(302 days)
Transfer of drugs contained in a vial.
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.
The provided document is a 510(k) premarket notification for a medical device called the "Vented Vial Adapter 20mm". This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring a full clinical trial for safety and efficacy. Therefore, the information typically found in a study proving acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert consensus, and comparative effectiveness studies, is not present here.
Instead, the document focuses on non-clinical performance data and biocompatibility testing to demonstrate that the new device meets relevant standards and is substantially equivalent to a previously cleared predicate device.
Here's an analysis of the provided information within the context of your request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly provide a table of acceptance criteria alongside reported device performance in the typical sense of a clinical study measuring a specific outcome (e.g., sensitivity, specificity for an AI diagnostic). Instead, it lists various performance tests conducted and indicates that the device "met the applicable design and performance requirements" and that "all product design requirements are verified."
Below is a table summarizing the types of tests conducted, which implicitly serve as criteria for performance, and the general statement of their success:
| Test Category | Specific Tests / Standards | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | Fragmentation Test (ISO 8536-2:2010 section 6.2.2) | Met applicable design and performance requirements; all product design requirements verified. |
| Detachment of Cap (BS EN ISO 80369-7:2016 Section 6.4) | Met applicable design and performance requirements; all product design requirements verified. | |
| Internal Diameter Upper Skirt (ISO 8362-6:2010 Section 4.2) | Met applicable design and performance requirements; all product design requirements verified. | |
| Luer Gauging Test (ISO 594-1:1986 and ISO 594-2:1998) | Met applicable design and performance requirements; all product design requirements verified. | |
| Luer Stability and compliance to ISO 80369-7:2016 (various annexes of BS EN ISO 80369-20:2015 for leakage, stress cracking, axial load, resistance separation, overriding, and dimensions) | Met applicable design and performance requirements; all product design requirements verified. | |
| Residual Volume (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Leakage (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Total Penetration Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Vial Adapter Detachment Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Product Retention in Blister (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Filter Clogging (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Skirt ("wings") Position on standard 20mm Vial (ISO 8362-6:2010) | Met applicable design and performance requirements; all product design requirements verified. | |
| Flow Rate (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Removal Force from Blister (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Tyvek Total Peel Test Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Air Filter Bursting Pressure (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Internal Diameter Dimensional Measurements Upper Skirt (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Functionality according to IFU (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Injection Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Aspiration Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Label Legibility (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Biological Safety | Cytotoxicity (ISO 10993-5:2009) | Successfully conducted; materials considered biocompatible. |
| Sensitization (ISO 10993-10:2010) | Successfully conducted; materials considered biocompatible. | |
| Intracutaneous Reactivity (ISO 10993-10:2010) | Successfully conducted; materials considered biocompatible. | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Successfully conducted; materials considered biocompatible. | |
| Material Mediated Pyrogenicity (ISO 10993-11:2017) | Successfully conducted; materials considered biocompatible. | |
| Systemic (Subacute) Toxicity (ISO 10993-11: 2017) | Successfully conducted; materials considered biocompatible. | |
| ASTM Hemolysis (ISO 10993-4: 2017) | Successfully conducted; materials considered biocompatible. | |
| Sterilization | Sterility (BS EN ISO 11137-1:2015 & A2:2019, BS EN ISO 11137-2:2015, AAMI TIR 33) | Sterility Assurance Level (SAL) of $10^{-6}$ achieved. |
| Bacterial Endotoxin Testing (limulus amebocyte lysate - LAL) | Passed with acceptable levels. |
Regarding the other requested information:
-
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for each non-clinical performance test. It mentions that an "in-house test method" was often used.
- The data provenance is not explicitly stated in terms of country of origin for the non-clinical tests. The manufacturer is West Pharma. Services IL, Ltd. in Ra'anana, Israel. The tests are non-clinical bench tests, not involving human data.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to a device submission of this nature. The "ground truth" for these tests are objective measurements against defined standards or specified functional parameters, not subjective expert interpretations.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. The performance testing is based on objective measurements against engineering and biological standards, not on human adjudication of subjective findings.
-
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or comparative effectiveness study was done. This device is a passive medical device (a vial adapter), not an AI/ML diagnostic or assistive technology.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML algorithm or software device.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For performance testing, the "ground truth" refers to the established specifications, international standards (e.g., ISO, BS EN ISO), or in-house defined criteria for mechanical properties, fluid dynamics, and biological safety. For biocompatibility and sterilization, the ground truth is defined by specific ISO standards and their associated pass/fail criteria (e.g., for cytotoxicity, sensitization, sterility assurance level).
-
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device that requires training data.
-
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device that requires a training set or associated ground truth.
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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
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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
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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)
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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)
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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.
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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.
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Substantial Equivalence Comparison
| Areas forComparison | Subject Device:Vented Vial Adapter HU | Predicate Device (K160503):Vented Vial Adapter TransferDevice - 13mm | Comparison |
|---|---|---|---|
| General Information | |||
| Manufacturer | West Pharma. Services IL,Ltd. | Medimop Medical Projects,Ltd./West Pharma. Services IL.,Ltd. (acquired by WestPharmaceutical Services, Inc. andname changed to West Pharma.Services IL, Ltd.) | Identical |
| Indications for Use | Transfer of drugs contained ina vial. | Transfer and mixing of drugscontained in a vial. | EquivalentThe predicate device hasreduced claims (removal ofmixing). This difference isconsidered minor and doesnot raise new or additionalquestions concerningsafety and effectiveness. |
| IntendedPopulation | Intended for use by patient,care giver and HealthcareProfessionals (HCPs) | Intended for use by patient, caregiver and Healthcareprofessionals (HCPs) | Identical |
| IntendedEnvironment | Intended for use at home, inhospitals, or outpatientnursing units | Intended for use in healthcarefacilities, or in the homeenvironment | Identical |
| Device Class &ClassificationName | Class II, Set, I.V. FluidTransfer | Class II, Set, I.V. Fluid Transfer | Identical |
| Regulation Number/ Name | 21CFR 880.5440Intravascular AdministrationSet | 21CFR 880.5440Intravascular 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 forComparison | Subject Device:Vented Vial Adapter HU | Predicate Device (K160503):Vented Vial Adapter TransferDevice - 13mm | Comparison |
| Design/construction | Featuring a 20mm VentedVial Adaptor body with tightgrip hold ("wings"), intendedto be attached to a standarddrug vial with a neck diameterof 20mm. The devicecontains a piercing spike, capwith air filter, vent and afemale Luer lock (BS EN ISO80369-7:2016) connector forattachment to a standardaccessory to access drugcontent. | Featuring a 13mm Vented VialAdaptor body with tight grip hold("wings"), intended to be attachedto a standard drug vial with aneck diameter of 13mm. Thedevice contains a piercing spike,cap with air filter, vent and afemale Luer lock (ISO 594-1:1986, ISO 594-2:1998)connector for attachment to astandard accessory to access drugcontent. | Equivalent device sizeand Luer lock ISO std -See Device DescriptionSection |
| Female Luer Lock | Complaint with BS EN ISO80369-7:2016 | Compliant with ISO 594-1:1986and ISO 594-2:1998 | Equivalent - SeePerformance Section |
| Compatible VialSize | 20mm | 13mm | Equivalent - See DeviceDescription Section |
| Body Diameter | 30.1mm to accommodate20mm standard vials | 18.5mm to accommodate 13mmstandard vials | Equivalent - See DeviceDescription Section |
| Piercing Spike | Dual lumen, non-siliconized | Dual lumen, non-siliconized | Identical |
| 0.2µm HydrophobicAir Filter Purpose | In concert with lumen, allowsfor pressure equilibriumbetween the environment andvial contents throughintroduction of air throughvent in vial adapter cap | In concert with lumen, allows forpressure equilibrium between theenvironment and vial contentsthrough introduction of airthrough 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):PolycarbonateCap for Vented Vial Adaptor:Polycarbonate0.2µm hydrophobic air filter,100% expanded PTFEmembrane over non-wovenpolyester membrane support | Vented Vial Adaptor Body(including spike): PolycarbonateCap for Vented Vial Adaptor:Polycarbonate0.2µm hydrophobic air filter,100% expanded PTFE membraneover non-woven polyestermembrane support | Identical |
| Biocompatible | Yes, Prolonged Use (24hrs -30 days) | Yes, Limited Contact (<24hrs) | Equivalent - SeeBiocompatibility Section |
| Areas forComparison | Subject Device:Vented Vial Adapter HU | Predicate Device (K160503):Vented Vial Adapter TransferDevice – 13mm | Comparison |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterilization | |||
| Sterility | Sterile | Sterile | Identical |
| SterilizationMethod | Gamma | Gamma | Identical |
| Sterility AssuranceLevel | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | |||
| Packaging | Sterile Barrier packagematerials: PETG blister withTyvek® sealSterile Barrier packageorientation: Devices aresupplied in an individualblister, vial first orientationDimensions: Designed toaccommodate subject device. | Sterile Barrier package materials:PETG blister with Tyvek® sealSterile Barrier packageorientation: Devices are suppliedorientationDimensions: Designed toaccommodate predicate device | Identical Sterile BarrierPackage MaterialsIdentical Sterile BarrierPackage OrientationEquivalent Dimensions—See Device DescriptionSection. |
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Traditional 510(k)
K213513
Vented Vial Adapter HU
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K213513
Vented Vial Adapter HU
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Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Performance Testing
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.
| Test | Test Method/ Standard |
|---|---|
| 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 | ISO 80369-7:2016 |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20:2015, Annex B &Annex C for the leakage reference connector(fluid leakage) |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20:2015, Annex D &Annex C for the leakage reference connector(air leakage) |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20: 2015, Annex E &Annex C for the stress cracking referenceconnector |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20: 2015, Annex F &Annex C for the axial load reference connector |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20: 2015, Annex G &Annex C for the resistance separation fromunscrewing reference connector |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-20: 2015, Annex G &Annex C for the overriding reference connector |
| Luer Stability and compliance to BS EN ISO80369-7 | BS EN ISO 80369-7 Table B.2 and B.5(compliance to dimensions) |
Summary of Performance Testing
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K213513
West Pharmaceutical Services, Inc.
| Test | Test Method/ Standard |
|---|---|
| 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 standard20mm 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 MeasurementsUpper 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.
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Biocompatibility Testing
In accordance with ISO 10993-1, the subject Vented Vial Adapter HU 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 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.
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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).
§ 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.