Vent Vial Adapter

K233287 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · LHI · Jul 26, 2024 · General Hospital

Device Facts

• Record ID: K233287
• Device Name: Vent Vial Adapter
• Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Jul 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: PCCP, Pediatric

Intended Use

The Vent Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. 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. This adapter is suitable for use across all age groups, including neonates, pediatrics, adults, and the elderly.

Device Story

Sterile, single-use device for drug vial access; features integrated piercing spike and housing to seat securely on vial ferrule; opposite end provides female Luer fitting for syringe connection. Used by healthcare professionals in clinical/hospital settings for drug reconstitution and removal. Device pierces elastomeric septum of vial; allows fluid transfer via Luer connection. Benefits include secure, standardized drug access and mixing. Available in 13mm and 20mm sizes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11137), shelf-life/packaging testing (ISO 11607, ASTM F1980), and performance testing (penetration force, detachment force, leakage, Luer connector compliance per ISO 80369-7).

Technological Characteristics

Materials: Polycarbonate, PTFE. Sensing/Actuation: Mechanical piercing spike. Energy: None (manual). Dimensions: 13mm, 20mm. Connectivity: None. Sterilization: Electron beam irradiation (SAL 10^-6). Software: None.

Indications for Use

Indicated for transfer and mixing of drugs in vials. Suitable for all age groups including neonates, pediatrics, adults, and elderly. No known contraindications.

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 (K222718)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 26, 2024

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

Re: K233287
Trade/Device Name: Vent Vial Adapter
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: Class II
Product Code: LHI
Dated: June 27, 2024
Received: June 27, 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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not

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K233287 - Esther Zhang
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required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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) 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 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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K233287 - Esther Zhang
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K233287 | |
| Device Name Vented Vial Adapter | |
| Indications for Use (Describe) The Vent Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. 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. This adapter is suitable for use across all age groups, including neonates, pediatrics, adults, and the elderly. | |
| Type of Use (Select one or both, as applicable) ☑ 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 [e-mail] | |
| "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." | |

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K233287- 510(k) Summary

I Submitter

Device submitter: Hangzhou Qiantang Longyue Biotechnology Co., LTD
104, 301, 302, building 12, building 1,619 WangMei Roadinping
street, Linping District, Hangzhou

Contact person: Chunyu Wang
Quality Assurance Manager
Phone: [phone]
Email: [e-mail]

Prepare Date: July 26, 2024

II Correspondent

Company: Shanghai Ling Fu Technology Co., Ltd.
4F, No.585-2 Wanyuan Road, Minhang District, Shanghai,
P.R.China

Contact person: Esther ZHANG
Regulatory affairs
Phone: [phone]
Email: [e-mail]

III Device

Trade Name of Device: Vented 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

IV Predicate Devices

Trade name: Vial Adapter

Common name: Set, I.V. Fluid Transfer

Classification: Class II, 21 CFR 880.5440

Product Code: LHI

Premarket Notification: K222718

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Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., LTD

# V 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 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 proposed Vented Vial Adapter is available in 13mm, 20mm diameter to accommodate respective size of drug vials.

# VI Indications for use

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

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. This adapter is suitable for use across all age groups, including neonates, pediatrics, adults, and the elderly.

# VII Comparison of technological characteristics with the predicate devices

The Vented Vial Adapter has the same intended use, and the technology, design, and performance specifications are either identical or substantially equivalent to the existing legally marketed predicate device. The differences between the Vented Vial Adapter and predicate device do not alter suitability of the proposed device for its intended use.

| Device feature | Subject Device | Predicate Device K222718 | Comments |
| --- | --- | --- | --- |
| Indications for use | The Vented vial adapter is indicated for the transfer and mixing of drugs contained in vials.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 | The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. | Identical. The predicate device is also used by Healthcare Professionals (HCPs) in a clinical, hospital, or other Healthcare environment. |
| | has the same intended use and the technology, design, and performance specifications. The device is intended for use by healthcare professionals (HCPs) in a clinical, hospital, or other healthcare environment. | | |

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| Device feature | Subject Device | Predicate Device K222718 | Comments |
| --- | --- | --- | --- |
| | has no known contraindications. This adapter is suitable for use across all age groups, including neonates, pediatrics, adults, and the elderly. | | |
| Product code | LHI | LHI | 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 | 13mm, 20mm, 28mm | Different Comment 1 |
| Material | Polycarbonate, PTFE | Polycarbonate | Different Comment 2 |
| Connector | Female Luer fitting | Female Luer fitting; Male Luer fitting | Different Comment 3 |
| Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Identical |
| Performance | Performance test of:
- Penetration force.
- Detachment force from Drug Vial.
- Spike Tip Ductility.
- Fluid Leakage.
Air filter | Performance test of:
- Penetration force;
- Detachment force from Drug Vial;
- Spike Tip Ductility; Fluid Leakage. | Different Comment 4 |
| Vial Adapter Fit (Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical |
| Sterilization Method | Electron beam Irradiation | Electron beam Irradiation | Identical |
| Sterility Assurance Level | SAL 10^{-6} | SAL 10^{-6} | Identical |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Identical |
| Labeling | Proposed device labeling (IFU) includes transfer and mixing instructions | Proposed device labeling (IFU) includes transfer and mixing instructions | Identical |
| Expiration Date | 4 years | 3 years | Different Comment 5 |

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Discussion:

Comment 1

Differences in the size of Vented vial adapter 13mm, 20mm 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 not raise new questions of substantially equivalence on safety and effectiveness.

Comment 2

The Vented vial adapter is available in PC and PTFE. The predicate product is only available in PC, but the product has passed the biocompatibility test according to ISO 10993-1:2018, and the difference in raw materials does not affect the substantial equivalence of safety and efficacy.

Comment 3

The connector of Vented Vial Adapter has only one type, while the predicated device has two types. This difference was addressed through ISO 80369-7 and this does not affect substantially equivalence on safety and effectiveness.

Comment 4

The Vented vial adapter with inlet and outlet functions, was tested in accordance to internal performance standards. The difference does not affect substantially equivalence on safety and effectiveness.

Comment 5

The Expiration Date of subject device is 4 years which is longer than the predicated device, and it has been passed through the Shelf-life validation. This difference does not affect intended use and does not raise new questions of substantially equivalence on safety and effectiveness.

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# 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

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# 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 |
| Detachment force | | ISO 8536-4 | Pass |
| Spike tip ductility | | Internal performance standards | Pass |
| Chemical Properties | Reducing substances (easy oxides) | Internal performance standards | Pass |
| | Metal ions | | |
| | pH | | |
| | Evaporation residues | | |
| | UV absorbance | | |
| Sterility | | Internal performance standards | Pass |
| Bacterial endotoxin | | Internal performance standards | Pass |

# IX Clinical Data

Not Applicable

# X Conclusion

The Vented vial adapter is substantially equivalent to the predicate device (Vial Adapter). The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed device and therefore, substantially equivalent.