(87 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a mechanical vial adapter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for the transfer and mixing of drugs, aiding in the reconstitution and removal of contents from drug vials. It facilitates the use of therapeutic drugs but is not itself a therapeutic device that administers treatment directly to the patient.
No
The device is described as a "Vial Adapter" for the transfer and mixing of drugs, which is a drug delivery accessory, not a diagnostic tool used for identifying diseases or conditions.
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 does not mention any components or functions related to analyzing biological specimens or providing diagnostic information.
- Lack of IVD Characteristics: The description and performance studies focus on the physical and chemical properties of the device itself, its sterility, and its ability to function as a drug transfer mechanism. There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic results
- Reagents or assays
In summary, the Vial Adapter is a medical device used for drug preparation and administration, not for in vitro diagnostic testing.
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 needle free 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 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.
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
Not Found
Intended User / Care Setting
healthcare facilities or in the home environment by the patient or care-giver
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 testing:
- 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)
All tests passed.
Sterilization and shelf life testing:
- Sterilization validated to ISO 11137-1 and ISO 11137-2 with minimum SAL 10-6.
- Shelf life determined by stability study including ageing test, according to ISO 11607-1: 2019, ISO 11607-2: 2019, and ASTM F1980-16.
Performance testing summary:
- 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): Pass
- Chemical Properties (Reducing substances (easy oxides), Metal ions, pH, Evaporation residues, UV absorbance): Pass
- Sterile: Pass
- Bacterial endotoxin: Pass
Simulated transportation testing:
- Transportation package tested according to ASTM D4169-DC13 test procedure to ensure integrity during transportation.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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 (1-800-638-2041 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
3
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.
4F, No.585-2 Wanyuan Road, Minhang District, Shanghai
P.R.China |
|-------------------|-------------------------------------------------------------------------------------------------------------|
| Contact person: | Esther ZHANG
Regulatory affairs
Phone: 0086-13771505757
Email: Esther.zhang@llins-tech.com |
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 |
| 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
5
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
K232055 | 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 |
| 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,
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 |
| Sterilization Method | Electron beam
Irradiation | Gamma Irradiation | Different
Comment 3 |
| 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 | Proposed device
labeling (IFU)
includes transfer | Identical |
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| | and mixing
instructions | and mixing
instructions | |
|-----------------|----------------------------|----------------------------|------------------------|
| Expiration Date | 3 years | 5 years | Different
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 (