(302 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as an I.V. Administration Set, part of a Closed System Transfer Device (CSTD), used to administer intravenous solutions and/or drugs. Its primary function is to transfer drugs and protect healthcare personnel from hazardous substances, not to provide therapeutic treatment or diagnostic information itself. Therapeutic devices are directly involved in treating or mitigating a disease or condition.
No
The device is an I.V. Administration Set designed to administer intravenous solutions and/or drugs. Its primary function is to transfer substances, not to diagnose conditions.
No
The device description clearly outlines physical components like spikes, tubing, clamps, and injection sites, and the performance studies focus on biological and physical testing of these components. There is no mention of software as a component or function of the device.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Tevadaptor® is a Closed System Transfer Device (CSTD) used to mechanically prohibit the release of drugs during preparation, compounding, and administration. This is a drug delivery and safety device, not a device used to perform tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details components like spikes, tubing, clamps, and connectors, all related to the administration of intravenous solutions and drugs. It explicitly states it's part of a CSTD intended to protect healthcare professionals, patients, and the environment during drug handling.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect analytes, or provide diagnostic information.
The device falls under the category of medical devices used for drug administration and safety, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ONB, FPA
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.
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)
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
Key Results: 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.
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
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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.
1
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
2
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)
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.
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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3
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 Zone
Kiryat Shmona
Israel 1101801
Tel. (972)4-690-8826
Fax (972)4-8921665 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shay Shaham
VP QA & RA
Simplivia Healthcare Ltd.
Tel. (972)52-831-3378
Fax (972)4-8921665 |
| Date Prepared: | February 21, 2021 |
| Name of Device: | Intravascular 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 |
| Common Name: | Closed Drug Reconstitution and Transfer System |
| Classification: | Product Code: ONB (primary), FPA (secondary)
Regulation No: 21 C.F.R. §880. 5440
Class: II
Regulation name: Intravascular administration set
Classification 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
4
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.
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.
5
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 tested
according to NIOSH and
proved to be a CSTD |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Indications for use | The I.V. Administration Set
is a single use, sterile I.V.
set for administration of
fluids from a container to a
patient's vascular system. | 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,
reconstitution,
compounding and
administration, minimizing
exposure of individuals,
healthcare personnel, and
the environment to
hazardous drugs. | Since K201142 sets are
under the ONB code, the
intended use includes the
following: The sets
mechanically prohibit the
release 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. |
| Components | Spike, drip chamber, tubing,
flow regulator, clamp,
ULTRASITE® Y injection
site, Luer connection | Spike, drip chamber, tubing,
flow regulator, clamp,
ULTRASITE® Y injection
site, Luer connection, twist-
off | Similar |
| Sterilization | Ethylene Oxide
validated cycle SAL 10-6 | Ethylene Oxide
validated cycle SAL 10-6 | Same |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Interconnecting
features | Mechanical snap
connections, Luer lock
connection, spike | Mechanical snap
connections, Luer lock
connection, spike | Same |
| Interaction with
patient | No direct interaction - this is
a secondary set | No direct interaction - this is
a secondary set | Same |
| Indirect interaction
with patient | Indirect interaction with the
patient is achieved through
the passage of IV fluids
through the central tubing of
the administration set | Indirect interaction with the
patient is achieved through
the passage of IV fluids
through the central tubing
of 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 with
other devices | For most uses, this
secondary administration set
will connect to an IV
solution container and a
primary administration set.
Other connections may be
made through specific
components of the set, such
as the Spike Port and the
ULTRASITE® Y injection
site.
while using the following
Chemfort™ or Tevadaptor™
components:
- Syringe Adaptor (K192866)
- Syringe Adaptor Lock
(K192866) - Luer Lock Adaptor
(K192866) | For most uses, this
secondary administration
set will connect to an IV
solution container and a
primary administration set.
Other connections may be
made through specific
components of the set, such
as the Spike Port and the
ULTRASITE® Y injection
site,
while using the following
Chemfort™ 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 NIOSH
and ISOPP
definition of a
CSTD | N/A (the first draft protocol
was issued in 2015) | Yes | The first draft protocol was
issued after predicate 510(k) |
6
7
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.