(373 days)
Not Found
No
The device description and intended use focus solely on the mechanical function of transferring fluids and do not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is used to reconstitute and transfer drugs and fluids, and to administer fluids, but it does not directly provide therapy; rather, it aids in the delivery of prescribed treatments.
No.
The device is described as an admixture device for drug reconstitution and transfer, serving as a fluid pathway. Its purpose is to aid in the administration of prescribed treatment, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a body, piercing spike, spike cover, IV port, and twist-off, indicating it is a hardware device for fluid transfer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer influsion liquid to patient." This describes a process for preparing and administering medication, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical components and function of transferring fluids and connecting to an IV set. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device facilitates the delivery of medication, which is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
The device is a medical device used in the preparation and administration of intravenous fluids and medications.
N/A
Intended Use / Indications for Use
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer influsion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are designed for drug reconstitution and transfer of fluids from drug vials into IV bag containing infusion solution. The VDB-13 & 20 serve as a fluid pathway for standard IV set to administer fluid to patient while minimizing exposure to drug aerosols and spills. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag.
Both IV fluid transfer system designs consist of a body, piercing spike, spike cover, IV port, and twist-off for the IV administration set. The VDB 13mm and 20mm has an integrated Vial Adaptor for access to the drug/solution vial. Both system transfer drug into an IV bag and to an external IV administration set to administer fluid to patient. The products do not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities by 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 environments by clinically trained healthcare professional providers / healthcare facilities by 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)
Performance testing was conducted to validate that the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices met the applicable design and performance requirements throughout its shelf life, conformity to applicable standards, and demonstrate substantial equivalent to the predicate device.
Conformity to Standard: ISO 8536-4: 2019
Additional Performance Testing to internal specifications: Product Functionality According to IFU, Cap Detachment Force, Spike Penetration Force, Air Leakage Test, Vial Adaptor Tensile Detachment Force From Drug Vial, Vial Adaptor Torsional Breakage Test, Spike to IV Bag Port Tensile Detachment Force, IV Admin Spike to VDB-IV Port Attachment Force, Vial Attachment Force, Vial Detachment Force, Flange Breakage, Flow Rate, Coring of IV Bag Port, Coring and Fragmentation of Vial Stopper, Twist-Off Bonding To IV Spike, Leakage After Removal of Twist OFF, Leakage at VDB-IV Spike to IV Bag port following assembly of components, Leakage at VDB-IV Port to IV Admin Spike following assembly of components, Dimensional Measurements of the IV spike lumens, Dimensional Measurements of the Vial Adaptor Retention Feature, Chemical Compatibility Testing, Dose Concentration Study, Dose Accuracy (Transfer of vial contents to the IV bag & to the administration set).
Biocompatibility: In accordance to ISO 10993-1, the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are classified as an externally communicating device with prolonged contact duration (>24 hours to 30 days) and blood path indirect contact. The following biocompatibility tests have been successfully conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute System Toxicity, Subacute System Toxicity, Pyrogenicity, Hemolysis, Particulate Test, Bacterial Endotoxin.
Sterilization: The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. The sterilization method provides a sterility assurance level (SAL) of 10-6.
No clinical trial was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K201415 Vial2Bag-Advanced
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 19, 2022
Advcare Medical Meng Tan CEO No. 36, Sinsing Street, Shulin District New Taipei, 23877 Taiwan
Re: K212525
Trade/Device Name: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: August 5, 2021 Received: August 11, 2021
Dear Meng Tan:
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 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
1
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 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 Wolloscheck, Ph.D. For Payal Patel 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
2
Indications for Use
510(k) Number (if known) K212525
Device Name
Advcare Vial Direct to Bag (VDB) Needle-Free Admixture Devices
Indications for Use (Describe)
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer influsion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
| 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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3
K212525 510(k) Summary
| Submitter: | Advcare Medical
No. 36 Sinsing Street
Shulin District, New Taipei City, 23877 |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Application Correspondent:
Telephone Number:
Fax Number:
E-mail:
Date Prepared: | Meng T. Tan
+886-2-3501-7479
+886-2-8970-1448
sales@advcaremed.com
August 17, 2022 |
| Trade Name: | Advcare Direct to Bag (VDB) Needle-free
Admixture Devices |
| Common or Usual Name: | I.V. Fluid Transfer Set |
| Regulation Medical Specialty: | General Hospital |
| Regulation Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | LHI |
| Device Class: | 2 |
| Predicate Device: | K201415 Vial2Bag-Advanced |
Device Indications For Use:
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer infusion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
Device Description:
4
Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are designed for drug reconstitution and transfer of fluids from drug vials into IV bag containing infusion solution. The VDB-13 & 20 serve as a fluid pathway for standard IV set to administer fluid to patient while minimizing exposure to drug aerosols and spills. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag.
Both IV fluid transfer system designs consist of a body, piercing spike, spike cover, IV port, and twist-off for the IV administration set. The VDB 13mm and 20mm has an integrated Vial Adaptor for access to the drug/solution vial. Both system transfer drug into an IV bag and to an external IV administration set to administer fluid to patient. The products do not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities by care-giver to aid and support prescribed treatment and therapy.
Technological Characteristics and Substantial Equivalence:
A technological comparison table is provided below that compares the subject devices and predicate device.
| Predicate K201415 | Advcare VDB 13 & 20 | Equivalence to Predicate | |
|---|---|---|---|
| Intended use | The Vial2Bag | ||
| Advanced intended | |||
| use is to allow the | |||
| administration of a | |||
| fluid from an IV | |||
| container to a | |||
| patient's vascular | |||
| system through a | |||
| needle or catheter | |||
| inserted into a | |||
| vein. The | |||
| Vial2bag- | |||
| Advanced has | |||
| 20mm vial adaptor | |||
| to access infusion | |||
| system. | Advcare IV fluid transfer | ||
| Vial Direct to Bag | |||
| (VDB) 13 & 20 intended | |||
| use is to allow the | |||
| administration of a fluid | |||
| from an IV container to a | |||
| patient's vascular system | |||
| through a needle or | |||
| catheter inserted into a | |||
| vein. The Advcare IV | |||
| fluid transfer Vial Direct | |||
| to Bag (VDB) Devices | |||
| has 13mm and 20mm | |||
| vial adaptor to access | |||
| infusion system. | Comment 1 | ||
| Target users | Pharmacist or | ||
| other healthcare | |||
| professionals | Pharmacist or other | ||
| healthcare professionals | Same | ||
| Use | |||
| Environment | Hospital, Clinics | Hospital, Clinics | Same |
5
| Page | 3 | of | 5 |
|---|---|---|---|
| ------ | --- | ---- | --- |
| Interaction with
other devices | For all uses, device
will connect to an
IV solution
container and a
primary
administration set.
Based on IFU. | For all uses, device will
connect to an IV solution
container and a primary
administration set. Based
on IFU | Same |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------|
| Vial size | 20mm | 20mm and 13 mm | Comment 1 |
| IV bag sizes | 50ml,100m,
250ml | All standard IV
bags | Comment 2 |
| Sterilization | Eto | Eto | Same |
| Prescription use | Rx only | Rx only | Same |
| Piercing Spike | Plastic-Single Lumen | Plastic-Single
Lumen | Same |
| Materials | Medical Grade
Plastics | Medical Grade
Plastics | Comment 3 |
Discussion of differences in technological characteristics:
Comment 1- Advcare IV fluid transfer Vial Direct to Bag (VDB) Devices has two designs, 13mm vial adaptor and 20mm vial adaptor designs. The predicate device only has a 20mm vial adaptor. The VDB-13 is to accommodate smaller drug vial sizes. Performance testing confirmed that the VDB- 13mm vial adaptor design does not raise different questions of safety and effectiveness. The materials, function, and principal of operation are very similar as the primary predicate 20mm vial adaptor.
Comment 2 - the predicate device is for use with 50ml, 100ml and 250ml IV solution bags. The Advcare IV fluid transfer Vial Direct to Bag (VDB) Devices are for use with all standard IV solution bags. Standard IV solution bags available on the market utilize a standard spike connector and this is consistent for all size standard solution bags. The Advcare IV fluid transfer Vial Direct to Bag (VDB) Devices utilize a standard bag spike that is compatible with all size standard IV solution bags and as such, will not raise any new safety or efficacy questions.
COMPARATIVE SAFETY AND PERFORMANCE: The Advcare fluid transfer Vial Direct to Bag (VDB) 13 & 20 uses the same technique and parameters as the predicate device for reconstituting and transferring medication. There are no differences in technology. Therefore, the technology used in the Adveare fluid transfer Vial Direct to Bag (VDB) 13 & 20 does not affect the comparative safety and performance of the device.
Comment 3- Biocompatibility testing demonstrated the materials are biocompatible.
PERFORMANCE DATA:
The following non-clinical data were provided in support of the substantial equivalence determination.
6
Performance Testing
Testing was conducted to validate that the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices met the applicable design and performance requirements throughout its shelf life, conformity to applicable standards, and demonstrate substantial equivalent to the predicate device.
Conformity to Standard:
ISO 8536-4: 2019
Additional Performance Testing to internal specifications:
- Product Functionality According to IFU
- Cap Detachment Force
- Spike Penetration Force ●
- Air Leakage Test ●
- Vial Adaptor Tensile Detachment Force From Drug Vial ●
- Vial Adaptor Torsional Breakage Test ●
- Spike to IV Bag Port Tensile Detachment Force ●
- IV Admin Spike to VDB-IV Port Attachment Force ●
- Vial Attachment Force
- Vial Detachment Force
- Flange Breakage
- Flow Rate ●
- Coring of IV Bag Port
- Coring and Fragmentation of Vial Stopper
- Twist-Off Bonding To IV Spike
- Leakage After Removal of Twist OFF
- Leakage at VDB-IV Spike to IV Bag port following assembly of components ●
- Leakage at VDB-IV Port to IV Admin Spike following assembly of components ●
- Dimensional Measurements of the IV spike lumens
- Dimensional Measurements of the Vial Adaptor Retention Feature. ●
- Chemical Compatibility Testing. ●
- Dose Concentration Study
- Dose Accuracy (Transfer of vial contents to the IV bag & to the administration set)
Biocompatibility
Accordance to ISO 10993-1, the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are classified as an externally communicating device with prolonged contact duration (>24 hours to 30 days) and blood path indirect contact. The finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk
7
management process." The following biocompatibility tests has been successfully conducted.
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- Acute System Toxicity ●
- Subacute System Toxicity ●
- Pyrogenicity
- Hemolysis ●
- Particulate Test ●
- Bacterial Endotoxin ●
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices. The sterilization method provides a sterility assurance level (SAL) of 10-6.
CLINICAL DATA:
No clinical trial was performed
CONCLUSION:
In summary, the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needlefree Admixture Devices subject of this Premarket Notification is considered to be substantially equivalent in its intended use, technological, material, and performance to the predicate device, Vial2bag: Advanced (K201415).