(239 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical function and material properties of a fluid transfer device. There is no mention of AI, ML, or any computational processing.
No
Explanation: The device is described as a 'fluid transfer device' that allows for the 'reconstitution and transfer of fluids from drug vials into the IV bag'. Its purpose is to facilitate the preparation and mixing of drugs, not to directly treat or diagnose a medical condition.
No
The device is described as a "fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution." Its intended use is to connect various components for drug admixture prior to administration, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical, single-use fluid transfer device made of materials and components like a body, Protector, IV Port, and integrated vial adapter. It is described as sterile and nonpyrogenic, and performance studies include chemical and biocompatibility testing, which are characteristic of hardware devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for connecting an IV bag, vial, and IV administration set to reconstitute and/or admix drugs prior to administration to the patient. This describes a device used in the preparation and delivery of medication, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description reinforces its function as a fluid transfer device for reconstituting and transferring fluids from drug vials into IV bags. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological samples (blood, urine, tissue, etc.)
- Mention of diagnostic testing, screening, or monitoring of a disease or condition.
- Mention of reagents, assays, or analytical methods.
Therefore, the Vial2Bag Advanced® 13mm Admixture Device is a medical device used in the preparation and administration of medication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm 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® 13mm Admixture Device is a single use, 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 provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm 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 there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm 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
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
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Performance testing was conducted to ensure that the Vial2Bag Advanced® 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 Human Factors Validation study was conducted to demonstrate that intended users are able to use the device safely and effectively without patterns of preventable use errors, or difficulties that could result in serious harm to the user or patient.
No clinical trial was performed for Vial2Bag Advanced 13mm Admixture Device.
Summary of Performance Testing (Table 7-1):
- Dose Concentration of Delivery Profile (In-house test methods)
- Twist Off Opening Torque from IV Port (In-house test method)
- Vial Adaptor Tensile Detachment Force (In-house test method)
- Vial Adaptor Torque Test (In-house test method)
- Vial Adapter to Vial Penetration Force (In-house test method)
- Detachment Force of Vial Adapter from Vial (In-house test method)
- Visual Inspection for Product Damage (In-house test method)
- Leakage test (Device) (ISO-8536-4; Section 7.2)
- Internal Diameter of the Upper Skirt for Vial Adapter (In-house test method)
- 1m Drop Durability (In-house test method)
- IV Port Tensile Strength (ISO 8536-4; Section 7.3)
- IV Spike to IV Port Attachment Force (In-house test method)
- Leakage test (IV spike to IV port) (In-house test method)
- IV Spike from IV Port Detachment Force (ISO 8536-4 Section 7.3)
- IV Spike Dimensions (ISO 8536-4:2019; Section 7.4)
- Flow rate (ISO 8536-4:2019; Section 7.10)
- IV Spike Protector Detachment Force (ISO 8536-4:2019; Section 7.13)
- Visual Inspection of Device (In-house test method)
- Finger Flange Break Force (In-house test method)
- Short Circuit Test Method (In-house test method)
- IV Spike Lumen Dimensions (In-house test method)
- Particulate (USP )
- 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)
- Coring (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.)
Chemical Tests:
- Tested to ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Annex B. The test results provide evidence that the device meets the requirements listed in ISO 8536-4:2019, Annex B Chemical Tests.
Biocompatibility Testing:
- Cytotoxicity (Tested to ISO 10993-5: 2009)
- Sensitization (Tested to ISO 10993-10: 2021)
- Intracutaneous Reactivity (Tested to ISO 10993-10: 2021)
- 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)
- Hemolysis (Tested to ISO 10993-4: 2017 and ASTM F756-17)
Human Factors:
- A Human Factors Validation study was conducted and validated that recruited nurses, physicians, and pharmacists can operate the subject device safely and effectively per the intended use. There were no repeatable patterns of use-related errors resulting in failures, close calls, operational difficulties, or foreseeable misuse.
Key results: Results of performance, biocompatibility, and human factors studies demonstrate that the differences between the subject device and the predicate device do not raise any additional concerns regarding risk, safety, and effectiveness. 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.
Key Metrics
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
December 1, 2023
West Pharma Services IL, Ltd. % Lynn Lundy Sr. Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton, Pennsylvania 19341
Re: K230988
Trade/Device Name: Vial2Bag Advanced® 13mm Admixture Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: November 3, 2023 Received: November 3, 2023
Dear Lynn Lundy:
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/cdrb/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"
1
(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).
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 820.70) 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,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices.
2
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
3
Indications for Use
510(k) Number (if known) K230988
Device Name
Vial2Bag Advanced® 13mm Admixture Device
Indications for Use (Describe)
The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K230988 - 510(K) SUMMARY
SUBMITTER 1
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:
Lynn Lundy Sr Director, Regulatory Affairs Phone: 484-885-3298 Fax: 610-717-0668 E-mail: lynn.lundy@westpharma.com
Date Prepared: 06 April 2023
2 DEVICE
| Trade Name: | Vial2Bag Advanced® 13mm 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 |
5
3 PREDICATE DEVICE
Vial2Bag Advanced 20mm Admixture Device; K201415 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION 4
4.1 Device Design and Operation
The subject Vial2Bag Advanced® 13mm Admixture Device is being developed as a new offering to the market.
The Vial2Bag Advanced® 13mm Admixture Device is a single use, 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 provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm 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 there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm Device for the device to meet its intended purpose.
4.2 Principle of Operation
The Vial2Bag Advanced® 13mm 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.
INDICATIONS FOR USE 5
The Vial2Bag Advanced® 13mm Admixture Device is indicated 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 prior to administration to the patient. Indicated for adolescent and adult patients only.
6
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL 6 EQUIVALAENCE
Both the subject and predicate devices have the similar intended uses 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. The predicate device is indicated for general use with a vial with 20mm closure and the subject device is indicated to be used with a vial with a 13mm closure for adolescent and adult patients only. Human Factors, Performance and Biocompatibility testing confirmed the subject device accommodating a smaller 13mm drug vial size and the adolescent and adult patient population do not raise new or additional concerns regarding device safety profile or clinical effectiveness.
A summary comparing the subject device and the predicate device are provided below:
| Areas for
Comparison | Subject Device
Vial2Bag Advanced® 13mm
Admixture Device | Predicate Device
(K201415):
Vial2Bag Advanced® 20mm
Admixture Device | Comparison |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Indications for Use | 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. | 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. | Difference #1 - Human
Factors, Performance and
Biocompatibility testing
confirmed the subject
device accommodating a
smaller 13mm drug vial
size and the adolescent and
adult patient population do
not raise new or additional
concerns regarding device
safety profile or clinical
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 | Identical |
| Areas for
Comparison | Subject Device
Vial2Bag Advanced® 13mm
Admixture Device | Predicate Device
(K201415):
Vial2Bag Advanced® 20mm
Admixture Device | Comparison |
| | | Intravascular Administration
Set | |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Design | | | |
| Operation Principle | Manual | Manual | Identical |
| Design | Made of plastic material,
featuring a 13mm Vial Adaptor
to access the drug content in the
13mm vial, an IV Spike
integrated for the connection to
the IV bag, and a twist off which
after removal opens the IV port
for connection to the IV
administration set. | Made of plastic material
featuring a 20mm Vial
Adaptor to access the drug
content in the 20mm vial, an
IV Spike integrated for the
connection to the IV bag, and
a twist off which after
removal opens the IV port for
connection to the IV
administration set. | Difference #2–
Performance, chemical and
biocompatibility testing
confirmed material and
vial adapter size do not
impact device intended
use, clinical effectiveness,
or safety profile. |
| Materials of
Construction | • 13mm Vial Adapter:
Polycarbonate (PC) + Orange
colorant masterbatch | • 20mm Vial Adapter: PC +
Blue colorant masterbatch | Difference #3 –
Performance, chemical and
biocompatibility testing
confirmed differences in
colorant do not impact
device intended use,
clinical effectiveness, or
safety profile. |
| | • IV Port Twist Off: PC +
Polyvinyl Chloride (PVC)
3224 | • IV Port Twist Off: PC +
Polyvinyl Chloride (PVC)
3250 | Difference #3 –
Polycarbonate is identical,
differs in PVC.
Performance, chemical and
biocompatibility testing
confirmed differences in
PVC grade do not impact
device intended use,
clinical effectiveness, or
safety profile. |
| | • Spike Protector: Low Density
Polyethylene (LDPE) | • Spike Protector: LDPE | Identical |
| Compatible Vial
Size | 13mm | 20mm | Difference #2–
Performance testing
confirmed differences
noted with compatible vial
size do not impact device
intended use, clinical
effectiveness, or safety
profile. |
| Areas for
Comparison | Subject Device
Vial2Bag Advanced® 13mm
Admixture Device | Predicate Device
(K201415):
Vial2Bag Advanced® 20mm
Admixture Device | Comparison |
| 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 |
| 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 for the
subject device. | Subject device can transfer
equivalent vial contents to
the IV bag and administration
set compared with the
predicate device. | 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 |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterilization | | | |
| Sterility | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterility Assurance
Level | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | | | |
| Packaging | Sterile Barrier package
materials: PETG blister with
Tyvek® seal | Sterile Barrier package
materials: PETG blister with
Tyvek® seal | Identical |
Table 6-1: Substantial Equivalence Comparison Table
7
8
The results of performance, biocompatibility, and human factors studies for the subject device, provided within this submission, demonstrate that the differences between the subject device and the predicate device do not raise any additional concerns regarding risk, safety, and effectiveness. See details as follows:
- . Difference #1 - Human Factors (Section 8.1), Performance (Table 7-1) and Biocompatibility (Section 7.3) testing confirmed the differences in indications for use, including the subject device accommodating a smaller 13mm drug vial size and the adolescent and adult patient population do not raise new or additional concerns regarding device safety profile or clinical effectiveness.
- Difference #2 Performance (Table 7-1), chemical (Section 7.2) and biocompatibility ● (Section 7.3) testing confirmed differences in design and compatible vial size do not impact device intended use, clinical effectiveness, or safety profile.
9
- . Difference #3 - Performance (Table 7-1), chemical (Section 7.2) and biocompatibility (Section 7.3) testing confirmed differences in materials of construction do not impact device intended use, clinical effectiveness, or safety profile.
For the reasons listed above, the Vial2Bag Advanced® 13mm Admixture Device, subject of this Traditional 510(k), is substantially equivalent in its intended use, design/construction. technology/principle of operation, materials, and performance to the predicate device, Vial2Bag Advanced 20mm Admixture Device, which is cleared under K201415.
PERFORMANCE DATA 7
The following non-clinical performance data were provided in support of the substantial equivalence determination.
7.1 Performance Testing
Performance testing was conducted to ensure that the Vial2Bag Advanced® 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. The table below provides a list of non-clinical bench performance tests that were completed on the device and provided within this submission.
| Test | Test Method/ Standard |
|---|---|
| Dose Concentration of Delivery Profile | In-house test methods |
| Twist Off Opening Torque from IV Port | In-house test method |
| Vial Adaptor Tensile Detachment Force | In-house test method |
| Vial Adaptor Torque Test | In-house test method |
| Vial Adapter to Vial Penetration Force | In-house test method |
| Detachment Force of Vial Adapter from Vial | In-house test method |
| Visual Inspection for Product Damage | In-house test method |
| Leakage test (Device) | ISO-8536-4; Section 7.2 |
| Internal Diameter of the Upper Skirt for Vial Adapter | In-house test method |
| 1m Drop Durability | In-house test method |
| IV Port Tensile Strength | ISO 8536-4; Section 7.3 |
Table 7-1: Summary of Performance Testing
10
| Test | Test Method/ Standard |
|---|---|
| IV Spike to IV Port Attachment Force | In-house test method |
| Leakage test (IV spike to IV port) | In-house test method |
| IV Spike from IV Port Detachment Force | ISO 8536-4 Section 7.3 |
| IV Spike Dimensions | ISO 8536-4:2019; Section 7.4 |
| Flow rate | ISO 8536-4:2019; Section 7.10 |
| IV Spike Protector Detachment Force | ISO 8536-4:2019; Section 7.13 |
| Visual Inspection of Device | In-house test method |
| Finger Flange Break Force | In-house test method |
| Short Circuit Test Method | In-house test method |
| IV Spike Lumen Dimensions | In-house test method |
| Particulate | USP |
| 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 |
| Coring | 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. |
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, the objective evidence satisfies the product requirements for performance, safety, and effectiveness and the results support a determination of substantial equivalence.
7.2 Chemical Tests
To assure the device can properly serve as a connection between IV bags and Administration Sets, Vial2Bag Advanced 13mm Admixture Devices were tested to ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Annex B. The test results provide evidence that the device meets the requirements listed in ISO 8536-4:2019, Annex B Chemical Tests.
11
7.3 Biocompatibility Testing
In accordance with ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, the subject Vial2Bag Advanced 13mm 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 2023 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 have been successfully conducted on the Vial2Bag Advanced 13mm Admixture Device:
Cytotoxicity (Tested to ISO 10993-5: 2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity)
Sensitization (Tested to ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
Intracutaneous Reactivity (Tested to ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
Acute Systemic Toxicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
Material Mediated Pyrogenicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
Systemic (Subacute) Toxicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
Hemolysis (Tested to ISO 10993-4: 2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood and ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials)
Based upon the results of the biocompatibility tests, the materials used to manufacture the subject device are considered biocompatibility results demonstrate the subject device does not raise any additional concerns regarding risk, safety, and effectiveness; therefore, the subject Vial2Bag Advanced 13mm Admixture Device is considered substantially equivalent to the predicate device.
7.4 Sterilization
The sterility of the subject device is assured using a sterilization method validated in accordance with ISO 11135:2014/AMD1:2018 Sterilization of Health Care Products -Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. The sterilization method provides a sterility assurance level (SAL) of 10-6.
12
8 CLINICAL DATA
No clinical trial was performed for Vial2Bag Advanced 13mm Admixture Device.
8.1 Human Factors
A Human Factors Validation study was conducted to demonstrate that intended users are able to use the device safely and effectively without patterns of preventable use errors, or difficulties that could result in serious harm to the user or patient.
The subject device related IFU was validated in simulated use sessions with representatives of the intended user groups to establish safe and effective preparation for drug administration by healthcare professionals. An evaluation of the subject device Blister Pack. Carton, and associated labeling were also included.
There were no repeatable patterns of use-related errors resulting in failures, close calls, operational difficulties, or foreseeable misuse of the Vial2Bag Advanced® 13mm admixture device. This Human Factors study validated that recruited nurses, physicians, and pharmacists can operate the subject device safely and effectively per the intended use. The results of this study provided objective evidence and determined that the potential use errors identified in the use-related risk analysis that could lead to serious harm have been mitigated to acceptable levels. All risk control measures were found to be effective.
CONCLUSION 9
In summary, the Vial2Bag Advanced® 13mm 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, materials, and performance to the predicate device, Vial2Bag Advanced 20mm Admixture Device (K201415).