Vial Adapter Ø20 mm , Vial Adapter Ø13 mm

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 19, 2019 Avenir Performance Europeenne Medical (APEM) % Om Singh Senior Scientific Consultant Technology Sciences Group, Inc. 1150 18th Street, NW, Suite 1000 Washington, District of Columbia 20036 Re: K190816 Trade/Device Name: Vial Adapter Ø20 mm, Vial Adapter Ø13 mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: October 22, 2019 Received: October 22, 2019 Dear Om Singh: 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 {1}------------------------------------------------ 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 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, for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190816 Device Name Vials Adapters Ø20mm Vials Adapters Ø13mm Indications for Use (Describe) Vials Adapters Ø20 mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------| | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ A VENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm for RayDyLyo® Vial Adapter Ø20mm for RayDyLyo® Image /page/3/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, curved accent mark that resembles a check mark or a stylized 'tick'. Below the letters, in a smaller font, is the word 'MEDICAL'. Above the letters is a red dot with a curved line extending from it, giving the impression of movement or a trajectory. # 510(K) Summary - K190816 Avenir Performance Européenne Medical 1. Submitter: ZI route de Souppes 77570 Château Landon France Tel:+330164785100 Fax : +330164785109 - Contact Person: Mrs Fatoumata DAO Quality Manager Office phone: 0033164785106 Cell Phone: 0033643953528 Fax: 0033164785109 E-mail: raq@ape-medical.fr Preparing Date: Oct. 22, 2019 #### US Agent: | Contact: | Om V. Singh, Ph.D., Senior Regulatory Consultant | |----------|--------------------------------------------------------------| | Address: | 1150 18th Street NW, Suite 1000<br>Washington, DC 20036, USA | | | Office Phone: +1 202-828-8983 | | | Fax: +1 202-872-0745 | | | Email: om.singh@tsgconsulting.com | #### Device name and classification: 2. | Regulation Name: | Intravascular Administration Set | |---------------------|----------------------------------| | Trade Name: | Vial adapter | | Common/ Usual Name: | Vial Adapter Ø20mm | | | Vial Adapter Ø13mm | {4}------------------------------------------------ AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm for RayDyLyo® Vial Adapter Ø20mm for RayDyLyo® Image /page/4/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, curved accent mark underneath it. Below the letters 'APE' is the word 'MEDICAL' in a smaller font size. Above the letters is a red line with a red circle at the end. | Product Code: | LHI | |-----------------------|------------------------| | Regulation No.: | 880.5440 | | Class: | II | | Panel identification: | General Hospital Panel | - Predicate Device: Vial Adapter 15mm - K171796 (Medimop Medical Project Ltd.) నే. #### 4. Device Description: The vial Adapters (VA) Ø20mm and Ø13mm are sterile polycarbonated devices which allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of a vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in two Ø20 mm and Ø13mm diameter to accommodate respective size of drug vials and is available in 3 configurations, no filter, in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration. #### 5. Indication for use: Vial Adapter Ø20mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials. #### 6. Intended use: Vial Adapter are intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. #### Technological Characteristics and Substantial Equivalence: 7. The proposed device, Vial Adapter Ø20mm and Ø13mm has the similar indications for use and {5}------------------------------------------------ AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm for RayDyLyo® Vial Adapter Ø20mm for RayDyLyo® Image /page/5/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters "APE" in a bold, sans-serif font, with the "A" having a red arrow pointing upwards from its lower-left corner. Below the letters, the word "MEDICAL" is written in a smaller font size. Above the letters, there is a red sphere connected to the letters by a curved line. the same principle of operation as the predicate device, Vial Adapter (K171796). However, following differences were noted in device design: The proposed device is offered in different size, i.e., Ø20mm and Ø13mm, however this difference is for a different diameter vial, but the intended use is the same. The size difference of proposed device led to the difference in packaging size from the predicate. The sterilization process is validated to a minimum SAL 10th. The proposed device can be equipped with an inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration. The performance testing of the filters met required acceptable criteria. These differences in device design do not raise different questions of safety and effectiveness. The predicate and proposed devices share the same principle of operation and fundamental technology when utilizing the proposed device. The following table compares Vial Adapter Ø20 mm and Ø13 mm to the Predicate Device Vial Adapter 15 mm with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Parameter | Proposed Device Vial<br>Adapter Ø20 mm<br>and Ø13mm | Predicate<br>(K171796)<br>Vial Adapter 15mm<br>(Medimop Medical<br>Project Ltd.) | Comparison | |-------------------|-----------------------------------------------------|----------------------------------------------------------------------------------|------------| | Regulation Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same | | Regulation Name | Intravascular<br>administration set | Intravascular<br>administration set | Same | | Regulatory Class | II | II | Same | | Product Code | LHI | LHI | Same | ## Comparison of proposed Vial Adaptor Ø20 mm and Ø13mm to the predicate device Vial Adapter 15 mm (K171796) {6}------------------------------------------------ AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm for RayDyLyo® Vial Adapter Ø20mm for RayDyLyo® Image /page/6/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters "APE" in a bold, sans-serif font, with the "A" having a red, curved accent mark that resembles a check mark. Below the letters, the word "MEDICAL" is written in a smaller font. Above the letters, there is a red curved line with a red dot at the end. | Indications for Use | Vials Adapter Ø20 mm & Ø13mm are indicated for the transfer and mixing of drugs contained in vials. | The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials. | Size difference | |------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------| | Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same | | Sterility Assurance Level | SAL 10-6 | SAL 10-6 | Same | | Single use | Yes | Yes | Same | | Body Material | Polycarbonate | Polycarbonate | Same | | Expiration Date | 5 years | 5 years | Same | | Vial Adapter Size | 20 mm and 13 mm | 15 mm | Different | | Labeling | Proposed device labeling (IFU) includes transfer and mixing instructions | Predicate device labeling (IFU) includes transfer and mixing instructions | Same | | Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Same | | Vial Adapter Fit (Vial Side) | Snap Fit to Vial “Tight Grip” on RayDyLyo® plastic cap | Snap Fit to Vial “Tight Grip” Feature that fits on any stopper on the vial | Same | | Packaging Size | Dimensioned for VA 20 mm and 13 mm | Dimensioned for 15 mm VA | Different | | Filtration | No filter, 5-micron or 15- micron disc filter configuration | No filter | Different | {7}------------------------------------------------ AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm Vial Adapter Ø20mm Image /page/7/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, curved accent mark that resembles a check mark or a stylized 'R'. Below the letters, the word 'MEDICAL' is written in a smaller, sans-serif font. Above the letters, there is a red sphere with a curved line extending from it, creating a sense of motion or trajectory. # 8. Substantial Equivalence: The proposed device, Vial Adapter Ø20mm and Ø13mm, has the same intended use and substantially similar indications for use, technological characteristics and principles of operation as the identified predicate device. Differences in the size of vial adapters Ø20mm and Ø13mm are for different diameter vials, but intended use is the same. Based on the size differences, the packaging size differ from the predicate device. The sterilization process is validated to a minimum SAL 10-6. The configurations of in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration is different than that of the predicate. However, the performance testing of the filters met required acceptable criteria. There are no significant differences between the vial adapters Ø20mm and Ø13mm and the predicate device that would adversely affect the use of the product. Any differences in technological characteristics do no raise new questions of safety or effectiveness. Further, testing demonstrates substantially equivalent performance between the device and the predicates. Accordingly, the Vial Adapter Ø20mm and Ø13mm are substantially equivalent to the predicate device in design, function, material, and intended use. # 9. Summary of Non-Clinical Testing: The vial adapter was evaluated, and risk assessment was performed to ensure that the device modifications did not introduce any new potential risks. The following tests were performed as a result of the risk assessment to ensure that all potential risks associated with the device design are mitigated to acceptable levels. # Non-Clinical/ Performance testing Summary | A: Packaging | | Testing standard | |-------------------------------|-------------------------------------------------------------------|-----------------------------------| | A1 | Seal integrity test by dye penetration | ISO 11607-1 | | A2 | Sealing strength (resistance) | ISO 11607-1 | | Ø20mm | | | | A3 | Peeling open characteristics test | ISO 11607-1 | | A4 | VA Extraction force from blister | Internal performance<br>standards | | A6 | Blister Dimensional Control | According Drawings | | | | | | B: Mechanical tests and leaks | | Testing standard | | B1 | VA Snapping force | Internal performance standards | | B2 | VA Unsnapping force | Internal performance standards | | B3 | Leak Spike/Vial | ISO 8871- 5:2016(F) | | B6 | Spike ductility | Internal performance standards | | D: Fluid flow | | Testing standard | | D1 | Flow injection from syringe to Vial | Internal performance standards | | D2 | Flow aspiration from Vial to syringe | Internal performance standards | | D3 | Dead volume | Internal performance standards | | E: Filter | | Testing standard | | E1 | Filter integrity | Internal performance standards | | E2 | Filter holding force / VA | Internal performance standards | | E3 | Leak external filter / internal VA | Internal performance standards | | E4 | Particle Filtration Efficiency<br>(Particulate) | Internal specification | | F : Luer Lock | | Testing standard | | F1 | Gauging | ISO 80369-7 | | F2 | Liquid leak Checking of the liquid-<br>tightness of the cone Luer | ISO 80369-7 | | F3 | Air leak Checking of the air- tightness<br>of the cone Luer | ISO 80369-7 | | F4 | Separation force | ISO 80369-7 | | F5 | Unscrewing torque force | ISO 80369-7 | | F6 | Friendly assembly | ISO 80369-7 | | F7 | Thread resistance | ISO 80369-7 | | F8 | Cracks and change color | ISO 80369-7 | ## Performance Testing Summary {8}------------------------------------------------ #### AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm Vial Adapter Image /page/8/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a bold, sans-serif font, with the 'A' having a red, stylized swoosh extending from its lower left. Below 'APE' is the word 'MEDICAL' in a smaller, less bold font. A red arc with a red dot at the end curves over the letters. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters 'APE' in a stylized, bold font, with the 'A' having a red, curved accent mark that resembles a swoosh or a stylized checkmark. Below the letters, the word 'MEDICAL' is written in a smaller, less bold font. Above the letters, there is a red circle with a curved line extending from it, giving the impression of a trajectory or a path. Particulate Testing per USP <788>; All testing met the required acceptance criteria. ## 10. Clinical Testing There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. ## 11. Sterilization Vial Adapter Ø20mm and Ø13mm are sterilized by Gamma irradiation in accordance to standard ISO 11137-1, ISO 11137-2 and AAMI TIR 33. The sterilization subcontractor is STERIS AST (Applied Sterilization Technologies). The sterilization process is validated to a minimum SAL 10-6. {10}------------------------------------------------ AVENIR PERFORMANCE EUROPEENNE MEDICAL Traditional 510(k) Premarket Submission Vial Adapter Ø13mm Vial Adapter Ø20mm Image /page/10/Picture/1 description: The image shows the logo for APE Medical. The logo features the letters "APE" in a bold, sans-serif font, with the letter "A" having a red, arrow-shaped element pointing upwards from its base. Below the letters, the word "MEDICAL" is written in a smaller, sans-serif font. Above the letters, there is a red circle connected to the letters by a curved line. ## 12. Biocompatibility ## LAL testing Bacterial endotoxin by a validated Limulus Amoebocyte Lysate (LAL) method. The biocompatibility assessments were conducted according to ISO 10993-1. The following biocompatibility testing has been successfully completed. - Cytotoxicity (Tested to ISO 10993-5) a. - b. Sensitization (Tested to ISO 10993-10) - ASTM Hemolysis (Tested to ASTM F756 and ISO 10993-4) C. - Intracutaneous Reactivity (Tested to ISO 10993-10) d. - Systemic Toxicity (Acute Systemic Injection) (Tested to ISO 10993-11) e. - Rabbit Pyrogen Test (Material Mediated Pyrogenicity) USP <151> f. ## 13. Conclusion The evaluation of the Vial Adapter Ø20mm and Ø13mm through performance testing demonstrates that the device is substantially equivalent to the predicate device.