(145 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid transfer properties, with no mention of AI or ML.
No.
The device is a fluid transfer device used to reconstitute and/or admix drugs, not to directly treat a patient's medical condition. It prepares medication for administration.
No
This device is for transferring and admixing drugs, not for diagnosing medical conditions. It facilitates the preparation of medication for administration, as stated in the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description clearly states it is a "single use, fluid transfer device" consisting of physical components like a body, Protector, IV Port, and integrated vial adapter. It is a hardware device for drug reconstitution and transfer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to serve as a connection for reconstituting and/or admixing drugs prior to administration to the patient. This is a drug delivery and preparation function, not a diagnostic function.
- Device Description: The device description focuses on its mechanical function of transferring fluids between a vial and an IV bag. It explicitly states it does not contain medicinal substances.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the device's mechanical integrity, fluid transfer capabilities, and conformity to standards related to infusion equipment. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
In summary, the Vial2Bag Advanced™ 20mm Admixture Device is a medical device used for preparing medications for administration, not for performing diagnostic tests.
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.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Vial2Bag Advanced™ 20mm Admixture Device is a single use, fluid transfer device that allows for the 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 provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced™ 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device is limited to a single device configuration. Users should not attach a Vial2Bag Advanced™ 20 mm Admixture Device to another Vial2Bag Advanced™ 20mm Admixture Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced™ 20mm Admixture Device for the 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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to 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. A list of non-clinical bench performance tests that were completed on the device are summarized below:
Conformity to Standard:
- ISO 8536-4:2010/ Amd.1:2013
Additional Performance Testing to internal specifications:
- Vial Adaptor Tensile Detachment Force
- Vial Adaptor Torsional Breakage
- IV Port Tensile Detachment Force
- Vial Adaptor Wings Breakage
- Vial Attachment Force
- Vial Detachment Force
- Twist Off Opening Torque from IV Port
- Leakage after Removal of Twist Off
- Leakage at the Vial Adapter and Stopper Interface
- Short Circuit Test
- Vial Adaptor Color Identification
- Dose Concentration of Delivery Profile
- Transfer of Vial Contents to the Administration Set
- Transfer of Vial Contents to the Bag
- Dimensional Measurements of the IV spike lumens
- Dimensional Measurements of the VA retention feature
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 and the results support a determination of substantial equivalence.
Biocompatibility Testing:
In accordance with ISO 10993-1, the 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 finished device’s patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process." The following biocompatibility tests has been successfully conducted on the Vial2Bag Advanced™ 20mm Admixture Device:
- Cytotoxicity (Tested to ISO 10993-5:2009)
- Sensitization (Tested to ISO 10993-10:2010)
- Intracutaneous Reactivity (Tested to ISO 10993-10:2010)
- Acute Systemic Toxicity (Tested to ISO 10993-11:2017)
- Material Mediated Pyrogenicity (Tested to ISO 10993-11:2017)
- Systemic (Subacute) Toxicity (Tested to ISO 10993-11: 2017)
- ASTM Hemolysis (Tested to ISO 10993-4: 2017)
- Particulate Testing
Sterilization:
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices. The sterilization method provides a sterility assurance level (SAL) of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image contains 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.
October 21, 2020
West Pharmaceutical Services AZ, Inc. % Di Wu Senior Regulatory Affairs Specialist West Pharmaceutical Services AZ, Inc. 14677 North 74th St. Scottsdale, Arizona 85260
Re: K201415
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: September 21, 2020 Received: September 23, 2020
Dear Di Wu:
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.
1
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 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 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).
Sincerely.
for Payal Patel Acting 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
2
Indications for Use
510(k) Number (if known) K201415
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.
| 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
5 510(K) SUMMARY-K201415
5.1 SUBMITTER
Applicant:
West Pharmaceutical Services AZ, Inc. 14677 North 74th St. Scottsdale, Arizona 85260
Manufacturer:
West Pharmaceutical Services AZ, Inc. 14677 North 74th St. Scottsdale, Arizona 85260
Contact Person:
Di Wu Senior Specialist Regulatory Affairs - Medical Devices Phone: 610-594-2933 Fax: 610-717-0668 E-mail: Di.Wu@westpharma.com
Date Prepared: October 21, 2020
5.2 DEVICE
| Trade Name: | Vial2Bag Advanced™ 20mm Admixture Device |
|---|---|
| Common/Usual Name: | Vial2Bag Advanced™ 20mm Device |
| Regulation Name: | Intravascular Administration Set |
| Product Code: | LHI |
| Regulation No.: | 880.5440 |
| Class: | II |
| Panel Identification: | General Hospital Panel |
4
5.3 PREDICATE DEVICE
VIAL-MATE Reconstitution Device, K142600
5.4 DEVICE DESCRIPTION
Device Design
The Vial2Bag Advanced [M 20mm Admixture Device is a single use, fluid transfer device that allows for the 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 provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced1™ 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device is limited to a single device configuration. Users should not attach a Vial2Bag Advanced™ 20 mm Admixture Device to another Vial2Bag Advanced™ 20mm Admixture Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced™ 20mm Admixture Device for the 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 patient.
INDICATION FOR USE ર્ રંડ
Both the subject and predicate devices have the same intended use for the reconstitution and transfer of drug content from the vial into the IV bag. Both devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
5
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL 5.6 EQUIVALENCE
The Vial2Bag Advanced™ 20mm Admixture Device, subject of this Traditional 510(k) is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate device VIAL-MATE Reconstitution Device, which is cleared under K142600.
A comparison of the technological characteristics is summarized in the table below:
| Areas for
Comparison | Subject Device:
Vial2Bag Advanced™ 20mm
Admixture Device | Predicate Device:
VIAL-MATE Reconstitution
Device | Comparison |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | To provide the pharmacist or
health practitioner a means of
connecting a standard 20mm
single dose drug vial to an I.V.
solution container without
mixing the vial contents with
the diluent until immediately
before administration of the
reconstituted drug to the
patient. | Different
(Both have the same
intended use for the
reconstitution and
transfer of drug
content from the vial
into the IV bag) |
| Prescription
Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Sterility | Sterile | Sterile | Identical |
| Sterilization
Method | Ethylene Oxide | Irradiation | Different |
| Operation
Principle | Manual | Manual | Identical |
| Design | Made of plastic material,
featuring a Vial Adaptor to
access the drug content in the
20mm vial, an IV Spike
integrated for the connection to a
standard IV bag utilizing the | Made of plastic material,
featuring a Vial gripper to
access to the drug content in
the 20mm vial and a port
adaptor for the connection to | Different |
Table 5-1: Summary of Substantial Equivalence Comparison
6
| Areas for
Comparison | Subject Device:
Vial2Bag Advanced™ 20mm
Admixture Device | Predicate Device:
VIAL-MATE Reconstitution
Device | Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| | administration port, and a twist
off which after removal opens the
IV port for connection to the IV
administration set. | the VIAFLEX bag utilizing
the medication port. | |
| Drug | Powdered or liquid drug | Powdered drug | Different |
| Vial Size | 20mm | 20mm | Identical |
| Bag System | Standard IV bag | VIAFLEX bag | Different |
| Bag Size | 50, 100, 250mL | 50, 100, 250mL | 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 |
The difference in the technological characteristics between the subject and predicate device have been identified as below:
- (1) The predicate device is designed to attach to a 50, 100, or 250 mL VIAFLEX Bag utilizing the medication port of the IV bag, while the subject device, Vial2Bag Advanced™ 20mm Admixture Device, is designed to connect to a 50, 100, or 250mL standard IV bag utilizing the IV port.
- (2) The predicate device does not connect to an external IV administration set while the subject device Vial2Bag Advanced™ 20mm Admixture Device contains an IV port with twist off for the connection with any commercially available IV administration set.
- (3) The connection with the IV bag IV port and the external IV administration set places Vial2Bag Advanced™ 20mm Admixture Device directly into the administration path while the predicate connects to the medication port of the bag and does not become part of the administration path.
- (4) The predicate device is for use with powdered drug and the subject device is for use with powered or liquid drug.
- The predicate device and the subject device are made of plastic material. The (ર) detailed chemical formulation used in the materials of construction are likely different. Biocompatibility testing was conducted to evaluate the materials of the subject device.
7
- (6) The sterilization method for the predicate device is irradiation, while Vial2Bag Advanced™ 20mm Admixture Device is ethylene oxide. The sterilization method was evaluated in the subject device.
5.7 PERFORMANCE DATA
The following non-clinical data were provided in support of the substantial equivalence determination.
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. A list of non-clinical bench performance tests that were completed on the device are summarized below:
Conformity to Standard:
ISO 8536-42010/ Amd.1:2013
Additional Performance Testing to internal specifications:
- Vial Adaptor Tensile Detachment Force ●
- Vial Adaptor Torsional Breakage .
- IV Port Tensile Detachment Force ●
- Vial Adaptor Wings Breakage ●
- Vial Attachment Force ●
- Vial Detachment Force ●
- . Twist Off Opening Torque from IV Port
- Leakage after Removal of Twist Off ●
- Leakage at the Vial Adapter and Stopper Interface
- Short Circuit Test ●
- Vial Adaptor Color Identification ●
- Dose Concentration of Delivery Profile ●
- Transfer of Vial Contents to the Administration Set
- Transfer of Vial Contents to the Bag ●
- Dimensional Measurements of the IV spike lumens .
- Dimensional Measurements of the VA retention feature ●
8
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 and the results support a determination of substantial equivalence.
Biocompatibility Testing
In accordance with ISO 10993-1, the 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 finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. " The following biocompatibility tests has been successfully conducted on the Vial2Bag Advanced™ 20mm Admixture Device:
Cytotoxicity (Tested to ISO 10993-5:2009)
Sensitization (Tested to ISO 10993-10:2010)
Intracutaneous Reactivity (Tested to ISO 10993-10:2010)
Acute Systemic Toxicity (Tested to ISO 10993-11:2017)
Material Mediated Pyrogenicity (Tested to ISO 10993-11:2017)
Systemic (Subacute) Toxicity (Tested to ISO 10993-11: 2017)
ASTM Hemolysis (Tested to ISO 10993-4: 2017)
Particulate Testing
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices. The sterilization method provides a sterility assurance level (SAL) of 10-6.
5.8 CLINICAL DATA
No clinical trial was performed for Vial2Bag Advanced™ 20mm Admixture Device.
CONCLUSION 5.9
In summary, the Vial2Bag Advanced™ 20mm Admixture Device, subject of this Premarket Notification, is considered to be substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate device, VIAL-MATE Reconstitution Device (K142600).