(302 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a vial adapter for drug transfer and do not mention any computational or learning capabilities.
No
The device is described as being "intended for the transfer of drugs contained in a vial" and facilitates the connection of an accessory to a vial for drug withdrawal; it does not directly treat or diagnose a medical condition.
No
This device is intended for the transfer of drugs from a vial and does not perform any diagnostic functions.
No
The device description clearly outlines physical components made of polycarbonate and PTFE, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Transfer of drugs contained in a vial." This is a drug delivery or preparation function, not a diagnostic function.
- Device Description: The description focuses on the mechanical aspects of transferring drugs from a vial (piercing spike, vent, Luer lock connector). It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, assays, or measurement systems described that would be typical of an IVD.
- Performance Studies: The performance studies described are bench tests related to the device's function in transferring drugs and meeting design requirements, not studies evaluating diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the physical transfer of drugs.
N/A
Intended Use / Indications for Use
Transfer of drugs contained in a vial.
Product codes
LHI
Device Description
The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.
The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.
The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.
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 by patient, care giver and Healthcare Professionals (HCPs)
Intended for use at home, in hospitals, or outpatient nursing units
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)
The following non-clinical performance data were provided in support of the substantial equivalence determination. Performance testing was conducted to ensure that the Vented Vial Adapter HU 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. Table 5-1 below provides a list of non-clinical bench performance tests that were completed on the device and provided within this submission.
Tests conducted include:
Fragmentation Test (ISO 8536-2:2010 section 6.2.2)
Detachment of Cap (BS EN ISO 80369-7:2016 Section 6.4)
Internal Diameter Upper Skirt (ISO 8362-6:2010 Section 4.2)
Luer Gauging Test (ISO 594-1:1986 and ISO 594-2:1998)
Luer Stability and compliance to ISO 80369-7:2016
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20:2015, Annex B & Annex C for the leakage reference connector (fluid leakage))
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20:2015, Annex D & Annex C for the leakage reference connector (air leakage))
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20: 2015, Annex E & Annex C for the stress cracking reference connector)
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20: 2015, Annex F & Annex C for the axial load reference connector)
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20: 2015, Annex G & Annex C for the resistance separation from unscrewing reference connector)
Luer Stability and compliance to BS EN ISO 80369-7 (BS EN ISO 80369-20: 2015, Annex G & Annex C for the overriding reference connector)
Luer Stability and compliance to BS EN ISO 80369-7 Table B.2 and B.5 (compliance to dimensions)
Residual Volume (In-house test method)
Device Leakage (In-house test method)
Device Total Penetration Force (In-house test method)
Vial Adapter Detachment Force (In-house test method)
Product Retention in Blister (In-house test method)
Filter Clogging (In-house test method)
Device Skirt ("wings") Position on standard 20mm Vial (ISO 8362-6:2010)
Flow Rate (In-house test method)
Device Removal Force from Blister (In-house test method)
Tyvek Total Peel Test Force (In-house test method)
Air Filter Bursting Pressure (In-house test method)
Internal Diameter Dimensional Measurements Upper Skirt (In-house test method)
Functionality according to IFU (In-house test method)
Injection Force (In-house test method)
Aspiration Force (In-house test method)
Label Legibility (In-house test method)
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 for performance, safety and effectiveness and the results support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2022
West Pharma Services IL, Ltd. % Fred Cowdery Director, Regulatory Affairs (Medical Devices) West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton, Pennsylvania 19341
Re: K213513
Trade/Device Name: Vented Vial Adapter 20mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: July 29, 2022 Received: August 1, 2022
Dear Fred Cowdery:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 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 Wolloscheck, Ph.D. For Payal Patel 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) K213513
Device Name Vented Vial Adapter 20mm
Indications for Use (Describe) 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)
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."
3
K213513 - 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, Medical Devices Phone: 484-787-6834 Fax: 610-717-0668 E-mail: fred.cowdery@westpharma.com
Date Prepared: 31 August 2022
Classification:
| Trade Name: | Vented Vial Adapter 20mm |
|---|---|
| Common/Usual Name: | I.V. Fluid Transfer Set |
| Product Code: | LHI |
| Regulation No.: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular Administration Set |
| Class: | II |
| Panel Identification: | General Hospital Panel |
Predicate Device(s): Vented Vial Adapter Transfer Device - 13mm (K160503)
4
Device Description
Device Design and Operation
The subject Vented Vial Adapter HU is being developed as a new offering to the market. The Trade Name of the subject device is Vented Vial Adapter 20mm, while the Common/Usual Name is Vented Vial Adapter HU. By altering the Common/Usual Name from the Trade Name, the intention is to differentiate the subject device from the predicate device and any potential future submissions.
The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.
The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.
The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.
Principle of Operation
The Vented Vial Adapter HU is operated by manual process. The subject device is first attached to the drug vial with a neck diameter of 20mm (supplied by the Drug Manufacturer). Puncturing of the elastomeric stopper on a drug vial is achieved by means of the integrated plastic cannulated spike located in the center of the vial adapter. This piercing spike consists of two lumens. The main lumen of the piercing spike is for transfer of fluids/solution between the vial and the syringe, the second lumen enables pressure equilibrium between the vial content and the environment by introducing air through the 0.2um hydrophobic air filter, located in the device cap. A syringe/accessory (supplied by the Drug manufacturer) with a female Luer lock is attached to the subject Vented Vial Adapter HU.
5
The process of transfer is performed through the attachment of drug-containing vial and syringe with diluent to the Vented Vial Adapter HU. Transfer of diluent into the vial takes place by injecting the diluent. Upon reconstitution, the drug is then withdrawn into the syringe by turning the vial up-side down. After reconstitution and withdrawal, the syringe is removed by twisting it counterclockwise and the drug is ready for administration through attached needle/syringe. There are no accessories provided with the subject device, as the user will be supplied with the drug vial and needle-less syringe/accessory by the Drug Manufacturer.
Indications for Use:
Transfer of drugs contained in a vial.
Technological Characteristics and Substantial Equivalence:
The Vented Vial Adapter HU, is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device Vial Adapter Transfer Device - 13mm, which is cleared under K160503.
A summary of the similarities and differences between the subject device and the predicate device are provided in the table below.
6
Substantial Equivalence Comparison
| Areas for
Comparison | Subject Device:
Vented Vial Adapter HU | Predicate Device (K160503):
Vented Vial Adapter Transfer
Device - 13mm | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Manufacturer | West Pharma. Services IL,
Ltd. | Medimop Medical Projects,
Ltd./West Pharma. Services IL.,
Ltd. (acquired by West
Pharmaceutical Services, Inc. and
name changed to West Pharma.
Services IL, Ltd.) | Identical |
| Indications for Use | Transfer of drugs contained in
a vial. | Transfer and mixing of drugs
contained in a vial. | Equivalent
The predicate device has
reduced claims (removal of
mixing). This difference is
considered minor and does
not raise new or additional
questions concerning
safety and effectiveness. |
| Intended
Population | Intended for use by patient,
care giver and Healthcare
Professionals (HCPs) | Intended for use by patient, care
giver and Healthcare
professionals (HCPs) | Identical |
| Intended
Environment | Intended for use at home, in
hospitals, or outpatient
nursing units | Intended for use in healthcare
facilities, or in the home
environment | Identical |
| Device Class &
Classification
Name | Class II, Set, I.V. Fluid
Transfer | Class II, Set, I.V. Fluid Transfer | Identical |
| Regulation Number
/ Name | 21CFR 880.5440
Intravascular Administration
Set | 21CFR 880.5440
Intravascular Administration Set | Identical |
| Product Code | LHI | LHI | Identical |
| Prescription Use | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Shelf life | 3 years | 3 years | Identical |
| Design | | | |
| Operation Principle | Manual | Manual | Identical |
| Areas for
Comparison | Subject Device:
Vented Vial Adapter HU | Predicate Device (K160503):
Vented Vial Adapter Transfer
Device - 13mm | Comparison |
| Design/construction | Featuring a 20mm Vented
Vial Adaptor body with tight
grip hold ("wings"), intended
to be attached to a standard
drug vial with a neck diameter
of 20mm. The device
contains a piercing spike, cap
with air filter, vent and a
female Luer lock (BS EN ISO
80369-7:2016) connector for
attachment to a standard
accessory to access drug
content. | Featuring a 13mm Vented Vial
Adaptor body with tight grip hold
("wings"), intended to be attached
to a standard drug vial with a
neck diameter of 13mm. The
device contains a piercing spike,
cap with air filter, vent and a
female Luer lock (ISO 594-
1:1986, ISO 594-2:1998)
connector for attachment to a
standard accessory to access drug
content. | Equivalent device size
and Luer lock ISO std -
See Device Description
Section |
| Female Luer Lock | Complaint with BS EN ISO
80369-7:2016 | Compliant with ISO 594-1:1986
and ISO 594-2:1998 | Equivalent - See
Performance Section |
| Compatible Vial
Size | 20mm | 13mm | Equivalent - See Device
Description Section |
| Body Diameter | 30.1mm to accommodate
20mm standard vials | 18.5mm to accommodate 13mm
standard vials | Equivalent - See Device
Description Section |
| Piercing Spike | Dual lumen, non-siliconized | Dual lumen, non-siliconized | Identical |
| 0.2µm Hydrophobic
Air Filter Purpose | In concert with lumen, allows
for pressure equilibrium
between the environment and
vial contents through
introduction of air through
vent in vial adapter cap | In concert with lumen, allows for
pressure equilibrium between the
environment and vial contents
through introduction of air
through vent in vial adapter cap | Identical |
| Vial Adapter Fit | Vial first, snap fit to vial | Vial first, snap fit to vial | Identical |
| Material | Vented Vial Adaptor Body
(including spike):
Polycarbonate
Cap for Vented Vial Adaptor:
Polycarbonate
0.2µm hydrophobic air filter,
100% expanded PTFE
membrane over non-woven
polyester membrane support | Vented Vial Adaptor Body
(including spike): Polycarbonate
Cap for Vented Vial Adaptor:
Polycarbonate
0.2µm hydrophobic air filter,
100% expanded PTFE membrane
over non-woven polyester
membrane support | Identical |
| Biocompatible | Yes, Prolonged Use (24hrs -
30 days) | Yes, Limited Contact (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 2016 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 Vented Vial Adapter HU:
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)
Based upon the results of the biocompatibility tests, the materials used to manufacture the subject device are considered biocompatible. The biocompatibility results demonstrate the subject device does not raise any additional concerns regarding risk, safety and efficacy; therefore, the subject Vented Vial Adapter HU is considered substantially equivalent to the predicate device.
Sterilization
The sterility of the subject device is assured using a Gamma irradiation sterilization method validated in accordance with standard BS EN ISO 11137-1:2015 & A2:2019 Sterilization of health care products – Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and BS EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose, as well as AAMI TIR 33 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose -Method VDmax. The sterilization method of Gamma irradiation provides a sterility assurance level (SAL) of 10-6.
Bacterial Endotoxin Testing by limulus amebocyte lysate (LAL) was also performed on the same batch of product used for sterility dose verification, which passed with acceptable levels, further ensuring the safety of the device. The Sterility Validation and Bacterial Endotoxin Testing are provided within this submission.
Clinical Data
No clinical trial was performed for Vented Vial Adapter HU.
12
Conclusion
In summary, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Vented Vial Adapter 20mm is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate device, Vented Vial Adapter Transfer Device - 13mm (K160503).