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.

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.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for GCMEDICA transfer devices. It primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility testing. The document does not describe a clinical study in the way typically expected for software or AI medical devices (i.e., with acceptance criteria related to accuracy, sensitivity, specificity, etc., or human reader studies).

It confirms that no clinical study was included in this submission (Section 5.9). Therefore, it's not possible to provide information related to AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis based on the information provided, focusing on the device's functional and safety acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the successful passing of various bench and biocompatibility tests. The "reported device performance" is the statement that all tests "were passing."

Test Category	Specific Test Criteria (Implied)	Reported Performance
Biocompatibility	ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11 Standards	All tests passing
In Vitro Cytotoxicity	Meets ISO 10993-5 requirements	Passing
Skin Sensitization	Meets ISO 10993-10 requirements (Guinea Pig Maximization Test)	Passing
Intracutaneous Reactivity	Meets ISO 10993-10 requirements	Passing
Acute Systemic Toxicity	Meets ISO 10993-11 requirements	Passing
Pyrogen	Meets ISO 10993-11 requirements	Passing
In Vitro Hemocompatibility	Meets ISO 10993-4 requirements	Passing
Performance (Bench)	Internal Standards (Appearance, Dimension, Unimpeded, Sealing, Conn. Strength, Penetration Force, Fluid Flow, Leakage)	All tests passing
Particulate Matter	Meets USP <788> requirements	Passing
Sterilization	Meets ISO 11135-1:2014 requirements	All tests passing

2. Sample Sizes Used for the Test Set and Data Provenance

This is not applicable as there was no clinical study or test set of patient data in the typical sense for AI/software. The "test set" refers to physical device samples used for bench and biological testing. The document does not specify the exact number of units tested for each benchmark test, only that "The results of all testing were passing." The provenance is "internal standards."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for these types of physical device tests typically involves standardized measurement instruments and validated laboratory procedures, not expert interpretation of diagnostic data.

4. Adjudication Method

Not applicable, as there was no expert review or human interpretation of diagnostic data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The submission explicitly states, "No Clinical Study is included in this submission."

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical device (transfer device), not a software or AI algorithm.

7. Type of Ground Truth Used

For biocompatibility: Recognized international standards (ISO 10993 series).
For performance bench testing: Internal standards, USP <788> for particulate matter, and ISO 11135-1:2014 for sterilization.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI or algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Summary

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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.

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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

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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)

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 LiuPhone: 0086-15216699240Fax: 0086-21-60732022Email: 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

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.

5.5 Indication for Use:

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 DeviceCommon name: Decanting DeviceSubmitter:GCMEDICA ENTERPRISELTD.,(WUXI)	Predicate device(K111577 )Trade/Devicename: MedlineVial DecanterSubmitter:MedlineIndustriesIncorporated	Comment
Model	Image: GC0652DDImage: GC0653DD,Image: GC0654DDImage: GC0654 DT	Image: DYNJDEC06	Different.GCMEDICA hasfour models whileMedline has onlyone model.GC0653DD is sameas DYNJDEC06.The other threemodels have similarconfigurations.Performance testingwas conducted todemonstrate anydifference will notraise questionsregarding its safetyand effectiveness.
Indication for Use	GCMEDICA Mini Transfer Device,GCMEDICA Vial Transfer Device:Intended for the aseptic dispensing ofsolutions from IV containers. For use in	Decanting deviceintended for theaseptic dispensingof solutions from
Item	Proposed DeviceCommon name: Decanting DeviceSubmitter:GCMEDICA ENTERPRISELTD.,(WUXI)	Predicate device(K111577 )Trade/Devicename: MedlineVial DecanterSubmitter:MedlineIndustriesIncorporated	Comment
	transferring IV fluids/medication from a vialto an IV fluid administration device.GCMEDICA Bag Transfer Device,GCMEDICA Clear Bag Transfer Device:Intended for the aseptic dispensing ofsolutions from IV containers. For use intransferring IV fluids/medication from a bagto an IV fluid administration device.	IV containers. Foruse in transferringIVfluids/medicationfrom a vial to anIV fluidadministrationdevice.
Configuration	Model GC0652DD, GC0654DD andGC0654 DT consist of spike and cap forspike. Model GC0653DD consists ofProtective Cap, Needle Tip, Cover and stick.	ModelDYNJDEC06consists ofProtective Cap,Needle Tip, Coverand stick.	Model GC0653DDis same as ModelDYNJDEC06. Theother three modelshave similarconfigurations. Thedifference will notraise any questionregarding its safetyand effectiveness.
Length	Model GC0652DD: 3inch;Model GC0653DD: 6inch;Model GC0654DD: 9inch;Model GC0654DT: 9inch.	DYNJDEC06:6inch;	Model GC0653DDis same as ModelDYNJDEC06, thelength is 6 inch,while the other threemodels' length is 3inch and 9 inch. Wehad performed
Item	Proposed DeviceCommon name: Decanting DeviceSubmitter:GCMEDICA ENTERPRISELTD.,(WUXI)	Predicate device(K111577 )Trade/Devicename: MedlineVial DecanterSubmitter:MedlineIndustriesIncorporated	Comment
			unimpededperformance,sealingperformance,connecting strength,fluid flow andleakage for allproposed models,the length differencewill not raise anydifference regardingits safety andeffectiveness.
Material	GC0652DD, GC0653DD, GC0654DD:ABS, PE;GC0654DT: K Resin, PE.	DYNJDEC06:ABS, PE;	Model GC0652DD,GC0653DD,GC0654DD aresame as ModelDYNJDEC06.Biocompatibilitytesting wasperformed per ISO10993-1. Thedifference will notraise any questionsregarding its safetyand 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".

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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

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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% SodiumChloride 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% SodiumChloride Injection Extract and Sesame Oil Extract)	ISO 10993-10:2010
Acute Systemic Toxicity (0.9% Sodium ChlorideInjection Extract, Intravenous)	ISO 10993-11:2017
Acute Systemic Toxicity (Sesame Oil Extract,Intraperitoneal)	ISO 10993-11:2017
Pyrogen Test (0.9% Sodium Chloride InjectionExtract, 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 <788> 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).

Regulation Number and Section

§ 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.