← Product Code [ONB](/productcode/ONB) · K170110 # Diana Medication Transfer Set (K170110) _Icu Medical, Inc. · ONB · Aug 10, 2018 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K170110 ## Device Facts - **Applicant:** Icu Medical, Inc. - **Product Code:** [ONB](/productcode/ONB.md) - **Decision Date:** Aug 10, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. ## Device Story Diana ChemoLock Transfer Set is a sterile, single-use ancillary device for the Diana Pharmacy Compounding System. It consists of a stopcock, tubing, ChemoLock connector, syringe, and cassette handle. The device facilitates the transfer of fluids between drug vials and IV bags for drug reconstitution or medication preparation. It functions as a closed system transfer device (CSTD) to prevent environmental contamination and the escape of hazardous drug vapors. Used in hospital pharmacies by trained personnel, the device is placed into the compounding system to automate fluid distribution. The healthcare provider uses the system to prepare medications safely, reducing exposure to hazardous drugs and maintaining sterility during the transfer process. ## Clinical Evidence Bench testing only. Testing included fluid flow, accuracy, chemical compatibility, seal integrity, component bond strength, packaging integrity (ASTM D4169, F1980, F2096, F88), biocompatibility (ISO 10993-1), microbial ingress, hazardous drug exposure evaluation, particulate testing (USP 788), and sterility validation (ISO 11137-1/2, AAMI ST72, USP 85). ## Technological Characteristics Multicomponent fluid transfer set including stopcock, tubing, ChemoLock, syringe, and cassette handle. Materials: Non-DEHP PVC tubing. Sterilization: E-beam (SAL 10^-6). Biocompatibility per ISO 10993-1. Closed system design prevents environmental contamination and vapor escape. ## Regulatory 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 - SETS GRI-FILL ([K050339](/device/K050339.md)) ## Reference Devices - ChemoLock ([K131549](/device/K131549.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. August 10, 2018 ICU Medical, Inc. Jason Ma Regulatory Affairs Manager 600 N. Field Drive Lake Forest, Illinois 60045 Re: K170110 Trade/Device Name: Diana ChemoLock Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 10, 2018 Received: July 11, 2018 Dear Jason Ma: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Alan M. Stevens -S Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170110 Device Name Diana ChemoLock Transfer Set Indications for Use (Describe) The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. | 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)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for the Diana ChemoLock Transfer Set. | I. SUBMITTER | | |------------------|--------------------------------------------------------------------------------| | Name | ICU Medical | | Address | 600 N. Field Drive, Lake Forest, Illinois 60045, USA | | Phone number | (224)-706-2411 | | Fax number | (224)-706-2917 | | Contact Person | Jason Ma, Regulatory Affairs Manager | | Date prepared | 08/01/2018 | | II. DEVICE | | | Name of Device | Diana ChemoLock Transfer Set | | Regulation Name | Intravascular Administration Sets, 21 CFR 880.5440 | | Common Name | Closed Antineoplastic And Hazardous Drug Reconstitution And
Transfer System | | Regulatory Class | II | | Product Code: | ONB | ## III. PREDICATE DEVICE Predicate - K050339 SETS GRI-FILL Reference - K131549 ChemoLock (utilized for vapor containment characteristics/methods) ## IV. DEVICE DESCRIPTION Diana ChemoLock Transfer Set is intended for use with the Diana Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD). The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoLock, syringe, and cassette handle. When placed in the Diana Compounding System, the Diana ChemoLock Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications. The purpose of this submission is to release a new closed system transfer device (CSTD) drug transfer set to be used with Diana Pharmacy Compounding System ## V. INDICATIONS FOR USE The Diana ChemoLock Transfer Set is a sterile, single-use closed systemÁda • ^ / Aâ ^; aa used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of druq or vapor concentrations outside the system. {4}------------------------------------------------ | VI. COMPARISON OF INTENDED USE WITH THE PREDICATE DEVICE | | | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate (K050339) | | Feature | Diana ChemoLock Transfer Set | SETS GRI-FILL | | Intended Use | Same | Same | | Indications for Use | The Diana ChemoLock Transfer Set is a sterile, single-use
closed system transfer device used for drug preparation to
transfer drug from a drug vial to an IV bag for intravenous
drug administration. It prohibits the transfer of
environmental contaminants into the system and the
escape of drug or vapor concentrations outside the
system. | SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are
ancillary devices used in conjunction with the GRI-FILL 3.0
pharmacy compounder in the hospital pharmacy to provide a
fluid pathway through which one or two source substances are
delivered into a final IV container or syringe.

SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary
devices used as fluid pathways in conjunction with the GRI-FILL
3.0 pharmacy compounder and associated I WAY or 2 WAY
transfer sets through which the same substance from up to 6
source containers may be delivered into a final IV container.

This device should not be used with lipids.

This device is intended to be used by trained health-care
personnel. It is restricted to sale by or on the order of a
physician. | | Classification | Class II | Class II | | Product Code | ONB | LHI | | Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | | Use | Single Use | Single Use | | Prescription/OTC
Use | Prescription Use | Prescription Use | {5}------------------------------------------------ | VI. COMPARISON OF INTENDED USE WITH THE PREDICATE DEVICE | | | |---------------------------------------------------------------------------------------|------------------------------------|------------------------------------| | | Subject Device | Predicate (K050339) | | Feature | Diana ChemoLock Transfer Set | SETS GRI-FILL | | Compatible Set to a particular compounding system | Diana Automated Compounding System | GRI-FILL 3.0 Compounding System | | Intended for Direct Connection to Patient During Compounding | No | No | | Use Environment for Compounding | Standard Hospital Pharmacy Setting | Standard Hospital Pharmacy Setting | | Target Users | Trained health-care personnel | Trained health-care personnel | | Closed system (fluid not in contact with any reusable part of the compounding device) | Yes | Yes | Overall, Diana ChemoLock Transfer Set has the same intended use as the predicate. The differences in indications (e.g. inclusion of hazardous drug transfer and vapor containment) do not alter the intended use of the compared to the predicate, as both devices are intended for fluid transfer and preparation, and do not raise different questions of safety and effectiveness. | VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | | |------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate (K050339) | | Feature | Diana ChemoLock Transfer Set | SETS GRI-FILL | | System | Syringe Unit | Syringe Unit | | VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | | | | Subject Device | Predicate (K050339) | | Feature | Diana ChemoLock Transfer Set | SETS GRI-FILL | | Components | Connector to Source Container(Drug Vial) | Connector to Source Container(Drug Vial) | | | Connector to Receiving Container (IV Bag) | Connector to Receiving Container (IV Bag) | | | Connection Tubing | Connection Tubing | | | Integral stopcock (distribution purpose) | Integral distributor (distribution purpose) | | | Cassette Handle | Not Applicable | | Principles
of
Operation | Multicomponent device compatible with compounding
system to distribute fluid from sourcing container to
receiving container | Multicomponent device compatible with compounding system to
distribute fluid from sourcing container to receiving container | | Fluid
Transfer
Mechanism | Integrated Syringe with connectors - Single Channel | Integrated Syringe with connector - Single or multiple Channel | | Closed
system
(fluid
not
in
contact
with
any
reusable
part
of
the
compounding
device) | Yes | Yes | | Connections
to
Source Containers | proprietary closed connector | Male luer connector or vented bag spike | | Connections
to
Final Containers | proprietary closed connector | Male luer connector. Also supplied with female to female luer to
allow for female to male luer connection | | Fluid
Contact
Material for tubing | PVC with Non-DEHP | PVC with DEHP Plasticizer | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | | VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | | | | Subject Device | Predicate (K050339) | | Feature | Diana ChemoLock Transfer Set | SETS GRI-FILL | | Biocompatibility | Per FDA Guidance and ISO 10993-1
Biological Effect
· Hemocompatibility
· Cytotoxicity
· Sensitization
· Intracutaneous Irritation
· Acute Systemic Toxicity
· Pyrogenicity | Information Not Available | | Sterilization | Radiation (E-beam) | Ethylene Oxide | | SAL | 10-6 | Information Not Available | {6}------------------------------------------------ {7}------------------------------------------------ The technological differences between the Diana ChemoLock Transfer Set and the predicate are: - Use in an integrated system including syringe, stopcock and ChemoLock system for the proposed to an integrated syringe • with luer or proprietary closed connector for the predicate - The Diana ChemoLock Transfer Set uses Non-DEHP PVC tubing compared to DEHP PVC tubing in the predicate - Sterilization method These differences in technology do not raise different questions of safety or effectiveness. {8}------------------------------------------------ ## VIII. PERFORMANCE DATA ### Functional Testing Functional testing was conducted to demonstrate the functionality of the Diana ChemoLock Transfer set that consists of ChemoLock, stopcock, tubing, syringe, and cassette handle. This testing follows the FDA quidance document of "Intravascular Administration Sets Premarket Notification Submissions [510(k)]". Functional Testing included - Fluid Flow ● . - . Accuracy Testing - Proid i Trow Positive Pressure Chemical Compatibility . - Internal Seal Integrity . - Stopcock Handle Torque ● - Component Bond Strenath Testing ● - Visual Inspection ### Packaging Integrity and Shelf Life Package integrity and Shelf Life was conducted according to FDA recognized consensus standards of ASTM D4169 Standard Practice For Performance Testing Of Shipping Containers And Systems, ASTM F1980 Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices, ASTM F2096 Standard Test Method For Detecting Gross Leaks In Packaging By Internal Pressurization (Bubble Test), and ASTM F88 Standard Test Method For Seal Strength Of Flexible Barrier Materials. #### Biocompatibility The biocompatibility evaluation for Diana ChemoLock Transfer Set device was conducted in accordance with the FDA Guidance for Industry and FDA Staff - "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", June 16, 2016; and ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", as recognized by FDA. Testing included: - Hemocompatibility ● - . Cytotoxicity - Sensitization ● - . Intracutaneous Irritation - Acute Systemic Toxicity . - Material Mediated Pyrogencity . ## Microbial Ingress Testing Microbial inqress testing was conducted to demonstrate that needless access site of Diana ChemoLock Transfer Set maintains physical integrity and mechanically prohibits the transfer of environmental contaminants into the system in use after access (the device is intended for singleuse). The tests were conducted consistent with the recommendations for microbial ingress testing provided in FDA guidance titled "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" issued on July 11, 2008. #### Emission, Dry Disconnection, and CSTD Hazardous Drug Exposure Evaluation Emission, Dry Disconnection, and CSTD Hazardous Drug Exposure Evaluation were performed to validate no escape of drug from the subject device outside the closed system. #### Particulates Particulate contamination testing was performed by following USP <788> (method 1) to demonstrate particulate levels in the subject device meet USP 788 requirements. {9}------------------------------------------------ ### Sterility Testing E-beam sterilization process validation was conducted according to ISO 11137-1 and ISO 11137-2, Sterilization of health care products – Radiation: Requirements for development, validation and routine control of a sterilization process for medical devices. Bacterial endotoxin testing was conducted based on AAMI ST72 and USP <85>, and followed FDA Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers. ### IX. CONCLUSION The Diana ChemoLock Transfer Set is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K170110](https://fda.innolitics.com/device/K170110) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com