← Product Code [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI) · K240748 # nextaro® v, 20/20 (K240748) _Sfm Medical Devices GmbH · LHI · Apr 16, 2024 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240748 ## Device Facts - **Applicant:** Sfm Medical Devices GmbH - **Product Code:** [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI.md) - **Decision Date:** Apr 16, 2024 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials. ## Device Story The nextaro® v, 20/20 is a sterile, single-use transfer device used to reconstitute and mix drugs contained in vials. It consists of two assembled components, each featuring a plastic spike to perforate vial seals. The upper component includes an air inlet (ventilation) to facilitate solvent transfer into low-pressure vials. The device creates an air-tight system between a solvent vial and a pharmaceutical vial. After solvent transfer and manual agitation to reconstitute the drug, the user unscrews the upper component and attaches a standard syringe to the female Luer-Lock adapter to aspirate the prepared solution. An integrated 15µm particle filter prevents vial seal fragments or undissolved particles from entering the syringe. The device is operated manually by healthcare professionals in clinical settings to prepare drug solutions for administration. ## Clinical Evidence Bench testing only. Testing included penetration force (ISO 22413), fragmentation (ISO 22413), transfer performance (internal standard), and design specification verification (ISO 22413). All acceptance criteria were met. ## Technological Characteristics Materials: Polypropylene (transfer device), Polyethylene terephthalate (filter). Components: Two-part assembly with plastic spikes, female Luer-Lock adapter, 15µm nominal particle filter. Operation: Manual, vacuum-assisted transfer. Sterilization: Ethylene Oxide (EtO) to SAL 10^-6. Packaging: PETG blister pack with Tyvek lid. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - nextaro® Transfer System ([K183187](/device/K183187.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Underneath that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 16, 2024 sfm medical devices GmbH Olaf Broemsen Head of Development & Regulatory Brueckenstrasse 5 Waechtersbach, 63607 Germany Re: K240748 Trade/Device Name: nextaro® v, 20/20 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI, Dated: March 11, 2024 Received: March 19, 2024 Dear Olaf Broemsen: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, David Walloschek David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240748 Device Name nextaro® v, 20/20 Indications for Use (Describe) The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials. Type of Use (Select one or both, as applicable) X 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. 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." {4}------------------------------------------------ # 510K SUMMARY | Submitter: | sfm medical devices GmbH
Brueckenstrasse 5
Waechtersbach Hessen
GERMANY 63607 | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dr. Olaf Brömsen
Head of Development & Regulatory
Phone: +49 (6053) 805-224
E-Mail: olaf.broemsen@sfm.de | | US Agent: | Phil Triolo
Phone: 801-699-9846
Facsimile: 801-328-2399 | | Date Prepared: | March 11, 2024 | | Device:
510(k) number: | nextaro® v, 20/20
K240748 | | FDA Product Code: | LHI | | Class: | II | | Common or Usual Name: | I.V. Fluid Transfer Set | | Regulation Description: | Intravascular Administration Set | | Regulation Number: | 21 CFR 880.5440 | | Legally Marketed Predicate: | nextaro® Transfer System (K183187),
sfm medical devices GmbH | | Indications for
Use: | The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in
vials. | | Device
Description: | The nextaro® v, 20/20 is a sterile-packaged transfer device with ventilation on
solvent side with built-in particle filter (15µm nominal) installed on solvent and drug
side and a female Luer-Lock adapter for the connection of a single-use syringe for a
low-particle withdrawal of the prepared drug solution. | {5}------------------------------------------------ # Technological Characteristics: The nextaro® v, 20/20 consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends at the spikes. Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system. To be used as intended, the spike of the blue ("upper") part of the nextaro® v, 20/20 is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("bottom") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial. The spike of the upper part has two lumen allows air to enter the solvent vial so that ventilation takes place during the transfer. The other lumen ensures that the solvent is transferred to the pharmaceutical vial. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the prepared solution. | Areas for Comparison | Predicate Device
nextaro® transfer
system
K183187 | Proposed Device
nextaro® v, 20/20 | Comparison | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------| | Indications for Use | | | | | Intended use or
indications | Indicated for the
transfer and mixing of
drugs contained in vials | Indicated for the
transfer and mixing of
drugs contained in vials | Same | | Regulatory Information | | | | | Device Classification
Name | Set I.V. Fluid Transfer | Set I.V. Fluid Transfer | Same | | Regulation Number | 880.5440 | 880.5440 | Same | | Regulation Description | Intravascular
Administration Set | Intravascular
Administration Set | Same | | Product Code | LHI | LHI | Same | | Regulatory Medical
Specialty | General Hospital | General Hospital | Same | | Device Class | 2 | 2 | Same | | GMP Exempt | No | No | Same | | Areas for Comparison | Predicate Device
nextaro® transfer
system
K183187 | Proposed Device
nextaro® v, 20/20 | Comparison | | Design Features | | | | | Vial size the product is
to be used with | 20 mm (water side)
20 mm (drug side) | 20 mm (water side)
20 mm (drug side) | Same | | Has vial adapter / vial
access component | Yes | Yes | Same | | Uses vacuum pressure | Yes | Yes | Same | | Air inlet at water side | No | Yes | Different
See Discussion of
Differences | | In-line liquid filter | Yes | Yes | Same | | Mesh opening | 11 μm | 11 μm | Same | | Female Luer adapter for
connection to syringes | Yes | Yes | Same | | Luer adapter and vial
adapter are integrated
in one component | Yes | Yes | Same | | Needleless access to vial | Yes | Yes | Same | | Sterile, biocompatible
fluid path | Yes | Yes | Same | | Manufactured by plastic
injection molding | Yes | Yes | Same | | Single use, sterile | Yes | Yes | Same | | Sterilization | EtO | EtO | Same | | Sterility Assurance Level | SAL 10-6 | SAL 10-6 | Same | | Biocompatibility | Pass | Pass | Same | | Shelf Life | 5 years | 5 years | Same | | Principles of Operation | | | | | Manually operated | Yes | Yes | Same | | Mechanically connected
to a drug and solvent
vial | Yes | Yes | Same | | Drug reconstitution
achieved through
manual agitation of vial
while connected to
device | Yes | Yes | Same | | Mixed drug is manually
aspirated into a syringe
barrel using the syringe
plunger rod | Yes | Yes | Same | | Areas for Comparison | Predicate Device
nextaro® transfer
system
K183187 | Proposed Device
nextaro® v, 20/20 | Comparison | | Single Use | Yes | Yes | Same | | Materials | | | | | Transfer device | Polypropylene | Polypropylene | Same | | In-line Filter | Polyethylene
terephthalate | Polyethylene
terephthalate | Same | | Packaging | Blister Pack: PETG
Lid: Tyvek | Blister Pack: PETG
Lid: Tyvek | Same | ## Substantial Equivalence Comparison: {6}------------------------------------------------ {7}------------------------------------------------ ## Discussion of Differences Air inlet at The proposed device has a different spike design with an air inlet at the water side water side (upper part). The air inlet on the water side enables the transfer of pharmaceuticals into low pressure vials. #### Performance Testing The modification to the proposed device was evaluated and a risk assessment has been performed. The following non-clinical tests were conducted on the proposed device, nextaro® v, 20/20, to ensure that potential risks associated with the modification were mitigated to acceptable levels. | Test name | Testing Standard | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | Penetration force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | | Fragmentation | ISO 22413 | | Transfer performance (practical
transfer and residual volume) | Internal performance standard | | Verification of the design
specification for Transfer devices
with housing | ISO 22413 | Testing verified that all acceptance criteria were met. ## Summary / Conclusion The nextaro® Transfer System and nextaro® v, 20/20, have the same indications, principles of operation, and technological characteristics, such as performance, materilization, biocompatibility, and packaging. The only technological difference is the spike design on the water side (upper part). Testing demonstrates that the difference does not present any new concerns of safety or effectiveness. The modifications made to the subject device, nextaro® v, 20/20, do not affect the intended use of the device, nor do they alter its fundamental scientific technology compared to the predicate device, the {8}------------------------------------------------ nextaro® Transfer System. Thus, the nextaro® v, 20/20 is substantially equivalent to the predicate, nextaro® Transfer System. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240748](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240748) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com