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.

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.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called the "Diana ChemoClave Transfer Set." The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in a quantitative manner that would be typical for an AI/ML device.

However, I can extract the types of tests conducted and list them as criteria that the device must have met to achieve substantial equivalence. The document does not provide numerical performance data against these criteria, but rather states that the tests were conducted and the device meets functional claims.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance

The document describes various performance tests conducted to demonstrate the safety and effectiveness of the Diana ChemoClave Transfer Set and its substantial equivalence to the predicate device. The "acceptance criteria" are implied to be that the device passes these tests, thereby meeting functional claims and ensuring safety and efficacy consistent with the predicate.

Missing Information: It's important to note that this document does not contain the specific numerical acceptance criteria or the reported device performance values for each test. For instance, it lists "Fluid Flow" as a test but doesn't specify a required flow rate (e.g., X ml/minute) or the measured flow rate of the Diana ChemoClave Transfer Set. It merely states that the functional testing was conducted.

Acceptance Criteria Category	Specific Test / Requirement	Implied Reported Device Performance (as per document)
Functional Performance	Fluid Flow	"Functional testing was conducted to demonstrate the functionality... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Positive Pressure Leakage	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Chemical Compatibility	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Stopcock Handle Torque	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Component Bond Strength Testing	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Visual Inspection	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Accuracy Testing	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
	Internal Seal Integrity	"Functional testing was conducted... The Diana ChemoClave Transfer Set meets the functional claims..." (Implied pass)
Environmental Containment	Microbial Ingress Test	"Microbial ingress testing was conducted to demonstrate that needless access site... maintains physical integrity and mechanically prohibits the transfer of environmental contaminants into the system..." (Implied pass)
	Emission (of drug/vapor)	"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." (Implied pass)
	Dry Disconnection (no drug escape)	"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." (Implied pass)
	CSTD Hazardous Drug Exposure Evaluation (no drug escape)	"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." (Implied pass)
Biocompatibility	Hemocompatibility (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Hemocompatibility." (Implied pass, consistent with standards)
	Cytotoxicity (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Cytotoxicity." (Implied pass, consistent with standards)
	Sensitization (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Sensitization." (Implied pass, consistent with standards)
	Intracutaneous Irritation (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Intracutaneous Irritation." (Implied pass, consistent with standards)
	Acute Systemic Toxicity (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Acute Systemic Toxicity." (Implied pass, consistent with standards)
	Pyrogenicity (Per FDA Guidance and ISO 10993-1)	"The biocompatibility evaluation... was conducted... Testing included: Pyrogenicity." (Implied pass, consistent with standards)
Sterility & Particulates	Sterility Assurance Level (SAL) of 10-6	"E-beam sterilization process validation was conducted according to ISO 11137-1 and ISO11137-2... (Implied achieved SAL of 10-6 as listed in comparison table)"
	Bacterial Endotoxin Testing (USP <85>, AAMI ST72)	"Bacterial endotoxin testing was conducted based on AAMI ST72 and USP <85>, and followed FDA Guidance..." (Implied pass)
	Particulate Contamination (USP <788> requirements)	"Particulate contamination testing was performed by following USP <788> to demonstrate particulate levels in the subject device meet USP 788 requirements." (Implied pass)
Packaging Integrity & Shelf Life	Package integrity (ASTM D4169, F1980, F2096, F88)	"Package integrity and Shelf Life was conducted according to FDA recognized consensus standards of ASTM D4169... F1980... F2096... and F88..." (Implied pass, meeting standards and demonstrating shelf life)
	Shelf Life (ASTM F1980)	"Package integrity and Shelf Life was conducted according to FDA recognized consensus standards... F1980..." (Implied pass, demonstrating shelf life)

Study Details for Device Performance

The document describes the various studies performed to demonstrate equivalence, but does not provide details on sample sizes, provenance, expert qualifications, or adjudication methods as these are not typically included in a 510(k) summary for this type of medical device (non-AI/ML).

Here's an analysis based on your specific questions:

A table of acceptance criteria and the reported device performance:
- See table above for the types of acceptance criteria (tests) and the implied reported performance ("passed" or "meets functional claims"). Specific numerical acceptance limits and measured performance values are not provided in this document.
Sample size used for the test set and the data provenance:
- Not specified. The document mentions various tests (Functional, Biocompatibility, Microbial Ingress, etc.) but does not provide details on the number of units tested (sample size) for any of these studies.
- Data Provenance: Not explicitly stated, but the submission is from ICU Medical, Inc. based in Lake Forest, Illinois, USA. It's typical for such testing to be conducted in-house or by contract labs in the company's country of origin or a region with accredited testing facilities. The document refers to FDA guidance and international standards, implying adherence to regulated testing environments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / not specified. This is not an AI/ML device where "ground truth" established by experts is a primary element of performance validation in the way it would be for diagnostic algorithms. Device performance is determined by meeting physical, chemical, and biological specifications through laboratory testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / none specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic AI/ML studies. This document describes physical, chemical, and biological testing governed by established standards, not expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device, so MRMC studies and "human readers improving with AI assistance" are not relevant or performed for this product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML algorithm. Its "standalone" performance refers to its physical and functional attributes as a mechanical device. The listed tests (Fluid Flow, Leakage, Biocompatibility, Sterility, etc.) represent its standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Benchmarking against established technical standards and specifications. For this type of device, "ground truth" comes from meeting pre-defined physical, chemical, and biological specifications as outlined in harmonized standards (e.g., ISO, ASTM, USP) and FDA guidance documents. For example, "Non-pyrogenic" means it passed specific tests to confirm absence of pyrogens, which is the "ground truth" for that characteristic.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set" or a corresponding "ground truth" establishment process for machine learning.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K190157

Device Name Diana ChemoClave Transfer Set

Indications for Use (Describe)

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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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 AndTransfer 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 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.

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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 asterile, single-use closed system transferdevice used for drug preparation to transferdrug from a drug vial to an IV bag forintravenous drug administration. It prohibitsthe transfer of environmental contaminantsinto the system and the escape of drug orvapor concentrations outside the system.	The Diana ChemoLock Transfer Set is a sterile,single-use closed system transfer device usedfor drug preparation to transfer drug from a drugvial to an IV bag for intravenous drugadministration. It prohibits the transfer ofenvironmental contaminants into the systemand the escape of drug or vapor concentrationsoutside 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 aparticularcompounding system	Diana Automated Compounding System	Diana Automated Compounding System
Intended for DirectConnection toPatient DuringCompounding	No	No
Use Environment forCompounding	Standard Hospital Pharmacy Setting	Standard Hospital Pharmacy Setting
Target Users	Trained health-care personnel	Trained health-care personnel
Closed SystemTransfer 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
SystemComponents	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 ofOperation	Multicomponent device compatible withcompounding system to distribute fluid fromsourcing container to receiving container	Multicomponent device compatible withcompounding system to distribute fluid fromsourcing container to receiving container
Fluid TransferMechanism	Integrated Syringe with connectors - SingleChannel	Integrated Syringe with connectors - SingleChannel
Closed System	Yes	Yes
Connections toSourcing/receivingContainers	ChemoClave connector	ChemoLock connector
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
CSTD ScientificMethods andPerformance Testing	Microbial Ingress TestDry Connection TestPositive Pressure Leakage TestHazardous Drug Exposure TestEmission TestFluid FlowChemical CompatibilityStopcock Handle TorqueComponent Bond Strength TestingVisual InspectionAccuracy TestingInternal Seal Integrity	Microbial Ingress TestDry Connection TestPositive Pressure LeakageTestHazardous Drug Exposure TestEmission TestFluid FlowChemical CompatibilityStopcock Handle TorqueComponent Bond Strength TestingVisual InspectionAccuracy TestingInternal Seal Integrity
Biocompatibility	Per FDA Guidance and ISO 10993-1Biological Effect• Hemocompatibility• Cytotoxicity• Sensitization• Intracutaneous Irritation• Acute Systemic Toxicity• Pyrogenicity	Per FDA Guidance and ISO 10993-1 BiologicalEffect• 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.

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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.

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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.

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Particulates

Particulate contamination testing was performed by following USP <788> 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 <85>, 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.

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.