(485 days)
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.
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.
The provided text is a 510(k) summary for the Fresenius Kabi Volumat™ Line, an Intravascular Administration Set. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility testing, rather than a clinical study involving human readers or AI algorithms.
Therefore, many of the requested details, such as MRMC studies, human reader improvement with AI, ground truth establishment for training and test sets, number of experts, and adjudication methods, are not applicable to this device submission as it is a physical medical device (IV administration set) and not an AI/ML-driven diagnostic or therapeutic device.
However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate the device meets these criteria.
Device: Volumat™ Line (Intravascular Administration Set)
Submission Type: 510(k) Premarket Notification (K220301)
Predicate Device: Baxter Administration Set (K203609)
The acceptance criteria for this type of device are primarily based on established performance standards for IV administration sets, ensuring safety and effectiveness through physical, chemical, and biological compatibility. The "study" proving the device meets these criteria is a series of bench tests and biocompatibility evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct table of "acceptance criteria" with specific pass/fail values for each test. Instead, it lists the types of tests and applicable ISO standards used to demonstrate that the Volumat™ Line performs as intended and is as safe and effective as the predicate device. The implicit acceptance criterion for each test is successful compliance with the respective standard.
General Acceptance Principles (Implied from the document):
- Functional Equivalence: The device must perform its intended function (infusion of fluids/medications/blood products) safely and accurately.
- Physical Integrity: The device components must withstand operational stresses without leakage, cracking, or separation.
- Biocompatibility: The materials used must be safe for patient contact.
- Sterility: The device must be sterile and maintain sterility until use.
- Compatibility: The device must be compatible with its intended use environment (e.g., infusion pumps, gravity flow).
Reported Device Performance:
The document states that all performance testing and design control activities were "conducted and has confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness." It explicitly states that the device was found to be "at least as safe and effective as the legally marketed predicate device" and "substantially equivalent."
While specific numerical performance results are not provided in this public summary, the successful completion of the listed tests implies that the device met the established acceptance criteria for each standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant industry standards (e.g., ISO, ASTM) and statistical methods to ensure representativeness and confidence in results.
- Data Provenance: This is bench testing of a physical medical device. The tests were performed to support a 510(k) submission to the FDA. The country of origin for the testing is not specified, but the applicant (Fresenius Kabi) has locations in Germany (address listed) and the USA. The testing would be prospective in the sense that it was conducted specifically to support this regulatory submission for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is a physical medical device. The "ground truth" for evaluating its performance is established by validated test methods and international standards (ISO, ASTM, USP), not by human expert opinion (e.g., radiologists interpreting images). The "experts" involved would be engineers, material scientists, and quality assurance professionals performing and reviewing the test results against the specified standards.
4. Adjudication Method for the Test Set
Not Applicable. There is no "adjudication" in the sense of multiple human evaluators reviewing outputs. The objective performance is measured against predefined pass/fail criteria from the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to evaluate the impact of the device on human reader performance. This is a physical IV administration set.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet its functional specifications independently, which was assessed through the various bench tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is derived from established international standards and validated test methods.
- Functional Performance Standards: ISO 8536-8, ISO 80369-20, ISO 8536-4, ISO 8536-14, USP<788>.
- Biocompatibility Standards: ISO 10993 series.
- Sterilization Standards: ISO 11135.
- Packaging Standards: ISO 11607-1, ASTM D4169.
These standards define the expected performance thresholds (e.g., maximum leakage, acceptable tensile strength, no cytotoxicity) against which the device's measured performance is compared.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's design and manufacturing processes are developed based on engineering principles and regulatory requirements.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no "training set" for an AI/ML model, there is no corresponding ground truth establishment process for a training set. The "ground truth" for the device's design and manufacturing are the established engineering principles, material science knowledge, and regulatory standards for medical device safety and efficacy.
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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
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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
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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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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 AG61346 Bad HomburgGermany |
| Contact Person: | Keith DunnDirector, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, Lake Zurich, IL 60047 USAPhone: (224) 817-2430Fax: (847) 550 2960E-mail: keith.dunn@fresenius-kabi.com |
| Secondary Contact Person: | Jason MaSr. Manager, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, Lake Zurich, IL 60047 USAPhone: (224) 817-4100Fax: (847) 550 2960E-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 |
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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 |
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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, dripchamber, 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, pumpsegment, 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, downstreamclamp, 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, downstreamclamp, 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, downstreamclamp, 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, downstreamclamp, 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.
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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.
| TechnologicalCharacteristics | Volumat TM Line(Subject Device) | BaxterAdministration SetK203609(Predicate Device) | Assessment of Differences |
|---|---|---|---|
| Indication for Use | I.V. Administration Setfor the infusion ofparenteral fluids andmedications from acontainer into thepatient's vascularsystem through avascular access devicewith Agilia VPMC/Volumat MC Agiliapump or gravity only.Transfusion set for theinfusion of blood andblood derivatives from acontainer into thepatient's vascularsystem through a | For theadministration offluids from acontainer into thepatients' vascularsystem through avascular accessdevice. | Similar. Both I.V.administration sets are usedto administer fluids from acontainer to a patient.However, the Subject Deviceinteroperates with infusionsystems that have beencleared in other 510(k)submissions includingK121613 and K210073. |
| TechnologicalCharacteristics | Volumat ™ Line(Subject Device) | BaxterAdministration SetK203609(Predicate Device) | Assessment of Differences |
| vascular access devicewith Agilia VPMC/Volumat MC Agiliapump or gravity only. | |||
| OperatingMechanism | The Volumatadministration setsdeliver the intravenousinfusions via an infusionpump through apumping mechanism("cassette") or bygravity flow. | The Baxteradministration setscan be used todeliver solutions forgravity or pump byinfusion of I.V.fluids. | Similar, both devices can beused with an infusion pumpor by gravity flow. Thepredicate device does nothave a pumping mechanism("cassette").Difference has been verifiedthrough performance testingincluding flow rate accuracyunder various environmentalconditions (temperature,pressure, humidity) whichdemonstrate 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 inthe subject device range inlength from 75 inches to 115inches which is within therange of the predicate device.Difference tested accordingto ISO 8536-4 and flow rateaccuracy to demonstrate thesubject device performance. |
| Priming Volume | 20-29 mL | 6.1 to 21.2 mL | Similar. The Volumat setrequires more primingvolume than the predicate.Bench testing confirmed thatthe differences in primingvolume do not impact safetyor effectiveness.Difference tested to ISO8536-4 to demonstrateequivalence. |
| Internal TubeDiameter | 0.098 to 118 inches | 0.102 to 133 inches | |
| TechnologicalCharacteristics | Volumat ™ Line(Subject Device) | BaxterAdministration SetK203609(Predicate Device) | Assessment of Differences |
| External TubeDiameter | 1.61 inches | 1.42 to 2.09 inches | Similar internal and externaldiameter and approximaterange of the predicate device.Difference tested to ISO8536-8 has demonstratedequivalence. |
| Components | |||
| Spike | Yes | Yes | Different. The subject deviceincludes an additionalpumping segment,downstream filter, andburette, however, nosignificant differencebetween the subject andpredicate administration setsthat would raise new issuesof 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 LuerLock | Yes | Yes | |
| Burette | Yes | No | The differences have beenverified in various aspects todemonstrate the subjectdevice's safety andperformance including:Biocompatibility testingaccording to ISO 10993collateral standards,Microbial Ingress Testing,and Particulate Testing;Performance Testingaccording to ISO 8536-4,ISO 80369-20, ISO 8536-8and ISO 8436-14. |
Table 1: Summary of Substantial Equivalence Comparison—Primary Sets
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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
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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
| TechnologicalCharacteristics | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministrationSet K203609(Predicate Device) | Assessment of Differences |
|---|---|---|---|
| Indication for Use | Transfusion set forinfusion pumps (AgiliaVP MC pumps/Volumat | For theadministration offluids from a | Similar. Slight differencebut both the subject device |
| TechnologicalCharacteristics | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministrationSet K203609(Predicate Device) | Assessment of Differences |
| MC Agilia pump orgravity only.) | container into thepatients' vascularsystem through avascular accessdevice. | and predicate device includea blood transfusion set.However, the Subject Deviceinteroperates with infusionsystems that have beencleared in other 510(k)submissions includingK121613 and K210073. | |
| OperatingMechanism | The Volumatadministration setsdeliver the transfusion viaan infusion pump througha pumping mechanism("cassette") or by gravityflow. | The Baxteradministration setscan be used todeliver solutionsfor gravity or pumpby infusion of I.V.fluids. | Similar, both devices can beused with an infusion pumpor by gravity flow. Thepredicate device does nothave a pumping mechanism("cassette").Difference has been verifiedthrough performance testingincluding flow rate accuracyunder various environmentalconditions (temperature,pressure, humidity) whichdemonstrate equivalence. |
| Sterile | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Length | 110 inches | 79 inches | Similar. The transfusion setincluded in the subject deviceis longer than the predicatedevice. Testing did not raiseany new issues of safety orefficacy.Difference tested accordingto ISO 8536-4 and flow rateaccuracy to demonstrate thesubject device performance. |
| Priming Volume | 33 ml | 6.1 to 21.2 mL | Similar. The Volumat setrequires more primingvolume than the predicate.Bench testing confirmed thatthe differences in primingvolume does not impactsafety or effectiveness. |
| TechnologicalCharacteristics | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministrationSet K203609(Predicate Device) | Assessment of Differences |
| Difference tested to ISO8536-4 to demonstrateequivalence. | |||
| Internal TubeDiameter | 0.118 inches | 0.102 to 0.133 inches | Similar internal diameter andapproximate range of the |
| External TubeDiameter | 1.61 inches | 1.42 to 2.09 inches | predicate device. |
| Difference tested to ISO8536-8 has demonstratedequivalence. | |||
| 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 ofsafety or efficacy. |
| The differences have beenverified in various aspects todemonstrate the subjectdevice's safety andperformance including:Biocompatibility testingaccording to ISO 10993collateral standards,Microbial Ingress Testing,and Particulate Testing:Performance Testingaccording to ISO 8536-4,ISO 80369-20, ISO 8536-8and ISO 8436-14. |
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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) | BaxterAdministrationSet K203609(Predicate Device) | Assessment of Differences |
|---|---|---|---|
| Spike | Polystyrene | AcrylonitrileButadiene Styrene | Similar, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Component | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministrationSet K203609(Predicate Device) | Assessment of Differences |
| Drip chamber | Polystyrene, styrene-butadiene-copolymer,Polyamide | Polyvinyl Chloride | Different, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Backcheck Valve | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene) | Polymethylmethacrylate(acrylic) | Similar, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Pump Segment | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene | N/A - predicatedevice does nothave a pumpsegmentSilicone Rubber | Testing to biocompatibilityand performance standardsdemonstrated equivalence |
| Downstream Filter | Polyacryl,polyethersulfone | N/A - predicatedevice does nothave a downstreamfilter | Testing to biocompatibilityand performance standardsdemonstrated equivalence |
| Needle Free Port | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene, Copolyester | Polyester | Similar, Testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Rotating Male LuerLock | Polyvinylchloride,Acrylonitrile butadienestyrene | Acrylonitrilebutadiene styrene | Similar, Testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Y-Connector | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene | Polyvinyl chloride | Different, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Tubing | Polyvinyl chloride,Polyurethane,Polypropylene | Polyvinyl chloride | Similar, Testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Burette | Acrylonitrile-Butadiene-Styrene,Polyvinylchloride,Copolyester,Polyethylene, Versapor,Stainless steel, Polyamid,Polycarbonate | N/A - predicatedevice does nothave a burette | Different, testing tobiocompatibility andperformance standardsdemonstrated 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<788> 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.
§ 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.