(183 days)
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
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 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.
This is a 510(k) Premarket Notification for a medical device called "Vial Adapter". The document describes the device, its intended use, and the evidence provided to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and study information, as requested:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative format for specific performance metrics in the way a clinical trial might, but rather lists various tests performed and reports a "Pass" result for each. These effectively serve as the acceptance criteria for ensuring the device's functional integrity and safety.
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Particulate | Pass |
| Tensile strength | Pass |
| Leakage | Pass |
| Unobstructed | Pass |
| Piercing Spike | Pass |
| Puncture force | Pass |
| Chips after puncture | Pass |
| Housing | Pass |
| Luer Connector (ISO 80369-7 compliant) | Pass |
| Detachment force | Pass |
| Spike tip ductility | Pass |
| Reducing substances (easy oxides) | Pass |
| Metal ions | Pass |
| pH | Pass |
| Evaporation residues | Pass |
| UV absorbance | Pass |
| Sterile (SAL 10-6) | Pass |
| Bacterial endotoxin | Pass |
| Biocompatibility (Cytotoxicity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Skin sensitization) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Hemolysis) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Intracutaneous reactivity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Acute systemic toxicity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Pyrogenicity) | Performed (Result Implied Pass for safety) |
| Sterilization validation (ISO 11137-1, 11137-2) | Validated to SAL 10-6 |
| Shelf life | 3 years (Verified by stability study, aging test per ISO 11607-1, ISO 11607-2, ASTM F1980-16) |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for individual performance tests (e.g., how many devices were tested for leakage or puncture force). The tests are described generally and report a "Pass" result. Data provenance is not explicitly stated beyond being "internal performance standards" and compliance with international standards (ISO, ASTM). It is implied these are lab-based tests, not human/patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes non-clinical performance testing of a physical medical device. Ground truth, in the sense of expert consensus on medical conditions or image interpretation, is not relevant here. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the device's physical properties and functionality are measured.
4. Adjudication method for the test set:
This information is not applicable as the document describes non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers.
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:
This information is not applicable. This submission is for a physical medical device (Vial Adapter) and does not involve AI or any form of human-in-the-loop performance evaluation. A MRMC comparative effectiveness study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical Vial Adapter; there is no algorithm or software component for which standalone performance would be relevant.
7. The type of ground truth used:
For the performance tests, the "ground truth" implicitly refers to:
- Established industry standards: Such as ISO 80369-7 for Luer connectors, ISO 11137-1/2 for sterilization, ISO 10993-1/4/5/10/11 for biocompatibility, and ISO 11607-1/2 and ASTM F1980-16 for shelf life and packaging.
- Internal performance standards: These are criteria developed by the manufacturer to ensure the device meets its design specifications, based on engineering principles and intended use.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML product.
9. How the ground truth for the training set was established:
This information is not applicable. Since there is no training set, there is no ground truth to establish for it.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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)
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K222718 - 510(k) summary
l Submitter
| Device submitter: | Hangzhou Qiantang Longyue Biotechnology Co., LTD302, building 12, building 1,619 WangMei Road, Linping streetLinping 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
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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 DeviceK171796 | Comments |
|---|---|---|---|
| Indications foruse | The Vial Adapter isindicated for the transferand mixing of drugscontained in vials. | The Vial Adapter 15mmis indicated for thetransfer and mixing ofdrugs contained in vials | Identical |
| Regulationnumber | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| Class | CLASS II | CLASS II | Identical |
| Principle ofoperation | Single use | Single use | Identical |
| Size | 13mm, 20mm, 28mm | 15mm | DifferentComment 1 |
| Material | Polycarbonate | Polycarbonate | Identical |
| Connector | Female Luer fitting;Male Luer fitting | Luer fitting | DifferentComment 2 |
| Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Identical |
| Vial Adapter Fit(Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical |
| Performance | Performance test of:- Penetration force;- Detachment force fromDrug Vial;- Spike Tip Ductility;- Fluid Leakage. | Performance test of:- Penetration force;- Detachment forcefrom Drug Vial;- Spike Tip Ductility;- Fluid Leakage. | Identical |
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| Device feature | Subject Device | Predicate DeviceK171796 | Comments |
|---|---|---|---|
| SterilizationMethod | Electron beam Irradiation | Gamma Irradiation | DifferentComment 3 |
| SterilityAssurance Level | SAL 10-6 | SAL 10-6 | Identical |
| Labeling | Proposed devicelabeling (IFU) includestransfer and mixinginstructions | Proposed devicelabeling (IFU) includestransfer and mixinginstructions | Identical |
| Expiration Date | 3 years | 5 years | DifferentComment 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.
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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
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| Detachment force | Internal performance standards | Pass | |
|---|---|---|---|
| Spike tip ductility | Internal performance standards | Pass | |
| ChemicalProperties | Reducing substances(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.
§ 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.