Vial Adapter

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March 10, 2023 Hangzhou Qiantang Longyue Biotechnology Co., LTD Zhengxu Xiang Quality Manager 302,building 12, building 1,619 WangMei Road,Linping street, Linping District, Hangzhou Hangzhou, Zhejiang 311199 China Re: K222718 Trade/Device Name: Vial Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: February 8, 2023 Received: February 8, 2023 Dear Zhengxu Xiang: 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, David Walloschek David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222718 Device Name Vial Adapter Indications for Use (Describe) The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. 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}------------------------------------------------ # K222718 - 510(k) summary ### l Submitter | Device submitter: | Hangzhou Qiantang Longyue Biotechnology Co., LTD<br>302, building 12, building 1,619 WangMei Road, Linping street<br>Linping District, Hangzhou | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Zhengxu Xiang | | | Quality Manager | | | Phone: 13757329925 | | | Email: 1599564180@qq.com | | Prepare Date: | Mar 09, 2023 | Prior submission: No prior submission of the device. ### II Device Trade Name of Device: Vial Adapter Common Name: Set, I.V. Fluid Transfer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product code: LHI Review Panel: General Hospital ### III Predicate Devices | Trade name: | Vial Adapter 15mm | |-------------------------|------------------------------| | Common name: | Set, I.V. Fluid Transfer | | Classification: | Class II, 21 CFR 880.5440 | | Product Code: | LHI | | Premarket Notification: | K171796 | | Manufacturer: | Medimop Medical Projects Ltd | ### IV Device description The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the {4}------------------------------------------------ connection of a standard Luer syringe for the reconstitution and removal of the contents of the drug vial. The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter to accommodate respective size of drug vials. And it is intended for use in healthcare facilities or in home environment by the patient or caregiver to aid and support prescribed treatment and therapy. The device is intended for use on population of all ages. ## V Indications for use The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. ## VI Comparison of technological characteristics with the predicate devices The Vial Adapter has the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Vial Adapter and predicate devices do not alter suitability of the proposed device for its intended use. | Device feature | Subject Device | Predicate Device<br>K171796 | Comments | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Indications for<br>use | The Vial Adapter is<br>indicated for the transfer<br>and mixing of drugs<br>contained in vials. | The Vial Adapter 15mm<br>is indicated for the<br>transfer and mixing of<br>drugs contained in vials | Identical | | Regulation<br>number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical | | Class | CLASS II | CLASS II | Identical | | Principle of<br>operation | Single use | Single use | Identical | | Size | 13mm, 20mm, 28mm | 15mm | Different<br>Comment 1 | | Material | Polycarbonate | Polycarbonate | Identical | | Connector | Female Luer fitting;<br>Male Luer fitting | Luer fitting | Different<br>Comment 2 | | Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Identical | | Vial Adapter Fit<br>(Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical | | Performance | Performance test of:<br>- Penetration force;<br>- Detachment force from<br>Drug Vial;<br>- Spike Tip Ductility;<br>- Fluid Leakage. | Performance test of:<br>- Penetration force;<br>- Detachment force<br>from Drug Vial;<br>- Spike Tip Ductility;<br>- Fluid Leakage. | Identical | {5}------------------------------------------------ | Device feature | Subject Device | Predicate Device<br>K171796 | Comments | |------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------| | Sterilization<br>Method | Electron beam Irradiation | Gamma Irradiation | Different<br>Comment 3 | | Sterility<br>Assurance Level | SAL 10-6 | SAL 10-6 | Identical | | Labeling | Proposed device<br>labeling (IFU) includes<br>transfer and mixing<br>instructions | Proposed device<br>labeling (IFU) includes<br>transfer and mixing<br>instructions | Identical | | Expiration Date | 3 years | 5 years | Different<br>Comment 4 | ## Discussion: ## Comment 1 Differences in the size of Vial Adapters 13mm, 20mm, 28mm are for different diameter standard vials, and the size of Vial Adapter was controlled by internal performance standards. This difference does not affect intended use and does no raise new questions of substantially equivalence on safety and effectiveness. ## Comment 2 The connector of Vial Adapter was divided into female Luer fitting and male Luer fitting, while the predicated device has only one type. This difference was addressed through ISO 80369-7 and this does not affect substantially equivalence on safety and effectiveness. ## Comment 3 The Vial Adapter was provided sterilized by Electron beam Irradiation method rather gamma irradiation. However, the validation of sterilization process in compliance with ISO 11137-1 and ISO 11137-2 to ensure the sterility of device. Therefore, the difference does not affect substantially equivalence on safety and effectiveness. ### Comment 4 The Expiration Date of subject device is 3 years which is shorter than the predicated device, and it has been verified through the Shelf-life validation. This difference does not affect intended use and does no raise new questions of substantially equivalence on safety and effectiveness. ## VII Performance data The following performance data were provided in support of the substantial equivalence determination. {6}------------------------------------------------ ## Biocompatibility testing Biocompatibility of the Vial Adapter was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: | Cytotoxicity | ISO 10993-5: 2009 | |---------------------------|--------------------| | Skin sensitization | ISO 10993-10: 2010 | | Hemolysis | ISO 10993-4: 2017 | | Intracutaneous reactivity | ISO 10993-10: 2010 | | Acute systemic toxicity | ISO 10993-11: 2017 | | Pyrogenicity | ISO 10993-11: 2017 | ## Sterilization and shelf life testing The sterilization method has been validated to ISO 11137-1 and ISO 11137-2, which has thereby determined the routine control and monitoring parameters. The sterilization process is validated to a minimum SAL 10-6. The shelf life of the Vial Adapter is determined based on stability study which includes ageing test. The testing is performed according to the following standards: - A ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - A ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - > ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Items | Testing standard | Result | |----------------------|--------------------------------|--------| | Appearance | Internal performance standards | Pass | | Particulate | Internal performance standards | Pass | | Tensile strength | Internal performance standards | Pass | | Leakage | Internal performance standards | Pass | | Unobstructed | Internal performance standards | Pass | | Piercing Spike | Internal performance standards | Pass | | Puncture force | Internal performance standards | Pass | | Chips after puncture | Internal performance standards | Pass | | Housing | Internal performance standards | Pass | | Luer Connector | ISO 80369-7 | Pass | ### Performance testing {7}------------------------------------------------ | Detachment force | Internal performance standards | Pass | | |------------------------|--------------------------------------|--------------------------------|------| | Spike tip ductility | Internal performance standards | Pass | | | Chemical<br>Properties | Reducing substances<br>(easy oxides) | Internal performance standards | Pass | | | Metal ions | | | | | pH | | | | | Evaporation residues | | | | | UV absorbance | | | | Sterile | Internal performance standards | Pass | | | Bacterial endotoxin | Internal performance standards | Pass | | ## VIII Clinical data Not applicable ## IX Conclusion The Vial Adapter are substantially equivalent to the predicate device (Vial Adapter 15mm). The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed device.