(215 days)
The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.
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 the vial adapter. The connector on opposite side of the vented vial adapter is for the connection of a standard luer syringe for the reconstitution and removal of the contents of the drug vial.
The device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications.
The proposed vented vial adapter is available in 13mm, 20mm diameter to accommodate respective sizes of drug vials.
This document is a 510(k) Premarket Notification from the FDA regarding a Vial Adapter with Filter. It does not present information about an AI/ML medical device, but rather a physical medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets these criteria cannot be fully answered from the provided text.
The provided text details the regulatory approval process for a physical medical device (Vial Adapter with Filter) and its substantial equivalence to a predicate device. It focuses on the physical, chemical, and biological performance of the device, rather than the performance of an AI/ML algorithm.
However, I can extract the general types of performance criteria and testing mentioned for this physical device, and point out what information is missing to answer the AI/ML-specific questions.
Based on the provided text, here's what can be inferred about the physical device's "acceptance criteria" and "study" (non-AI/ML context), and why AI/ML specific questions cannot be answered:
Device: Vial Adapter with Filter (physical medical device)
Regulatory ID: K233284
1. A table of "Acceptance Criteria" and "Reported Device Performance":
For a physical device, acceptance criteria are typically defined by compliance with recognized standards and internal performance specifications. The "reported device performance" are the results of tests conducted against these standards/specifications.
| Acceptance Criteria (based on standards/internal specs) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5: 2009) | Pass |
| Skin sensitization (ISO 10993-10: 2010) | Pass |
| Hemolysis (ISO 10993-4: 2017) | Pass |
| Intracutaneous reactivity (ISO 10993-23: 2021) | Pass |
| Acute systemic toxicity (ISO 10993-11: 2017) | Pass |
| Pyrogenicity (ISO 10993-11: 2017) | Pass |
| Sterilization & Shelf Life: | |
| Sterilization validated to SAL 10-6 (ISO 11137-1, 11137-2) | Validated to SAL 10-6 |
| Packaging integrity (ISO 11607-1, ISO 11607-2, ASTM F1980-16, ASTM F1929-15) | Pass (after accelerated aging for 4-year shelf life) |
| Performance Testing: | |
| Appearance (Internal performance standards) | Pass |
| Particulate (ISO 22413 -2021) | Pass |
| Tensile strength (ISO 22413 -2021) | Pass |
| Leakage (ISO 22413 -2021) | Pass |
| Unobstructed (ISO 22413 -2021) | Pass |
| Piercing Spike (ISO 22413 -2021) | Pass |
| Puncture force (ISO 22413 -2021) | Pass |
| Puncture chip (ISO 22413 -2021) | Pass |
| Dimension (Internal performance standards) | Pass |
| Housing (ISO 22413 -2021) | Pass |
| Luer Connector (ISO 80369-7) | Pass |
| Detachment force (Internal performance standards) | Pass |
| Spike tip ductility (Internal performance standards) | Pass |
| Filtration rate (ISO 22413 -2021) | Pass |
| Chemical property (e.g., Reducing substances, Metal ions, pH, Evaporation residues, UV absorbance) (ISO 8536-4:2019 & Internal standards) | Pass |
| Sterile (USP46-NF41) | Pass |
| Bacterial endotoxin (USP-NF<71>) | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes for any of the performance tests. It only states that "performance data were provided."
- Data Provenance: The manufacturer is Hangzhou Qiantang Longyue Biotechnology Co., LTD, based in China (implied by address and country code in phone number). The nature of the studies (retrospective/prospective) for a physical device's performance testing is implicitly "prospective" as new devices would be tested to these standards.
Regarding AI/ML specific questions (which are not applicable to this physical device):
The following points are not addressed in the provided document because it pertains to a physical medical device, not an AI/ML algorithm:
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device is established through direct measurements, chemical analyses, and biological assays against established standards, not expert annotation of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a study design for AI-assisted diagnostic devices.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth is based on the results of validated physical, chemical, and biological tests according to international and internal standards (as listed in the table above).
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. This device is not an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2024
Hangzhou Qiantang Longyue Biotechnology Co., Ltd % Esther Zhang Regulatory Affairs Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K233284
Trade/Device Name: Vial Adapter with Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: April 3, 2024 Received: April 3, 2024
Dear Esther Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
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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) K233284
Device Name Vial Adapter with Filter
Indications for Use (Describe)
The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K233284- 510(k) Summary
Submitter l
| Device submitter: | Hangzhou Qiantang Longyue Biotechnology Co., LTD104, 301, 302, building 12, building 1,619 WangMei Roadinpingstreet, Linping District, Hangzhou |
|---|---|
| Contact person: | Chunyu WangQuality Assurance Manager |
| Phone: 0086-13965638723 | |
| Email: chunyu_wang@nextech-x.com | |
| Prepare Date: | April 26, 2024 |
ll Correspondent
| Company | Shanghai Ling Fu Technology Co., Ltd. |
|---|---|
| 4F, No.585-2 Wanyuan Road, Minhang District, ShanghaiP.R.China | |
| Contact person: | Esther ZHANGRegulatory affairsPhone: 0086-13771505757Email: Esther.zhang@llins-tech.com |
��� Subject Device
Trade Name of Device: Vial Adapter with Filter Common Name: Fluid Transfer IV Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product code: LHI Review Panel: General Hospital
IV Predicate Device
| Trade name: | Vial Adapter |
|---|---|
| Regulation Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Classification: | Class II |
| Product Code: | LHI |
| Premarket Notification: | K222718 |
| Manufacturer: | Hangzhou Qiantang Longyue Biotechnology Co., LTD |
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> Device description
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 the vial adapter. The connector on opposite side of the vented vial adapter is for the connection of a standard luer syringe for the reconstitution and removal of the contents of the drug vial.
The device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications.
The proposed vented vial adapter is available in 13mm, 20mm diameter to accommodate respective sizes of drug vials.
VI Indications for use
The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.
VII Comparison of technological characteristics with the predicate devices
The Vial Adapter intended use, technological characteristics, design and performance specifications are either identical or substantially equivalent to the existing legally marketed predicate device. The differences between the subject and predicate devices do not raise different questions of safety and effectiveness.
| Device feature | Subject DeviceK233284 | Predicate DeviceK222718 | Comments |
|---|---|---|---|
| Indications for use | The Vial adapter with filteris intended for use byHealthcare Professionalsfor the transfer and mixingof drugs contained in vialswithin clinical, hospital, orhealthcare environments. | The Vial Adapter isindicated for the transferand mixing of drugscontained in vials. | Identical |
| Product code | LHI | LHI | Identical |
| Regulationnumber | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
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| Class | Class II | Class II | Identical |
|---|---|---|---|
| Principle of operation | Single use | Single use | Identical |
| Size | 13mm, 20mm | 13mm, 20mm, 28mm | DifferentComment 1 |
| Material | Polycarbonate,Polyethylene, Acrylic,Polyamide | Polycarbonate | DifferentComment 2 |
| Connector | Female Luer fitting | Female Luer fitting;Male Luer fitting | DifferentComment 3 |
| Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Identical |
| Filter | Yes | No | DifferentComment 4 |
| Performance | Performance test of:Penetration force.Detachmentforce from DrugVial.Spike Tip Ductility.Fluid Leakage.Liquid Filtration | Performance test of:Penetration force;Detachmentforce from DrugVial;Spike Tip Ductility;Fluid Leakage. | DifferentComment 5 |
| Vial Adapter Fit(Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical |
| SterilizationMethod | Electron beam Irradiation | Electron beam Irradiation | Identical |
| SterilityAssurance Level | SAL 10-6 | SAL 10-6 | Identical |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Identical |
| Labeling | Proposed devicelabeling (IFU) includestransfer and mixinginstructions | Proposed devicelabeling (IFU) includestransfer and mixinginstructions | Identical |
| Shelf life | 4 years | 3 years | DifferentComment 6 |
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Discussion:
Comment 1
The subject device consists of Vial Adapters that are 13mm, 20mm for different diameter standard vials. The size of Vial Adapter with filter was demonstrated to meet specification according to internal performance standards. This difference does not raise new questions of safety and effectiveness.
Comment 2
The material of the subject device is polycarbonate, polyethylene, acrylic/polyamide, and the predicate device material is polycarbonate. Although there is a difference in the material, the biocompatibility test of the subject device complies with the standard requirements. This difference does not raise new questions of safety and effectiveness.
Comment 3
The connector of the Vial Adapter with filter have only one type, while the predicated device has two types. This difference was addressed through ISO 80369-7 testing and therefore, this difference does not raise new questions of safety and effectiveness.
Comment 4
The inclusion of a Filtration Membrane in the subject device (K233284) differentiates it from the predicate device (K222718), which does not include a filter. Despite this difference, the additional filtration functionality in K233284 does not raise new questions of safety and effectiveness. It is supported by adherence to standards detailed below, which set requirements for transfer sets and infusion equipment, including the performance of fluid filters. The subject device has been tested to ensure that the filter performs adequately. Testing includes visual inspection for defects, dimensional measurements of the membrane, and filtration efficiency tests, all of which the device has passed. Therefore, the difference does not raise different questions of safety and effectiveness.
Comment 5
Performance testing of the Vial adapter with filter inlet and outlet functions demonstrates that the difference does not raise new questions of safety and effectiveness.
Comment 6
The shelf life of the subject device is 4 years which is longer than the predicated device; however, performance testing after accelerated aging passed all applicable and internal test methods. The difference does not raise new questions of substantially equivalence on safety
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and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
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 10993-23: 2021 |
| 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:
ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems
-
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
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare A
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applications Part 7: Connectors for intravascular or hypodermic applications
» ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
A ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
Performance testing
Performance testing Summary
| Items | Testing standard | Result | |
|---|---|---|---|
| Appearance | Internal performance standards | Pass | |
| Particulate | ISO 22413 -2021 | Pass | |
| Tensile strength | ISO 22413 -2021 | Pass | |
| Leakage | ISO 22413 -2021 | Pass | |
| Unobstructed | ISO 22413 -2021 | Pass | |
| Piercing Spike | ISO 22413 -2021 | Pass | |
| Puncture force | ISO 22413 -2021 | Pass | |
| puncture chip | ISO 22413 -2021 | Pass | |
| Dimension | Internal performance standards | Pass | |
| Housing | ISO 22413 -2021 | Pass | |
| Luer Connector | ISO 80369-7 | Pass | |
| Detachment force | Internal performance standards | Pass | |
| Spike tip ductility | Internal performance standards | Pass | |
| Filtration rate | ISO 22413 -2021 | Pass | |
| Chemical property | ISO 8536-4:2019 | Pass | |
| ChemicalProperties | Reducing substances(easy oxides) | Internal performance standards | Pass |
| Metal ions | |||
| pH | |||
| Evaporation residues | |||
| UV absorbance | |||
| Sterile | USP46-NF41 | Pass | |
| Bacterial endotoxin | USP-NF<71> | Pass |
IX Clinical Data
Clinical data was not conducted to support a substantial equivalence determination.
× Conclusion
The Vial Adapter with Filter are substantially equivalent to the predicate device (Vial Adapter). The non-clinical testing demonstrates that the differences between the subject and
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predicate device do not raise different questions of safety and effectiveness.
§ 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.