Vial Adapter

K232055 · Shanghai Lingfu Technology Co., Ltd. · LHI · Oct 6, 2023 · General Hospital

Device Facts

• Record ID: K232055
• Device Name: Vial Adapter
• Applicant: Shanghai Lingfu Technology Co., Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Oct 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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

Device Story

Vial Adapter is a single-use, sterile fluid transfer device; consists of polycarbonate housing, piercing spike, and luer connector. Used in healthcare facilities or home settings by patients/caregivers. Device pierces elastomeric septum of drug vial; seats securely around vial ferrule via snap-fit. Opposite side features female/male luer fitting for connection to standard needle-free syringe. Facilitates reconstitution and removal of drug contents. Available in 13mm, 20mm, and 28mm configurations for various vial sizes. Enables safe drug transfer and mixing.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included appearance, particulate, tensile strength, leakage, piercing spike functionality, puncture force, chip generation, housing integrity, luer connector (ISO 80369-7), and chemical properties. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 11137-1/2. Shelf life validated per ISO 11607-1/2 and ASTM F1980-16. Transportation integrity tested per ASTM D4169-DC13.

Technological Characteristics

Materials: Polycarbonate. Principle: Single-lumen piercing spike with snap-fit housing. Dimensions: 13mm, 20mm, 28mm configurations. Connectivity: Standard Luer (female/male). Sterilization: Electron beam irradiation (SAL 10^-6). Biocompatibility: ISO 10993-1 compliant. Mechanical standards: ISO 80369-7 (Luer).

Indications for Use

Indicated for the transfer and mixing of drugs contained in vials. Intended for use in healthcare facilities or in the home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

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

• Vial Adapter 15mm (K171796)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 6, 2023

Shanghai Ling Fu Technology Co., Ltd. Esther Zhang Regulatory Affairs 4F, No.585-2 Wanyuan Road, Minhang District Shanghai, Shanghai 201102 China

Re: K232055

Trade/Device Name: Vial Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: July 7, 2023 Received: July 11, 2023

# 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 (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/cdrb/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" (https://www.fda.gov/media/99812/download).

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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 QS 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 (OS) 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-devices/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 [phone] or 301-796-7100).

Sincerely,

David Walloschek

Daivd Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

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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) K232055

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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# 510(k) Summary- K232055

#### l Submitter

| Device submitter: | Shanghai Ling Fu Technology Co., Ltd.<br>4F, No.585-2 Wanyuan Road, Minhang District, Shanghai<br>P.R.China |
|-------------------|-------------------------------------------------------------------------------------------------------------|
| Contact person: | Esther ZHANG<br>Regulatory affairs<br>Phone: [phone]<br>Email: [e-mail] |

Prepare Date: October 6, 2023

#### II Device

Trade Name of Device: Vial Adapter 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

#### III Predicate Devices

| Trade name: | Vial Adapter 15mm |
|-----------------------------------|-------------------------------------|
| Common name: | Set, I.V. Fluid Transfer |
| Classification/Regulation Number: | Class II, 21 CFR 880.5440 |
| Regulation Name: | Intravascular Administration<br>Set |
| 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 connection

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of a standard Luer needle free syringe for the reconstitution and removal of the contents of the druq vial.

The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter configurations to accommodate respective size of drug vials. The device is intended for use in healthcare facilities or in the home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

### V Indications for use

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

### VI Comparison of technological characteristic with the predicate device

The Vial Adapter has the same intended use as the legally marketed predicate device. The differences in technological characteristics between the subject and predicate device do not raise new or different questions of safety and effectiveness.

| Device feature | Subject Device<br>K232055 | Predicate Device<br>K171796 | Comments |
|---------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------|
| Indications for use | The Vial Adapter is<br>indicated for the<br>transfer and mixing<br>of drugs contained<br>in vials. | The Vial Adapter<br>15mm is indicated<br>for the transfer and<br>mixing of drugs<br>contained in vials | Identical |
| Product code | LHI | LHI | Identical |
| Regulation 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,<br>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<br>Lumen | Plastic - Single<br>Lumen | Identical |
| Vial Adapter Fit<br>(Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical |
| Sterilization Method | Electron beam<br>Irradiation | Gamma Irradiation | Different<br>Comment 3 |
| Sterility Assurance<br>Level | SAL 10-6 | SAL 10-6 | Identical |
| Biocompatibility | Conforms to ISO<br>10993 | Conforms to ISO<br>10993 | Identical |
| Labeling | Proposed device<br>labeling (IFU)<br>includes transfer | Proposed device<br>labeling (IFU)<br>includes transfer | Identical |

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| | and mixing<br>instructions | and mixing<br>instructions | |
|-----------------|----------------------------|----------------------------|------------------------|
| Expiration Date | 3 years | 5 years | Different<br>Comment 4 |

Discussion:

### Comment 1

There are differences in the size of Vial Adapters of the subject device which consist of 13mm, 20mm, 28mm configurations. The different sizes are for different diameter standard vials. The subject device performance testing demonstrates that the difference does not affect the intended use and does not raise new questions of safety and effectiveness.

# Comment 2

The connector of Vial Adapter was divided into a female Luer fitting and a male Luer fitting, while the predicated device has only one luer fitting. This difference was addressed through ISO 80369-7 as well as biocompatibility, sterility and performance testing. The difference does not raise new or different questions of safety and effectiveness.

# Comment 3

The Vial Adapter is provided sterilized by an Electron beam Irradiation method rather than gamma irradiation for the predicate device. However, the validation of the sterilization process in compliance with ISO 11137-1 and ISO 11137-2 ensures the device is adequately sterilized. Therefore, the difference does not raise new or different questions of safety and effectiveness.

# Comment 4

The expiration date of subject device is 3 years which is shorter than the predicated device. The performance of the device over the proposed shelf life was tested to demonstrate that the difference does not affect the intended use and does not raise new questions of safety and effectiveness.

# VII Data

The following 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

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

| Performance testing | |
|---------------------|--|
|---------------------|--|

| Performance testing Summary | | | |
|-----------------------------|--------------------------------------|--------------------------------|------|
| 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 | |
| Chemical<br>Properties | Reducing substances<br>(easy oxides) | Internal performance standards | Pass |
| | Metal ions | Internal performance standards | |
| | pH | Internal performance standards | |
| | Evaporation residues | Internal performance standards | |
| | UV absorbance | Internal performance standards | |
| Sterile | Internal performance standards | Pass | |
| Bacterial endotoxin | Internal performance standards | Pass | |

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#### Simulated transportation testing

The transportation package has been tested according to ASTM D4169-DC13 test procedure to ensure its integrity during transportation.

#### VIII Conclusion

The Vial Adapter is substantially equivalent to the predicate device, Vial Adapter 15mm cleared under K171796. The non-clinical testing demonstrates that the device is as safe and effective as the predicate device and that the differences in technological characteristics do not raise new or different questions of safety and effectiveness.