(485 days)
No
The summary describes a standard IV administration set and its compatibility with infusion pumps. There is no mention of AI/ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices.
No
Explanation: This device is an IV administration set designed for the infusion of fluids and medications, which are therapeutic, but the device itself does not provide a therapeutic effect. It is a delivery mechanism for therapies.
No
The device is an IV administration set and transfusion set, designed for infusing fluids and medications, not for diagnosing conditions.
No
The device description clearly lists multiple physical components (spike, drip chamber, roller clamp, tubing, etc.) and the performance studies focus on the physical and functional characteristics 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 clearly states the device is for the "infusion of parenteral fluids and medications" and "infusion of blood derivatives" into the patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The components listed (spike, drip chamber, tubing, etc.) are typical of devices used for delivering substances into the body, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
IV Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
Transfusion Set for the infusion of blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Volumat 100 Line is available for dedicated use with the Volumat MC Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Volumat MC Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613, and the Agilia VP MC Pump was cleared under K210073. The Volumat TM Line components include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, upstream filter, needle free port, rotating male luer lock, luer lock connector, Y-connector, tubing, and burette.
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
The device may be used for adult patients. The devices M46445260 and M46445270 may be used for pediatric patients.
Intended User / Care Setting
Not Found
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)
Functional performance bench testing was conducted to demonstrate that the Volumat I.V. Administration Set performs as intended.
The following performance testing was conducted to support the substantial equivalence determination:
- ISO 8536-8
- Leakage Testing
- Tensile Strength Testing
- Storage Tube Volume Testing
- ISO 80369-20
- Luer Fittings Leakage Testing
- Stress Cracking
- Resistance to Separation from Axial Loading
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- ISO 8536-4
- Closure-piercing Device Testing
- Air-inlet Device Testing
- Tubing Testing
- Fluid Filter Testing
- Flow Rate Testing of the Infusion Pump
- Drip Chamber Testing
- Clamp Opening and Closing
- Protective Cap Testing
- Chemical Compatibility Testing
- ISO 8536-14
- Clamps and flow regulators Testing
- ISO 11607-1 and ASTM D4169
- Sterile barrier and packaging systems and simulated shipping
- USP Particulate Matter in Injections
- Particulate Testing
- Pump Segment Compatibility Testing with Infusion Pump
- Operation under Temperature, Pressure and Humidity
- Microbial Ingress Testing
No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
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.
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.
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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.
June 2, 2023
Fresenius Kabi % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047
Re: K220301
Trade/Device Name: Volumat™ Line Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 3, 2023 Received: May 3, 2023
Dear Keith Dunn:
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
1
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 devices or postmarketing safety reporting (21 CFR 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 (OS) 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 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,
Porsche Bennett
For Dr. 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
2
Indications for Use
510(k) Number (if known) K220301
Device Name Volumat™ Line
Indications for Use (Describe)
IV Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
Transfusion Set for the infusion of blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. The word "FRESENIUS" is on top of the word "KABI".
Fresenius Kabi Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 847-550-2300
T 888-391-6300 www.fresenius-kabi.us
510(k) SUMMARY- K220301
| 1. Date Prepared: | June 2, 2023 |
|---|---|
| ------------------- | -------------- |
- Submitter Information
| Name: | Fresenius Kabi |
|---|---|
| Address: | Fresenius Kabi AG |
| 61346 Bad Homburg | |
| Germany | |
| Contact Person: | Keith Dunn |
| Director, Regulatory Affairs | |
| Fresenius Kabi USA, LLC | |
| Three Corporate Drive, Lake Zurich, IL 60047 USA | |
| Phone: (224) 817-2430 | |
| Fax: (847) 550 2960 | |
| E-mail: keith.dunn@fresenius-kabi.com | |
| Secondary Contact Person: | Jason Ma |
| Sr. Manager, Regulatory Affairs | |
| Fresenius Kabi USA, LLC | |
| Three Corporate Drive, Lake Zurich, IL 60047 USA | |
| Phone: (224) 817-4100 | |
| Fax: (847) 550 2960 | |
| E-mail: Jason.ma01@fresenius-kabi.com |
3. Device Name and Classification
| Device Trade Name: | Volumat™ Line |
|---|---|
| Common Name: | I.V. Administration Set |
| Classification Name: | Intravascular administration set |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |
| 4. Predicate Device | |
| Device Trade Name: | Intravascular Administration Sets |
4
Image /page/4/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI".
Fresenius Kabi Three Corporate Drive ake Zurich, Illinois 60047 847-550-2300 1 888-391-6300 www.fresenius-kabi.us
Common Name: Classification Name: Regulatory Class: Product Code: 510(k) Number:
Intravascular Administration Set 21 CFR 880.5440 Class II FPA K203609
5. Device Description
The Volumat 100 Line is available for dedicated use with the Volumat MC Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Volumat MC Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613, and the Agilia VP MC Pump was cleared under K210073. The Volumat TM Line components include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, upstream filter, needle free port, rotating male luer lock, luer lock connector, Yconnector, tubing, and burette.
| Set Number | Description |
|---|---|
| M46441960 | Volumat Line IV Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, downstream clamp, needle-free port, and rotating male luer |
| M46441985 | Volumat Line IV Administration Set with non-siliconized spike, air vent, drip chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer |
| M46442460 | Volumat Line IV Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, 1.2micron filter (neutrally charged), downstream clamp, downstream needle-free port, rotating male luer |
| M46443160 | Volumat Line Transfusion Set with spike, roller clamp, drip chamber with 200micron filter, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer |
| M46443450 | Volumat Line IV Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer |
| M46444160 | Volumat Line IV Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, 0.2micron filter downstream clamp, downstream needle-free port, rotating male luer |
| M46444175 | Volumat Line IV Administration Set with non-siliconized spike, air vent, drip chamber, roller clamp, pump segment, 0.2micron filter, downstream clamp, downstream needle-free port, rotating male luer, |
| M46445260 | Volumat Line IV Administration Set with spike, air vent spike, upstream clamp, (5) air vent burette, 150 mL burette with 15 $ \mu $ m filter and upstream needle-free port, drip chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer |
| M46445270 | Volumat Line IV Administration Set with spike, air vent spike, upstream clamp, air vent |
5
Image /page/5/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, curved lines on the left side, followed by the text "FRESENIUS" in bold, blue letters on the right. Below "FRESENIUS" is the word "KABI", also in bold, blue letters.
resenius K
ree Cornorate Drive 888-391-6300 www.fresenius-kabi.us
| Set Number | Description |
|---|---|
| burette, 150 mL burette with 15µm filter and upstream needle-free port, drip | |
| chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, | |
| rotating male luer | |
| M46445475 | Volumat Line IV Administration Set with non-siliconized spike, air vent, drip chamber, |
| upstream clamp, backcheck valve, upstream, needle-free port, roller clamp, pump | |
| segment, downstream clamp, downstream needle-free port, rotating male luer | |
| M46445660 | Volumat Line IV Administration Set with spike, air vent, drip chamber, upstream clamp, |
| backcheck valve, upstream needle-free port, roller clamp, pump segment, downstream | |
| clamp, downstream needle-free port, rotating male luer | |
| M46445670 | Volumat Line IV Administration Set with spike, air vent, drip chamber, upstream clamp, |
| backcheck valve, 2 upstream needle-free ports, roller clamp, pump segment, downstream | |
| clamp, downstream needle-free port, rotating male luer | |
| M46445690 | Volumat Line IV Administration Sets with spike, air vent, drip chamber, upstream clamp, |
| backcheck valve, upstream needle-free ports, roller clamp, pump segment, downstream | |
| clamp, 2 downstream needle-free ports, rotating male luer | |
| M46445780 | Volumat Line IV Administration Set with spike, air vent, drip chamber, upstream clamp, |
| backcheck valve, upstream needle-free port, roller clamp, pump segment, downstream | |
| clamp, 2 downstream needle-free ports, rotating male luer | |
| M46445860 | Volumat Line IV Administration Set with spike, air vent, drip chamber, upstream clamp, |
| backcheck valve, upstream needle-free port, roller clamp, pump segment, 0.2micron filter, | |
| downstream clamp, downstream needle-free port, rotating male luer |
6. Principle of Operation
The range of sets provides options for intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted intravenous (I.V.) routes of administration and transfusions of blood and blood derivative products.
The device may be used for adult patients. The devices M46445260 and M46445270 may be used for pediatric patients.
7. Indication for Use/ Intended Use
Indication for Use:
I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
Transfusion set for the infusion of blood and blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.
6
Image /page/6/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. The word "FRESENIUS" is on top of the word "KABI".
v.fresenius-kabi.us
Intended Use:
The Volumat TM Line is intended for the administration of drugs, solutions and blood products.
8. Comparison of the Technological Characteristics with the Predicate Device
The technological characteristics of the subject device are substantially equivalent to those of the predicate device in regard to the following technological characteristics:
- Principle of operation and conditions of use of the subject device are the same as ● those of the predicate device.
- . Materials of the proposed device do not raise new questions of safety and effectiveness, as demonstrated by performance testing and biocompatibility evaluation.
- . Physical specifications of the subject device are equivalent to those of the predicate device. Both devices have a needle free access port. The subject device incorporates a neutral displacement needleless access port with the same intended use
A comparison between the predicate device and the subject device is provided in Table 1 and Table 2.
| Technological
Characteristics | Volumat TM Line
(Subject Device) | Baxter
Administration Set
K203609
(Predicate Device) | Assessment of Differences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | I.V. Administration Set
for the infusion of
parenteral fluids and
medications from a
container into the
patient's vascular
system through a
vascular access device
with Agilia VP
MC/Volumat MC Agilia
pump or gravity only.
Transfusion set for the
infusion of blood and
blood derivatives from a
container into the
patient's vascular
system through a | For the
administration of
fluids from a
container into the
patients' vascular
system through a
vascular access
device. | Similar. Both I.V.
administration sets are used
to administer fluids from a
container to a patient.
However, the Subject Device
interoperates with infusion
systems that have been
cleared in other 510(k)
submissions including
K121613 and K210073. |
| Technological
Characteristics | Volumat ™ Line
(Subject Device) | Baxter
Administration Set
K203609
(Predicate Device) | Assessment of Differences |
| | vascular access device
with Agilia VP
MC/Volumat MC Agilia
pump or gravity only. | | |
| Operating
Mechanism | The Volumat
administration sets
deliver the intravenous
infusions via an infusion
pump through a
pumping mechanism
("cassette") or by
gravity flow. | The Baxter
administration sets
can be used to
deliver solutions for
gravity or pump by
infusion of I.V.
fluids. | Similar, both devices can be
used with an infusion pump
or by gravity flow. The
predicate device does not
have a pumping mechanism
("cassette").
Difference has been verified
through performance testing
including flow rate accuracy
under various environmental
conditions (temperature,
pressure, humidity) which
demonstrate equivalence. |
| Sterile | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Length | 75-115 inches | 69-133.5 inches | Similar. The sets included in
the subject device range in
length from 75 inches to 115
inches which is within the
range of the predicate device.
Difference tested according
to ISO 8536-4 and flow rate
accuracy to demonstrate the
subject device performance. |
| Priming Volume | 20-29 mL | 6.1 to 21.2 mL | Similar. The Volumat set
requires more priming
volume than the predicate.
Bench testing confirmed that
the differences in priming
volume do not impact safety
or effectiveness.
Difference tested to ISO
8536-4 to demonstrate
equivalence. |
| Internal Tube
Diameter | 0.098 to 118 inches | 0.102 to 133 inches | |
| Technological
Characteristics | Volumat ™ Line
(Subject Device) | Baxter
Administration Set
K203609
(Predicate Device) | Assessment of Differences |
| External Tube
Diameter | 1.61 inches | 1.42 to 2.09 inches | Similar internal and external
diameter and approximate
range of the predicate device.
Difference tested to ISO
8536-8 has demonstrated
equivalence. |
| Components | | | |
| Spike | Yes | Yes | Different. The subject device
includes an additional
pumping segment,
downstream filter, and
burette, however, no
significant difference
between the subject and
predicate administration sets
that would raise new issues
of safety or efficacy. |
| Drip chamber | Yes | Yes | |
| Backcheck Valve | Yes | Yes | |
| Pump Segment | Yes | No | |
| Downstream Filter | Yes | No | |
| Needle Free Port | Yes | Yes | |
| Male Luer | Yes | Yes | |
| Roller Clamp | Yes | Yes | |
| Connector Luer
Lock | Yes | Yes | |
| Burette | Yes | No | The differences have been
verified in various aspects to
demonstrate the subject
device's safety and
performance including:
Biocompatibility testing
according to ISO 10993
collateral standards,
Microbial Ingress Testing,
and Particulate Testing;
Performance Testing
according to ISO 8536-4,
ISO 80369-20, ISO 8536-8
and ISO 8436-14. |
Table 1: Summary of Substantial Equivalence Comparison—Primary Sets
7
Image /page/7/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. The word "FRESENIUS" is on top of the word "KABI".
Fresenius Kabi
Fresemius Kabi
Thresemius Italia Drive
Lake Zurion atabile Drive
Lake Zurion 223000
T 888-3991-233000
www.fresenius-kabil.us
8
Image /page/8/Picture/0 description: The image contains the logo for Fresenius Kabi. On the left side of the logo are three blue vertical wavy lines. To the right of the wavy lines is the text "FRESENIUS" in blue, with the text "KABI" in blue below it.
Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 847-550-2300
T 888-391-6300 www.fresenius-kabi.us
Table 2: Summary of Substantial Equivalence Comparison—Transfusion Sets
| Technological
Characteristics | Modified Volumat I.V.
Administration Set
(Subject Device) | Baxter
Administration
Set K203609
(Predicate Device) | Assessment of Differences |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Transfusion set for
infusion pumps (Agilia
VP MC pumps/Volumat | For the
administration of
fluids from a | Similar. Slight difference
but both the subject device |
| Technological
Characteristics | Modified Volumat I.V.
Administration Set
(Subject Device) | Baxter
Administration
Set K203609
(Predicate Device) | Assessment of Differences |
| | MC Agilia pump or
gravity only.) | container into the
patients' vascular
system through a
vascular access
device. | and predicate device include
a blood transfusion set.
However, the Subject Device
interoperates with infusion
systems that have been
cleared in other 510(k)
submissions including
K121613 and K210073. |
| Operating
Mechanism | The Volumat
administration sets
deliver the transfusion via
an infusion pump through
a pumping mechanism
("cassette") or by gravity
flow. | The Baxter
administration sets
can be used to
deliver solutions
for gravity or pump
by infusion of I.V.
fluids. | Similar, both devices can be
used with an infusion pump
or by gravity flow. The
predicate device does not
have a pumping mechanism
("cassette").
Difference has been verified
through performance testing
including flow rate accuracy
under various environmental
conditions (temperature,
pressure, humidity) which
demonstrate equivalence. |
| Sterile | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Length | 110 inches | 79 inches | Similar. The transfusion set
included in the subject device
is longer than the predicate
device. Testing did not raise
any new issues of safety or
efficacy.
Difference tested according
to ISO 8536-4 and flow rate
accuracy to demonstrate the
subject device performance. |
| Priming Volume | 33 ml | 6.1 to 21.2 mL | Similar. The Volumat set
requires more priming
volume than the predicate.
Bench testing confirmed that
the differences in priming
volume does not impact
safety or effectiveness. |
| Technological
Characteristics | Modified Volumat I.V.
Administration Set
(Subject Device) | Baxter
Administration
Set K203609
(Predicate Device) | Assessment of Differences |
| | | | Difference tested to ISO
8536-4 to demonstrate
equivalence. |
| Internal Tube
Diameter | 0.118 inches | 0.102 to 0.133 inches | Similar internal diameter and
approximate range of the |
| External Tube
Diameter | 1.61 inches | 1.42 to 2.09 inches | predicate device. |
| | | | Difference tested to ISO
8536-8 has demonstrated
equivalence. |
| | | Components | |
| Spike | Yes | Yes | Different. The subject device |
| Drip chamber | Yes | Yes | includes a pump segment, |
| Pump Segment | Yes | No | however, no significant |
| Needle Free Port | Yes | Yes | difference between the |
| Male Luer | Yes | Yes | administration sets that |
| Y-Connector | Yes | Yes | would raise new issues of
safety or efficacy. |
| | | | The differences have been
verified in various aspects to
demonstrate the subject
device's safety and
performance including:
Biocompatibility testing
according to ISO 10993
collateral standards,
Microbial Ingress Testing,
and Particulate Testing:
Performance Testing
according to ISO 8536-4,
ISO 80369-20, ISO 8536-8
and ISO 8436-14. |
9
Image /page/9/Picture/0 description: The image shows the logo for Fresenius Kabi. The logo consists of a blue abstract symbol on the left, resembling three wavy lines. To the right of the symbol, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI". The logo is simple and modern, with a focus on the company name.
Fresenius Kabi
Fresemius Kabi
Thresemius Italia Drive
Lake Zurion atabile Drive
Lake Zurion 223000
T 888-3991-233000
www.fresenius-kabil.us
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Image /page/10/Picture/0 description: The image shows the logo for Fresenius Kabi. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol appears to be three vertical wavy lines. The words "FRESENIUS" and "KABI" are stacked on top of each other.
Fresenius Kabi
Thee Corporation Drive
Lake Zurich, Illinois 60047
T 847-5550-2330
T 8847-5550-23300
T 888-3391-23300
www.fresenius-kabi.us
Table 3: Administration/Transfusion Set Material Comparison Table
| Component | Modified Volumat I.V.
Administration Set
(Subject Device) | Baxter
Administration
Set K203609
(Predicate Device) | Assessment of Differences |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Spike | Polystyrene | Acrylonitrile
Butadiene Styrene | Similar, testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Component | Modified Volumat I.V.
Administration Set
(Subject Device) | Baxter
Administration
Set K203609
(Predicate Device) | Assessment of Differences |
| Drip chamber | Polystyrene, styrene-
butadiene-copolymer,
Polyamide | Polyvinyl Chloride | Different, testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Backcheck Valve | Methylmethacrylate-
Acrylonitrile-Butadiene-
Styrene) | Polymethyl
methacrylate
(acrylic) | Similar, testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Pump Segment | Methylmethacrylate-
Acrylonitrile-Butadiene-
Styrene | N/A - predicate
device does not
have a pump
segment
Silicone Rubber | Testing to biocompatibility
and performance standards
demonstrated equivalence |
| Downstream Filter | Polyacryl,
polyethersulfone | N/A - predicate
device does not
have a downstream
filter | Testing to biocompatibility
and performance standards
demonstrated equivalence |
| Needle Free Port | Methylmethacrylate-
Acrylonitrile-Butadiene-
Styrene, Copolyester | Polyester | Similar, Testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Rotating Male Luer
Lock | Polyvinylchloride,
Acrylonitrile butadiene
styrene | Acrylonitrile
butadiene styrene | Similar, Testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Y-Connector | Methylmethacrylate-
Acrylonitrile-Butadiene-
Styrene | Polyvinyl chloride | Different, testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Tubing | Polyvinyl chloride,
Polyurethane,
Polypropylene | Polyvinyl chloride | Similar, Testing to
biocompatibility and
performance standards
demonstrated equivalence |
| Burette | Acrylonitrile-Butadiene-
Styrene,
Polyvinylchloride,
Copolyester,
Polyethylene, Versapor,
Stainless steel, Polyamid,
Polycarbonate | N/A - predicate
device does not
have a burette | Different, testing to
biocompatibility and
performance standards
demonstrated equivalence |
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Image /page/11/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue, curved lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI."
Fresenius Kabi
Three Corporate Drive Lake Zurich, Illinois 60047
T 847-550-2300
T 847-550-2300
T 888-391-6300 www.fresenius-kabi.us
9. Substantial Equivalence Discussion
Intended Use/Indication for Use-Discussion of Differences
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Image /page/12/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI". The logo is simple and modern, with a focus on the company name.
vw.fresenius-kabi.us
Both the subject and predicate device have the same intended use and similar indication for use. Both I.V. administration sets are used to administer fluids with infusion pumps as well as for gravity flow.
Technological Characteristics-Discussion of Differences
Note: All performance testing / design control activities has been conducted and has confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness. See performance testing below for standards/methods used to evaluate these technological characteristic differences.
- Both the subject and predicate device can be used with an infusion pump or by gravity flow. The subject device delivers the intravenous infusions via an infusion pump through a pumping mechanism ("cassette") or by gravity flow, and the predicate device does not have a pumping mechanism ("cassette"). However, both devices have a pump set interface that was verified through flow rate testing.
- The subject device ranges in length from 75 inches to 115 inches, which is within the length range of the predicate device. Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance.
- . The subject device carries more priming volume than the predicate. Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness. Difference tested to ISO 8536-4 to demonstrate equivalence.
- . The subject device includes an additional downstream filter and burette. However, no significant difference between the subject and predicate administration sets that would raise new questions of safety and efficacy. The differences have been verified in various aspects to demonstrate the subject device's safety and performance including Biocompatibility testing according to ISO 10993 collateral standards, Microbial Ingress Testing, and Particulate Testing: Performance Testing according to ISO 8536-4, ISO 80369-20, ISO 8536-8.
Conclusion on Substantial Equivalence
The subject device has the same intended use and equivalent indications fruse as the predicate device. It also has similar technological characteristics to the predicate, and the descriptive as well as the performance information provided within this premarket notification demonstrates that:
- . any differences do not raise different questions of safety and effectiveness compared to the predicate device; and
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Image /page/13/Picture/0 description: The image contains the logo for Fresenius Kabi. On the left side of the logo are three blue wavy lines stacked vertically. To the right of the wavy lines is the text "FRESENIUS" stacked on top of the text "KABI". The text is also in blue.
ee Cornorate Drive Zurich, Illinois 60047 888-391-6300 www.fresenius-kabi.us
- the proposed device is at least as safe and effective as the legally marketed predicate device.
Based on the comparison of the intended use and the technological characteristics, the subject device is substantially equivalent to the predicate device.
10.Performance Testing
Performance Testing-Bench
Functional performance bench testing was conducted to demonstrate that the Volumat I.V. Administration Set performs as intended.
The following performance testing was conducted to support the substantial equivalence determination:
- ISO 8536-8 .
- o Leakage Testing
- Tensile Strength Testing o
- o Storage Tube Volume Testing
- ISO 80369-20 ●
- o Luer Fittings Leakage Testing
- Stress Cracking o
- Resistance to Separation from Axial Loading O
- Resistance to Separation from Unscrewing о
- Resistance to Overriding o
- ISO 8536-4 ●
- Closure-piercing Device Testing o
- Air-inlet Device Testing O
- Tubing Testing O
- Fluid Filter Testing O
- O Flow Rate Testing of the Infusion Pump
- Drip Chamber Testing O
- O Clamp Opening and Closing
- Protective Cap Testing o
- o Chemical Compatibility Testing
- ISO 8536-14
- 0 Clamps and flow regulators Testing
- ISO 11607-1 and ASTM D4169 ●
- o Sterile barrier and packaging systems and simulated shipping
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Image /page/14/Picture/0 description: The image shows the logo for Fresenius Kabi. The logo consists of three blue, curved lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI".
w.fresenius-kabi.us
- USP Particulate Matter in Injections ●
- o Particulate Testing
- Pump Segment Compatibility Testing with Infusion Pump
- Operation under Temperature, Pressure and Humidity ●
- Microbial Ingress Testing ●
11.Biocompatibility Testing
Following the FDA Guidance: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process", the tests selected were for prolonged, blood path indirect, externally communicating devices. The following biocompatibility tests were successfully conducted on the Volumat I.V. Administration Set:
- Acute Systemic Toxicity ●
- Hemolysis ●
- Intracutaneous Reactivity ●
- Sensitization ●
- Cytotoxicity ●
- Pyrogens ●
- Subacute/subchronic toxicity ●
- Targeted Chemical Analysis for DEHP
12. Sterilization Validation
Sterilization was achieved by ethylene oxide and meets the requirements of ISO 11135:2020, which is equivalent to ISO 11135 (2014-7) + AMD 1 (2018-10). The ethylene oxide sterilization method achieves a Sterilization Assurance Level (SAL) of 10-6.
13. Clinical Testing
No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
14. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device, Volumat™
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Image /page/15/Picture/0 description: The image contains the logo for Fresenius Kabi. On the left side of the logo are three blue vertical wavy lines. To the right of the wavy lines is the text "FRESENIUS KABI" in blue font. The word "FRESENIUS" is on the top line and the word "KABI" is on the bottom line.
Fresenius Kabi Thee Corporation Drive
Lake Zurich, Illinois 60047
T 847-5550-2330
T 8847-5550-23300
T 888-3391-23300
www.fresenius-kabi.us
Line is substantially equivalent to the predicate device, I.V. Administration Set, cleared under K203609.