(116 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties for drug transfer and mixing, with no mention of AI/ML or related concepts.
No.
The device is used for the transfer and mixing of drugs, not for therapeutic purposes itself. It facilitates drug preparation rather than delivering a therapeutic effect.
No
The device is designed for the transfer and mixing of drugs, not for diagnosing medical conditions or diseases. Its purpose is to facilitate the preparation of medication.
No
The device description clearly outlines physical components made of plastic with spikes, Luer adapters, and filter elements, indicating it is a hardware device for transferring and mixing drugs. The performance studies also focus on physical characteristics and functionality of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "for the transfer and mixing of drugs contained in vials." This describes a process related to preparing medication for administration to a patient, not for performing diagnostic tests on biological samples.
- Device Description: The description details a system for transferring and mixing fluids between vials, specifically mentioning solvent and pharmaceutical vials. It focuses on the mechanical aspects of transfer, filtration of particles, and connection to syringes for aspiration of the prepared solution. This aligns with drug preparation, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a drug transfer and mixing system, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials. The nextaro® Transfer System and nextaro® va is practically one system with two variants which are to be used independently.
The nextaro® Transfer System 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 for fluid transfer. 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® Transfer System is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("lower") 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.
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 ready-to-use solution.
The nextaro® va is a standalone device. Basically, it is the lower part of the nextaro® Transfer System, but without the thread which the latter has to connect the upper part. After connecting the nextaro® va to a pharmaceutical vial by pushing it downwards, a solvent can be transferred by a syringe via the female Luer. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a standard syringe with a male Luer is attached to the female Luer of the device to aspirate the ready-to-use solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted to demonstrate that the nextaro® Transfer System and nextaro® va perform as intended.
- ISO 22413: Fragmentation, Penetration Force, Piercing, Verification of Design Specifications for Transfer Devices with Housing
- ISO 594-2: Male Conical Fitting / Luer Connector
- ISO 8536-4: Flow Rate of Infusion Fluid, Fluid Filter (Retention Rate), Leakage (Aging/ Submersion Test), Metal Ions, Particulate Contamination, Penetration Force, Reduction of Oxidizable Matter, Residue on Evaporation, Tensile Strength, Titration Acidity or Alkalinity, UV Absorption of Extract Solution
- ISO 11607: Sterile Barrier and Packaging Systems
- ASTM D3078: Bubble Emissions
- ASTM F 1886: Integrity of Seals
- ASTM F 1929-12: Seal Leakage
- ASTM F 1980-07: Accelerated Aging
- ASTM F 2054-07, EN 868-5: Seal Strength
- ISTA 2A: Transport Testing
- USP , USP : Bacterial Endotoxin
- N/A: Roll Inhibition (to design specification), Transfer performance for residual volume (to design specification), Opening torque (to design specification)
Biocompatibility tests were conducted in accordance with ISO 10993-1, including Material Mediated Pyrogenicity LAL Testing.
The sterility was validated in accordance with ISO 11135:2014, with maximum levels of ethylene oxide (EtO) and ethylene chlorohydrin (ECH) residuals within guidelines per ISO 10993-7:2008.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
March 15, 2019
sfm medical devices GmbH % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K183187
Trade/Device Name: nextaro® Transfer System, nextaro® va Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: February 18, 2019 Received: February 21, 2019
Dear Mark Job:
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
K183187 - Mark Job
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sapana Patel -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183187
Device Name
The nextaro® Transfer System and nextaro® va
Indications for Use (Describe) The nextaro® Transfer System and nextaro® va 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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3
Traditional 510(k) 510k Summary
510K SUMMARY K183187
| Submitter's Name
and Address | sfm medical devices GmbH
Brueckenstrasse 5
Waechtersbach Hessen
GERMANY 63607 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | sfm medical devices GmbH
Brueckenstrasse 5
Waechtersbach Hessen
GERMANY 63607 |
| Contact Person: | Phil Triolo
Phone: 801-699-9846
Facsimile: 801-328-2399 |
| Date Prepared: | March 14, 2019 |
| Device: | nextaro® Transfer System and nextaro® va |
| 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: | Mix2Vial® Transfer Device (K031861)
West Pharmaceutical Services, Inc. |
| Reason for Submission: | New Device |
| Device Description: | The nextaro® Transfer System and nextaro® va is indicated for the transfer and
mixing of drugs contained in vials. The nextaro® Transfer System and nextaro® va is |
practically one system with two variants which are to be used independently.
4
| Technological
Characteristics: | The nextaro® Transfer System 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 for fluid
transfer. 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®
Transfer System is used to perforate the seal of the solvent vial. The assembly is
flipped vertically and the spike of the white ("lower") 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. |
| | 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 ready-to-use solution. |
| | The nextaro® va is a standalone device. Basically, it is the lower part of the
nextaro® Transfer System, but without the thread which the latter has to connect
the upper part. After connecting the nextaro® va to a pharmaceutical vial by
pushing it downwards, a solvent can be transferred by a syringe via the female Luer.
After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a
standard syringe with a male Luer is attached to the female Luer of the device to
aspirate the ready-to-use solution. |
Indications for The nextaro® Transfer System and nextaro® va is indicated for the transfer and Use: mixing of drugs contained in vials.
| Areas for Comparison | Predicate Device
Mix2Vial
K031861 | Proposed Device
nextaro®
Transfer System | Proposed Device
nextaro® va | Comparison |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------|
| Indications for Use | | | | |
| Intended use or
indications | Intended for
transferring and
mixing drugs
contained in two
vials | Indicated for the
transfer and mixing
of drugs contained
in vials | Indicated for the
transfer and mixing
of drugs contained
in vials | See Discussion of
Differences |
| Regulatory Information | | | | |
| Device Classification
Name | Set I.V. Fluid
Transfer | Set I.V. Fluid
Transfer | Set I.V. Fluid
Transfer | Equivalent |
| Regulation Number | 880.5440 | 880.5440 | 880.5440 | Equivalent |
| Regulation Description | Intravascular
Administration Set | Intravascular
Administration Set | Intravascular
Administration Set | Equivalent |
| Product Code | LHI | LHI | LHI | Equivalent |
| Areas for Comparison | Predicate Device
Mix2Vial
K031861 | Proposed Device
nextaro®
Transfer System | Proposed Device
nextaro® va | Comparison |
| Regulatory Medical
Specialty | General Hospital | General Hospital | General Hospital | Equivalent |
| Device Class | 2 | 2 | 2 | Equivalent |
| GMP Exempt | No | No | No | Equivalent |
| Design Features | | | | |
| Uses vacuum pressure | Yes | Yes | No | See Discussion of
Differences |
| Vial size the product is
to be used with | 20 mm /
14 mm | 20 mm | 20 mm | Equivalent
to 20 mm model |
| Vial adapter / vial access
component | Yes | Yes | Yes | Equivalent |
| In-line liquid filter | Yes | Yes | Yes | Equivalent |
| Mesh opening | 15 μm | 11 μm | 11 μm | See Discussion of
Differences |
| Open area | 9 % | 5 % | 5 % | See Discussion of
Differences |
| Female Luer adapter for
connection to syringes | Yes | Yes | Yes | Equivalent |
| Luer adapter and vial
adapter are integrated
in one component | Yes | Yes | Yes | Equivalent |
| Needleless access to vial | Yes | Yes | Yes | Equivalent |
| Sterile, biocompatible
fluid path | Yes | Yes | Yes | Equivalent |
| Manufactured by plastic
injection molding | Yes | Yes | Yes | Equivalent |
| Single use, sterile | Yes | Yes | Yes | Equivalent |
| Sterilization | Gamma / EtO | EtO | EtO | Equivalent to one of
the methods (EtO) |
| Sterility Assurance Level | SAL 10-6 | SAL 10-6 | SAL 10-6 | Equivalent |
| Biocompatibility | Pass | Pass | Pass | Equivalent |
| Shelf Life | > 3 years | 5 years | 5 years | Equivalent |
| Principles of Operation | | | | |
| Manually operated | Yes | Yes | Yes | Equivalent |
| Mechanically connected
to a drug vial | Yes | Yes | Yes | Equivalent |
| Transfers solvent
manually using a syringe
plunger rod | No | No | Yes | similar |
| Drug reconstitution
through manual
agitation of vial while
connected to device | Yes | Yes | Yes | Equivalent |
| Mixed drug is manually
aspirated into a syringe
barrel using the syringe
plunger rod | Yes | Yes | Yes | Equivalent |
| Areas for Comparison | Predicate Device
Mix2Vial
K031861 | Proposed Device
nextaro®
Transfer System | Proposed Device
nextaro® va | Comparison |
| Single Use | Yes | Yes | Yes | Equivalent |
| Materials | | | | |
| Transfer device | Polycarbonate | Polypropylene, TPE | Polypropylene | Similar |
| In-line Filter | Polyethylene
terephthalate | Polyethylene
terephthalate | Polyethylene
terephthalate | Equivalent |
| Packaging | Blister Pack: PETG
Lid: Tyvek | Blister Pack: PETG
Lid: Tyvek | Blister Pack: PETG
Lid: Tyvek | Equivalent |
Substantial Equivalence Comparison:
5
6
Discussion of Differences
- Difference in While the indications for use for the nextaro® Transfer System and nextaro® va are worded slightly different than that of the predicate device, both the subject devices Indications: and predicate device are used for the same purpose: The transfer of solvents into a drug vial / the aspiration of the ready-to-use solution of the dissolved pharmaceuticals which are contained in vials. The nextaro® Transfer System is intended to be used with two vials (solvent and pharmaceutical agent vial) just as is the predicate device, while the nextaro® va is intended to be used with one vial (pharmaceutical agent vial; the solvent transferred into pharmaceutical agent vial by a syringe with male Luer adapter filled with solvent). There is no critical difference in the intended therapeutic use of the subject and predicate devices.
- Uses Vacuum The nextaro® Transfer System, the nextaro® va and the Mix2Vial all are used to Pressure: transfer solvent into a vial which contains a freeze-dried pharmaceutical agent (lyophilizate). All of the devices use pressure to transfer the solvent: In the case of the nextaro® Transfer System, the devices use the negative pressure within the pharmaceutical agent vial to transfer the solvent from the solvent vial which was connected to the device beforehand, just as is the case with the predicate device. The nextaro® va also uses pressure to transfer the solvent, but due to the design of the nextaro® va, the solvent must be applied by means of a syringe. However, the direction of the solvent flow is the same for all predicate and subject devices.
There is no critical difference in the use of vacuum pressure or manual pressure (to the plunger of the syringe) to transfer the solvent. The solvent transfer methods of the subject and predicate devices can be regarded as equivalent.
Filter The nextaro® Transfer System, the nextaro® va and the Mix2Vial all are equipped with Elements: filter elements, to retain fragments which could be punched out during perforation of the vial seals from being transferred or aspirated into the ready-to-use solution. The same applies for undissolved pharmaceutical agent particles.
The filter mesh used in the nextaro® and nextaro® va are capable to retain particles of ≥ 15 um size. A retention rate of > 95 % of particles sized ≥ 15 um has been confirmed by testing. The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent.
7
- Shelf life: The predicate device has a shelf-life of > 3 years while the subject devices have a shelflife of 5 years. The packaging materials are equivalent. The subject devices are substantially equivalent with regard to their shelf-life. This does not raise different questions of safety or effectiveness
- Both the predicate and the nextaro® devices are made of biocompatible thermoplastic Materials: polymer materials. Although the basic materials for the manufacturing of the devices is not the same, the performance tests show that the subject devices are substantially equivalent regarding the performance of the devices. Both the subject device and predicate use the same filter material (PET). The biocompatibility tests show that the subject devices are biocompatible and can therefore be regarded as substantially equivalent in regard to biocompatibility.
Testing
The following tests were conducted to demonstrate that the nextaro® Transfer System and nextaro® va perform as intended.
| Standard | Test Performed |
|---|---|
| ISO 22413 | • Fragmentation |
| • Penetration Force | |
| • Piercing | |
| • Verification of Design Specifications for Transfer Devices with Housing | |
| ISO 594-2 | • Male Conical Fitting / Luer Connector |
| ISO 8536-4 | • Flow Rate of Infusion Fluid |
| • Fluid Filter (Retention Rate) | |
| • Leakage (Aging/ Submersion Test) | |
| • Metal Ions | |
| • Particulate Contamination | |
| • Penetration Force | |
| • Reduction of Oxidizable Matter | |
| • Residue on Evaporation | |
| • Tensile Strength | |
| • Titration Acidity or Alkalinity | |
| • UV Absorption of Extract Solution |
8
| Standard | Test Performed |
|---|---|
| ISO 11607 | • Sterile Barrier and Packaging Systems |
| ASTM D3078 | • Bubble Emissions |
| ASTM F 1886 | • Integrity of Seals |
| ASTM F 1929-12 | • Seal Leakage |
| ASTM F 1980-07 | • Accelerated Aging |
| ASTM F 2054-07, EN 868-5 | • Seal Strength |
| ISTA 2A | • Transport Testing |
| USP , USP | • Bacterial Endotoxin |
| N/A | • Roll Inhibition (to design specification) |
| • Transfer performance for residual volume (to design specification) | |
| • Opening torque (to design specification) |
Biocompatibility
Tests were conducted to show that the nextaro® Transfer System and the nextaro® va were evaluated for biocompatibility in accordance with ISO 10993-1. Filter particulate testing was also conducted (see above table).
Material Mediated Pyrogenicity LAL Testing
Sterility
The sterility of the nextaro® Transfer System and nextaro® va were validated in accordance with ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The maximum levels of ethylene oxide (EtO) and ethylene chlorohydrin (ECH) residuals remaining on the products were within the guidelines for limited and tolerable contact limit devices according to ISO 10993-7:2008.
Summary / Conclusion
The evaluation of the proposed nextaro® devices has demonstrated through performance testing to be substantially equivalent to the predicate device. Based on the device type, indications, intended use, technological characteristics, physical characteristics, the nextaro® Transfer Device and nextaro® va are substantially equivalent to the predicate device.