Vented Vial Adapter 20mm

K213513 · West Pharma. Services IL, Ltd. · LHI · Aug 31, 2022 · General Hospital

Device Facts

• Record ID: K213513
• Device Name: Vented Vial Adapter 20mm
• Applicant: West Pharma. Services IL, Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Aug 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Transfer of drugs contained in a vial.

Device Story

Vented Vial Adapter 20mm is a single-use, sterile, non-pyrogenic device for transferring drugs from a vial to a syringe. It features a dual-lumen piercing spike and a 0.2µm hydrophobic air filter. The device attaches to a 20mm neck diameter vial via a snap-fit mechanism. A syringe with a female Luer lock connects to the adapter. During operation, the main lumen transfers fluid while the second lumen, connected to the air filter, allows pressure equilibrium without pressurizing the vial. The device is operated manually by patients, caregivers, or healthcare professionals. It facilitates rapid drug withdrawal and reconstitution. The device contains no medicinal substances and is supplied sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included fragmentation, Luer stability (ISO 80369-7), leakage, flow rate, filter clogging, and biocompatibility (ISO 10993-1, -4, -5, -10, -11).

Technological Characteristics

Polycarbonate body and cap; 0.2µm hydrophobic air filter (100% expanded PTFE membrane over non-woven polyester support). Dual-lumen piercing spike. Female Luer lock (BS EN ISO 80369-7:2016). Gamma sterilization (SAL 10^-6). Manual operation. Designed for 20mm neck diameter vials.

Indications for Use

Indicated for the transfer of drugs contained in a vial. Intended for use by patients, caregivers, and healthcare professionals in home, hospital, or outpatient nursing unit settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Vented Vial Adapter Transfer Device - 13mm (K160503)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] E-mail: [e-mail]

### 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 for<br>Comparison | Subject Device:<br>Vented Vial Adapter HU | Predicate Device (K160503):<br>Vented Vial Adapter Transfer<br>Device - 13mm | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Manufacturer | West Pharma. Services IL,<br>Ltd. | Medimop Medical Projects,<br>Ltd./West Pharma. Services IL.,<br>Ltd. (acquired by West<br>Pharmaceutical Services, Inc. and<br>name changed to West Pharma.<br>Services IL, Ltd.) | Identical |
| Indications for Use | Transfer of drugs contained in<br>a vial. | Transfer and mixing of drugs<br>contained in a vial. | Equivalent<br>The predicate device has<br>reduced claims (removal of<br>mixing). This difference is<br>considered minor and does<br>not raise new or additional<br>questions concerning<br>safety and effectiveness. |
| Intended<br>Population | Intended for use by patient,<br>care giver and Healthcare<br>Professionals (HCPs) | Intended for use by patient, care<br>giver and Healthcare<br>professionals (HCPs) | Identical |
| Intended<br>Environment | Intended for use at home, in<br>hospitals, or outpatient<br>nursing units | Intended for use in healthcare<br>facilities, or in the home<br>environment | Identical |
| Device Class &<br>Classification<br>Name | Class II, Set, I.V. Fluid<br>Transfer | Class II, Set, I.V. Fluid Transfer | Identical |
| Regulation Number<br>/ Name | 21CFR 880.5440<br>Intravascular Administration<br>Set | 21CFR 880.5440<br>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<br>Comparison | Subject Device:<br>Vented Vial Adapter HU | Predicate Device (K160503):<br>Vented Vial Adapter Transfer<br>Device - 13mm | Comparison |
| Design/construction | Featuring a 20mm Vented<br>Vial Adaptor body with tight<br>grip hold ("wings"), intended<br>to be attached to a standard<br>drug vial with a neck diameter<br>of 20mm. The device<br>contains a piercing spike, cap<br>with air filter, vent and a<br>female Luer lock (BS EN ISO<br>80369-7:2016) connector for<br>attachment to a standard<br>accessory to access drug<br>content. | Featuring a 13mm Vented Vial<br>Adaptor body with tight grip hold<br>("wings"), intended to be attached<br>to a standard drug vial with a<br>neck diameter of 13mm. The<br>device contains a piercing spike,<br>cap with air filter, vent and a<br>female Luer lock (ISO 594-<br>1:1986, ISO 594-2:1998)<br>connector for attachment to a<br>standard accessory to access drug<br>content. | Equivalent device size<br>and Luer lock ISO std -<br>See Device Description<br>Section |
| Female Luer Lock | Complaint with BS EN ISO<br>80369-7:2016 | Compliant with ISO 594-1:1986<br>and ISO 594-2:1998 | Equivalent - See<br>Performance Section |
| Compatible Vial<br>Size | 20mm | 13mm | Equivalent - See Device<br>Description Section |
| Body Diameter | 30.1mm to accommodate<br>20mm standard vials | 18.5mm to accommodate 13mm<br>standard vials | Equivalent - See Device<br>Description Section |
| Piercing Spike | Dual lumen, non-siliconized | Dual lumen, non-siliconized | Identical |
| 0.2µm Hydrophobic<br>Air Filter Purpose | In concert with lumen, allows<br>for pressure equilibrium<br>between the environment and<br>vial contents through<br>introduction of air through<br>vent in vial adapter cap | In concert with lumen, allows for<br>pressure equilibrium between the<br>environment and vial contents<br>through introduction of air<br>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<br>(including spike):<br>Polycarbonate<br>Cap for Vented Vial Adaptor:<br>Polycarbonate<br>0.2µm hydrophobic air filter,<br>100% expanded PTFE<br>membrane over non-woven<br>polyester membrane support | Vented Vial Adaptor Body<br>(including spike): Polycarbonate<br>Cap for Vented Vial Adaptor:<br>Polycarbonate<br>0.2µm hydrophobic air filter,<br>100% expanded PTFE membrane<br>over non-woven polyester<br>membrane support | Identical |
| Biocompatible | Yes, Prolonged Use (24hrs -<br>30 days) | Yes, Limited Contact (<24hrs) | Equivalent - See<br>Biocompatibility Section |
| Areas for<br>Comparison | Subject Device:<br>Vented Vial Adapter HU | Predicate Device (K160503):<br>Vented Vial Adapter Transfer<br>Device – 13mm | Comparison |
| Non-pyrogenic | Yes | Yes | Identical |
| Sterilization | | | |
| Sterility | Sterile | Sterile | Identical |
| Sterilization<br>Method | Gamma | Gamma | Identical |
| Sterility Assurance<br>Level | SAL of 10-6 | SAL of 10-6 | Identical |
| Packaging | | | |
| Packaging | Sterile Barrier package<br>materials: PETG blister with<br>Tyvek® seal<br><br>Sterile Barrier package<br>orientation: Devices are<br>supplied in an individual<br>blister, vial first orientation<br><br>Dimensions: Designed to<br>accommodate subject device. | Sterile Barrier package materials:<br>PETG blister with Tyvek® seal<br><br>Sterile Barrier package<br>orientation: Devices are suppliedorientation<br><br>Dimensions: Designed to<br>accommodate predicate device | Identical Sterile Barrier<br>Package Materials<br><br>Identical Sterile Barrier<br>Package Orientation<br><br>Equivalent Dimensions—<br>See Device Description<br>Section. |

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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-<br>7:2016 | ISO 80369-7:2016 |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20:2015, Annex B &<br>Annex C for the leakage reference connector<br>(fluid leakage) |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20:2015, Annex D &<br>Annex C for the leakage reference connector<br>(air leakage) |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20: 2015, Annex E &<br>Annex C for the stress cracking reference<br>connector |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20: 2015, Annex F &<br>Annex C for the axial load reference connector |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20: 2015, Annex G &<br>Annex C for the resistance separation from<br>unscrewing reference connector |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-20: 2015, Annex G &<br>Annex C for the overriding reference connector |
| Luer Stability and compliance to BS EN ISO<br>80369-7 | BS EN ISO 80369-7 Table B.2 and B.5<br>(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 standard<br>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<br>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.

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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).