Tevadaptor® is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Device Description

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.

The I.V. Administration set is comprised of various components such as: Spike, tubing, clamp, ULTRASITE® needless injection site (Y-site), 'twist-off' and Luer connection.

The I.V. Administration set is part of the Tevadaptor® closed system transfer device (CSTD) and is intended to interact with Tevadaptor® and/or Chemfort™ system's Syringe Adaptor (SA), Syringe Adaptor Lock (SAL) and Luer Lock Adaptor (LLA) components that were cleared under K192866. The Tevadaptor® and Chemfort™ CSTD are intended to protect the healthcare professional, the patient and the environment during preparation, reconstitution, compounding and administration of hazardous drugs in the form of liquid, vapor or aerosol.

The Tevadaptor® and/or Chemfort™ SA connects to the Tevadaptor® port located on the I.V. Administration set's Spike component. After the connection is made, a fluid path is opened which allows to inject of the drug to the patient's IV bag. The Tevadaptor® and/or Chemfort™ LLA connects to any female luer connection located on the I.V. Administration set to create a Tevadaptor® port connection that enables the Tevadaptor® and/or Chemfort™ SA to administer the drug directly to the patient.

The purpose of this submission is to add five new designs of I.V. Administration Sets to the Tevadaptor® and/or Chemfort™ Closed System Transfer Device (CSTD) that was cleared for sale in the US under K192866, the descriptions of the added sets, subject of this submission:

Tevadaptor® IV Secondary Safety Set with ULTRASITE®
Tevadaptor® IV Secondary Safety Set .
Tevadaptor® Bag Adaptor LL ●
Tevadaptor® Bag Adaptor LL with ULTRASITE® .
. Tevadaptor® Bag Adaptor SP with ULTRASITE®

All of the components used in the five new I.V. Administration Sets were previously used in the predicate device cleared under K121269, except for the Spike component which has been redesigned in comparison to the predicate's Spike component that was cleared under K121269. The redesigned Spike component is substantially equivalent to the reference device, Chemfort™ Bag Adaptor SP's Spike component, which was cleared under K192866. The Spike component of both the IV Administration Set and of the reference device are identical in terms of design and raw material.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary for an "Intravascular Administration Set" (TEVADAPTOR Bag Adaptor) that has an "ONB" product code, indicating it is a Closed System Transfer Device (CSTD).

The document mentions that the proposed device (TEVADAPTOR Bag Adaptor LL, etc.) was tested according to NIOSH guidelines and "proved to be a CSTD." This is stated as a comparison point to the predicate device, which was cleared before the NIOSH draft protocol for CSTD was issued.

Therefore, I cannot extract the requested information, such as:

Table of acceptance criteria and reported device performance: Not present for an AI/ML device. The document lists performance tests against ISO standards for medical devices and biocompatibility.
Sample size used for the test set and data provenance: Not mentioned.
Number of experts used to establish ground truth and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
MRMC comparative effectiveness study effect size: Not mentioned.
Standalone (algorithm only) performance: Not applicable as it's not an AI/ML device.
Type of ground truth used: Not applicable as it's not an AI/ML device.
Sample size for the training set: Not applicable as it's not an AI/ML device.
How the ground truth for the training set was established: Not applicable as it's not an AI/ML device.

The document discusses the substantial equivalence of the proposed device to a predicate device (K121269) based on intended use, technological characteristics, and principles of operation, and compliance with various ISO standards for medical devices, specifically for an intravenous administration set. The key change highlighted is that the proposed device now meets the NIOSH and ISOPP definition of a CSTD.

Summary

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February 25, 2021

Simplivia Healthcare Ltd. Shay Shaham VP Qa/ra North Industrial Zone Kiryat Shmona, 1011801 Israel

Re: K201142

Trade/Device Name: TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB, FPA Dated: January 19, 2021 Received: January 25, 2021

Dear Shay Shaham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 medical devices and radiation-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 Payal Patel 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201142

Device Name

I.V. Administration Set: TEVADAPTOR Bag Adaptor LL; TEVADAPTOR Bag Adaptor LL with ULTRASITE; TEVADAPTOR Bag Adaptor SP with ULTRASITE; TEVADAPTOR IV Secondary Safety Set with ULTRASITE; TEVADAPTOR IV Secondary Safety

Indications for Use (Describe)

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)
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Image /page/3/Picture/0 description: The image contains the logo for Simplivia. The logo consists of a green circular symbol on the left and the word "SIMPLIVIA" in gray, sans-serif font on the right. The circular symbol appears to be an abstract design, possibly representing a stylized letter S.

K201142 510(k) Summary

Name:	Simplivia Healthcare Ltd.North Industrial ZoneKiryat ShmonaIsrael 1101801Tel. (972)4-690-8826Fax (972)4-8921665
Contact Person:	Shay ShahamVP QA & RASimplivia Healthcare Ltd.Tel. (972)52-831-3378Fax (972)4-8921665
Date Prepared:	February 21, 2021
Name of Device:	Intravascular Administration Set:TEVADAPTOR Bag Adaptor LLTEVADAPTOR Bag Adaptor LL with ULTRASITETEVADAPTOR Bag Adaptor SP with ULTRASITETEVADAPTOR IV Secondary Safety Set with ULTRASITETEVADAPTOR IV Secondary Safety
Common Name:	Closed Drug Reconstitution and Transfer System
Classification:	Product Code: ONB (primary), FPA (secondary)Regulation No: 21 C.F.R. §880. 5440Class: IIRegulation name: Intravascular administration setClassification Panel: General Hospital
Predicate Device:	I.V. Administration Set (K121269)
Reference Device:	Chemfort™ Closed System Transfer Device (CSTD) (K192866)

Intended Use / Indications for Use

Tevadaptor® is a Closed System Transfer Device (CSTD) that mechanically prohibits the release

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of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Device Description

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.

The I.V. Administration set is comprised of various components such as: Spike, tubing, clamp, ULTRASITE® needless injection site (Y-site), 'twist-off' and Luer connection.

Tevadaptor® IV Secondary Safety Set with ULTRASITE®
Tevadaptor® IV Secondary Safety Set .
Tevadaptor® Bag Adaptor LL ●
Tevadaptor® Bag Adaptor LL with ULTRASITE® .
. Tevadaptor® Bag Adaptor SP with ULTRASITE®

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Summary of Technological Characteristics Including Modifications to the Device:

The following table compares the I.V. Administration sets to the predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

Item	Predicate Device:Simplivia Healthcare Ltd.IV Administration Set(K121269)	Proposed Device:Simplivia Healthcare Ltd.IV Administration Set(K201142)	Equivalence to predicate
Product Code	FPA	ONB (primary)FPA (secondary)	K201142 sets were testedaccording to NIOSH andproved to be a CSTD
Regulation Number	880.5440	880.5440	Same
Indications for use	The I.V. Administration Setis a single use, sterile I.V.set for administration offluids from a container to apatient's vascular system.	Tevadaptor® is a ClosedSystem Transfer Device(CSTD) that mechanicallyprohibits the release ofdrugs, includingantineoplastic andhazardous drugs, in vapor,aerosol or liquid formduring preparation,reconstitution,compounding andadministration, minimizingexposure of individuals,healthcare personnel, andthe environment tohazardous drugs.	Since K201142 sets areunder the ONB code, theintended use includes thefollowing: The setsmechanically prohibit therelease of drugs, includingantineoplastic and hazardousdrugs, in vapor, aerosol orliquid form duringpreparation, reconstitution,compounding andadministration, minimizingexposure of individuals,healthcare personnel, and theenvironment to hazardousdrugs.
Components	Spike, drip chamber, tubing,flow regulator, clamp,ULTRASITE® Y injectionsite, Luer connection	Spike, drip chamber, tubing,flow regulator, clamp,ULTRASITE® Y injectionsite, Luer connection, twist-off	Similar
Sterilization	Ethylene Oxidevalidated cycle SAL 10-6	Ethylene Oxidevalidated cycle SAL 10-6	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Interconnectingfeatures	Mechanical snapconnections, Luer lockconnection, spike	Mechanical snapconnections, Luer lockconnection, spike	Same
Interaction withpatient	No direct interaction - this isa secondary set	No direct interaction - this isa secondary set	Same
Indirect interactionwith patient	Indirect interaction with thepatient is achieved throughthe passage of IV fluidsthrough the central tubing ofthe administration set	Indirect interaction with thepatient is achieved throughthe passage of IV fluidsthrough the central tubingof the administration set	Same
Item	Predicate Device:Simplivia Healthcare Ltd.IV Administration Set(K121269)	Proposed Device:Simplivia Healthcare Ltd.IV Administration Set(K201142)	Equivalence to predicate
Interaction withother devices	For most uses, thissecondary administration setwill connect to an IVsolution container and aprimary administration set.Other connections may bemade through specificcomponents of the set, suchas the Spike Port and theULTRASITE® Y injectionsite.while using the followingChemfort™ or Tevadaptor™components:- Syringe Adaptor (K192866)- Syringe Adaptor Lock(K192866)- Luer Lock Adaptor(K192866)	For most uses, thissecondary administrationset will connect to an IVsolution container and aprimary administration set.Other connections may bemade through specificcomponents of the set, suchas the Spike Port and theULTRASITE® Y injectionsite,while using the followingChemfort™ or Tevadaptor™components:- Syringe Adaptor (K192866)- Syringe Adaptor Lock(K192866)- Luer Lock Adaptor(K192866)	Same
Intended Shelf life	3 years	3 years	Same
Meets the NIOSHand ISOPPdefinition of aCSTD	N/A (the first draft protocolwas issued in 2015)	Yes	The first draft protocol wasissued after predicate 510(k)

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Performance Data

Simplivia conducted several performance tests to demonstrate that the modified I.V. Administration sets comply with the following standards and that they function as intended.

ISO 10993-1:2009, Biological Evaluation of Medical Devices. Part 1: Evaluation and . testing within a risk management process.
ISO 10993-4:2017, Biological Evaluation of Medical Devices. Part 4: Selection of tests for interactions with blood.
. ISO 10993-5:2009, Biological Evaluation of Medical Devices. Part 5: Tests for in vitro cytotoxicity.
. ISO 10993-7:2008, Biological Evaluation of Medical Devices. Part 7: Ethylene oxide sterilization residuals.
. ISO 10993-10:2010, Biological Evaluation of Medical Devices. Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017, Biological Evaluation of Medical Devices. Part 11: Tests for . systemic toxicity.
ISO 10993-18:2005. Biological Evaluation of Medical Devices. Part 18: Chemical . characterization of medical device materials within a risk management process.
ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements . for the development, validation and routine control of a sterilization process for medical devices.
ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems.
. ISO 8536-4:2010, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed.
ISO 80369-7:2016. Small-bore connectors for liquids and gases in healthcare . applications — Part 7: Connectors for intravascular or hypodermic applications.
ISO 14971:2007 Medical devices Medical devices Application of risk management . to medical devices

Substantial Equivalence

Simplivia Healthcare's modified I.V. Administration sets have the same intended use and principles of operation as its predicate device, K121269. Performance data demonstrate that the modified I.V. Administration sets are as safe and effective as their predicate device and do not raise any new safety and effectiveness issues. Thus, Simplivia Healthcare's modified I.V. Administration Sets are substantially equivalent to their predicate device, K121269.

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.