(28 days)
The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials.
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® v, 20/20. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (nextaro® Transfer System).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the "Testing verified that all acceptance criteria were met." However, it does not provide the specific numerical acceptance criteria for each test or the exact performance values observed for the proposed device (nextaro® v, 20/20). It only lists the tests performed and the standards used.
| Test Name | Testing Standard | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document, but affirmed as "met acceptance criteria") |
|---|---|---|---|
| Penetration force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | Not provided in document | Met acceptance criteria |
| Fragmentation | ISO 22413 | Not provided in document | Met acceptance criteria |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | Not provided in document | Met acceptance criteria |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | Not provided in document | Met acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes used for any of the performance tests.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the document describes performance testing of a physical medical device (intravascular administration set), not software or an AI algorithm requiring expert ground truth for interpretation. The tests mentioned are physical and functional assessments.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI devices to assess the impact on human reader performance. The device in question is a physical transfer system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study was not done. This concept is relevant for AI algorithms. The nextaro® v, 20/20 is a physical medical device, not an AI algorithm. Its performance is inherent to its design and function.
7. The Type of Ground Truth Used:
For the performance tests mentioned (Penetration force, Fragmentation, Transfer performance, Design verification), the "ground truth" would be established by the defined specifications and requirements of the relevant ISO standards (ISO 22413, ISO 8536-2) and the internal performance standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather objective measurements against pre-defined engineering and safety limits.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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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).
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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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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)
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510K SUMMARY
| Submitter: | sfm medical devices GmbHBrueckenstrasse 5Waechtersbach HessenGERMANY 63607 |
|---|---|
| Contact Person: | Dr. Olaf BrömsenHead of Development & RegulatoryPhone: +49 (6053) 805-224E-Mail: olaf.broemsen@sfm.de |
| US Agent: | Phil TrioloPhone: 801-699-9846Facsimile: 801-328-2399 |
| Date Prepared: | March 11, 2024 |
| Device:510(k) number: | nextaro® v, 20/20K240748 |
| 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 forUse: | The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained invials. |
| DeviceDescription: | The nextaro® v, 20/20 is a sterile-packaged transfer device with ventilation onsolvent side with built-in particle filter (15µm nominal) installed on solvent and drugside and a female Luer-Lock adapter for the connection of a single-use syringe for alow-particle withdrawal of the prepared drug solution. |
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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 Devicenextaro® transfersystemK183187 | Proposed Devicenextaro® v, 20/20 | Comparison |
|---|---|---|---|
| Indications for Use | |||
| Intended use orindications | Indicated for thetransfer and mixing ofdrugs contained in vials | Indicated for thetransfer and mixing ofdrugs contained in vials | Same |
| Regulatory Information | |||
| Device ClassificationName | Set I.V. Fluid Transfer | Set I.V. Fluid Transfer | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Regulation Description | IntravascularAdministration Set | IntravascularAdministration Set | Same |
| Product Code | LHI | LHI | Same |
| Regulatory MedicalSpecialty | General Hospital | General Hospital | Same |
| Device Class | 2 | 2 | Same |
| GMP Exempt | No | No | Same |
| Areas for Comparison | Predicate Devicenextaro® transfersystemK183187 | Proposed Devicenextaro® v, 20/20 | Comparison |
| Design Features | |||
| Vial size the product isto be used with | 20 mm (water side)20 mm (drug side) | 20 mm (water side)20 mm (drug side) | Same |
| Has vial adapter / vialaccess component | Yes | Yes | Same |
| Uses vacuum pressure | Yes | Yes | Same |
| Air inlet at water side | No | Yes | DifferentSee Discussion ofDifferences |
| In-line liquid filter | Yes | Yes | Same |
| Mesh opening | 11 μm | 11 μm | Same |
| Female Luer adapter forconnection to syringes | Yes | Yes | Same |
| Luer adapter and vialadapter are integratedin one component | Yes | Yes | Same |
| Needleless access to vial | Yes | Yes | Same |
| Sterile, biocompatiblefluid path | Yes | Yes | Same |
| Manufactured by plasticinjection 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 connectedto a drug and solventvial | Yes | Yes | Same |
| Drug reconstitutionachieved throughmanual agitation of vialwhile connected todevice | Yes | Yes | Same |
| Mixed drug is manuallyaspirated into a syringebarrel using the syringeplunger rod | Yes | Yes | Same |
| Areas for Comparison | Predicate Devicenextaro® transfersystemK183187 | Proposed Devicenextaro® v, 20/20 | Comparison |
| Single Use | Yes | Yes | Same |
| Materials | |||
| Transfer device | Polypropylene | Polypropylene | Same |
| In-line Filter | Polyethyleneterephthalate | Polyethyleneterephthalate | Same |
| Packaging | Blister Pack: PETGLid: Tyvek | Blister Pack: PETGLid: Tyvek | Same |
Substantial Equivalence Comparison:
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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 (practicaltransfer and residual volume) | Internal performance standard |
| Verification of the designspecification for Transfer deviceswith 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
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nextaro® Transfer System. Thus, the nextaro® v, 20/20 is substantially equivalent to the predicate, nextaro® Transfer System.
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.