| Single/inline
configuration | Single configuration only
Do not attach one device
to another device. | Single configuration only
Do not attach one device to
another device. | Identical |
| Vial Adapter Fit | Vial first, snap fit to vial | Vial first, snap fit to vial | Identical |
| Performance on
fluid transfer | Transfer of vial contents
to the IV bag and to the
administration set was
quantified to establish
product requirement. | Transfer of vial contents to
the IV bag and to the
administration set was
quantified to establish
product requirement. | Identical |
| Biocompatibility | ISO 10993-1:2018
External Communicating,
Prolonged Indirect Blood
Contact (>24hr to 30 days) | ISO 10993-1:2018
External Communicating,
Prolonged Indirect Blood
Contact (>24hr to 30 days) | Identical |
| Areas for
Comparison | Subject Device
Vial2Bag Advanced®
20mm Admixture Device | Predicate Device
(K230988)
Vial2Bag Advanced®
13mm Admixture Device | Comparison |
| | Contact (>24hr to 30
days) | | |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterility | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterility Assurance
Level | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | Sterile Barrier package
materials: PETG blister
with Tyvek® seal | Sterile Barrier package
materials: PETG blister
with Tyvek® seal | Identical |
Substantial Equivalence Comparison Table
6
7
- Difference #1- Although the subject device Vial Adapter size differs from the predicate . device, the reference device, performance test results confirm the vial adapter size does not raise new or different questions of safety and effectiveness.
- . Difference #2 - Although the subject device Vial Adapter colorant differs from the predicate device, the reference device Biocompatibility and Chemical test reports confirm subject device colorant does not impact device intended use, clinical effectiveness, or safety profile.
Although the subject and reference devices are similar in design and technology, the reference device materials contain a DEHP plasticizer additive, which is not present in the subject device components. Functionally, the subject device, Vial2Bag Advanced® 20mm Admixture Device, is otherwise the same as the reference device cleared under K201415.
8
PERFORMANCE DATA
Performance Testing
Performance testing was conducted to ensure that the Vial2Bag Advanced® 20mm Admixture Device met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
Risks associated with the proposed changes to the subject device do not alter or introduce new device risks. The Risk Management Files prepared for both the predicate and reference devices have been maintained and remain applicable to the subject device.
This change does not raise new or different questions of safety and effectiveness. Therefore, the subject device is as safe and effective as the predicate device.
| Test | Test Method/ Standard |
|---|---|
| Vial Adaptor Tensile Detachment Force | In-house test method |
| Vial Adaptor Torque Test | In-house test method |
| Detachment Force of Vial Adapter from Vial | In-house test method |
| Attachment Force of Vial Adapter to the Vial | In-house test method |
| Leakage Testing | In-house test method |
| Internal Diameter of the Upper Skirt for Vial Adapter | In-house test method |
| 1m Drop Durability | In-house test method |
| Fragmentation | Acceptance criteria based on EN ISO 8536-2, section 6.2.2 and sample size based on EN ISO 7864, Annex B, Section B.4. |
| Mass Transfer | In-house test method |
| Residual Volume | In-house test method |
| Dose Concentration | In-house test method |
Summary of Performance Testing
Biocompatibility Testing
In accordance with ISO 10993-1. the subject device, Vial2Bag Advanced® 20mm Admixture Device, is classified as an externally communicating device with prolonged contact duration (>24 hours to 30 days) and blood path indirect contact.
The subject device materials are identical to materials included in the predicate device submission (K230988), except for the vial adapter component colorant additive. While the predicate device contains an orange colorant, the subject device contains a blue colorant identical to the reference device colorant.
Since the subject device vial adapter colorant is identical to the colorant used in the reference device vial adapter component, the reference device (K201415) biocompatibility test reports are deemed applicable and are being leveraged for the subject device to demonstrate the subject device biological safety.
9
CLINICAL DATA
No clinical trial was performed for the subject device, Vial2Bag Advanced® 20mm Admixture Device, nor required to support the proposed changes.
CONCLUSION
In summary, the Vial2Bag Advanced® 20mm Admixture Device, the subject of this Premarket Notification, is as safe, as effective, and is substantially equivalent in its intended use, technology/principle of operation, and performance to the predicate device, Vial2Bag Advanced® 13mm Admixture Device (K230988).