(63 days)
The nextaro® va. 15mm, 5um is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal of drug solutions with a single-use syringe via Luer adapter from drug vials or for one-time injection of a low-particle and sterile solution with immediate withdrawal of the prepared drug solution with a single-use syringe via Luer adapter from drug vials.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® va, 15mm, 5µm. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a legally marketed predicate device (nextaro® va, K183187).
This type of submission focuses on demonstrating substantial equivalence rather than proving device performance against specific clinical acceptance criteria in the way an AI-powered diagnostic device would. Therefore, the information typically requested in your prompt regarding AI/machine learning device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes a physical medical device (an intravascular administration set) and changes to its physical characteristics, not an AI or software device.
However, I can extract the information that is relevant to the "acceptance criteria" and "proof" provided within this regulatory context.
Acceptance Criteria and Study for nextaro® va, 15mm, 5µm
The "acceptance criteria" in this context refer to the performance standards and regulatory requirements that the modified device must meet to demonstrate its substantial equivalence to the predicate device and ensure its safety and effectiveness for its intended use. The "study that proves" the device meets these criteria is the performance testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a typical AI performance table (e.g., sensitivity, specificity), the "acceptance criteria" here are defined by various testing standards and the "reported device performance" is a general statement of compliance with those standards.
| Test Name | Testing Standard | Acceptance Criteria Implicitly Met | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Asssessment (e.g., Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemocompatibility, EO Residues) | ISO 10993 Series, ASTM F756, USP <151> | Device materials must be safe for patient contact and not cause adverse biological reactions (e.g., toxicity, irritation, sensitization, fever, hemolysis). EO residues must be within acceptable limits. Implicitly, the proposed device must show biocompatibility equivalent or superior to the predicate and meet the specific criteria outlined in the referenced standards for each test (e.g., no significant cytotoxicity, no sensitization, etc.). | "Pass," "Pass," "Pass," "Pass," "Pass," "Pass," "Pass" (from table, indicating compliance with the respective standards). Also, "The biocompatibility tests show that the subject device is biocompatible and can be regarded as substantially equivalent regarding biocompatibility." |
| Chemical Characterization (Leachables/Extractables) | ISO 10993-18 | Leachables and extractables from the device materials must be within safe limits and not pose a toxicological risk. | Not explicitly stated as "Pass" but implied by passing biocompatibility and risk assessment. |
| Reducing (oxidizable) ingredients | ISO 8536-4 | The device must not release substances that would act as reducing agents in the drug solution beyond acceptable limits. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Titration acidity or alkalinity | ISO 8536-4 | The device must not significantly alter the pH of the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Residue on Evaporation | ISO 8536-4 | The device must not release an unacceptable amount of non-volatile residue into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| UV absorption of the extract | ISO 8536-4 | Extracts from the device should not show unacceptable UV absorption, indicating the presence of harmful or undesirable substances. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Detection of metal ions | ISO 8536-4 | The device must not release an unacceptable amount of metal ions into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Particulate contamination | ISO 8536-4 and USP <788> | The device must not shed an unacceptable number of particulate contaminants into the drug solution during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Filter Retention Rate | ISO 8536-4 | The filter must retain a specified percentage of particles of a given size. Specifically, "A retention rate of ≥80 % of particles with a size of ≥ 20 µm was confirmed for the subject device." This is compared to the predicate device, also meeting this criterion. | "Confirmed" to meet the ≥80% retention rate for ≥20µm particles. "The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent." |
| Leakage / Tightness of the system | ISO 8536-4 / ISO 22413 | The device must maintain its integrity and not leak during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Tensile strength | ISO 8536-4 / ISO 22413 | The device components must withstand specified tensile forces without breaking. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Penetration Force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | The force required to penetrate the vial stopper must be within acceptable limits for user ease and safety. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Fragmentation Test | ISO 22413 | The device must not cause excessive fragmentation of the vial stopper during penetration. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | The physical design and dimensions must conform to specified requirements for safe and effective use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Luer connector testing | ISO 80369-7 (test methods according to ISO 80369-20) | The Luer connector must meet international standards for secure and leak-free connection to syringes. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Retention Force | Internal performance standard | The device must securely attach to the vial and retain the syringe, preventing accidental detachment. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | The device must allow for efficient transfer of liquid with minimal residual volume. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Conformity of the packaging / packaging process validation (e.g., seal width, peel feature, seal strength, dye penetration, transport test, bubble test, visual inspection, burst testing) | ISO 11607-1 / ISO 11607-2, DIN EN 868-5, ASTM F1929, ASTM D4169, ASTM F2096, ASTM F1886/1886M, ASTM F2054/F2054M | The sterile barrier system must maintain sterility and product integrity until the point of use. Packaging must withstand handling (transport test) and maintain seals (seal strength, dye penetration, bubble test, burst testing), and be easily opened (peel feature). | "Packaging testing has been shown that the packaging of the subject and the predicate device are substantially equivalent." Implied passage of all listed tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (N) for each of the performance tests. Regulatory submissions often report that tests were conducted according to the relevant standards, which themselves may define minimum sample sizes for specific tests.
- Data Provenance: The tests were conducted by the manufacturer, SFM Medical Devices GmbH, located in Waechtersbach, Hessen, Germany. The data is prospective, as it was generated specifically for this 510(k) submission to demonstrate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This is not applicable. For a physical medical device like an intravascular administration set, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, DIN, USP) and by direct physical and chemical testing, not by expert human interpretation of data in the way a diagnostic AI device would require (e.g., radiologists reviewing images). The acceptance criteria are objective measurements against these standards.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests are objective physical and chemical analyses based on established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- This is not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic performance. This device is an intravenous fluid transfer set, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an AI/software algorithm. Its "performance" is determined by its physical and chemical properties and functionality, not by an algorithm's output.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is established through objective measurements and analyses against pre-defined engineering, chemical, and biological performance specifications derived from international and national standards (e.g., ISO 10993 for biocompatibility, ISO 8536-4 for infusions sets, ISO 22413 for vial adapters, ISO 80369-7 for Luer connectors, ISO 11607 for packaging). These standards represent the accepted scientific and engineering consensus for safe and effective device performance.
8. The Sample Size for the Training Set:
- This is not applicable. This is a physical device, not an AI/machine learning model that undergoes "training" on a dataset. The device design and manufacturing processes are developed through engineering and quality management systems, not through machine learning.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable for the reasons stated above.
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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).
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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 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).
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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
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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)
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K241976 - 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: | July 05, 2024 | |
| Device:510k number: | nextaro® va, 15mm, 5μmK241976 | |
| 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),sfm medical devices GmbH | |
| Indications forUse: | The nextaro® va, 15mm, 5μm is indicated for the transfer and mixing of drugscontained in vials. | |
| DeviceDescription: | The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawalof drug solutions with a single-use syringe via Luer adapter from drug vials or forone-time injection of a low-particle and sterile solution with immediate withdrawalof the prepared drug solution with a single-use syringe via Luer adapter from drugvials. |
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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 Devicenextaro® vaK183187 | Proposed Devicenextaro® va, 15mm, 5µm | Comparison |
|---|---|---|---|
| Indications for Use | |||
| Intended use orindications | Indicated for the transferand mixing of drugscontained in vials | Indicated for the transferand mixing of drugscontained 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 | Intravascular AdministrationSet | Intravascular AdministrationSet | Same |
| Product Code | LHI | LHI | Same |
| Regulatory MedicalSpecialty | General Hospital | General Hospital | Same |
| Device Class | 2 | 2 | Same |
| GMP Exempt | No | No | Same |
| Design Features | |||
| Vial size the product isto be used with | 20 mm | 15 mm | Different,seeDiscussion ofDifferences |
| Packaging size | Dimensioned for 20mm vialadapter | Dimensioned for 15mm vialadapter | Different,seeDiscussion ofDifferences |
| Areas for Comparison | Predicate Devicenextaro® vaK183187 | Proposed Devicenextaro® va, 15mm, 5µm | Comparison |
| Has vial adapter / vialaccess component | Yes | Yes | Same |
| Uses vacuum pressure | No | No | Same |
| In-line liquid filter | Yes | Yes | Same |
| Filter type | Mesh filter,Mesh size 15 µm nominal | Membrane filter,Pore size 5µm nominal | Different,seeDiscussion ofDifferences |
| Female Luer adapter forconnection to syringes | Yes | Yes | Same |
| Luer adapter and vialadapter are integrated inone component | Yes | Yes | Same |
| Needleless access tovial | 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 AssuranceLevel | SAL 10⁻⁶ | SAL 10⁻⁶ | Same |
| Biocompatibilityevaluation | Pass | Pass | Same |
| Shelf Life | 5 years | 5 years | Same |
| Principles ofOperation | |||
| Manually operated | Yes | Yes | Same |
| Mechanically connectedto a drug vial | Yes | Yes | Same |
| Transfer solventmanually using asyringe plunger rod | Yes | Yes | Same |
| Mixing / Drugreconstitution achievedthrough manualagitation of vial whileconnected to device | Yes | Yes | Same |
| Areas for Comparison | Predicate Devicenextaro® vaK183187 | Proposed Devicenextaro® va, 15mm, 5µm | Comparison |
| Mixed drug is manuallyaspirated into a syringebarrel using the syringeplunger rod | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Materials | |||
| Transfer device | Polypropylene | Polypropylene | Same |
| In-line Filter | Polyethylene terephthalate | Acrylic copolymer matrix onnon-woven nylon support | Different,seeDiscussion ofDifferences |
| Packaging | Blister Pack: PETGLid: Tyvek | Blister Pack: PETGLid: Tyvek | Same |
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Discussion of Differences
| Vial size theproduct is to beused with | The predicate device is designed for vials with a diameter of 20 mm and the proposeddevice is designed for vials with a diameter of 15 mm. The basic design remainsunchanged 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 VialAdapter to accommodate a 15mm Vial Adapter. The packaging material is the same.Packaging testing has been shown that the packaging of the subject and the predicatedevice are substantially equivalent. |
| Filter type andfilter material | The subject and the predicate device are equipped with filter elements, to retainfragments which could be punched out during perforation of the vial seals from beingtransferred or aspirated into the ready-to-use solution. The same applies forundissolved pharmaceutical agent particles.The proposed device has an alternative material for the in-line filter. The filter in thepredicate device is made of woven polyethylene terephthalate (mesh filter), while thefilter in the subject device is made of an acrylic copolymer matrix on non-woven nylonsupport (membrane filter).A retention rate of ≥80 % of particles with a size of ≥ 20 µm was confirmed for thepredicate device and for the subject device, so that both devices meet therequirements of ISO 8536-4. The performance of the filters (retention) of the subjectand predicate devices has been shown to be substantially equivalent.The biocompatibility tests show that the subject device is biocompatible and can beregarded as substantially equivalent regarding biocompatibility. |
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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(Leachables/Extractables) | ISO 10993-18 |
| Cytotoxicity(Extraction with DMEM – FBS) | ISO 10993-5 |
| Skin Sensitization - Maximization(Polar and Nonpolar Extract) | ISO 10993-10 |
| Intracutaneous Reactivity(Irritation) | ISO 10993-10 |
| Acute Systemic Toxicity | ISO 10993-11 |
| Materials Mediated Pyrogenicity | ISO 10993-11 (tested according to USP <151>) |
| Hemocompatibility(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 AnnexB of ISO 8536-2) |
| Fragmentation Test | ISO 22413 |
| Verification of the design specification for Transferdevices with housing | ISO 22413 |
| Luer connector testing | ISO 80369-7 (test methods according to ISO 80369-20) |
| Test name | Testing Standard |
| Retention Force | Internal performance standard |
| Transfer performance (practical transfer andresidual volume) | Internal performance standard |
| Conformity of the packaging / packaging processvalidation (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 |
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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.
§ 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.