(117 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties for drug transfer and containment, with no mention of AI or ML technologies.
No
The device is a Closed System Drug Transfer Device (CSTD) designed to transfer drugs safely, minimizing exposure to hazardous substances and preventing microbial ingress. It does not directly treat or diagnose a disease or condition in a patient, which is the primary function of a therapeutic device.
No
Explanation: The device is a Closed System Drug Transfer Device (CSTD) designed for the preparation, compounding, and administration of drugs, specifically to minimize exposure to hazardous drugs and prevent microbial ingress. Its function is to transfer substances, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines multiple physical components (syringe, adaptors, connectors, etc.) and describes their mechanical functions and material properties. There is no mention of software as a component or the primary function of the device.
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 for the "preparation, compounding and administration of drugs." This is a therapeutic and drug handling function, not a diagnostic one.
- Device Description: The description details components for transferring and administering drugs (syringes, adaptors for vials and IV bags, etc.). It focuses on maintaining a closed system to protect users and the environment from hazardous drugs and prevent microbial ingress. This aligns with drug handling and administration, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on aspects relevant to drug handling and safety, such as biocompatibility, sterility, drug compatibility, hazardous vapor containment, and microbial ingress protection. These are not typical performance metrics for IVDs.
In summary, the device's purpose is to safely handle and administer drugs, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Closed System drug Transfer Device (CSTD) for 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 also prevents microbial ingress up to 7 days.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
Equashield is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Equashield closed system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), an adaptor for the IV bag for withdrawal (Spike Adaptor-W), adaptors for injection into IV lines, syringes, or catheters (Luer Lock Adaptors). Nursing Pair connectors for standard IV tubing set ports (Female Luer Lock Connector and Male Luer Lock Connector), a Protective Plug, an adaptor for injection into an IV line with a Y-Site Tubing Set, or Secondary Tubing Accessory, and a Reconstitution Tubing Set for reconstituting powder drugs. The variable sterile air chamber integrated into the encapsulated syringe provides self-contained 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 seals off 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 add new components to the system including a thin size for components, introduce different material to the components and make labeling changes.
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)
Biocompatibility: Biocompatibility testing was performed on the Equashield materials according to FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization. irritation, systemic toxicity, and hemocompatibility according to standards set forth in ISO 10993-4, Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood, ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, and ISO 10993-11 Biological evaluation of medical devices --Part 11: Tests for systemic toxicity. All testing passed.
Sterility: Sterilization vas performed on the finish sterile Equashield components according to ISO 11135 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices and ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Testing included pyrogenicity, bioburden, and EO residuals to standards set forth in ISO 10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, ISO 11737-1 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products, and AAMI/ANSI ST72 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing. All testing passed.
Package Integrity and Shelf Life: Packaging and Shelf Life validation was performed on aged Equashield packaging according to ASTM F1140 standard test methods for internal pressurization failure resistance of unrestrained packages, ASTM F129 standard test method for detecting seal leaks in porous medical packaging by dye penetration, and ASTM F88 standard test method for seal strength of flexible barrier materials. All testing passed.
Bench Performance: Performance testing was performed on the Equashield including visual inspection, detachment force, penetration force, and leak testing according to ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements, ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. ISO 7886-1 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use, ISO 8536-4 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed, and ISO 22413 Transfer sets for pharmaceutical preparations - Requirements and test methods.
Sharps Protection: Sharps protection testing was performed according to ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Drug/DMA Compatibility: Antineoplastic drug compatibility testing was performed to validate Equashield compatibility with antineoplastic drugs and DMA (N,N-dimethylacetamid). Equashield was found to be compatible with antineoplastic drugs and DMA.
Extractables Screening: Determine what compounds and their estimated concentrations are extracted from the Equashield Closed System Transfer Device for hazardous drugs (CSTD) under the conditions of the extractions (24 hours. 370C and 500C respectively) extracted in the following solvents: 50% ethanol, pH 3 (HCl adjusted) 0.9% saline, and 33% aqueous dimethylacetamide (DMA).
Leachables Screening and Health Risk Assessment (ISO 10993-17): Determine what compounds (and their estimated concentration) are leached from the Equashield Closed System Transfer Device (CSTD) assemblies at 25°C±2°C for 24 hours using four different hazardous drug carrier simulants. Drugs that were chosen carry warnings and traditionally represent in literature the most deleterious and corrosive drugs to devices, these drug simulants were carriers for Etoposide, Busulfan and Taxol along with a saturated aqueous solution of Mannitol representative for long-term treatment drugs Velcade and Vidaza.
Hazardous Vapors Containment: Hazardous vapor containment testing was performed on the Equashield to validate no escape of vapors from Equashield during use was performed using gas chromatography (GC) analysis using Flame Ionization (FID). Testing met alcohol residual levels criteria.
Microbial Ingress Protection: Microbial ingress testing was performed on Equashield to validate microbial ingress protection after repetitive needle penetration of the septum. Testing results demonstrate Equashield was protected against microbial ingress for a period of 7 days after breaching the septum 10 times with the needle. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
Particulates: Particulate contamination testing was performed on the Equashield according to USP 788 to demonstrate lack of contamination. Testing results demonstrated particulate levels in the Equashield are low and meet USP 788 requirements.
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.
K132899 Equashield Closed System drug Transfer Device (CSTD), K150219 Equashield Closed System drug Transfer Device (CSTD)
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2017
Equashield Medical Ltd. % Mr. Raymond Kelly Consultant Licensale Inc. 68 Southwoods Terrace Southbury, Connecticut 06488
Re: K170706
Trade/Device Name: Equashield Closed System drug Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: ONB Dated: May 28, 2017 Received: May 31, 2017
Dear Mr. Kelly:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT 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)
Device Name
Equashield Closed System drug Transfer Device (CSTD)
Indications for Use (Describe)
Closed System drug Transfer Device (CSTD) for 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 also prevents microbial ingress up to 7 days.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: July 3, 2017
510k Number: K170706
Applicant Equashield Medical Ltd. POB 12, Tefen Industrial Park Migdal Tefen 24959, Israel Attn: Dorit Valal Phone: +972-49873737 (ex. 114)
Contact Person Raymond Kelly 68 Southwoods Terrace Southbury, CT 06488 USA Phone: (203) 400-7566
Device Information
| Trade Name: | Equashield Closed System drug Transfer Device (CSTD) |
|---|---|
| Model Numbers: | Generation 2: (VA-x, SU-x, SA-x, LL-x, MC-x, FC-x, PP-x) |
| Regulation Name: | Intravascular administration set |
| Review Panel: | General Hospital |
| Product Code: | ONB |
| Common Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer |
| System | |
| Device Class: | Class II |
| Regulation: | 21 C.F.R. §880.5440 |
Predicate Device Information
K132899 Equashield Closed System drug Transfer Device (CSTD) K150219 Equashield Closed System drug Transfer Device (CSTD)
Indications for Use
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.
4
Device Description
Equashield is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Equashield closed system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), an adaptor for the IV bag for withdrawal (Spike Adaptor-W), adaptors for injection into IV lines, syringes, or catheters (Luer Lock Adaptors). Nursing Pair connectors for standard IV tubing set ports (Female Luer Lock Connector and Male Luer Lock Connector), a Protective Plug, an adaptor for injection into an IV line with a Y-Site Tubing Set, or Secondary Tubing Accessory, and a Reconstitution Tubing Set for reconstituting powder drugs. The variable sterile air chamber integrated into the encapsulated syringe provides self-contained 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 seals off 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 add new components to the system including a thin size for components, introduce different material to the components and make labeling changes.
5
Summary of Technological Characteristics Including Modifications to the Device:
Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed modified device is SE to the predicate device and does not raise different questions of safety or effectiveness.
| Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) | |
|---|---|---|---|
| Intended Use | Same | Same | Same |
| Indications 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. | 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. | 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. | |||
| Classification | Class II | Class II | Class II |
| Regulation | |||
| Number | 888.5440 | 888.5440 | 888.5440 |
| Product Code | ONB | ONB | ONB |
| Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) | |
| System | |||
| components | Vial Adaptor (VA) | Vial Adaptor | Vial Adaptor |
| Syringe Unit (SU) | Syringe Unit | Syringe Unit | |
| Spike Adaptor for injection (SA- | |||
| Regular and Thin Size) | Spike Adaptor for injection | Spike Adaptor for injection | |
| Spike Adaptor W- for withdrawal (SA-W) | Spike Adaptor W- for withdrawal | Spike Adaptor W- for withdrawal | |
| Luer Lock Adaptor (LL-1) | Luer Lock Adaptor | Luer Lock Adaptor | |
| Male Luer Lock Connector (MC-1) | Male Luer Lock Connector | Male Luer Lock Connector | |
| Female Luer Lock Connector (FC-1) | Female Luer Lock Connector | Female Luer Lock Connector | |
| Protective Plug (PP-1) | Protective Plug | Protective Plug | |
| Y-Site Tubing (Accessory) (LL-1Y) | Y-Site Tubing (Accessory) | Y-Site Tubing (Accessory) | |
| Secondary Tubing (Accessory) (SA- | |||
| 1S) (Regular and Thin Size) | Secondary Tubing (Accessory) | Secondary Tubing (Accessory) | |
| Reconstitution Tubing(Accessory) | |||
| (LL-1R) | NA | Reconstitution Tubing(Accessory) | |
| Catheter Luer Lock Adaptor (LL-1C) | NA | NA | |
| Syringe-Syringe Luer Lock Adaptor | |||
| (LL-1DC) | NA | NA | |
| 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 | 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 | |||
| 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 | Multi-component system. | ||
| Components are intended to be used as | |||
| a system | |||
| Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) | |
| 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. | A leak-proof connector with a single | ||
| use syringe permanently attached to | |||
| it as part of the system. | |||
| 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. | 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. | 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. | |||
| Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) | |
| Secondary Tubing | |||
| Sets | Spike Adaptor with drip chamber and | ||
| secondary tubing attached, Y Tubing | |||
| set with Y-Connector attached. | Spike Adaptor with drip chamber | ||
| and secondary tubing attached, Y | |||
| Tubing set with Y-Connector | Spike Adaptor with drip chamber and | ||
| secondary tubing attached, Y Tubing | |||
| set with Y-Connector attached. | |||
| A fully encapsulated Syringe Unit is | A fully encapsulated Syringe Unit is | A fully encapsulated Syringe Unit is | |
| the active transfer device of this closed | |||
| system. | the active transfer device of this | ||
| closed system. | the active transfer device of this closed | ||
| system. | |||
| System | The syringe barrel is sealed airtight | The syringe barrel is sealed airtight | The syringe barrel is sealed airtight also |
| also at its rear end, thereby isolating | also at its rear end, thereby isolating | at its rear end, thereby isolating the | |
| the plunger rod and the interior of the | the plunger rod and the interior of | plunger rod and the interior of the | |
| barrel. | barrel. | barrel. | |
| A leak-proof connector is permanently | A leak-proof connector is | A leak-proof connector is permanently | |
| welded to the syringe. | permanently welded to the syringe. | 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. | 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. | 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. | 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. | 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. | |||
| Device Type | Rx/Single Use | Rx/Single Use | Rx/Single Use |
| Target Users | Licensed Pharmacists/Health Care | Licensed Pharmacists/Health Care | Licensed Pharmacists/Health Care |
| Professionals | Professionals | Professionals | |
| Environment | Hospitals and clinics | Hospitals and clinics | Hospitals and clinics |
| Sterilization | EO and Gamma SAL 10-6 | EO and Gamma SAL 10-6 | EO and Gamma SAL 10-6 |
No differences in regulatory classification, risk, or indications for use except for the addition of 7 days for microbial ingress prevention claim.
6
7
No differences in technological characteristics
8
9
No differences in system function, sharps protection, use environment, user populations, or sterilization method.
| Changed
| Component | Change Description | Change Discussion on SE |
|---|---|---|
| Material | ABS to Polypropylene | Changed components because DMA may degrade components made from ABS or PC if |
| contact duration is extended. The PP used in the changes is already used throughout the | ||
| predicate device and has been fully tested for biocompatibility and vapor escape. No | ||
| different questions of safety or effectiveness are raised. | ||
| Components | Added Luer Lock | |
| Adaptors LL-1C and LL- | ||
| 1DC, thin version Spike | ||
| Adaptor, and a 17mm | ||
| Vial Adaptor. | Added luer lock adaptors to allow luer lock to connections between two syringes and to | |
| allow connection to a catheter, also Spike Adaptor in thinner form and 17mm Vial | ||
| Adaptor are similar or same design and dimensions as the existing predicate components. | ||
| No different questions of safety or effectiveness are raised. | ||
| Labeling | DMA warning removed, | |
| directions for LL-1C and | ||
| LL-1DC were added. | Edited the labeling in order to provide directions for using the added Luer Lock Adaptors | |
| and remove the warning which is no longer applicable. Also added labels for the new | ||
| components. No different questions of safety or effectiveness are raised. |
Discussion of Differences:
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Performance Testing
Biocompatibility: Biocompatibility testing was performed on the Equashield materials according to FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization. irritation, systemic toxicity, and hemocompatibility according to standards set forth in ISO 10993-4, Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood, ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, and ISO 10993-11 Biological evaluation of medical devices --Part 11: Tests for systemic toxicity. All testing passed.
Sterility: Sterilization vas performed on the finish sterile Equashield components according to ISO 11135 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices and ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Testing included pyrogenicity, bioburden, and EO residuals to standards set forth in ISO 10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, ISO 11737-1 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products, and AAMI/ANSI ST72 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing. All testing passed.
Package Integrity and Shelf Life: Packaging and Shelf Life validation was performed on aged Equashield packaging according to ASTM F1140 standard test methods for internal pressurization failure resistance of unrestrained packages, ASTM F129 standard test method for detecting seal leaks in porous medical packaging by dye penetration, and ASTM F88 standard test method for seal strength of flexible barrier materials. All testing passed.
Bench Performance: Performance testing was performed on the Equashield including visual inspection, detachment force, penetration force, and leak testing according to ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements, ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. ISO 7886-1 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use, ISO 8536-4 Infusion equipment for medical use - Part 4: Systems for single use, gravity feed, and ISO 22413 Transfer sets for pharmaceutical preparations - Requirements and test methods.
Sharps Protection: Sharps protection testing was performed according to ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
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Drug/DMA Compatibility: Antineoplastic drug compatibility testing was performed to validate Equashield compatibility with antineoplastic drugs and DMA (N,N-dimethylacetamid). Equashield was found to be compatible with antineoplastic drugs and DMA.
Extractables Screening: Determine what compounds and their estimated concentrations are extracted from the Equashield Closed System Transfer Device for hazardous drugs (CSTD) under the conditions of the extractions (24 hours. 370C and 500C respectively) extracted in the following solvents: 50% ethanol, pH 3 (HCl adjusted) 0.9% saline, and 33% aqueous dimethylacetamide (DMA).
Leachables Screening and Health Risk Assessment (ISO 10993-17): Determine what compounds (and their estimated concentration) are leached from the Equashield Closed System Transfer Device (CSTD) assemblies at 25°C±2°C for 24 hours using four different hazardous drug carrier simulants. Drugs that were chosen carry warnings and traditionally represent in literature the most deleterious and corrosive drugs to devices, these drug simulants were carriers for Etoposide, Busulfan and Taxol along with a saturated aqueous solution of Mannitol representative for long-term treatment drugs Velcade and Vidaza.
Hazardous Vapors Containment: Hazardous vapor containment testing was performed on the Equashield to validate no escape of vapors from Equashield during use was performed using gas chromatography (GC) analysis using Flame Ionization (FID). Testing met alcohol residual levels criteria.
Microbial Ingress Protection: Microbial ingress testing was performed on Equashield to validate microbial ingress protection after repetitive needle penetration of the septum. Testing results demonstrate Equashield was protected against microbial ingress for a period of 7 days after breaching the septum 10 times with the needle. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
Particulates: Particulate contamination testing was performed on the Equashield according to USP 788 to demonstrate lack of contamination. Testing results demonstrated particulate levels in the Equashield are low and meet USP 788 requirements.
Substantial Equivalence Conclusion:
Performance testing on the proposed Equashield performed substantially equivalent (SE) to the performance testing on the predicate Equashield. Equivalence was determined using a side by side tabular comparison between the predicate and proposed Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed device is Substantially Equivalent to the predicate device.
Based on the analysis of the comparison between the predicate and proposed devices regarding risk analysis, design controls, and performance evaluation the data shows the modification does not raise different questions of safety or efficacy and demonstrates substantial equivalence to the predicate device without the need for additional testing.