(424 days)
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.
The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.
The provided text describes the regulatory clearance of a medical device, the "Volumat Polyethylene I.V. Administration Set," by the FDA. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Baxter Administration Set K203609) rather than establishing novel performance metrics or conducting a clinical study with acceptance criteria.
Therefore, the specific information requested cannot be fully extracted from the provided text. However, I can provide the available information relevant to performance and testing:
Response based on available information:
The document outlines performance testing conducted to support the substantial equivalence determination by showing the device performs as intended and that differences from the predicate device do not raise new questions of safety or effectiveness. It does not explicitly state "acceptance criteria" in a quantitative table with "reported device performance" against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists various standards and tests that were applied, and it states that these tests "demonstrate equivalence" or confirmed that differences "do not impact safety or effectiveness."
For example, regarding the listed technological characteristic differences:
- Operating Mechanism (presence of pumping cassette): "Difference has been verified through performance testing including flow rate accuracy under various environmental conditions (temperature, pressure, humidity) which demonstrate equivalence." (No specific flow rate accuracy acceptance criteria or results are given).
- Length: "Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance." (No specific length or flow rate acceptance criteria or results are given).
- Priming Volume: "Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness." (No specific priming volume acceptance criteria or results are given).
- Internal/External Tube Diameter: "Difference tested to ISO 8536-8 has demonstrated equivalence." (No specific diameter acceptance criteria or results are given).
- Components (e.g., pump segment): "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." (No specific acceptance criteria or results for these tests are provided).
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail the sample sizes used for the "performance bench testing" or the specific data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessments, such as imaging AI algorithms. The described testing is primarily bench testing of a hardware device.
4. Adjudication Method for the Test Set
Not applicable for the type of bench testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a physical medical device (I.V. administration set) and not an interpretive diagnostic tool or AI algorithm requiring human reader comparison. The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."
6. Standalone Performance Study (Algorithm Only)
Not applicable, as this is a physical medical device, not an algorithm. The testing described is for the physical device's performance.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards (e.g., ISO 8536-4, ISO 80369-20, ISO 8536-8, ISO 8436-14, ISO 11607-1 & 2, USP<788>). The device's performance was compared against the pass/fail criteria within these standards to "demonstrate equivalence" and that it "performs as intended."
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
June 16, 2023
Fresenius Kabi % Jason Ma Sr. Manager, Regulatory Affairs Fresenius Kabi USA,LLC 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047
Re: K221121
Trade/Device Name: Volumat Polyethylene I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 18, 2023 Received: May 18, 2023
Dear Jason Ma:
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 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) K221121
Device Name
Volumat Polyethylene I.V. Administration Set
Indications for Use (Describe)
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.
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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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- K221121
| 1. Date Prepared: | June 16, 2023 |
|---|---|
| 2. Submitter Information | |
| Name: | Fresenius Kabi |
| Address: | Fresenius Kabi AG61346 Bad HomburgGermany |
| Contact Person: | Jason MaSr. Manager, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USAPhone: 224-817-4100Fax: 847 550 2960E-mail: Jason.ma01@fresenius-kabi.com |
| Secondary Contact Person: | Keith DunnDirector, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USAPhone: 224-817-2430Fax: 847 550 2960E-mail: Keith.Dunn@fresenius-kabi.com |
3. Device Name and Classification
| Device Trade Name: | Volumat Polyethylene I.V. Administration Set |
|---|---|
| Common Name: | I.V. Administration Set |
| Classification Name: | Intravascular administration set |
| Regulation Number | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |
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Image /page/4/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 stacked on top of each other, also in blue. The logo is simple and modern, with a focus on the company name.
hree Cornorate Drive ke Zurich, Illinois 60047 847-550-2300 888-391-6300 ww.fresenius-kabi.us
4. Predicate Device
| Device Trade Name: | Intravascular Administration Sets |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |
| 510(k) Number: | K203609 |
5. Device Description
The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.
| Set Number | Description |
|---|---|
| M46441395 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, rotating male luer |
| M46441995 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer |
| M46444495 | Volumat Polyethylene I.V. 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 |
| M46445495 | Volumat Polyethylene I.V. 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 |
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.
The device may be used for Adults and Pediatrics Patients.
7. Indication for Use/ Intended Use
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w.fresenius-kabi.us
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.
Intended Use:
Volumat Polyethylene I.V. Administration Sets are intended for the administration of drugs and solutions.
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.
A comparison between the predicate device and the subject device is provided in Table 1 and Table 2 below.
| TechnologicalCharacteristics | Volumat PolyethyleneI.V. AdministrationSets (Subject Device) | Baxter AdministrationSet K203609(Predicate Device) | Assessment ofDifferences |
|---|---|---|---|
| Indication for Use | IV Administration setfor the infusion ofparenteral fluids andmedications from acontainer into thepatient's vascularsystem through avascular access devicewith Agilia VP MCpumps/Volumat MCAgilia pump or gravityonly. | For the administration offluids from a containerinto the patients'vascular system througha vascular access device. | Similar. Both I.V.administration sets areused to administer fluidsfrom a container to apatient. However, theSubject Deviceinteroperates withinfusion systems thathave been cleared inother 510(k) submissionsincluding K121613 andK210073.. |
| OperatingMechanism | The Volumatadministration setsdeliver the intravenous | The Baxteradministration sets canbe used to deliver | Similar, both devices canbe used with an infusionpump or by gravity flow. |
| TechnologicalCharacteristics | Volumat PolyethyleneI.V. AdministrationSets (Subject Device) | Baxter AdministrationSet K203609(Predicate Device) | Assessment ofDifferences |
| infusions via an infusionpump through apumping mechanism("cassette") or bygravity flow. | solutions for gravity orpump by infusion of I.V.fluids. | The predicate devicedoes not have a pumpingmechanism ("cassette").Difference has beenverified throughperformance testingincluding flow rateaccuracy under variousenvironmental conditions(temperature, pressure,humidity) whichdemonstrate equivalence. | |
| Sterile | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Length | 75-105 inches | 69-133.5 inches | Similar. The setsincluded in the subjectdevice range in lengthfrom 75 inches to 105inches which is withinthe range of the predicatedevice.Difference testedaccording to ISO 8536-4and flow rate accuracy todemonstrate the subjectdevice performance. |
| Priming Volume | 21-27 ml | 6.1 to 21.2 mL | Similar. The Volumat setrequires more primingvolume than thepredicate. Bench testingconfirmed that thedifferences in primingvolume do not impactsafety or effectiveness. |
| Internal TubeDiameter | 0.122 inches | 0.102 to 133 inches | Similar internal andexternal diameter andapproximate range of thepredicate device.Difference tested to ISO8536-8 has demonstratedequivalence. |
| External TubeDiameter | 0.164 inches | 0.140-0.209 inches | |
| Components | |||
| Spike | Yes | Yes | Different. The subjectdevice includes an |
| Drip chamber | Yes | Yes | |
| TechnologicalCharacteristics | Volumat PolyethyleneI.V. AdministrationSets (Subject Device) | Baxter AdministrationSet K203609(Predicate Device) | Assessment ofDifferences |
| Backcheck Valve | Yes | Yes | additional pumping |
| Pump Segment | Yes | No | segment. However, no |
| Needle Free Port | Yes | Yes | significant difference |
| Male Luer | Yes | Yes | between the subject and |
| Roller Clamp | Yes | Yes | predicate administration |
| Connector LuerLock | Yes | Yes | sets that would raise newissues of safety orefficacy.The differences havebeen verified in variousaspects to demonstratethe subject device'ssafety and performanceincluding:Biocompatibility testingaccording to ISO 10993collateral standards,Microbial IngressTesting, and ParticulateTesting; PerformanceTesting according to ISO8536-4, ISO 80369-20,ISO 8536-8 and ISO8436-14. |
Table 1: Summary of Substantial Equivalence Comparison
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Image /page/6/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol is made up of three curved lines.
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/7/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
Theo Corporation Drive
Lake Zunich, Illinois 60047
Take Zunich, Illinois 60047
Trad47-5550-2300
www.fresenius-kabi.us
Table 2: Summary of Material Comparison
| Component | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministration SetK203609(Predicate Device) | Assessment of Differences |
|---|---|---|---|
| Spike | Polystyrene | AcrylonitrileButadiene Styrene | Similar, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Drip chamber | Polystyrene, styrene-butadiene-copolymer,Polyamide | Polyvinyl Chloride | Different, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Backcheck Valve | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene) | Polymethylmethacrylate (acrylic)Silicone Rubber | Similar, testing tobiocompatibility andperformance standardsdemonstrated equivalence |
| Pump Segment | Methylmethacrylate-Acrylonitrile-Butadiene-Styrene | N/A – predicatedevice does not havea pump segment | Testing to biocompatibilityand performance standardsdemonstrated equivalence |
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Image /page/8/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".
888-391-6300 ww.fresenius-kabi.us
| Component | Modified Volumat I.V.Administration Set(Subject Device) | BaxterAdministration SetK203609(Predicate Device) | Assessment of Differences |
|---|---|---|---|
| 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 |
| Tubing | Polyvinyl chloride,ethylene-vinyl acetate,polyethylene | Polyvinyl chloride | Similar, Testing tobiocompatibility andperformance standardsdemonstrated equivalence |
9. Substantial Equivalence
Intended Use/Indication for Use-Discussion of Differences
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.
Technological Characteristics—Discussion of 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").
- The subject device ranges in length from 75 inches to 105 inches, which is within . the length range of the predicate device.
- . 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.
- . The subject device includes an additional pumping segment. However, no significant difference between the subject and predicate administration sets that would raise new issues of safety or efficacy.
Conclusion on Substantial Equivalence
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ee Cornorate Drive Zurich, Illinois 60047 888-391-6300 ww.fresenius-kabi.us
The Volumat Polyethylene I.V. Administration Set has the same intended use and equivalent indication for use as the predicate device. The subject device has similar technological characteristics to the predicate, and the descriptive and 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
- . 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 currently marketed predicate device.
10.Performance Testing
Performance Testing-Bench
Functional performance bench testing was conducted to demonstrate that the Volumat Polyethylene I.V. Administration Set performs as intended.
The following performance testing was conducted to support the substantial equivalence determination:
- ISO 8536-8 .
- o Leakage
- o Tensile Strength
- o Storage Tube Volume
- ISO 80369-20 ●
- o Luer Fittings
- Stress Cracking о
- Resistance to Separation from Axial Loading o
- Resistance to Separation from Unscrewing O
- o Resistance to Overriding
- ISO 8536-4 ●
- o Closure-piercing Device Testing
- Air-inlet Device Testing о
- Tubing Testing O
- Flow Requirements of the Infusion Pump O
- Drip Chamber Testing O
- Clamp Opening and Closing O
- Protective Cap Testing о
- Chemical Compatibility Testing O
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Image /page/10/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol is made up of three curved lines that are parallel to each other.
w.fresenius-kabi.us
- ISO 8536-14 ●
- 0 Clamps and Flow Regulators Testing
- ISO 11607-1 & 2 and ASTM D4169 ● O Sterile Barrier and Packaging Systems and Simulated Shipping
- Particulate 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 ●
- . Usability 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 Polyethylene I.V. Administration Set:
- Acute Systemic Toxicity
- Hemolysis ●
- Irritation ●
- Sensitization ●
- Cytotoxicity ●
- Pyrogens ●
- Subacute/subchronic toxicity ●
12. Sterilization Validation
Sterilization was achieved by ethylene oxide and meets the requirements of DIN EN 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.
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Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
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 Polyethylene I.V. Administration Set 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.