Decanting Device

K182819 · Gcmedica Enterprise Ltd.(Wuxi) · LHI · Dec 2, 2019 · General Hospital

Device Facts

• Record ID: K182819
• Device Name: Decanting Device
• Applicant: Gcmedica Enterprise Ltd.(Wuxi)
• Product Code: LHI · General Hospital
• Decision Date: Dec 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended 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.

Device Story

Decanting devices facilitate sterile fluid path creation for aseptic transfer of IV fluids/medication from containers (vials/bags) to administration sets. Models include spike/cap or protective cap/needle tip/cover/stick configurations. Operated by clinicians in clinical settings; device is inserted into container rubber opening or port; user tilts device to initiate flow. Air ventilation holes ensure pressure equalization. Single-use, sterile, disposable. Benefits include reduced contamination risk during fluid transfer.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (ISO 10993-4, -5, -10, -11), performance testing (appearance, dimension, unimpeded performance, sealing, connection strength, penetration force, fluid flow, leakage), particulate matter (USP <788>), and ethylene oxide sterilization validation (ISO 11135-1:2014). All results passed.

Technological Characteristics

Materials: ABS, PE, K Resin. Principle: Mechanical spike/stick for fluid path creation. Dimensions: 3, 6, and 9 inches. Sterilization: Ethylene oxide (ISO 11135-1:2014). Single-use, non-powered, manual operation.

Indications for Use

Indicated for aseptic dispensing of IV solutions and transfer of fluids/medication from vials or bags to IV administration devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medline Vial Decanter (K111577)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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) | |
|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-family: DejaVu Sans, sans-serif;">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-family: DejaVu Sans, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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)<br>Loujin Industrial Park,Shuofang,Wuxi,Jiangsu,PRC |
|-----------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Ethan Liu<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>Common name: Decanting Device<br>Submitter:GCMEDICA ENTERPRISE<br>LTD.,(WUXI) | Predicate device<br>(K111577 )<br>Trade/Device<br>name: Medline<br>Vial Decanter<br>Submitter:<br>Medline<br>Industries<br>Incorporated | Comment |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Image: GC0652DD<br>Image: GC0653DD,<br>Image: GC0654DD<br>Image: GC0654 DT | Image: DYNJDEC06 | Different.<br>GCMEDICA has<br>four models while<br>Medline has only<br>one model.<br>GC0653DD is same<br>as DYNJDEC06.<br>The other three<br>models have similar<br>configurations.<br>Performance testing<br>was conducted to<br>demonstrate any<br>difference will not<br>raise questions<br>regarding its safety<br>and effectiveness. |
| Indication for Use | GCMEDICA Mini Transfer Device,<br>GCMEDICA Vial Transfer Device:<br>Intended for the aseptic dispensing of<br>solutions from IV containers. For use in | Decanting device<br>intended for the<br>aseptic dispensing<br>of solutions from | |
| Item | Proposed Device<br>Common name: Decanting Device<br>Submitter:GCMEDICA ENTERPRISE<br>LTD.,(WUXI) | Predicate device<br>(K111577 )<br>Trade/Device<br>name: Medline<br>Vial Decanter<br>Submitter:<br>Medline<br>Industries<br>Incorporated | Comment |
| | transferring IV fluids/medication from a vial<br>to an IV fluid administration device.<br><br>GCMEDICA Bag Transfer Device,<br>GCMEDICA Clear Bag Transfer Device:<br>Intended for the aseptic dispensing of<br>solutions from IV containers. For use in<br>transferring IV fluids/medication from a bag<br>to an IV fluid administration device. | IV containers. For<br>use in transferring<br>IV<br>fluids/medication<br>from a vial to an<br>IV fluid<br>administration<br>device. | |
| Configur<br>ation | Model GC0652DD, GC0654DD and<br>GC0654 DT consist of spike and cap for<br>spike. Model GC0653DD consists of<br>Protective Cap, Needle Tip, Cover and stick. | Model<br>DYNJDEC06<br>consists of<br>Protective Cap,<br>Needle Tip, Cover<br>and stick. | Model GC0653DD<br>is same as Model<br>DYNJDEC06. The<br>other three models<br>have similar<br>configurations. The<br>difference will not<br>raise any question<br>regarding its safety<br>and effectiveness. |
| Length | Model GC0652DD: 3inch;<br>Model GC0653DD: 6inch;<br>Model GC0654DD: 9inch;<br>Model GC0654DT: 9inch. | DYNJDEC06:<br>6inch; | Model GC0653DD<br>is same as Model<br>DYNJDEC06, the<br>length is 6 inch,<br>while the other three<br>models' length is 3<br>inch and 9 inch. We<br>had performed |
| Item | Proposed Device<br>Common name: Decanting Device<br>Submitter:GCMEDICA ENTERPRISE<br>LTD.,(WUXI) | Predicate device<br>(K111577 )<br>Trade/Device<br>name: Medline<br>Vial Decanter<br>Submitter:<br>Medline<br>Industries<br>Incorporated | Comment |
| | | | unimpeded<br>performance,<br>sealing<br>performance,<br>connecting strength,<br>fluid flow and<br>leakage for all<br>proposed models,<br>the length difference<br>will not raise any<br>difference regarding<br>its safety and<br>effectiveness. |
| Material | GC0652DD, GC0653DD, GC0654DD:<br>ABS, PE;<br>GC0654DT: K Resin, PE. | DYNJDEC06:<br>ABS, PE; | Model GC0652DD,<br>GC0653DD,<br>GC0654DD are<br>same as Model<br>DYNJDEC06.<br>Biocompatibility<br>testing was<br>performed per ISO<br>10993-1. The<br>difference will not<br>raise any questions<br>regarding its safety<br>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".

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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:<br>Guinea Pig Maximization Test (0.9% Sodium<br>Chloride Injection Extract) | ISO 10993-10:2010 |
| Skin Sensitization Test:<br>Guinea Pig Maximization Test (Sesame oil Extract) | ISO 10993-10:2010 |
| Intracutaneous Reactivity Test (0.9% Sodium<br>Chloride Injection Extract and Sesame Oil Extract) | ISO 10993-10:2010 |
| Acute Systemic Toxicity (0.9% Sodium Chloride<br>Injection Extract, Intravenous) | ISO 10993-11:2017 |
| Acute Systemic Toxicity (Sesame Oil Extract,<br>Intraperitoneal) | ISO 10993-11:2017 |
| Pyrogen Test (0.9% Sodium Chloride Injection<br>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 <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).