(268 days)
Not Found
No
The description focuses on the mechanical and physical properties of the device components for safe drug transfer and containment, with no mention of AI or ML capabilities.
No
The device is described as a Closed System Drug Transfer Device (CSTD) for safe preparation, compounding, and administration of drugs, not for treating a disease or condition itself. Its purpose is to prevent exposure to hazardous drugs and microbial ingress during drug handling.
No
This device is described as a Closed System Drug Transfer Device (CSTD) for the safe preparation, compounding, and administration of drugs, designed to minimize exposure to hazardous drugs and prevent microbial ingress. It does not perform any diagnostic function.
No
The device description clearly outlines multiple physical components (Syringe Unit, Vial Adaptor, Spike Adaptor, etc.) that are combined to form a system. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs." This describes a device used in the handling and delivery of medications, not for testing biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a system of components designed to create a closed system for drug transfer, minimizing exposure to hazardous substances and preventing microbial ingress. This aligns with drug handling and administration, not in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly described as a Closed System Drug Transfer Device (CSTD), which is a type of medical device used in the preparation and administration of drugs.
N/A
Intended Use / Indications for Use
Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs
Product codes
ONB
Device Description
The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs.
EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below:
| Name | Description |
|---|---|
| Syringe Unit | Syringe for drug transfer |
| Vial Adaptor | Adaptor to the drug vial |
| Spike Adaptor & Spike Adaptor 180 | Adaptor for the IV bag for injection and for infusion administration |
| Spike Adaptor W & Spike Adaptor W180 | Adaptor for the IV bag for withdrawal |
| Luer Lock Adaptor 1 | Adaptor for injection into IV lines |
| Luer Lock Adaptor 2 | Adaptor for injection and withdrawal for IV lines |
| Female Luer Lock connector | Connector for standard IV tubing set ports |
| Protective Plug | A plug to protect connectors during transportation |
| Tubing sets | Accessory for injection into an IV line |
| Reconstitution Set Accessory | Accessory for reconstituting powdered drugs |
| Luer Lock Adaptor 1C | Adaptor for injection into catheters |
| Luer Lock Adaptor 1DC | Adaptor for medication transfer between EQUASHIELD® Syringe Units |
| Male Priming Connector | Connector for priming of IV line |
The above components are combined to create a system and are not intended to be used individually.
The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.
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
Target Users: Licensed Pharmacists/Health Care Professionals
Environment: Hospitals and clinics
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 meets all design specifications and complies with applicable standards as follows:
- ISO 8536-4 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed
- ISO 8536-10 Infusion Equipment for Medical Use Part 10: Accessories for ● Fluid Lines for Single Use with Pressure Infusion Equipment
- ISO 80369-7 Small-bore connectors for liguids and gases in healthcare ● applications - Part 7: Connectors for intravascular or hypodermic applications
- . ISO 1135-4 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
- USP and USP Visible and Sub-visible Particulate Matters in ● Injections
Biocompatibility testing was performed on the EQUASHIELD® CSTD components (finished and sterilized) as an Externally Communicating Device. Blood Path Indirect. Prolonged Contact (>24hrs to 30days) according to FDA Guidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. The following tests were conducted:
- . Cytotoxicity
- Sensitization
- Irritation ●
- Acute systemic toxicity ●
- Material mediated pyrogenicity ●
- Hemocompatibility ●
- Subacute Toxicity (dual route repeated exposure method)
Sterility Shelf life and Shipping Simulation:
- The EQUASHIELD® CSTD is a sterile medical device. The sterilization process ● uses Ethylene Oxide (EtO) to achieve a sterility assurance level (SAL) of at least 10-6. The validation process followed the "overkill" approach according to 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.
- Bacterial Endotoxin test (LAL) was performed and passed the acceptance criteria of USP.
- Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) residuals were found ● to comply with ISO 10993-7:2008 Biological evaluation of medical devices part 7: Ethylene oxide sterilization residuals for prolonged exposure devices.
- The shelf life of the EQUASHIELD® CSTD is 3 years, established using ASTM . F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices." The study included sterilized samples of the CSTD which was accelerated aged to the equivalent of 3 years. Performance, functional and package integrity tests were conducted following accelerated aging and transportation simulation and passed acceptance criteria.
- Packaging integrity was conducted after sterilization, accelerated aging and . simulated transportation in accordance with ASTM D4169-16 under DC13. The tests included final, packed, and sterile samples of the EQUASHIELD CSTD which were tested for
- Visual inspection ASTM F1886 o
- Dye test ASTM F1929 o
- Pell test ASTM F88 o
- Burst test ASTM F2054 o
- Bubble emission test ASTM D3078 o
- Sterility USP o
- o Microbiological Barrier Test (for the package) ASTM F1608
Microbial Ingress:
Microbial Ingress study was conducted per the 2008 FDA guidance, "Intravascular Administration Sets Premarket Notification Submissions [510(k)]." The study included sterile and aged EQUASHIELD® CSTD samples which were repeatedly accessed in a total of 10 times over the period of 7 days. None of the tested samples showed growth, therefore, the samples met the acceptance criteria and the EQUASHIELD® CSTD was verified to prevent microbial ingress after aging as labeled.
Drug Compatibility:
Hazardous drug compatibility testing was performed on the EQUASHIELD® CSTD using hazardous drugs commonly used clinically with CSTDs and that may react aggressively with polymers (such as N.N-dimethylacetamid, known as DMA). Compatibility was verified using chemical analytic experiments and mechanical, functional and performance testing. Study results showed that the EQUASHIELD® CSTD does not affect the drugs' stability and the drugs do not negatively impact the devices' mechanical, functions, or performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EQUASHIELD® Closed System Transfer Device, manufactured by . EQUASHIELD Medical Ltd., cleared under K170706
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 17, 2023
EQUASHIELD Medical Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K221513
Trade/Device Name: EQUASHIELD® Closed System Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: January 16, 2023 Received: January 17, 2023
Dear Bosmat Friedman:
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
1
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 (OS) 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,
Danil Walloscher
David Wolloscheck, PhD Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221513
Device Name
EQUASHIELD® Closed System Transfer Device
Indications for Use (Describe)
Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with 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
K221513 - 510(k) Summary
SUBMITTER
Applicant's Name: EQUASHIELD Medical Ltd. Ktalav St.1. POB 12 Migdal Tefen, 2495900, Israel Tel: +972 4 9873737, Fax: +97 4 9873001
Contact Person:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 647-975-3974 bosmat.f@promedoss.com
Date Prepared: February 17, 2023
DEVICE
Trade Name: EQUASHIELD® Closed System Transfer Device
Common Name: Closed Antineoplastic and Hazardous Drug Reconstitution And Transfer System Product Code: ONB Regulation Name: Intravascular administration set Regulation No: 880.5440 Class: 2 Review Panel: General Hospital
PREDICATE DEVICE
Predicate device:
- EQUASHIELD® Closed System Transfer Device, manufactured by . EQUASHIELD Medical Ltd., cleared under K170706; Product Code: ONB.
DEVICE DESCRIPTION
The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the
4
transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs.
EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below:
| Name | Description |
|---|---|
| Syringe Unit | Syringe for drug transfer |
| Vial Adaptor | Adaptor to the drug vial |
| Spike Adaptor & Spike Adaptor | |
| 180 | Adaptor for the IV bag for injection and for infusion |
| administration | |
| Spike Adaptor W & Spike Adaptor | |
| W180 | Adaptor for the IV bag for withdrawal |
| Luer Lock Adaptor 1 | Adaptor for injection into IV lines |
| Luer Lock Adaptor 2 | Adaptor for injection and withdrawal for IV lines |
| Female Luer Lock connector | Connector for standard IV tubing set ports |
| Protective Plug | A plug to protect connectors during transportation |
| Tubing sets | Accessory for injection into an IV line |
| Reconstitution Set Accessory | Accessory for reconstituting powdered drugs |
| Luer Lock Adaptor 1C | Adaptor for injection into catheters |
| Luer Lock Adaptor 1DC | Adaptor for medication transfer between |
| EQUASHIELD® Syringe Units | |
| Male Priming Connector | Connector for priming of IV line |
The above components are combined to create a system and are not intended to be used individually.
The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.
5
| Characteristic | Subject Device
Equashield Closed System Drug
Transfer Device
K221513 | Predicate Device
Equashield Closed System Drug
Transfer Device
K170706 | Comments |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Closed System Drug Transfer Device
(CSTD) for safe preparation,
reconstitution, compounding and
administration of drugs, including
antineoplastic and hazardous drugs.
This closed system mechanically
prohibits the transfer of environmental
contaminants into the system and the
escape of drug or vapor concentrations
outside the system, thereby
minimizing individual and
environmental exposure to drug vapor,
aerosols, and spills and also prevents
microbial ingress up to 7 days. The
system's closed Syringe Unit prevents
intended and unintended syringe
plunger detachment and can be used
safely up to its maximal nominal
volume with hazardous drugs | Closed System drug Transfer Device
(CSTD) for preparation,
reconstitution, compounding and
administration of drugs, including
antineoplastic and hazardous drugs.
This closed system mechanically
prohibits the transfer of
environmental contaminants into the
system and the escape of drug or
vapor concentrations outside the
system, thereby minimizing
individual and environmental
exposure to drug vapor, aerosols,
and spills and also prevents
microbial ingress up to 7 days. | Different. Please see
discussions of
differences in
Indications for Use
statement, below the
Summary of
Technological
Characteristics table |
| Prescription (Rx)
or Over the
Counter | Rx | Rx | Same |
INDICATIONS FOR USE
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
| Characteristic | CSTD System
Proposed Device | CSTD System
Predicate device (K170706) | Comments |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| System
components | - Vial Adaptors
- Syringe Unit
- Spike Adaptors for injection
- Spike Adaptor for withdrawal
- Luer Lock Adaptors
- Female Luer Lock connectors
- Luer Lock Adaptor DC
- Luer Lock Adaptor C
- Protective Plug
- Y-Site Tubing (Accessory)
- Secondary Tubing (Accessory)
- Male Priming Connector | - Vial Adaptor
- Syringe Unit
- Spike Adaptor for injection
- Spike Adaptor W- for withdrawal
- Luer Lock Adaptor
- Male Luer Lock Connector
- Female Luer Lock Connector
- Protective Plug
- Y-Site Tubing (Accessory)
- Secondary Tubing (Accessory)
- Reconstitution Tubing (Accessory)
- Catheter Luer Lock Adaptor
- Syringe-Syringe Luer Lock Adaptor | Different. Please see
comment # 1 |
| Characteristic | CSTD System
Proposed Device | CSTD System
Predicate device (K170706) | Comments |
| Characteristics | Closed System used for
antineoplastic and hazardous drug
reconstitution, transfer and
administration, in order to prevent
contamination of the surrounding
environment and of the drug | Closed System used for
antineoplastic and hazardous drug
reconstitution, transfer and
administration, in order to prevent
contamination of the surrounding
environment and of the drug | Same |
| Principles of
Operation | Multi-component system.
Components are intended to be
used as a system. | Multi-component system.
Components are intended to be
used as a system. | Same |
| Technological
Characteristics | A leak-proof connector with a
single use syringe permanently
attached to it as part of the system. | A leak-proof connector with a
single use syringe permanently
attached to it as part of the system. | Same |
| | All system components are sealed
with resealing membranes
(Septum). When components are
joined together the two membranes
are pressed together and then
pierced by needles. System has
integrated closed pressure
equalization. | All system components are sealed
with resealing membranes
(Septum). When components are
joined together the two membranes
are pressed together and then
pierced by needles. System has
integrated closed pressure
equalization. | |
| | The system syringe is closed from
all sides. The syringe barrel is
sealed airtight also at its rear end,
thereby isolating the plunger rod
and the interior of the barrel. | The system syringe is closed from
all sides. The syringe barrel is
sealed airtight also at its rear end,
thereby isolating the plunger rod
and the interior of the barrel. | |
| System | A fully encapsulated Syringe Unit
is the active transfer device of this
closed system.
The syringe barrel is sealed airtight
also at its rear end, thereby
isolating the plunger rod and the
interior of the barrel. A leak-proof
connector is permanently welded
to the syringe.
The closed pressure equalization
system with a chamber containing
sterile air is built-in the Syringe
Unit and makes the system airtight
consequently containing all
aerosols, particles and vapors.
For transfer of fluids the Syringe
Unit connects to the passive Vial
Adaptors, infusion bag and
infusion tubing adaptors of the
system, using the double
membrane method to create a leak-
proof and drug residual-free
connection. | A fully encapsulated Syringe Unit
is the active transfer device of this
closed system.
The syringe barrel is sealed airtight
also at its rear end, thereby
isolating the plunger rod and the
interior of the barrel. A leak-proof
connector is permanently welded
to the syringe.
The closed pressure equalization
system with a chamber containing
sterile air is built-in the Syringe
Unit and makes the system airtight
consequently containing all
aerosols, particles and vapors.
For transfer of fluids the Syringe
Unit connects to the passive Vial
Adaptors, infusion bag and
infusion tubing adaptors of the
system, using the double
membrane method to create a leak-
proof and drug residual-free
connection. | Difference. Please see
comment # 2 |
| Materials within
the drug path | Polypropylene, PVC, Silicone, 304
SST, POM, ABS, Polyisoprene,
Hydrophobic filter | Polypropylene, PVC, Silicone, 304
SST, POM, ABS, Polyisoprene,
Hydrophobic filter | Same |
| Drug compatibility | Compatible with hazardous drug
usage | Compatible with hazardous drug
usage | Same |
| Characteristic | CSTD System
Proposed Device | CSTD System
Predicate device (K170706) | Comments |
| Device Type | Rx/Single Use | Rx/Single Use | Same |
| Target Users | Licensed Pharmacists/Health Care
Professionals | Licensed Pharmacists/Health Care
Professionals | Same |
| Environment | Hospitals and clinics | Hospitals and clinics | Same |
| Sterilization | EO/SAL 10-6
(Plug - Gamma) | EO/SAL 10-6
(Plug - Gamma) | Same |
6
7
EQUASHIELD® CSTD – 510(k) Summary
Discussions of differences in Indications for Use statement:
The EQUASHIELD® CSTD System has the same intended use and the same indications for use as the predicate, the previously cleared EQUASHIELD® CSTD System (K170706) except for the addition of a sentence to the indications for use to clarify the functionality of the Syringe Unit with respect to syringe plunger detachment. This is not a new feature to the product and was described in the predicate 510(k), even though it was not included in the indication for use of the predicate device.
Discussion of differences in technological characteristics:
Comment #1 The new components added to the CSTD family are (by Ref#):
- Vial Adaptor: VA-13C/2 i
- Spike Adaptors: SA-180 & SA-W180
- Luer Lock Adaptors: LL-2S & LL-2
- Male Priming Connector: MC-2
- Female Luer Lock connectors: FC-1S &FC-180
- Protective Plug: PP-2
The design and principle of operation of all new system components are based on the predicate components. All components have been tested and validated and perform as intended. Risk assessment identified no new or modified risks relative to predicate components. Differences do not raise new or different questions of safety or effectiveness
Comment #2 The subject device includes a number of new components that are each based on a variant of a component included in the cleared predicate system. All the new components have been validated and perform as intended. Risk assessment identified no new or modified risks of the proposed CSTD relative to the predicate. Differences do not raise new or different questions of safety or effectiveness
The proposed changes, which include changes relating to the materials used in some components and the inclusion of several additional components, have been assessed through bench testing, biocompatibility testing, drug compatibility testing, usability testing and a biological risk assessment. None of the proposed additions and modifications were found to raise new safety or effectiveness concerns and the results of the testing support the substantial equivalence claim. With respect to principles of operation, both systems are identical. Consequently, the EQUASHIELD® CSTD System is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns.
8
PERFORMANCE DATA
Non-clinical testing:
Non-clinical tests were conducted to verify that the proposed device meets all design specifications and complies with applicable standards as follows:
- ISO 8536-4 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed
- ISO 8536-10 Infusion Equipment for Medical Use Part 10: Accessories for ● Fluid Lines for Single Use with Pressure Infusion Equipment
- ISO 80369-7 Small-bore connectors for liguids and gases in healthcare ● applications - Part 7: Connectors for intravascular or hypodermic applications
- . ISO 1135-4 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
- USP and USP Visible and Sub-visible Particulate Matters in ● Injections
Biocompatibility:
Biocompatibility testing was performed on the EQUASHIELD® CSTD components (finished and sterilized) as an Externally Communicating Device. Blood Path Indirect. Prolonged Contact (>24hrs to 30days) according to FDA Guidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. The following tests were conducted:
- . Cytotoxicity
- Sensitization
- Irritation ●
- Acute systemic toxicity ●
- Material mediated pyrogenicity ●
- Hemocompatibility ●
- Subacute Toxicity (dual route repeated exposure method)
Sterility Shelf life and Shipping Simulation:
- The EQUASHIELD® CSTD is a sterile medical device. The sterilization process ● uses Ethylene Oxide (EtO) to achieve a sterility assurance level (SAL) of at least 10-6. The validation process followed the "overkill" approach according to 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.
- Bacterial Endotoxin test (LAL) was performed and passed the acceptance criteria of USP.
- Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) residuals were found ● to comply with ISO 10993-7:2008 Biological evaluation of medical devices part 7: Ethylene oxide sterilization residuals for prolonged exposure devices.
- The shelf life of the EQUASHIELD® CSTD is 3 years, established using ASTM . F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for
9
Medical Devices." The study included sterilized samples of the CSTD which was accelerated aged to the equivalent of 3 years. Performance, functional and package integrity tests were conducted following accelerated aging and transportation simulation and passed acceptance criteria.
- Packaging integrity was conducted after sterilization, accelerated aging and . simulated transportation in accordance with ASTM D4169-16 under DC13. The tests included final, packed, and sterile samples of the EQUASHIELD CSTD which were tested for
- Visual inspection ASTM F1886 o
- Dye test ASTM F1929 o
- Pell test ASTM F88 o
- Burst test ASTM F2054 o
- Bubble emission test ASTM D3078 o
- Sterility USP o
- o Microbiological Barrier Test (for the package) ASTM F1608
Microbial Ingress:
Microbial Ingress study was conducted per the 2008 FDA guidance, "Intravascular Administration Sets Premarket Notification Submissions [510(k)]." The study included sterile and aged EQUASHIELD® CSTD samples which were repeatedly accessed in a total of 10 times over the period of 7 days. None of the tested samples showed growth, therefore, the samples met the acceptance criteria and the EQUASHIELD® CSTD was verified to prevent microbial ingress after aging as labeled.
Drug Compatibility:
Hazardous drug compatibility testing was performed on the EQUASHIELD® CSTD using hazardous drugs commonly used clinically with CSTDs and that may react aggressively with polymers (such as N.N-dimethylacetamid, known as DMA). Compatibility was verified using chemical analytic experiments and mechanical, functional and performance testing. Study results showed that the EQUASHIELD® CSTD does not affect the drugs' stability and the drugs do not negatively impact the devices' mechanical, functions, or performance characteristics.
CONCLUSION
The EQUASHIELD® CSTD System has the same indications for use as the predicate, the previously cleared CSTD System (K170706) except for the addition of clarification text associated with a previously cleared feature of the syringe component. The proposed design changes, which include changes relating to the materials used in some components and the inclusion of several additional components, have been assessed through bench testing and biocompatibility testing. None of the proposed additions and modifications were found to raise new safety or effectiveness concerns and the results of the testing support substantial equivalence to the predicate system. With respect to principles of operation, both systems are identical. Consequently, the EQUASHIELD® CSTD System is substantially equivalent to its predicate.