(424 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple fluid transfer device, with no mention of AI or ML capabilities.
No
The device is described as a "Decanting Device" intended for "aseptic dispensing of solutions from IV containers" and "transferring IV fluids/medication." It facilitates the creation of a sterile fluid path to "ensure an aseptic transfer or removal of fluids/medication." This function is for preparing or handling medications, not for directly treating a patient's medical condition.
No
The device is described as a "Mini Transfer Device" or "Vial Transfer Device" and its intended use is for "aseptic dispensing of solutions from IV containers" or "transferring IV fluids/medication." This function does not involve diagnosing a condition or disease.
No
The device description clearly outlines physical components like spikes, caps, needles, and sticks, and the performance studies focus on physical characteristics and biocompatibility, indicating it is a hardware device.
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 "aseptic dispensing of solutions from IV containers" and "transferring IV fluids/medication from a vial to an IV fluid administration device" or "from a bag to an IV fluid administration device." This describes a device used for the physical manipulation and transfer of substances within the body or for administration into the body, not for testing samples outside the body to diagnose a condition.
- Device Description: The description focuses on the physical components (spike, cap, needle tip, stick) and their function in creating a sterile fluid path for transfer. This aligns with a device used for fluid handling in a clinical setting, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical for fluid transfer.
- Performance Studies: The performance studies focus on physical characteristics (dimension, flow, sealing, strength), sterility, particulate matter, and biocompatibility. These are relevant to a medical device used for fluid administration, not an IVD which would typically involve performance metrics related to analytical accuracy, sensitivity, specificity, etc.
In summary, the device's purpose is to facilitate the safe and sterile transfer of fluids for administration, which falls under the category of a medical device used in patient care, not an in vitro diagnostic device used for testing samples to diagnose conditions.
N/A
Intended Use / Indications for Use
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Decanting Device is provided as sterile and is intended for use in a single procedure only. There are four proposed models: GC0652DD, GC 0653DD and GC0654DD and GC0654 DT. Model GC0652DD, GC0654DD and GC0654 DT consist of spike and cap for spike. Model GC0653DD consists of Protective Cap, Needle Tip, Cover and stick.
Through the use of a spike/stick, facilitates creation of a sterile fluid path. Decanting device help ensure an aseptic transfer or removal of fluids/medication from flexible and rigid containers.
For models GC0653DD and GC0652DD, insert the decanter spike/stick by piercing the rubber opening of the glass vial. Tilt the decanting device body until desired flow is reached, ensuring the spike/stick air ventilation holes remain inside the glass vial.
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
Not Found
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: The biocompatibility evaluation for this device was conducted in accordance with the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA. The following Biocompatibility tests were conducted by GC0654DD and GC0654DT: In Vitro Cytotoxicity Test (ISO 10993-5:2009), Skin Sensitization Test: Guinea Pig Maximization Test (0.9% Sodium Chloride Injection Extract) and Skin Sensitization Test: Guinea Pig Maximization Test (Sesame oil Extract) (both ISO 10993-10:2010), Intracutaneous Reactivity Test (0.9% Sodium Chloride Injection Extract and Sesame Oil Extract) (ISO 10993-10:2010), Acute Systemic Toxicity (0.9% Sodium Chloride Injection Extract, Intravenous) and Acute Systemic Toxicity (Sesame Oil Extract, Intraperitoneal) (both ISO 10993-11:2017), Pyrogen Test (0.9% Sodium Chloride Injection Extract, Rabbit) (ISO 10993-11:2017), and In Vitro Hemocompatibility Testing (Rabbit blood) (ISO 10993-4:2017). The results of all testing were passing.
Performance Testing: The following bench tests were performed on Decanting device according to internal standards: Appearance, dimension, unimpeded performance, sealing performance, connection strength, penetration force, fluid flow and leakage. Testing was also conducted according USP Particulate Matter in Injections. Sterilization validation was performed according to ISO 11135-1:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The results of all testing were passing.
Clinical Test Conclusion: No Clinical Study is included in this submission.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
GCMEDICA ENTERPRISE LTD., (WUXI) % Ethan Liu QA Specialist Shanghai Thinkwell Consulting Co., Ltd Xinling Road, 211/6F Shanghai, 201100 China
Re: K182819
Trade/Device Name: GCMEDICA Mini Transfer Device GCMEDICA Vial Transfer Device GCMEDICA Bag Transfer Device GCMEDICA Clear Bag Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: October 21, 2019 Received: October 29, 2019
Dear Ethan Liu:
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.
1
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 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 (OS) 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.
for Geeta Pamidimukkala Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182819
Device Name
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device, GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device
Indications for Use (Describe)
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for GCiMEDICA. The logo is blue and features the company name in a stylized font. Below the name is the text "SINCE 1998".
Decanting Device
510(k) Summary (K182819)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | GCMEDICA ENTERPRISE LTD.,(WUXI)
Loujin Industrial Park,Shuofang,Wuxi,Jiangsu,PRC |
|-----------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Ethan Liu
Phone: 0086-15216699240
Fax: 0086-21-60732022
Email: xtdeepwater@126.com |
| Date Prepared: | Nov. 25, 2019 |
5.2 Device
| Trade Name | ||
|---|---|---|
| GC0652DD | GCMEDICA Mini Transfer Device | |
| GC0653DD | GCMEDICA Vial Transfer Device | |
| GC0654DD | GCMEDICA Bag Transfer Device | |
| GC0654DT | GCMEDICA Clear Bag Transfer Device | |
| Common Name: | Decanting Device | |
| Regulation Number: | 880.5440 | |
| Regulation Name: | Intravascular administration set. | |
| Regulatory Class: | Class II | |
| Product Code: | LHI |
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Image /page/4/Picture/0 description: The image shows the logo for GCiMEDICA. The logo is in blue and features the company name in a stylized font. Below the name is the text "SINCE 1998".
Decanting Device
| Product Code Name | Set, I.V. Fluid Transfer |
|---|---|
| ------------------- | -------------------------- |
5.3 Predicate Device
| Trade Name: | Medline Vial Decanter (K111577) |
|---|---|
| Common Name: | Decanting device |
| Regulation Number: | 880.5440 |
| Regulation Name: | Intravascular administration set. |
| Regulatory Class: | Class II |
| Product Code: | LHI |
| Product Code Name: | Set, I.V. Fluid Transfer |
5.4 Device Description
The Decanting Device is provided as sterile and is intended for use in a single procedure only. There are four proposed models: GC0652DD, GC 0653DD and GC0654DD and GC0654 DT. Model GC0652DD, GC0654DD and GC0654 DT consist of spike and cap for spike. Model GC0653DD consists of Protective Cap, Needle Tip, Cover and stick.
Through the use of a spike/stick, facilitates creation of a sterile fluid path. Decanting device help ensure an aseptic transfer or removal of fluids/medication from flexible and rigid containers.
For models GC0653DD and GC0652DD, insert the decanter spike/stick by piercing the rubber opening of the glass vial. Tilt the decanting device body until desired flow is reached, ensuring the spike/stick air ventilation holes remain inside the glass vial.
5.5 Indication for Use:
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device.
Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: GCMEDICA
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Image /page/5/Picture/0 description: The image shows the logo for GC Medica. The logo is blue and features the text "GC Medica" in a stylized font. Below the text is the phrase "Since 1998".
Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
| Item | Proposed Device
Common name: Decanting Device
Submitter:GCMEDICA ENTERPRISE
LTD.,(WUXI) | Predicate device
(K111577 )
Trade/Device
name: Medline
Vial Decanter
Submitter:
Medline
Industries
Incorporated | Comment |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Image: GC0652DD
Image: GC0653DD,
Image: GC0654DD
Image: GC0654 DT | Image: DYNJDEC06 | Different.
GCMEDICA has
four models while
Medline has only
one model.
GC0653DD is same
as DYNJDEC06.
The other three
models have similar
configurations.
Performance testing
was conducted to
demonstrate any
difference will not
raise questions
regarding its safety
and effectiveness. |
| Indication for Use | GCMEDICA Mini Transfer Device,
GCMEDICA Vial Transfer Device:
Intended for the aseptic dispensing of
solutions from IV containers. For use in | Decanting device
intended for the
aseptic dispensing
of solutions from | |
| Item | Proposed Device
Common name: Decanting Device
Submitter:GCMEDICA ENTERPRISE
LTD.,(WUXI) | Predicate device
(K111577 )
Trade/Device
name: Medline
Vial Decanter
Submitter:
Medline
Industries
Incorporated | Comment |
| | transferring IV fluids/medication from a vial
to an IV fluid administration device.
GCMEDICA Bag Transfer Device,
GCMEDICA Clear Bag Transfer Device:
Intended for the aseptic dispensing of
solutions from IV containers. For use in
transferring IV fluids/medication from a bag
to an IV fluid administration device. | IV containers. For
use in transferring
IV
fluids/medication
from a vial to an
IV fluid
administration
device. | |
| Configur
ation | Model GC0652DD, GC0654DD and
GC0654 DT consist of spike and cap for
spike. Model GC0653DD consists of
Protective Cap, Needle Tip, Cover and stick. | Model
DYNJDEC06
consists of
Protective Cap,
Needle Tip, Cover
and stick. | Model GC0653DD
is same as Model
DYNJDEC06. The
other three models
have similar
configurations. The
difference will not
raise any question
regarding its safety
and effectiveness. |
| Length | Model GC0652DD: 3inch;
Model GC0653DD: 6inch;
Model GC0654DD: 9inch;
Model GC0654DT: 9inch. | DYNJDEC06:
6inch; | Model GC0653DD
is same as Model
DYNJDEC06, the
length is 6 inch,
while the other three
models' length is 3
inch and 9 inch. We
had performed |
| Item | Proposed Device
Common name: Decanting Device
Submitter:GCMEDICA ENTERPRISE
LTD.,(WUXI) | Predicate device
(K111577 )
Trade/Device
name: Medline
Vial Decanter
Submitter:
Medline
Industries
Incorporated | Comment |
| | | | unimpeded
performance,
sealing
performance,
connecting strength,
fluid flow and
leakage for all
proposed models,
the length difference
will not raise any
difference regarding
its safety and
effectiveness. |
| Material | GC0652DD, GC0653DD, GC0654DD:
ABS, PE;
GC0654DT: K Resin, PE. | DYNJDEC06:
ABS, PE; | Model GC0652DD,
GC0653DD,
GC0654DD are
same as Model
DYNJDEC06.
Biocompatibility
testing was
performed per ISO
10993-1. The
difference will not
raise any questions
regarding its safety
and effectiveness. |
5.6 Substantial Equivalence and Technological Characteristics
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Image /page/6/Picture/0 description: The image shows the logo for GCiMEDICA. The logo is blue and features the company name in a stylized font. Below the company name is the text "SINCE 1998".
7
Image /page/7/Picture/0 description: The image shows the logo for GCiMEDICA. The logo is in blue and features the company name in a stylized font. Below the company name, it says "SINCE 1998".
Decanting Device
8
Image /page/8/Picture/0 description: The image shows the logo for GCI Medica. The logo is blue and features the text "GCI Medica" in a stylized font. Below the text is a blue swoosh and the text "Since 1998".
5.7 Substantial Equivalence
Medline Vial Decanter ( Medline Industries Incorporated, K111577) is used as predicate device compared to proposed device Decanting Device manufactured by GCMEDICA ENTERPRISE LTD.,(WUXI).
5.8 Performance Data
5.8.1 Biocompatibility Testing
The biocompatibility evaluation for this device was conducted in accordance with the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA.
The following Biocompatibility tests were conducted by GC0654DD and GC0654DT. The results of all testing were passing.
| Biocompatibility Test | Standards |
|---|---|
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 |
| Skin Sensitization Test: | |
| Guinea Pig Maximization Test (0.9% Sodium | |
| Chloride Injection Extract) | ISO 10993-10:2010 |
| Skin Sensitization Test: | |
| Guinea Pig Maximization Test (Sesame oil Extract) | ISO 10993-10:2010 |
| Intracutaneous Reactivity Test (0.9% Sodium | |
| Chloride Injection Extract and Sesame Oil Extract) | ISO 10993-10:2010 |
| Acute Systemic Toxicity (0.9% Sodium Chloride | |
| Injection Extract, Intravenous) | ISO 10993-11:2017 |
| Acute Systemic Toxicity (Sesame Oil Extract, | |
| Intraperitoneal) | ISO 10993-11:2017 |
| Pyrogen Test (0.9% Sodium Chloride Injection | |
| Extract, Rabbit) | ISO 10993-11:2017 |
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Image /page/9/Picture/0 description: The image shows the logo for GC Medica. The logo is blue and features the text "GC Medica" in a stylized font. Below the text is a blue swoosh and the text "Since 1998".
Decanting Device
| Biocompatibility Test | Standards |
|---|---|
| In Vitro Hemocompatibility Testing (Rabbit blood). | ISO 10993-4:2017 |
5.8.2 Performance Testing
The following bench tests were performed on Decanting device according to internal standards: Appearance, dimension, unimpeded performance, sealing performance, connection strength, penetration force, fluid flow and leakage. Testing was also conducted according USP Particulate Matter in Injections. Sterilization validation was performed according to ISO 11135-1:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The results of all testing were passing.
5.9 Clinical Test Conclusion
No Clinical Study is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, GCMEDICA ENTERPRISE LTD., (WUXI) has demonstrated that proposed device Decanting Device is substantially equivalent to Medline Industries Incorporated's currently marketed Medline Vial Decanter (K111577).