K Number
K222718
Device Name
Vial Adapter
Date Cleared
2023-03-10

(183 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
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 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.
More Information

Not Found

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing.

No.
The device description states its purpose is for the "transfer and mixing of drugs contained in vials" and the "reconstitution and removal of the contents of the drug vial," which are preparation steps for drug administration, not direct therapeutic action on the patient.

No

The device is described as a Vial Adapter, indicated for the transfer and mixing of drugs from vials. Its purpose is to facilitate the connection of a syringe to a drug vial for reconstitution and removal of contents, not to diagnose medical conditions or provide diagnostic information.

No

The device description clearly outlines physical components (luer connector, housing, piercing spike) made of polycarbonate, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for the transfer and mixing of drugs contained in vials." This describes a device used to manipulate and prepare medications, not to perform diagnostic tests on biological samples.
  • Device Description: The description details a mechanical device for accessing and transferring contents from drug vials. It doesn't mention any components or functions related to analyzing biological specimens or providing diagnostic information.
  • Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely related to drug preparation.
  • Performance Studies: The performance studies focus on the physical and chemical properties of the device itself (biocompatibility, sterilization, shelf life, leakage, etc.) and its ability to function as a vial adapter. They do not involve evaluating its performance in a diagnostic context.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This Vial Adapter does not fit that description.

N/A

Intended Use / Indications for Use

The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.

Product codes

LHI

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The device is intended for use on population of all ages.

Intended User / Care Setting

healthcare facilities or in home environment by the patient or caregiver

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (

§ 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.

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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., LTD
302, building 12, building 1,619 WangMei Road, Linping street
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
K171796 | Comments |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indications for
use | The Vial Adapter is
indicated for the transfer
and mixing of drugs
contained in vials. | The Vial Adapter 15mm
is indicated for the
transfer and mixing of
drugs contained in vials | Identical |
| Regulation
number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| Class | CLASS II | CLASS II | Identical |
| Principle of
operation | Single use | Single use | Identical |
| Size | 13mm, 20mm, 28mm | 15mm | Different
Comment 1 |
| Material | Polycarbonate | Polycarbonate | Identical |
| Connector | Female Luer fitting;
Male Luer fitting | Luer fitting | Different
Comment 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 from
    Drug Vial;
  • Spike Tip Ductility;
  • Fluid Leakage. | Performance test of:
  • Penetration force;
  • Detachment force
    from Drug Vial;
  • Spike Tip Ductility;
  • Fluid Leakage. | Identical |

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| Device feature | Subject Device | Predicate Device
K171796 | Comments |
|------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------|
| Sterilization
Method | Electron beam Irradiation | Gamma Irradiation | Different
Comment 3 |
| Sterility
Assurance Level | SAL 10-6 | SAL 10-6 | Identical |
| Labeling | Proposed device
labeling (IFU) includes
transfer and mixing
instructions | Proposed device
labeling (IFU) includes
transfer and mixing
instructions | Identical |
| Expiration Date | 3 years | 5 years | Different
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.

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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 ( ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ItemsTesting standardResult
AppearanceInternal performance standardsPass
ParticulateInternal performance standardsPass
Tensile strengthInternal performance standardsPass
LeakageInternal performance standardsPass
UnobstructedInternal performance standardsPass
Piercing SpikeInternal performance standardsPass
Puncture forceInternal performance standardsPass
Chips after punctureInternal performance standardsPass
HousingInternal performance standardsPass
Luer ConnectorISO 80369-7Pass

Performance testing

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Detachment forceInternal performance standardsPass
Spike tip ductilityInternal performance standardsPass
Chemical
PropertiesReducing substances
(easy oxides)Internal performance standardsPass
Metal ions
pH
Evaporation residues
UV absorbance
SterileInternal performance standardsPass
Bacterial endotoxinInternal performance standardsPass

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.