B Dispensing Line

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". September 27, 2021 AEA srl Michele Mengoni Quality Assurance & Regulatory Affairs Via Fiume 16 Angeli de Rosora, Ancona 60030 Italy Re: K203674 Trade/Device Name: B Dispensing Line Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI, NEP Dated: August 5, 2021 Received: August 26, 2021 Dear Michele Mengoni: 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 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 {1}------------------------------------------------ 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 Payal Patel 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) K203674 Device Name B Dispensing Line #### Indications for Use (Describe) B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system. B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system. B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system. B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system. B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | <span style="white-space: nowrap;"> <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="white-space: nowrap;"> <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ # LOCCIONI ### 510k K203674 - Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92. # I. SUBMITTER AEA SRL Via Fiume, 16 Angeli di Rosa 60030 Ancona Italy Phone: 0039-0731-816689 Contact Person: Michele Mengoni Date prepared: September 27th, 2021 ### II. DEVICE | Name of device: | B Dispensing Line | |-----------------------|---------------------------------------------| | Common or Usual Name: | IV Fluid Transfer Set | | Classification Name: | Set, IV Fluid Transfer | | Regulation Number: | 880.5440 - Intravascular administration set | | Regulatory Class: | II | | Product Code: | LHI – NEP (Secondary product code) | | Panel Identification: | General Hospital | # III. PREDICATE DEVICE KIRO Set (510k Number: K152441, Regulation number: 880.5440, Product code: LHI) | Subject device: B Dispensing Line | |-----------------------------------| | Traditional 510(k) | {4}------------------------------------------------ # LOCCIONI ### IV. DEVICE DESCRIPTION B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers. The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube. The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag. The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method. | List of products/variants | Code | UDI-DI | |----------------------------------------|--------|---------------| | B Recon Line | BDL-01 | 5060304050830 | | B Double Filling Line | BDL-02 | 5060304050847 | | B Filling Line | BDL-03 | 5060304050854 | | B Recon Line with needle | BDL-04 | 5060304050878 | | B Double Filling Line with vial needle | BDL-05 | 5060304050885 | | B Filling Line for bag | BDL-06 | 5060304050892 | Six different variants of the device are available: # V. INDICATION FOR USE # B Recon Line (BDL-01) B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. # B Double Filling Line (BDL-02) B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system. # B Filling Line (BDL-03) B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "LOCCIONI" in a bold, red, sans-serif font. The letters are evenly spaced and appear to be a logo or brand name. The background is plain white, which makes the red text stand out. ### B Recon Line with needle (BDL-04) B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. #### B Double Filling Line with vial needle (BDL-05) B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system. ### B Filling Line for bag (BDL-06) B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system. B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs. {6}------------------------------------------------ # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES | | B Dispensing Line (BDL-01,<br>BDL-02, BDL-03, BDL-04, BDL-<br>05, BDL-06) | KIRO set | Differences | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | BRIEF<br>DESCRIPTION<br>AND INTENDED<br>USE | B Dispensing Line is a single-use<br>transfer set device intended to<br>be used by pharmacists as<br>disposable in an automated<br>drug compounding systems,<br>called APOTECAbag. Six<br>different variants of the device<br>exist:<br>B Recon Line (BDL-01) and B<br>Recon Line with vial needle<br>(BDL-04) for the transfer of<br>solvent inside drug vials with<br>the purpose of<br>reconstitution of lyophilized<br>drugs B Double Filling Line (BDL-<br>02) and B Double Filling Line<br>with vial needle (BDL-05) for<br>the transfer inside a bag of<br>liquid drug and solvent B Filling Line (BDL-03) for the<br>transfer of drug from a vial<br>to a bag B Filling Line for bag (BDL-<br>06) for the transfer of liquid<br>drug from a bag to another<br>bag B Dispensing Line is provided of<br>a section compatible with a<br>peristaltic pump. | The KIRO Set is a sterile,<br>single-use disposable<br>ancillary device used with the<br>peristaltic pump in the KIRO<br>Oncology pharmacy<br>compounding device for the<br>transfer of fluids in the<br>preparation of final<br>medication containers and<br>the reconstitution of drug<br>vials in hospital pharmacies. | Same intended use:<br>transfer of fluids in<br>the preparation of<br>final medication<br>containers and the<br>reconstitution of drug<br>vials in hospital<br>pharmacies by means<br>of peristaltic pumps | | PRODUCT CODE | LHI, NEP (Secondary Product<br>Code) | LHI, NEP (Secondary Product<br>Code) | Same | | PHARMACY<br>COMPOUNDING<br>DEVICE<br>SPECIFIED | APOTECAbag | KIRO Oncology | Different | | USE<br>ENVIRONMENT | Hospital pharmacy, inside<br>APOTECAbag (PCD). ISO 5<br>environment | Hospital pharmacy inside the<br>KIRO Oncology PCD ISO 5<br>environment | Same use<br>environment | | | B Dispensing Line (BDL-01,<br>BDL-02, BDL-03, BDL-04, BDL-<br>05, BDL-06) | KIRO set | Differences | | TARGET USERS | Health-care personnel,<br>specifically trained in injectable<br>drug manipulation and<br>compounding | Trained health-care<br>personnel | Same | | TUBING | Medical Grade Polyvinylchloride<br>(PVC) | Medical Grade<br>Polyvinylchloride (PVC) and<br>Medicale Grade Silicone | Different | | CONNECTOR<br>MATERIAL | ABS | ABS | Same | | INFUSION<br>METHOD | Peristaltic pump | Peristaltic pump | Same | | STERILIZATION | Ethylene Oxide | Gamma Radiation | Different | | SINGLE USE | Yes | Yes | Same | | INPUT<br>LINE<br>CONNECTOR(S) | B Recon Line: Vented Spike<br>B Double Filling Line: Vented Spike and Vented Microspike<br>B Filling Line: Vented Microspike<br>B Recon Line with vial: Vented Spike<br>B Double Filling Line with vial needle: Vented Spike and needle<br>B Filling Line for bag: Vented spike | Vented Spike or Male Luer | Same | | OUTPUT<br>LINE<br>CONNECTOR(S) | B Recon Line: Vented Microspike<br>B Double Filling Line: Needle<br>B Filling Line: Needle<br>B Recon Line with vial: Needle<br>B Double Filling Line with vial needle: Needle<br>B Filling Line for bag: Needle | Male Luer Connector | Different | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "LOCCIONI" in all capital letters. The font is a blocky, sans-serif style, and the color is a dark red. The letters are evenly spaced and aligned horizontally. ### Differences discussion B Dispensing Line and KIRO set have the same purpose, both are used for the compounding of drugs and reconstitution of vials containing lyophilized drugs by means of peristaltic pumps. The liquid transfer method is therefore the same. Reference and subject device have product code. The use environment and target users are the same except the systems in which they have to be used. To address this difference, performance tests of B Dispensing Line with APOTECAbag system have been performed. KIRO Set and B Dispensing Line are both for single use and provided sterile. Both devices are provided of vented spikes and mini-spikes as input line connector | Subject device: B Dispensing Line<br>Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 | |----------------------------------------------------------|---------------------------------|----------| |----------------------------------------------------------|---------------------------------|----------| {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "LOCCIONI" in a bold, sans-serif font. The letters are all capitalized and are a dark red color. The background is white, which makes the text stand out. The sterilization method is different, B Dispensing Line is provided sterile by means of EO sterilization cycle, while KIRO Set is sterilized using gamma radiations. A complete validation of sterilization method of B Dispensing Line has been performed according to standard ISO 11135. The tube material is different, B Dispensing Line is made of PVC, while KIRO Set is made of PVC and silicone. To address this difference a drug compatibility analysis has been performed and a biocompatibility test campaign according to ISO 10993 has been performed. The connector material (spikes, mini-spikes and luer connection) is the same. As input connector B Double Filling Line with vial needle and a spike, KIRO Set is provided with spike and with male luer connectors. The material of connector in both devices is the same. As output line connector, KIRO Set is provided of male luer connector and B Dispensing Line is provided of a mini-spike (only B Recon Line) or needle (all the other models). The material of connector in both devices is the same. To address the difference of the output line connector performance tests according to ISO 8536-9 have been performed. {9}------------------------------------------------ # VII. PERFORMANCE DATA ### Non-Clinical Testing AEA srl has performed the following non-clinical/design verification testing based on the risk analysis conducted and the favourable outcome of these tests demonstrate that the AEA proposed devices perform in an equivalent manner to the predicate devices. | TEST | CONCLUSIONS | ACCEPTANCE CRITERIA / STANDARD | |---------------------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing | | | | Performance test (in APOTECAbag) | PASS | Acceptable dosage time and accuracy<br>• No leakage<br>• Right disconnection, no ruptures<br>• Ability to maintain acceptable performances after prolonged used<br>• Dosage accuracy | | Dose accuracy and repeatability | PASS | Acceptable dosage accuracy, mean<br>• and maximum error in the limits imposed by US Pharmacopoeia<br>• Ability to maintain performances after prolonged use | | Leakage test | PASS | ISO 8536-9 | | Tensile stress test | PASS | ISO 8536-9 | | Test for transparency | PASS | ISO 8536-9 | | Drug Compatibility | PASS | No adverse compatibility effects | | Biocompatibility Testing | | | | Cytotoxicity MEM Elution | PASS | ISO 10993-5:2009, ISO 10993-12:2012 | | Acute Systemic Toxicity | PASS | ISO 10993-11:2017, ISO 10993-12:2012 | | Guinea Pig Sensitization Test | PASS | ISO 10993-10:2010, ISO 10993-12:2012 | | Haemolysis test direct and indirect contact | PASS | ISO 10993-4:2017, ISO 10993-12:2012 | | Pyrogen Test on rabbits | PASS | USP 41-NF36:2018 <151> Pyrogen Test<br>(USP Rabbit Test) | | Rabbit Intracutaneous injection test | PASS | ISO 10993-10:2010, ISO 10993-12:2012 | | Bacterial Endotoxins Test | PASS | USP 41-NF36:2019 <85> Bacterial<br>Endotoxins Test; | | Particulate contamination | PASS | ISO 8536-4 | | Chemical characterization | PASS | ISO 8536-4 | | Particulate Matter for Injections | PASS | USP <788> (Method 1 Light Obscuration<br>Particle Count Test) | | Sterilization and Shelf Life Testing | | | | Packaging Validation | PASS | Effective microbiological barrier, product<br>sterility and integrity preservation | | Sterilization Validation | PASS | ISO 11135:2014 | | Subject device: B Dispensing Line<br>Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 | |---------------------------------------------------------|---------------------------------|----------| |---------------------------------------------------------|---------------------------------|----------| {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "LOCCIONI" in a bold, sans-serif font. The word is displayed in a dark red color. The letters are evenly spaced and appear to be capitalized. | TEST | CONCLUSIONS | ACCEPTANCE CRITERIA / STANDARD | |-----------------------|-------------|--------------------------------------------------------------------------| | Shelf life, Real time | Ongoing | Sterility and product integrity maintained<br>over the entire shelf life | | Labelling validation | PASS | Correctness and completeness of labeling | # Clinical Testing Clinical testing was not required for this submission. ## Substantial Equivalence B Dispensing Line is substantially equivalent to the predicate device in its intended use, principles of operation, technology, design, materials and performance. ## VIII. CONCLUSION Results of performance and biocompatibility testing conducted on the proposed devices demonstrate that B Dispensing Line is substantially equivalent to the predicate devices. | Subject device: B Dispensing Line<br>Traditional 510(k) | Section: 510 (k) Summary Rev.04 | VOL#:005 | |---------------------------------------------------------|---------------------------------|----------| |---------------------------------------------------------|---------------------------------|----------|