Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of a Closed System Transfer Device (CSTD) and does not mention any AI or ML components. The performance studies are based on physical and chemical testing, not algorithmic performance.

Therapeutic

No
The device is described as a Closed System Transfer Device (CSTD) designed to prevent contamination and exposure to hazardous drugs during preparation and administration. Its function is to protect the user and the environment from hazardous drugs, not to directly treat a medical condition in a patient.

Diagnostic

No

The device is described as a Closed System Transfer Device (CSTD) that mechanically prevents the transfer of environmental contaminants and the escape of hazardous drugs, primarily for drug preparation and administration. Its stated purpose and performance tests focus on safety and containment during drug handling, not on diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (vial access devices, bag access devices, adapters, administration sets, syringes) that form a closed fluid path. The performance studies also focus on physical characteristics like microbial ingress, emission testing, and compatibility, indicating a hardware-based device. There is no mention of software as a component or the primary function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a Closed System Transfer Device (CSTD) for the preparation and administration of hazardous drugs. Its purpose is to prevent contamination and exposure during these processes. This is a function related to drug handling and delivery, not diagnostic testing.
Device Description: The description details the components and how they form a closed fluid path for transferring medications. This aligns with the intended use of a CSTD.
Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are designed for these purposes.
Performance Studies: The performance studies focus on functional aspects like microbial ingress, emission testing, and hazardous drug exposure, which are relevant to the safety and efficacy of a CSTD, not diagnostic accuracy.

Therefore, the ChemoClave is a medical device used for drug preparation and administration, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Product codes

ONB

Device Description

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.

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

healthcare personnel

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)

Non-clinical tests were conducted to verify that the proposed device met all design specifications and is substantially equivalent (SE) to the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System. The device was subjected to the following functional and performance tests to demonstrate that it performs as intended:

Microbial Ingress Testing
Emission Testing- Assess Vapor Leakage
Hazardous Drug Exposure Testing - Assess Liquid/Vapor Leakage
Urinary Catheter Compatibility Testing
ANSI/AAMI/ISO 11137-2 2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose".
ANSI/AAMI ST72:2011/(R)2016 Bacterial endotoxins -- Test methods, routine . monitoring, and alternatives to batch testing
ISO 11607:2017 Packaging For Terminally Sterilized Medical Devices

In all testing, the pre-determined acceptance criteria were met.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K081361

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 31, 2018

ICU Medical, Inc. Catherine Kang Manager, Global Regulatory Affairs 600 N. Field Drive Lake Forest, Illinois 60045

Re: K173477

Trade/Device Name: ChemoCLAVE Cytotoxic Medication Preparation and Delivery System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 20, 2018 Received: July 24, 2018

Dear Catherine Kang:

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 mediation-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,

Alan M.
Stevens -S

for 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) K173477

Device Name

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

Indications for Use (Describe)

The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

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

K173477 510(k) Summary

| Submitter: | ICU Medical, Inc.
600 North Field Drive
Lake Forest, IL 60045
Establishment Registration: 3013319212
(Owner/Operator #2025816) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Catherine Kang, Ph.D
Manager, Global Regulatory Affairs
Phone: (224) 706-2372
Fax: (224) 706-2917
E-mail: catherine.kang@icumed.com |
| Preparation Date: | August 29, 2018 |
| Trade Name: | ChemoCLAVE® Cytotoxic Medication
Preparation and Delivery System |
| Common or Usual Name: | Closed Antineoplastic and Hazardous Drug
Reconstitution and Transfer System |
| Regulation Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | ONB |
| Device Class: | Class II |
| Primary Predicate Device: | K081361 - ChemoCLAVE Cytotoxic
Medication Preparation and Delivery
System |

Submission Purpose:

The purpose of this submission is to provide information demonstrating that the ChemoClave devices meet the design input requirements of a Closed System Transfer Device (CSTD) and to demonstrate substantial equivalence to K081361.

Device Indications For Use:

The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system

4

during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Device Description:

The ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.

Technological Characteristics and Substantial Equivalence:

A technological comparison table is provided below that compares the subject device and predicate device:

Characteristic	Proposed Device	Predicate 510(k) K081361	Assessment of Differences
Indications for
Use	The ChemoCLAVE is a needle-free
Closed System Transfer Device
(CSTD) that mechanically prohibits
the transfer of environmental
contaminants, including bacterial
and airborne contaminants into the
system, and the escape of drug or
vapor concentrations outside the
system during drug preparation and
administration, thereby minimizing
exposure of individuals, healthcare
personnel and the environment to
hazardous drugs.	The ChemoCLAVE Cytotoxic
Medication Preparation and
Delivery System consists of 6
previously cleared components
(CLAVE®, Spikes, SPIROSTM,
GENIETM, Vial Access, and Admin
Sets) that can be combined into
various configurations intended for
use in the preparation and patient
administration of cytotoxic
medications.	The Indications for Use has
been updated to provide
information consistent with a
Closed System Transfer
Device (CSTD) and devices
under the ONB product code.

5

| | Bag Spikes | Bag Spikes | Minor dimensional changes
to improve manufacturing of
the proposed device. |
|--|----------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Administration sets | Administration sets | Minor material modifications
to connecting components in
the proposed device; material
is identical to materials used
in other components on the
set. |
| | Syringes with Spiros | Syringes with Spiros | Same. |

Substantial Equivalence Discussion

The differences between predicate and proposed devices are identified in the table above. The proposed devices have equivalent technological characteristics as ICU Medical's current legally marketed devices cleared under 510(k) premarket notification K081316.

These minor differences, between subject device and predicate device, do not raise different questions of safety and effectiveness.

Non-Clinical Testing Summary:

Non-clinical tests were conducted to verify that the proposed device met all design specifications and is substantially equivalent (SE) to the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System. The device was subjected to the following functional and performance tests to demonstrate that it performs as intended:

Microbial Ingress Testing ●
Emission Testing- Assess Vapor Leakage
Hazardous Drug Exposure Testing - Assess Liquid/Vapor Leakage
Urinary Catheter Compatibility Testing
ANSI/AAMI/ISO 11137-2 2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose".
ANSI/AAMI ST72:2011/(R)2016 Bacterial endotoxins -- Test methods, routine . monitoring, and alternatives to batch testing
ISO 11607:2017 Packaging For Terminally Sterilized Medical Devices ●

The materials of construction are the same as those used in the predicate device cleared under K081361. Biocompatibility testing provided in K081361 demonstrated the biocompatibility of ChemoCLAVE products.

The ChemoCLAVE products are supplied sterile for single use. The subject device is sterilized by E-beam or Gamma Radiation to achieve a sterility assurance level (SAL) of 10th. Sterility was validated in accordance with ISO 11137-2: 2013 - Dose setting using Bioburden. Packaging testing was performed per ISO 11607:2017.

6

A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.

In all testing, the pre-determined acceptance criteria were met.

Substantially Equivalence Conclusion

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The ChemoCLAVE products are Substantially Equivalent (SE) to the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System, cleared under K081361.