nextaro® va, 15mm, 5µm

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 6, 2024 SFM Medical Devices GmbH Olaf Broemsen Head of Development & Regulatory Brueckenstrasse 5 Waechtersbach Hessen, 63607 Germany Re: K241976 Trade/Device Name: nextaro® va, 15mm, 5um Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: August 9, 2024 Received: August 9, 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 OS 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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). {2}------------------------------------------------ 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 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241976 Device Name nextaro® va. 15mm. 5µm Indications for Use (Describe) The nextaro® va. 15mm, 5um 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}------------------------------------------------ # K241976 - 510K SUMMARY | Submitter: | | sfm medical devices GmbH<br>Brueckenstrasse 5<br>Waechtersbach Hessen<br>GERMANY 63607 | |-----------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | | Dr. Olaf Brömsen<br>Head of Development & Regulatory<br>Phone: +49 (6053) 805-224<br>E-Mail: olaf.broemsen@sfm.de | | US Agent: | | Phil Triolo<br>Phone: 801-699-9846<br>Facsimile: 801-328-2399 | | Date Prepared: | | July 05, 2024 | | Device:<br>510k number: | | nextaro® va, 15mm, 5μm<br>K241976 | | 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® va (K183187),<br>sfm medical devices GmbH | | Indications for<br>Use: | | The nextaro® va, 15mm, 5μm is indicated for the transfer and mixing of drugs<br>contained in vials. | | Device<br>Description: | | The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal<br>of drug solutions with a single-use syringe via Luer adapter from drug vials or for<br>one-time injection of a low-particle and sterile solution with immediate withdrawal<br>of the prepared drug solution with a single-use syringe via Luer adapter from drug<br>vials. | {5}------------------------------------------------ #### Technological Characteristics: The nextaro® va has a plastic spike which is used to perforate the seal of a vial and a female luer adapter for connecting a standard syringe with male luer lock. The fluid transfer assembly is designed with an in-line filter to ensure that any particulates (fragments of vial seals, undissolved pharmaceutical) remain in the vial. To be used as intended, the nextaro® va is attached to a vial and the spike perforates the rubber stopper of the vial. After attachment to the drug vial, a low-particle, sterile solvent can be transferred into the drug vial with a syringe via the female luer and mixed and/or the drug solution can be drawn up with the single-use syringe. #### Substantial Equivalence Comparison: | Areas for Comparison | Predicate Device<br>nextaro® va<br>K183187 | Proposed Device<br>nextaro® va, 15mm, 5µm | Comparison | |--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------| | Indications for Use | | | | | Intended use or<br>indications | Indicated for the transfer<br>and mixing of drugs<br>contained in vials | Indicated for the transfer<br>and mixing of drugs<br>contained in vials | Same | | Regulatory Information | | | | | Device Classification<br>Name | Set I.V. Fluid Transfer | Set I.V. Fluid Transfer | Same | | Regulation Number | 880.5440 | 880.5440 | Same | | Regulation Description | Intravascular Administration<br>Set | Intravascular Administration<br>Set | Same | | Product Code | LHI | LHI | Same | | Regulatory Medical<br>Specialty | General Hospital | General Hospital | Same | | Device Class | 2 | 2 | Same | | GMP Exempt | No | No | Same | | Design Features | | | | | Vial size the product is<br>to be used with | 20 mm | 15 mm | Different,<br>see<br>Discussion of<br>Differences | | Packaging size | Dimensioned for 20mm vial<br>adapter | Dimensioned for 15mm vial<br>adapter | Different,<br>see<br>Discussion of<br>Differences | | Areas for Comparison | Predicate Device<br>nextaro® va<br>K183187 | Proposed Device<br>nextaro® va, 15mm, 5µm | Comparison | | Has vial adapter / vial<br>access component | Yes | Yes | Same | | Uses vacuum pressure | No | No | Same | | In-line liquid filter | Yes | Yes | Same | | Filter type | Mesh filter,<br>Mesh size 15 µm nominal | Membrane filter,<br>Pore size 5µm nominal | Different,<br>see<br>Discussion of<br>Differences | | Female Luer adapter for<br>connection to syringes | Yes | Yes | Same | | Luer adapter and vial<br>adapter are integrated in<br>one component | Yes | Yes | Same | | Needleless access to<br>vial | Yes | Yes | Same | | Sterile, biocompatible<br>fluid path | Yes | Yes | Same | | Manufactured by plastic<br>injection molding | Yes | Yes | Same | | Single use, sterile | Yes | Yes | Same | | Sterilization | EtO | EtO | Same | | Sterility Assurance<br>Level | SAL 10⁻⁶ | SAL 10⁻⁶ | Same | | Biocompatibility<br>evaluation | Pass | Pass | Same | | Shelf Life | 5 years | 5 years | Same | | Principles of<br>Operation | | | | | Manually operated | Yes | Yes | Same | | Mechanically connected<br>to a drug vial | Yes | Yes | Same | | Transfer solvent<br>manually using a<br>syringe plunger rod | Yes | Yes | Same | | Mixing / Drug<br>reconstitution achieved<br>through manual<br>agitation of vial while<br>connected to device | Yes | Yes | Same | | Areas for Comparison | Predicate Device<br>nextaro® va<br>K183187 | Proposed Device<br>nextaro® va, 15mm, 5µm | Comparison | | Mixed drug is manually<br>aspirated into a syringe<br>barrel using the syringe<br>plunger rod | Yes | Yes | Same | | Single Use | Yes | Yes | Same | | Materials | | | | | Transfer device | Polypropylene | Polypropylene | Same | | In-line Filter | Polyethylene terephthalate | Acrylic copolymer matrix on<br>non-woven nylon support | Different,<br>see<br>Discussion of<br>Differences | | Packaging | Blister Pack: PETG<br>Lid: Tyvek | Blister Pack: PETG<br>Lid: Tyvek | Same | {6}------------------------------------------------ {7}------------------------------------------------ ### Discussion of Differences | Vial size the<br>product is to be<br>used with | The predicate device is designed for vials with a diameter of 20 mm and the proposed<br>device is designed for vials with a diameter of 15 mm. The basic design remains<br>unchanged and has only been adapted to the size of the vials to be used. | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Packaging size | The packaging dimensions have been changed from the currently marketed 20mm Vial<br>Adapter to accommodate a 15mm Vial Adapter. The packaging material is the same.<br>Packaging testing has been shown that the packaging of the subject and the predicate<br>device are substantially equivalent. | | Filter type and<br>filter material | The subject and the predicate device are equipped with filter elements, to retain<br>fragments which could be punched out during perforation of the vial seals from being<br>transferred or aspirated into the ready-to-use solution. The same applies for<br>undissolved pharmaceutical agent particles.<br>The proposed device has an alternative material for the in-line filter. The filter in the<br>predicate device is made of woven polyethylene terephthalate (mesh filter), while the<br>filter in the subject device is made of an acrylic copolymer matrix on non-woven nylon<br>support (membrane filter).<br>A retention rate of ≥80 % of particles with a size of ≥ 20 µm was confirmed for the<br>predicate device and for the subject device, so that both devices meet the<br>requirements of ISO 8536-4. The performance of the filters (retention) of the subject<br>and predicate devices has been shown to be substantially equivalent.<br>The biocompatibility tests show that the subject device is biocompatible and can be<br>regarded as substantially equivalent regarding biocompatibility. | {8}------------------------------------------------ #### Performance Testing The modifications to the proposed device were evaluated and a risk assessment has been performed. The following non-clinical tests were conducted on the proposed device, nextaro® va, 15mm, 5μm, to ensure that potential risks associated with the modification were mitigated to acceptable levels. | Test name | Testing Standard | |----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Biocompatibility assessment | ISO 10993-1 | | Chemical Characterization<br>(Leachables/Extractables) | ISO 10993-18 | | Cytotoxicity<br>(Extraction with DMEM – FBS) | ISO 10993-5 | | Skin Sensitization - Maximization<br>(Polar and Nonpolar Extract) | ISO 10993-10 | | Intracutaneous Reactivity<br>(Irritation) | ISO 10993-10 | | Acute Systemic Toxicity | ISO 10993-11 | | Materials Mediated Pyrogenicity | ISO 10993-11 (tested according to USP <151>) | | Hemocompatibility<br>(Hemolysis - Extract) | ISO 10993-4 (tested according to ASTM F756) | | EO Residues | ISO 10993-7 | | Reducing (oxidizable) ingredients | ISO 8536-4 | | Titration acidity or alkalinity | ISO 8536-4 | | Residue on Evaporation | ISO 8536-4 | | UV absorption of the extract | ISO 8536-4 | | Detection of metal ions | ISO 8536-4 | | Particulate contamination | ISO 8536-4 and USP <788> | | Filter Retention Rate | ISO 8536-4 | | Leakage / Tightness of the system | ISO 8536-4 / ISO 22413 | | Tensile strength | ISO 8536-4 / ISO 22413 | | Penetration Force | ISO 22413 (using a test procedure outlined in Annex<br>B of ISO 8536-2) | | Fragmentation Test | ISO 22413 | | Verification of the design specification for Transfer<br>devices with housing | ISO 22413 | | Luer connector testing | ISO 80369-7 (test methods according to ISO 80369-<br>20) | | Test name | Testing Standard | | Retention Force | Internal performance standard | | Transfer performance (practical transfer and<br>residual volume) | Internal performance standard | | Conformity of the packaging / packaging process<br>validation (packaging integrity testing): | ISO 11607-1 / ISO 11607-2 | | - seal width | DIN EN 868-5 | | - peel feature | DIN EN 868-5 | | - seal strength | DIN EN 868-5 | | - dye penetration | ASTM F1929 | | - transport test | ASTM D4169 | | - bubble test | ASTM F2096 | | - visual inspection | ASTM F1886/1886M | | - burst testing | ASTM F2054/F2054M | {9}------------------------------------------------ Testing verified that all acceptance criteria were met. #### Summary / Conclusion The nextaro® va and nextaro® va, 15mm, 5μm have equivalent indications, principles of operation and technological characteristics. The only technical differences are: (1) the modified geometry / dimensions of the device (adapted to vials with a diameter of 15mm), (2) the adapted packaging design and (3) the material of the filter. Testing demonstrates that the differences do not present any new concerns of safety or effectiveness. The modifications made to the subject device, nextaro® va, 15mm, do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate device, the nextaro® va. Thus, the nextaro® va, 15mm, 5μm is substantially equivalent to the predicate device, nextaro® va.