(87 days)
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
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.
This document is a 510(k) summary for a medical device (Vial Adapter) and describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers.
Therefore, many of the requested details, such as those pertaining to AI/ML acceptance criteria, ground truth establishment for AI/ML, human reader studies (MRMC), number of experts for ground truth, and training/test set sample sizes for AI/ML models, are not applicable to this document.
However, I can extract information related to the performance testing of the device itself and its acceptance criteria, as well as the overall study design of the non-clinical testing.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted. The acceptance criteria are implicitly "Pass" for each item, indicating that the device met the required standards for each test.
| Items | Testing Standard | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|---|
| Appearance | Internal performance standards | Pass | Pass |
| Particulate | Internal performance standards | Pass | Pass |
| Tensile strength | Internal performance standards | Pass | Pass |
| Leakage | Internal performance standards | Pass | Pass |
| Unobstructed | Internal performance standards | Pass | Pass |
| Piercing Spike | Internal performance standards | Pass | Pass |
| Puncture force | Internal performance standards | Pass | Pass |
| Chips after puncture | Internal performance standards | Pass | Pass |
| Housing | Internal performance standards | Pass | Pass |
| Luer Connector | ISO 80369-7 | Pass | Pass |
| Chemical Properties | Internal performance standards | Pass | Pass |
| (Reducing substances) | |||
| (Metal ions) | |||
| (pH) | |||
| (Evaporation residues) | |||
| (UV absorbance) | |||
| Sterile | Internal performance standards | Pass | Pass |
| Bacterial endotoxin | Internal performance standards | Pass | Pass |
Biocompatibility Testing:
The following tests were performed with acceptance criteria implicitly being "conforming" to the respective ISO standards.
| Test Name | Standard | Implied Acceptance (Conformity) | Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009 | Conforms to standard | Performed |
| Skin sensitization | ISO 10993-10: 2010 | Conforms to standard | Performed |
| Hemolysis | ISO 10993-4: 2017 | Conforms to standard | Performed |
| Intracutaneous reactivity | ISO 10993-10: 2010 | Conforms to standard | Performed |
| Acute systemic toxicity | ISO 10993-11: 2017 | Conforms to standard | Performed |
| Pyrogenicity | ISO 10993-11: 2017 | Conforms to standard | Performed |
Sterilization and Shelf Life Testing:
The acceptance criterion for sterilization is a minimum SAL 10-6. The shelf life testing acceptance is that the device performs as intended over its 3-year proposed shelf life.
| Test Name | Standard | Acceptance Criteria (Implicit) | Performance |
|---|---|---|---|
| Sterilization Validation | ISO 11137-1, -2 | Minimum SAL 10-6 | Validated |
| Shelf Life (Stability Study) | ISO 11607-1, -2; ASTM F1980-16 | Device performs over 3 years | Tested |
Simulated Transportation Testing:
| Test Name | Standard | Acceptance Criteria (Implicit) | Performance |
|---|---|---|---|
| Transportation Package Integrity | ASTM D4169-DC13 | Package integrity maintained | Tested |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size (the number of units tested) for each of the performance tests. It states that "The following data were provided in support of the substantial equivalence determination," indicating tests were conducted. Standard practice for such tests involves using a statistically relevant sample size, but the specific number is not disclosed in this document.
- Data Provenance: The tests were performed by the manufacturer, Shanghai Ling Fu Technology Co., Ltd. The document is silent on the specific country of origin for the data collection (beyond the manufacturer's location in China) or whether the data was retrospective or prospective. Given the nature of performance validation, it would be prospective testing of newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the device performance testing (e.g., sterilization, leakage, material properties) of a physical medical device (Vial Adapter), not a diagnostic or AI/ML-based device that requires expert interpretation for ground truth. The "ground truth" here is the physical measurement or outcome of the prescribed test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is physical device performance testing, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The "adjudication" is inherently built into the testing protocol and measurement against a standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device. Therefore, no MRMC study with human readers was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's testing is based on objective measurements and adherence to established engineering and medical device standards (e.g., ISO, ASTM, internal performance standards). For example, a "Pass" for Luer Connector leakage means it met the leakage requirements specified in ISO 80369-7. For biocompatibility, the ground truth is conformance to the biological response defined by ISO 10993 series.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device. There is no "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device. There is no "training set."
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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
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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.4F, No.585-2 Wanyuan Road, Minhang District, ShanghaiP.R.China |
|---|---|
| Contact person: | Esther ZHANGRegulatory affairsPhone: 0086-13771505757Email: 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 AdministrationSet |
| 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 DeviceK232055 | Predicate DeviceK171796 | Comments |
|---|---|---|---|
| Indications for use | The Vial Adapter isindicated for thetransfer and mixingof drugs containedin vials. | The Vial Adapter15mm is indicatedfor the transfer andmixing of drugscontained 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 ofoperation | Single use | Single use | Identical |
| Size | 13mm, 20mm,28mm | 15mm | DifferentComment 1 |
| Material | Polycarbonate | Polycarbonate | Identical |
| Connector | Female Luer fitting;Male Luer fitting | Luer fitting | DifferentComment 2 |
| Piercing Spike | Plastic - SingleLumen | Plastic - SingleLumen | Identical |
| Vial Adapter Fit(Vial Side) | Snap Fit to Vial | Snap Fit to Vial | Identical |
| Sterilization Method | Electron beamIrradiation | Gamma Irradiation | DifferentComment 3 |
| Sterility AssuranceLevel | SAL 10-6 | SAL 10-6 | Identical |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 | Identical |
| Labeling | Proposed devicelabeling (IFU)includes transfer | Proposed devicelabeling (IFU)includes transfer | Identical |
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| and mixinginstructions | and mixinginstructions | ||
|---|---|---|---|
| Expiration Date | 3 years | 5 years | DifferentComment 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 | |
| ChemicalProperties | Reducing substances(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.
§ 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.