(224 days)
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.
The BD Secondary Infusion Set is an administration set consisting primarily of a bag spike, drip chamber, tubing, roller clamp, micro luer lock connector, and a hanger. The drip chamber cap is located at the proximal end of the administration set, and the micro luer lock cap is located at the distal end of the administration set. The bag spike, located on the proximal end of the drip chamber is inserted into a prepared fluid container. The BD Secondary Infusion Set is supplied as fluid-path sterile using gamma irradiation in a perforated pouch, is non-pyrogenic, and is for single-use only. The BD Secondary Infusion Set is for gravity administration. The device is intended for prescription use (RX) only. DEHP or natural rubber latex are not part of the material formulation. The set can be used for up to 7 days (168 hours) provided the set is continuously attached to the primary administration set.
This request is about a medical device, not an AI/ML powered device. The document describes a 510(k) premarket notification for a medical device called the "BD Secondary Infusion Set." It does not involve any AI or machine learning components. Therefore, the questions related to acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical safety and performance testing, and biocompatibility testing. It explicitly states: "Not Applicable. There are no clinical data included in this submission."
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several FDA-recognized consensus standards that the device met. It states: "The subject device met the applicable test specifications and acceptance criteria as described in the submission." However, it does not provide a table with specific numerical acceptance criteria and reported performance values. It only lists the standards themselves:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 594-1:1986 (Conical fittings with a 6% (Luer) taper) | Met applicable test specifications and acceptance criteria |
| ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper - Lock fittings) | Met applicable test specifications and acceptance criteria |
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Met applicable test specifications and acceptance criteria |
| ISO 8536-14:2016 (Clamps and flow regulators) | Met applicable test specifications and acceptance criteria |
| USP 41, National Formulary 36 (USP), General Chapter <788> (Particulate Matter In Injections) | Met applicable test specifications and acceptance criteria |
| ISO 11137-1:2006 (Sterilization - Radiation - Requirements) | Met applicable test specifications and acceptance criteria |
| ISO 11137-2:2013 (Sterilization - Radiation - Establishing sterilization dose) | Met applicable test specifications and acceptance criteria |
| ISO 11737-1:2018 (Microbiological methods - Determination of a population of microorganisms) | Met applicable test specifications and acceptance criteria |
| ISO 11607-1:2019 (Packaging for terminally sterilized medical devices) | Met applicable test specifications and acceptance criteria |
| ISO 10993-1, -4, -5, -10, -11 (Biocompatibility) | Met applicable test specifications and acceptance criteria |
| ASTM F756 (Hemocompatibility) | Met applicable test specifications and acceptance criteria |
| Specific functional characteristics mentioned in comparison table: | |
| Priming Volume (10016073: 11 mL; 72215N: 13 mL) | Verification testing completed |
| Drip Rate (10016073: 20/mL; 72215N: 15/mL) | Verification testing conducted to confirm performance |
| Device Duration (Up to 7 days (168 hours)) | Verification testing was conducted to show performance |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "bench and nonclinical testing" was conducted according to various standards, but does not detail the sample sizes for these tests.
- Data provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by CareFusion/BD, as is typical for non-clinical device testing for 510(k) submissions. There is no mention of country of origin of data in a research context. It's retrospective in the sense that the testing was completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. For non-AI/ML medical device testing like this, "ground truth" is typically established by physical measurements, chemical analysis, and adherence to established engineering and biological standards, rather than expert consensus on data interpretation.
4. Adjudication method for the test set:
This is not applicable. Device performance is assessed against predefined specifications and standard test methods (e.g., fluid flow rates, material compatibility, sterility checks), not through human adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical and biocompatibility testing, the "ground truth" is based on:
- Adherence to recognized consensus standards (e.g., ISO, USP, ASTM).
- Physical and chemical measurements meeting predefined engineering specifications (e.g., priming volume, drip rate accuracy, material properties).
- Biological responses in controlled laboratory tests (e.g., cytotoxicity, sensitization, hemocompatibility).
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" as this is not an AI/ML device.
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May 12, 2023
CareFusion Paulina Davis Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121
Re: K223101
Trade/Device Name: BD Secondary Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 12, 2023 Received: April 13, 2023
Dear Paulina Davis:
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/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
David Walloschek
David Wolloscheck, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223101
Device Name BD Secondary Infusion Set
Indications for Use (Describe)
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 8 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K223101
| Submitter Name: | CareFusion | |
|---|---|---|
| Submitter Address: | 10020 Pacific Mesa BlvdSan Diego, CA 92121, USA | |
| SubmitterInformation | Contact Person: | Paulina DavisStaff Regulatory Affairs SpecialistPhone: 714-330-6037Email Address: Paulina.Davis@BD.com |
| Date of Preparation: | May 8, 2023 | |
| Trade Name: | BD Secondary Infusion Set | |
| Common Name: | Intravascular Administration Set and Extension Set | |
| Regulation Name: | Intravascular Administration Set | |
| Subject Device | Classification Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 | |
| Regulatory Class: | Class II | |
| Product Code: | FPA | |
| Trade Name: | Intravascular Administration Set and Extension Set | |
| Premarket Notification #: | K051499 | |
| Regulation Name: | Intravascular Administration Set | |
| Classification Panel: | General Hospital | |
| Predicate Device | Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II | |
| Product Code: | FPA | |
| Manufacturer: | Medegen Medical Manufacturing Services(Now owned by Becton, Dickinson and Company) |
| Reason forSubmission | CareFusion is submitting this traditional premarket notification for the BDSecondary Infusion Set in support of a new 510(k) baseline for theSecondary Infusion Set. |
|---|---|
| Device Description | The BD Secondary Infusion Set is an administration set consistingprimarily of a bag spike, drip chamber, tubing, roller clamp, micro luerlock connector, and a hanger. The drip chamber cap is located at theproximal end of the administration set, and the micro luer lock cap islocated at the distal end of the administration set. The bag spike, locatedon the proximal end of the drip chamber is inserted into a prepared fluidcontainer. The BD Secondary Infusion Set is supplied as fluid-path sterileusing gamma irradiation in a perforated pouch, is non-pyrogenic, and is for |
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Image /page/4/Picture/0 description: The image shows the CareFusion logo, which includes an orange circle with a white shield inside. A portion of the shield is colored yellow. To the right of the logo is the text "CareFusion" in gray. Below the word "CareFusion" is the text "has joined BD" in a smaller, lighter gray font.
| single-use only. The BD Secondary Infusion Set is for gravityadministration. The device is intended for prescription use (RX) only.DEHP or natural rubber latex are not part of the material formulation. Theset can be used for up to 7 days (168 hours) provided the set iscontinuously attached to the primary administration set. | |
|---|---|
| Intended Use | The BD Secondary Infusion Set is intended for the intravascularadministration of fluids from a container to a patient's vascular system. |
| Indications for Use | The BD Secondary Set is indicated for continuous or intermittent delivery ofIV fluids, medications, including lipids, through intravascular routes ofadministration. The BD Secondary Set may be used with any patientpopulation with consideration given to the procedure being performed andfluids being infused. |
| TechnologicalCharacteristics | The BD Secondary Infusion Set was shown to be substantially equivalent tothe predicate device cleared per K051499. Any differences in technologicalcharacteristics such as the material were addressed throughbiocompatibility and performance testing. The biocompatibility andperformance data demonstrated substantial equivalence. There were nonew questions of safety or effectiveness. |
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The following table provides a comparison between the subject and the predicate device.
| Characteristic | Subject Device:BD Secondary Infusion Sets | Predicate Device:Intravascular Administration andExtension Sets | Equivalence Discussion |
|---|---|---|---|
| 510(k) Status | Subject of 510(k) | K051499Clearance date June 22, 2005 | N/A |
| Applicant | CareFusion (Now BD) | Medegen Medical ManufacturingServices (Now BD) | N/A |
| Model Numbers | 72215N10016073 | Various | N/A |
| ClassificationRegulation | Same as predicate | 21 CFR 880.5440 | N/A |
| Regulation Name | Same as predicate | Intravascular Administration Set | N/A |
| Device Class | Same as predicate | ll | N/A |
| Product Code | Same as predicate | FPA | N/A |
| Review Branch | Same as predicate | General Hospital | N/A |
| Indications for Use | The BD Secondary Set is indicatedfor continuous or intermittentdelivery of IV fluids, medications,including lipids through intravascularroutes of administration. The BDSecondary Set may be used with | The Intravascular Administration Set andExtension Set is a device used toadminister fluids from a container to apatient's vascular system through aneedle or catheter inserted into thepatient's artery or vein. The Intravascular | The indications are essentially thesame with the exception being thesubject device lists specific fluidtypes and a general patientpopulation. The predicate devicedoes not specify fluid types or |
| Characteristic | Subject Device:BD Secondary Infusion Sets | Predicate Device:Intravascular Administration andExtension Sets | Equivalence Discussion |
| any patient population withconsideration given to theprocedure being performed andfluids being infused. | Administration Set and Extension Setmay incorporate componentry that aid inthe prevention of accidental needlesticks. | patient population. The subjectdevice fluids were assessed basedon clinical use. Functional testingon the subject device wasconducted to demonstratecompatibility with fluid types. | |
| Intended Use | The BD Secondary Infusion Set isintended for the intravascularadministration of fluids from acontainer to a patient's vascularsystem. | The Intravascular Administration Set andExtension Set is a device used toadminister fluids from a container to apatient's vascular system through aneedle or catheter inserted into thepatient's artery or vein. | The subject device intended use isthe same; intended for fluidadministration to the patient'svascular system through a needleor catheter. |
| Drip Chamber | PVC, AcrylonitrileButadiene Styrene (ABS),Polyethylene | Butadiene Styrene (ABS),Polypropylene, PTFE/PES, PVC | The safety of materials thatcomprise the finished device wasdemonstrated by the results ofbiocompatibility. |
| Tubing (NonDEHP) | Same as predicate | PVC | The safety of materials thatcomprise the finished device wasdemonstrated by the results ofbiocompatibility. |
| Characteristic | Subject Device:BD Secondary Infusion Sets | Predicate Device:Intravascular Administration andExtension Sets | Equivalence Discussion |
| Roller Clamp | AcrylonitrileButadiene Styrene (ABS) | Material type not listed in predicate510(k) | Roller clamp is not patientcontacting. Verification testing wascompleted to demonstrate theperformance of the roller clamp. |
| Male Luer Lock | Modified AcrylonitrileButadiene Styrene (MABS) | Acrylic | The safety of materials thatcomprise the finished device wasdemonstrated by the results ofbiocompatibility. |
| Male Luer LockCap | Polyethylene | Polypropylene | The safety of materials thatcomprise the finished device wasdemonstrated by the results ofbiocompatibility. |
| Hanger | Same as predicate | HDPE | N/A |
| Set Length | 10016073: 31 inches72215N: 40 inches | 40 inches | Substantially equivalent; the subjectand predicate devices have asimilar set length. |
| Priming Volume | 10016073: 11 mL72215N: 13 mL | Not listed in predicate 510(k) | Verification testing was completedfor the priming volume. |
| Drip Rate | 10016073: 20/mL72215N: 15/mL | 15/mL and 20/mL | Verification testing was conductedto confirm performance of drip rate. |
| Characteristic | Subject Device:BD Secondary Infusion Sets | Predicate Device:Intravascular Administration andExtension Sets | Equivalence Discussion |
| Packaging Type | Perforated Pouch | Peelable Tyvek/Film Pouch | The packaging is not the sterilebarrier. The sterile barrier consistsof the drip chamber cap and maleluer cap. Microbial barrier testingwas conducted as part of shelf-lifeperformance testing. |
| SterilizationMethod | Same as predicate | Irradiation | N/A |
| Sterility AssuranceLevel | Same as predicate | 10-6 | N/A |
| Device Utility | Same as predicate | Disposable, Single use only, Fluid pathsterile | N/A |
| Shelf Life | Same as predicate | 3 years | N/A |
| Device Duration | Up to 7 days (168 hours) | Up to 96 hours | Verification testing was conductedto show performance of the subjectdevice for the intended duration of 7days (168 hours). |
| Mode of FluidDelivery | Same as predicate | Gravity | N/A |
| Biocompatibility | Same as predicate | Meets ISO 10993 | N/A |
3 | Раде
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Safety and Performance Testing
Nonclinical Testing
The BD Secondary Infusion Set was evaluated via non-clinical safety and performance testing to demonstrate that the subject device is substantially equivalent to the predicate device.
The bench and nonclinical testing on the BD Secondary Infusion Set was conducted according to the following FDA recognized consensus standards listed below. The subject device met the applicable test specifications and acceptance criteria as described in the submission.
- . FDA Recognition Number 6-11, ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- . FDA Recognition Number 6-129, ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- . FDA Recognition Number 6-447, ISO 8536-4:2019, Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed
- . ISO 8536-14:2016, Infusion equipment for medical use – Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- . USP 41, National Formulary 36 (USP), General Chapter <788> Particulate Matter In Injections
- FDA Recognition Number 14-528, ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
- FDA Recognition Number 14-409, ISO 11137-2:2013, Sterilization of health care . products - Radiation - Part 2: Establishing the sterilization dose
- FDA Recognition Number 14- 514, ISO 11737-1:2018, Sterilization of health care . products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
- . FDA Recognition Number 14-530. ISO 11607-1:2019. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Biocompatibility
Biocompatibility tests for the subject device were performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk
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Management Process as recognized by the FDA. The BD Secondary Infusion Set is categorized as an externally communicating, indirect blood path, prolonged (> 24 hours to 30 days) device in accordance with ISO 10993-1 and 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 battery of tests included the following:
- Cytotoxicity (ISO 10993-5, FDA recognition number 2-245) ●
- Sensitization (ISO 10993-10, FDA recognition number 2-296) .
- Irritation or Intracutaneous Activity (ISO 10993-10, FDA recognition number 2-296) ●
- Acute Systemic Toxicity (ISO 10993-11, FDA recognition number 2-255) ●
- Sub-acute/ Sub-chronic Toxicity (ISO 10993-11, FDA recognition number 2-255) ●
- Material Mediated Pyrogenicity (ISO 10993-11, FDA recognition number 2-255) ●
- Hemocompatibility (ASTM F756, FDA Recognition number 2-250 and ISO 10993-4, ● FDA recognition number 2-248)
Clinical Data
Not Applicable. There are no clinical data included in this submission.
Conclusion
The information provided in this 510(k) submission, including the non-clinical safety and performing testing, is sufficient to demonstrate substantial equivalence of the BD Secondary Infusion Set to the predicate device. The BD Secondary Infusion Set and its predicate have similar indications for use, the same intended use, and similar technological characteristics. Any differences between the subject and predicate devices are supported by performance data and do not raise new questions of safety and effectiveness.
§ 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.