(266 days)
No
The device is a mechanical transfer set and the description focuses on its physical components and functional testing, with no mention of AI/ML.
No
Explanation: This device is a closed system transfer device used for drug preparation, specifically to transfer drugs from a vial to an IV bag. It is an ancillary device for pharmacy compounding devices and its function is to facilitate the safe transfer of fluids, not to treat or diagnose a medical condition.
No
This device is a closed system transfer device (CSTD) primarily used for safely transferring drugs from vials to IV bags, preventing environmental contamination and drug escape. It is a drug preparation and transfer tool, not a diagnostic one.
No
The device description clearly outlines multiple physical components (stopcock, tubing, ChemoClave, syringe, cassette handle) that are bonded together to form a single device. The performance studies also focus on physical and functional characteristics of these hardware components.
Based on the provided information, the Diana ChemoClave Transfer Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the preparation and transfer of drugs for intravenous administration. This is a process related to drug delivery and handling, not the diagnosis of a disease or condition using samples from the human body.
- Device Description: The device is described as a "disposable, single use ancillary device for Pharmacy Compounding Devices (PCD)". It facilitates the transfer of fluids between containers. This aligns with drug preparation and compounding, not diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease.
- Performance Studies: The performance studies focus on functional aspects of the device related to fluid transfer, leakage, compatibility, sterility, and preventing drug exposure. These are relevant to a drug preparation and delivery device, not an IVD.
In summary, the Diana ChemoClave Transfer Set is a device used in the process of preparing and transferring medications, which falls under the category of drug delivery or compounding devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Diana ChemoClave 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.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
Diana ChemoClave Transfer Set is intended for use with the Diana Automated 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, ChemoClave, syringe, and cassette handle. When placed in the Diana Automated Compounding System, the Diana ChemoClave 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. Connections to sourcing/receiving containers are enabled using the dedicated ChemoClave connector.
The purpose of this submission is to modify the predicate's Closed System Transfer Device (CSTD) from ChemoLock to ChemoClave, as an alternative to be used with Diana Automated Compounding System.
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
Trained health-care personnel / Standard Hospital Pharmacy Setting
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)
Functional testing was conducted to demonstrate the functionality of the Diana ChemoClave Transfer Set that consists of ChemoClave, 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, Positive Pressure Leakage, Chemical Compatibility, Stopcock Handle Torque, Component Bond Strength Testing, Visual Inspection, Accuracy Testing, Internal Seal Integrity.
Packaging 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.
The biocompatibility evaluation for Diana ChemoClave Transfer Set 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, Pyrogenicity.
Microbial ingress testing was conducted to demonstrate that needless access site of Diana ChemoClave 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 single use). 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 were performed to validate no escape of drug from the subject device outside the closed system.
Particulate contamination testing was performed by following USP to demonstrate particulate levels in the subject device meet USP 788 requirements.
E-beam sterilization process validation was conducted according to ISO 11137-1 and ISO11137-2, Sterilization of health care products - Radiation: Requirements for development, validation androutine control of a sterilization process for medical devices. Bacterial endotoxin testing was conducted based on AAMI ST72 and USP , and followed FDA Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers.
Key results: The Diana ChemoClave Transfer Set meets the functional claims and intended use as described in the product labeling. The Diana ChemoClave Transfer Set is substantially equivalent to the predicate device.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 23, 2019
ICU Medical Yuliya Matlin Director, Global Regulatory Affairs 600 N. Field Drive Lake Forest, Illinois 60045
Re: K190157
Trade/Device Name: Diana ChemoClave Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: September 27, 2019 Received: September 30, 2019
Dear Yuliya Matlin:
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.
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
Indications for Use
510(k) Number (if known) K190157
Device Name Diana ChemoClave Transfer Set
Indications for Use (Describe)
The Diana ChemoClave 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 ChemoClave Transfer Set.
| I. SUBMITTER | |
|---|---|
| Name | ICU Medical, Inc. |
| Address | 600 N. Field Drive, Lake Forest, Illinois 60045, USA |
| Phone number | (224)-706-2419 |
| Contact Person | Yuliya Matlin, M.S., M.B.A., Director, Global Regulatory Affairs |
| Date prepared | 10/22/2019 |
| II. DEVICE | |
| Name of Device | Diana ChemoClave Transfer Set (K190157) |
| 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 - K170110 Diana ChemoLock Transfer Set
Reference - K173477 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (utilized for justifying all components in the system cleared under ONB)
IV. DEVICE DESCRIPTION
Diana ChemoClave Transfer Set is intended for use with the Diana Automated 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, ChemoClave, syringe, and cassette handle. When placed in the Diana Automated Compounding System, the Diana ChemoClave 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. Connections to sourcing/receiving containers are enabled using the dedicated ChemoClave connector.
The purpose of this submission is to modify the predicate's Closed System Transfer Device (CSTD) from ChemoLock to ChemoClave, as an alternative to be used with Diana Automated Compounding System.
V. INDICATIONS FOR USE
The Diana ChemoClave 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 escape of drug or vapor concentrations outside the system.
4
| VI. COMPARISON OF INTENDED USE WITH THE PREDICATE DEVICE | ||
|---|---|---|
| Subject Device | Predicate (K170110) | |
| Feature | Diana ChemoClave Transfer Set | Diana ChemoLock Transfer Set |
| Intended Use | Same | Same |
| Indications for Use | The Diana ChemoClave 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. | 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. | ||
| Classification | Class II | Class II |
| Product Code | ONB | ONB |
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 |
| Use | Single Use | Single Use |
| Prescription/OTC Use | Prescription Use | Prescription Use |
| Compatible Set to a | ||
| particular | ||
| compounding system | Diana Automated Compounding System | Diana Automated 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 | ||
| Transfer Device | ||
| (CSTD) | Yes | Yes |
| VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | ||
| Subject Device | Predicate (K170110) | |
| Feature | Diana ChemoClave Transfer Set | Diana ChemoLock Transfer Set |
| System | ||
| Components | Syringe Unit | Syringe Unit |
| Connector to Sourcing/receiving containers | Connector to Sourcing/receiving containers | |
| Connection Tubing | Connection Tubing | |
| Integral stopcock | Integral stopcock | |
| Cassette Handle | Cassette Handle | |
| 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 connectors - Single | |
| Channel | ||
| Closed System | Yes | Yes |
| Connections to | ||
| Sourcing/receiving | ||
| Containers | ChemoClave connector | ChemoLock connector |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| CSTD Scientific | ||
| Methods and | ||
| Performance Testing | Microbial Ingress Test | |
| Dry Connection Test | ||
| Positive Pressure Leakage Test | ||
| Hazardous Drug Exposure Test | ||
| Emission Test | ||
| Fluid Flow | ||
| Chemical Compatibility | ||
| Stopcock Handle Torque | ||
| Component Bond Strength Testing | ||
| Visual Inspection | ||
| Accuracy Testing | ||
| Internal Seal Integrity | Microbial Ingress Test | |
| Dry Connection Test | ||
| Positive Pressure LeakageTest | ||
| Hazardous Drug Exposure Test | ||
| Emission Test | ||
| Fluid Flow | ||
| Chemical Compatibility | ||
| Stopcock Handle Torque | ||
| Component Bond Strength Testing | ||
| Visual Inspection | ||
| Accuracy Testing | ||
| Internal Seal Integrity | ||
| Biocompatibility | Per FDA Guidance and ISO 10993-1 | |
| Biological Effect | ||
| • Hemocompatibility | ||
| • Cytotoxicity | ||
| • Sensitization | ||
| • Intracutaneous Irritation | ||
| • Acute Systemic Toxicity | ||
| • Pyrogenicity | Per FDA Guidance and ISO 10993-1 Biological | |
| Effect | ||
| • Hemocompatibility | ||
| • Cytotoxicity | ||
| • Sensitization | ||
| • Intracutaneous Irritation | ||
| • Acute Systemic Toxicity | ||
| • Pyrogenicity | ||
| Sterilization Method | Radiation (E-beam) | Radiation (E-beam) |
| SAL | 10-6 | 10-6 |
Overall, the Diana ChemoClave Transfer Set carries the same intended use as the predicate in accordance with the FDA's guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", dated 28 July 2014.
5
The technological differences between the Diana ChemoClave Transfer Set and the predicate is the Use ChemoClave as the closed connector to sourcing and receiving containers to form a closed system as compared to ChemoLock closed connector within the predicate. The difference in technology does not raise different questions of safety or effectiveness.
6
VIII. Performance Data Functional Testing
Functional testing was conducted to demonstrate the functionality of the Diana ChemoClave Transfer Set that consists of ChemoClave, 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 .
- . Positive Pressure Leakage
- . Chemical Compatibility
- . Stopcock Handle Torque
- . Component Bond Strength Testing
- . Visual Inspection
- Accuracy Testing
- . Internal Seal Integrity
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 ChemoClave Transfer Set 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
- . Pyrogenicity
Microbial Ingress Testing
Microbial ingress testing was conducted to demonstrate that needless access site of Diana ChemoClave 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 single use). 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.
7
Particulates
Particulate contamination testing was performed by following USP to demonstrate particulate levels in the subject device meet USP 788 requirements.
Sterility Testing
E-beam sterilization process validation was conducted according to ISO 11137-1 and ISO11137-2, Sterilization of health care products - Radiation: Requirements for development, validation androutine control of a sterilization process for medical devices. Bacterial endotoxin testing was conducted based on AAMI ST72 and USP , and followed FDA Guidance for Industry -Pyrogen and Endotoxins Testing: Questions and Answers.
IX. CONCLUSION
The Diana ChemoClave Transfer Set meets the functional claims and intended use as described in the product labeling. The Diana ChemoClave Transfer Set is substantially equivalent to the predicate device.