Chemfort CSTD

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May 7, 2020 Simplivia Healthcare Ltd. % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 Rome, 00153 ITALY Re: K192866 Trade/Device Name: Chemfort™ Closed System Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: April 2, 2020 Received: April 7, 2020 Dear Roger Gray: 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 Tina Kiang, Ph.D. 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) K192866 Device Name Chemfort Closed System Transfer Device (CSTD) #### Indications for Use (Describe) Chemfort 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. Chemfort prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The "S" is made up of curved lines that create a sense of movement. # 510(k) Summary in accordance with 21 CFR 807.92(c) | Device Name: | Chemfort™ Closed System Transfer Device (CSTD) | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type of 510(k) submission: | Abbreviated | | Date Prepared: | 1 March 2020 | | 510(k) Owner & Submitter | Simplivia Healthcare Ltd.<br>North Industrial Zone P.O. Box 888<br>Kiryat Shmona<br>Israel 1101801 | | Phone: | +972-4-6908830 | | Fax: | +972-9-892-1659 | | FDA Registration Number: | 9611423 | | 510(k) Application Correspondent: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy<br>Phone: +39 06 578 2665<br>Fax: +30 06 574 3786<br>Email: rgray@donawa.com | | FDA Product Code: | ONB | | FDA Regulation Number: | 880.5440 | | FDA Regulation Name: | Intravascular administration set | | Classification Panel: | General Hospital | | Common Name: | Closed Drug Reconstitution and Transfer System | | FDA Classification: | Class II | | Indications for Use: | Chemfort™ is a Closed System Transfer Device (CSTD) that<br>mechanically prohibits the release of drugs, including<br>antineoplastic and hazardous drugs, in vapor, aerosol or liquid<br>form during preparation, reconstitution, compounding and<br>administration, minimizing exposure of individuals, healthcare<br>personnel, and the environment to hazardous drugs.<br>Chemfort™ prevents the introduction of microbial and airborne<br>contaminants into the drug or fluid path for up to 7 days. | #### Predicate Device: The predicate device selected for comparison with the Chemfort™ Closed System Transfer Device (CSTD) is: Predicate Device Name: TEVADAPTOR® Closed Drug Reconstitution and Transfer System {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Simplivia logo. The logo consists of a green circular symbol on the left and the word "SIMPLIVIA" in gray on the right. The circular symbol is made up of two curved shapes that resemble an "S" shape. | 510(k) Sponsor: | Teva Medical | |--------------------|----------------------------------| | 510(k) Number: | K141448 | | Clearance Date: | 23 January 2015 | | FDA Product Code: | ONB | | Regulation Name: | Intravascular administration set | | Regulation Number: | 880.5440 | ## Device Description: The Chemfort™ Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion container. The Chemfort™ CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron. The components of the Chemfort™ CSTD system are: - . Vial Adaptor 20 mm with 13 mm Vial Converter - Vial Adaptor 28 mm - Vial Adaptor 32 mm - Syringe Adaptor - Syringe Adaptor Lock - Luer Lock Adaptor - Bag Adaptor SP Each of the Chemfort™ system components is available separately. The environment of use is unchanged from that of the predicate TEVADAPTOR® system cleared under K141448. The device labeling includes the following statement: "The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding manufacturer's labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding quidelines for shelf life and sterility information." This submission for the Chemfort™ CSTD includes identification of changes in certain materials that are used in the predicate device in order to improve durability when used with drugs containing aggressive solvents, such as N'N' Dimethylacetamide. Design changes has also been made to the Vial Adaptor 20mm, Syringe Adaptor Hub, Luer Lock Adaptor, and Bag Adaptor SP. ## Comparison with Predicate Device: Table 1 provides a comparison of the Chemfort™ CSTD with the identified predicate device. | Table 1: Predicate device comparison | | | | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Subject device: ChemfortTM CSTD | Predicate device: TEVADAPTOR® | Equivalence to<br>Predicate | | Device name | ChemfortTM Closed System Drug<br>Transfer Device (CSTD) | TEVADAPTOR® Closed Drug<br>Reconstitution and Transfer System | N/A | | Manufacturer | Simplivia Healthcare, Israel | Teva Medical, Israel | N/A | | 510(k) number | K192866 | K141448 | N/A | | Table 1: Predicate device comparison | | | | | ltem | Subject device: Chemfort™ CSTD | Predicate device: TEVADAPTOR® | Equivalence to<br>Predicate | | Product Code | ONB | ONB | Same | | Reg No | 880.5440 | 880.5440 | Same | | Indications for use | Chemfort™ is a Closed System<br>Transfer Device (CSTD) that<br>mechanically prohibits the release of<br>drugs, including antineoplastic and<br>hazardous drugs, in vapor, aerosol or<br>liquid form during preparation,<br>reconstitution, compounding and<br>administration, minimizing exposure<br>of individuals, healthcare personnel,<br>and the environment to hazardous<br>drugs.<br>Chemfort™ prevents the<br>introduction of microbial and<br>airborne contaminants into the drug<br>or fluid path for up to 7 days. | TEVADAPTOR® is a Closed System<br>Drug Transfer Device (CSTD) that<br>mechanically prohibits the release of<br>the drug in vapor, aerosol or liquid<br>form during preparation and<br>administration, and prevents the<br>introduction of microbial and<br>airborne contaminants into the drug<br>or fluid path, allowing the system to<br>minimize exposure of individuals,<br>healthcare personnel, and the<br>environment to hazardous drugs. | Very similar | | Components | Vial Adaptor 20 mm with 13 mm Vial<br>Converter<br>Vial Adaptor 28 mm<br>Vial Adaptor 32 mm<br>Syringe Adaptor<br>Syringe Adaptor Lock<br>Luer Lock Adaptor<br>Bag Adaptor SP | Vial Adaptor 20 mm with 13 mm Vial<br>Converter<br>Vial Adaptor 28 mm<br>No equivalent<br>Syringe Adaptor<br>Syringe Adaptor Lock (K170680)<br>Luer Lock Adaptor<br>Spike Port Adaptor | Equivalent - the<br>devices differ in<br>details, but the<br>combination of<br>components is<br>intended to<br>achieve an<br>equivalent<br>intended use. | | Reuse capability | All components are for single use<br>only | All components are for single use<br>only | Same | | Vial venting/<br>microbial barrier | Vial venting through 0.2 micron<br>microbial membrane barrier | Vial venting through 0.2 micron<br>microbial membrane barrier | Same | | Prevents escape of<br>drug or vapor<br>concentration | Yes | Yes | Same | | Closed drug<br>transfer mechanism | Elastomeric double membrane | Elastomeric double membrane | Same | | Interconnecting<br>features | Mechanical snap connections, with<br>elastomeric double membrane | Mechanical snap connections, with<br>elastomeric double membrane | Same | | Activation<br>mechanism | Push-together connection with clip<br>locks | Push-together connection with clip<br>locks | Same | | Safety features | 0.2 micron venting membrane<br>Charcoal cloth<br>Needle tip protector<br>Septum to septum contact | 0.2 micron venting membrane<br>Charcoal cloth<br>Needle tip protector<br>Septum to septum contact | Same | | Direct interaction<br>with patient | No direct interaction | No direct interaction | Same | | Indirect interaction<br>with patient | Indirect interaction with the patient<br>is achieved through the passage of IV<br>fluids through the central lumen of<br>the applicable components | Indirect interaction with the patient<br>is achieved through the passage of IV<br>fluids through the central lumen of<br>the applicable components | Same | | Table 1: Predicate device comparison | | | | | Item | Subject device: Chemfort™ CSTD | Predicate device: TEVADAPTOR® | Equivalence to<br>Predicate | | Interaction with<br>other devices | Normal use would involve connection<br>of device components with vial,<br>syringe, IV line, IV bag - see following<br>rows for further details | Normal use would involve connection<br>of device components with vial,<br>syringe, IV line, IV bag - see following<br>rows for further details | Same | | Connection to<br>external syringe | Luer connections with permanent<br>locking feature which prevents<br>removal and remains protective<br>through preparation, use and<br>disposal | Luer connections with permanent<br>locking feature which prevents<br>removal and remains protective<br>through preparation, use and<br>disposal | Same | | Connection to<br>external standard<br>IV line | Luer lock or spike port | Luer lock or spike port | Same | | Connection to<br>external standard<br>IV bag | Spike | Spike | Same | | Sterilization | Ethylene oxide SAL 10⁻⁶ | Ethylene oxide SAL 10⁻⁶ | Same | | Materials | Thermoplastics, silicone rubber and<br>stainless steel:<br>• Polypropylene RTP 199 X 143425 A<br>NS, E-202384 White or PET<br>Eastman Tritan Copolyester<br>MX731 with white colorant EMD-<br>202914;<br>• PET Eastman Tritan Copolyester<br>MX731;<br>• PET Eastman Tritan Copolyester<br>MX731 with orange colorant EC-<br>481953 MB 4% PC TRANS. | Thermoplastics, silicone rubber and<br>stainless steel:<br>• ABS Polylac 757 White A79614B5;<br>• Polycarbonate LEXAN 144R-112;<br>• Polycarbonate LEXAN 144R-112<br>with orange colorant EC-481953<br>MB 4% PC TRANS. | Specific<br>differences | | Safety mechanism | Sleeve | Sleeve | Same | | Power<br>requirements | None | None | Same | | Biocompatibility | In accordance with ISO 10993 and<br>FDA guidance | In accordance with ISO 10993 and<br>FDA guidance | Same | | Prescription use | Rx only | Rx only | Same | | Meets the NIOSH<br>and ISOPP<br>definition of a CSTD | Yes | Yes | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green, stylized "S" shape on the left, followed by the word "SIMPLIVIA" in gray, sans-serif font. The "S" shape is a rounded, curved design, and the text is in all capital letters. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green, stylized "S" shape on the left, followed by the word "SIMPLIVIA" in gray, sans-serif font. The "S" shape is made up of two curved lines that create a circular form with a gap in the middle. ## Substantial Equivalence Discussion The Chemfort™ CSTD includes two new system components that were not included with the predicate device, these being the Vial Adaptor 32 mm and the Syringe Adaptor Lock. The introduction of these new system components raises no new issues of safety and/or effectiveness, because of their close similarity to components included in the predicate device. In addition, the Syringe Adaptor Lock was separately FDA-cleared under K170680. Chemfort™ CSTD components that are the result of design and/or material changes from the predicate and reference devices have been subjected to successful bench, biocompatibility, shelf life and usability testing, in addition to sterilization validation, and there are no new questions of safety and/or effectiveness have been identified. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green, stylized "S" shape on the left, followed by the word "SIMPLIVIA" in gray, sans-serif font. The "S" shape is made up of two curved lines that create a sense of movement and flow. The introduction of the additional wording "Chemfort prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days" in the indications for use statement has been verified by means of bench tests. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding manufacturer's labeling recommendations for drug storage and expiration dating, however. ## Non-Clinical Performance Testing: Bench testing has been carried out on the Chemfort™ system components to demonstrate equivalence with the predicate device, including a number of tests at the labeled 12-month shelf life: - Disconnection force tests ● - . Assembly connection force tests - Breakage of Syringe Adaptor Lock Luer retention teeth - Bidirectional flow tests - Air tightness tests - Fluid tightness tests - Residual volume tests - Microbial ingress tests (7 days) - Particulate matter tests per USP <788> - Filter efficiency tests - ISO 8536-4 & ISO 80369-7 tests, including: ● - Gauging test O - Resistance for overriding O - Unscrewing torque o - O Ease of assembly - Liquid leakage O - Air leakage O - Separation force of conical fitting assembly O - Stress cracking o - Resistance to cytotoxic drugs - Packaging integrity ● - o Visual (ASTM F1886) - Peel (ASTM F88/F88M O - Dye penetration (ASTM F1929) O - Leakage (ASTM F2096) O - Burst (ASTM F1140/F1140M) O - Seven-day filter exposure test - Vapor containment - Sterility validation (ISO 11135-1) - ETO residuals (ISO 10993-7) - . Bacterial endotoxins (USP <85> and <161>) #### Biocompatibility Biocompatibility tests have been carried out on sterile components from the Chemfort™ system in accordance with ISO 10993 and FDA guidance, including: - ISO 10993-5:2009: Cytotoxicity - ISO 10993-10:2010: Sensitization, Irritation - ISO 10993-11:2006: Acute Systemic Toxicity, Material Mediated Pyrogenicity - ISO 10993-4: 2006: Hemocompatibility - ISO 10993-18:2005, Chemical Characterization ● - ISO 8536-4:2010: Chemical Tests - Extractables and Leachables Tests ● {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green, stylized letter "S" on the left and the word "SIMPLIVIA" in gray, sans-serif font on the right. The "S" is made up of two curved shapes that resemble a leaf or a wave. #### Substantial Equivalence Conclusion: Based on the performance testing conducted on the subject device, the Chemfort™ CSTD, does not raise new types of safety and effectiveness questions. It is concluded that the Chemfort™ CSTD is substantially equivalent to the identified predicate device TEVADAPTOR®.