(262 days)
Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.
Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.
Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.
The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (< 0.1% DEHP) tubing, blood chamber, 200 um Filter, Clearlink Luer Activated Valve (LAV), notch clamp, female Luer lock, dual anti-syphon valve, male Luer lock, and a filter vented cap for a male Luer lock. It can be used to administer solutions, blood, and blood products to the patient.
The blood set (2N3385) will be used for syringe-based infusion. The clinician attaches the blood set to a blood bag and manually draws blood into a syringe. The blood is then delivered into the patient's vascular system through a vascular access device.
The provided text describes a medical device, "Blood Administration Sets," and its substantial equivalence to a predicate device, but it does not contain information relevant to AI/ML device acceptance criteria or studies. The document is a 510(k) premarket notification for a traditional medical device (intravascular administration set), not an AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from this document.
The document focuses on:
- Device Description: Physical components, materials, and intended use as a blood administration set.
- Technological Characteristics Comparison: A detailed table comparing the proposed device (2N3385) with a predicate device (2N3383), highlighting differences like length, priming volume, and specific components (e.g., spike, blood chamber, dual anti-siphon valve, Clearlink LAV).
- Nonclinical Tests: Bench tests (e.g., Luer tests, tensile strength, leak tests, blood filter tests, spike tests, LAV tests, particulate matter, DEHP claim, blood compatibility, microbial ingress, shelf-life, shipping simulation) to evaluate functional performance and safety.
- Biocompatibility: Assessments per ISO 10993-1.
- Sterility: Validation of gamma radiation sterilization according to ISO 11137-2.
- Shelf-Life: 3-year claim supported by aging testing.
- Microbial Ingress Testing: Evaluations of potential entry points.
All these tests are standard for conventional medical devices and do not involve AI/ML performance evaluation.
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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.
November 17, 2022
Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K220558
Trade/Device Name: Blood Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ Dated: October 17, 2022 Received: October 21, 2022
Dear Meaghan Bonn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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. For Joyce M. Whang, Ph.D. Acting 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) K220558
Device Name
Blood Administration Sets
Indications for Use (Describe)
Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.
Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.
| 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 word "Baxter" in a bold, blue font. The font is sans-serif and appears to be italicized. The word is the logo for the healthcare company Baxter International.
K220558 510(k) Summary
November 17, 2022
OWNER:
Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073
CONTACT PERSON:
Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 6470 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Blood Administration Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Common Name: Blood Transfusion Set Regulation Name: Intravascular Administration Sets Regulatory Class: Class II Product Code: BRZ
Image /page/3/Figure/9 description: This image shows a medical device called a Blood Extension Set. The code for the device is 2N3383, and the device is 59 inches (150 cm) long with a volume of 4.7 mL. The image shows the different parts of the device, including a Non-Vented Cap for Female Luer Lock, Female Luer Lock, Notch Clamp, Tube, Male Luer Lock, and Filter Vented Cap for Male Luer Lock.
Table 1. Current Product Line
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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the logo for the healthcare company Baxter International.
Image /page/4/Figure/1 description: The image shows a table with two rows describing medical devices. The first row describes a "Blood Extension Set, 59" (150 cm), Vol. 4.7 mL" with code "2N3383", and it includes a diagram of the device with numbered components, along with a numbered list describing each component. The second row describes an "Integrated Blood Set, 71" (180 cm), Vol 6.3 mL" with code "2N3385", and it also includes a diagram of the device with numbered components, along with a numbered list describing each component.
Table 2. Proposed Product Line
PREDICATE DEVICE:
Table 3. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Blood AdministrationSets | Baxter HealthcareCorporation | K210335(Model 2N3383) | June 10, 2021 |
REASON FOR SUBMISSION:
The basis for this premarket notification is the addition of another blood set configuration (Product Code 2N3385) to the current product line to provide an additional option to the clinician. The proposed device is a single use, non-pyrogenic, sterile, disposable device, intended for the administration of fluids from a container into the patient's vascular system through a vascular access device.
DESCRIPTION OF THE DEVICE:
Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.
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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the primary focus of the image and is positioned horizontally.
The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (< 0.1% DEHP) tubing, blood chamber, 200 um Filter, Clearlink Luer Activated Valve (LAV), notch clamp, female Luer lock, dual anti-syphon valve, male Luer lock, and a filter vented cap for a male Luer lock. It can be used to administer solutions, blood, and blood products to the patient. See Table 2 for the proposed device's configuration (Product Code 2N3385). See Figure 1 for a photograph of the proposed device.
Image /page/5/Picture/2 description: The image shows an intravenous (IV) infusion set laid out on a wooden surface. The IV set includes a drip chamber at the top, connected to a series of clear plastic tubes. There are several clamps along the tubing to control the flow of fluid. The tubing is arranged in loops and straight lines, leading to a connector at the end.
Figure 1. Photograph of the proposed Blood Set (Code # 2N3385)
The blood set (2N3385) will be used for syringe-based infusion. The clinician attaches the blood set to a blood bag and manually draws blood into a syringe. The blood is then delivered into the patient's vascular system through a vascular access device. See Figure 2 for the clinical set up for the proposed device. The total blood component volume administered via this set would be equivalent to the number of syringes filled from an aliquot of blood (i.e. typically a volume of 120-150 mL), therefore, clinical applications for the proposed device (2N3385) are limited to pediatric and neonatal patients requiring small volumes of blood.
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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the primary focus of the image and is positioned horizontally.
Image /page/6/Figure/1 description: This image shows a diagram of a blood transfusion process. The diagram includes labels such as "Blood Container", "Blood Drip Chamber with 200um Filter", "Male Luer Lock", "Shut Off", "Clearlink (LAV)", "Dual Anti-Siphon", and "Syringe". The diagram also includes two steps: "Step 1: Draw blood from the blood container to the syringe manually" and "Step 2: Deliver blood from the syringe to the patient."
Figure 2. Clinical Use Set Up of the proposed Blood Set (Code # 2N3385)
INDICATIONS FOR USE:
Applicable to Product Code 2N3383: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Applicable to Product Code 2N3385: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device. Only for use with Neonates and Pediatrics. Not for use in Trauma situations.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device is substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K210335 on June 10, 2021. The intended use and function of the proposed device is equivalent to the predicate device.
Table 4 is a device comparison table outlining the differences between the predicate and proposed devices.
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| Features | Predicate DeviceK210335(Product Code2N3383) | Proposed Device(Product Code2N3385) | Assessment of Differences |
|---|---|---|---|
| Intended Use | For the administrationof fluids from acontainer into thepatient's vascularsystem through avascular access device. | Same | N/A |
| Indicationfor Use | For the administrationof blood, bloodcomponents orsolutions from acontainer into thepatient's vascularsystem through avascular access device. | For the administrationof blood, bloodcomponents orsolutions from acontainer into thepatient's vascularsystem through avascular accessdevice. Only for usewith Neonates andPediatrics. Not foruse in Traumasituations. | The total blood component volumeadministered via the proposeddevice would be equivalent to thenumber of syringes filled from analiquot of blood (i.e. typically avolume of 120-150 mL), therefore,clinical applications for theproposed device are limited topediatric and neonatal patientsrequiring small volumes of blood.Trauma situations would requirelarger volumes of blood than the120-150 mL in an aliquot of blood,therefore, the integrated blood setwould not be clinically appropriatefor a trauma situation. |
| RegulationNumber | 21 CFR 880.5440 | Same | N/A |
| ProductCode | BRZ | Same | N/A |
| Sterility | Sterile; Gammaradiation | Same | N/A |
| SterilityAssuranceLevel (SAL) | 10-6 | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 59" (150 cm) | 71" (180 cm)(from the ClearlinkLAV to the FilterVented Cap for MaleLuer Lock) | The proposed device is longer thanthe predicate device.Design control activities have beenconducted and have confirmed,through design validation, that thelength of the proposed deviceensures a safe delivery withoutexcessive manipulation of the set |
| Features | Predicate DeviceK210335(Product Code2N3383) | Proposed Device(Product Code2N3385) | Assessment of Differences |
| and patient discomfort. The longerlength of the proposed device doesnot raise different questions ofsafety and effectiveness. | |||
| Tubing Inner/ OuterDiameter | Inner Diameter: 2.0mmOuter Diameter: 3.6mm | Same | N/A |
| PrimingVolume | 4.7 mL | 6.3 mL(from the ClearlinkLAV to the FilterVented Cap for MaleLuer Lock) | The proposed device primingvolume is nominally more than thepredicate device priming volume.Design control activities have beenconducted and have confirmed thatthe different technologicalcharacteristics of the proposeddevice does not raise differentquestions of safety andeffectiveness. Priming volume wasdetermined per Baxter test method. |
| Fluid Path Components/Materials | |||
| Spike | N/A | AcrylonitrileButadiene Styrene | The predicate device does not havethis spike design.Design control activities have beenconducted and have confirmed thatthe different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. Testing wasperformed per the standards and/oracceptance criteria listed in Table 5,line 12 through line 16. |
| BloodChamber | N/A | Polyvinyl Chloride(Chamber)Polypropylene(Filter Housing)Polyamide (Nylon)(Filter Mesh) | The predicate device does not havethis type of blood filter design.Design control activities have beenconducted and have confirmed thatthe different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. Testing was |
| Predicate DeviceK210335(Product Code2N3383) | Proposed Device(Product Code2N3385) | ||
| Features | Assessment of Differences | ||
| Dual Anti-SiphonValve | N/A | Polycarbonate(Housing)Silicone (Membrane) | acceptance criteria listed in Table 5,line 9 through line 11.The predicate device does not have adual anti-syphon valve.Design control activities have beenconducted and have confirmed thatthe different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. Testing wasperformed per the standards and/oracceptance criteria listed in Table 5,line 6 through line 8. |
| Tubing | Polyvinyl Chloride | Same | N/A |
| Injection Site | N/A | Clearlink LAVPolycarbonate(Inlet/Outlet Housing)Silicone (Gland)Polycarbonate(Center Post) | The predicate device does not have aClearlink LAV.Design control activities have beenconducted and have confirmed thatthe different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. Testing wasperformed per the standards and/oracceptance criteria listed in Table 5,line 17. |
| Female LuerLock | Polymethylmethacrylate (Acrylic) | Same | N/A |
| Male LuerLock | Acrylonitrile ButadieneStyrene | Same | N/A |
Table 4. Device Comparison
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Table 4. Device Comparison
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Table 4. Device Comparison
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DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.
Performance Data:
The following bench tests (Table 5) were conducted to evaluate the functional performance of the proposed device:
| LineItem# | Test | Acceptance Criteria |
|---|---|---|
| 1 | ISO 80369-7 Luer Tests on male Luer Lock Connector | ISO 80369-7:2016, Clause 6.1.2 or 6.1.3,ISO 80369-7:2016, Clause 6.2,ISO 80369-7:2016, Clause 6.3,ISO 80369-7:2016, Clause 6.4,ISO 80369-7:2016, Clause 6.5,ISO 80369-7:2016, Clause 6.6,ISO 80369-7:2016, Clause 5 |
| 2 | Tensile Strength Test | ISO 1135-5:2015, Clause 6.3 |
| 3 | Leak Test (Pressure Test) | ISO 1135-5:2015, Clause 6.2 |
| 4 | Notch Clamp Activation Force Test | Activation force ≤ 50 N |
| 5 | Notch Clamp Shut-Off Test | No liquid or air leakage when subjected to 50 kPa for 15 sec |
| 6 | Counter Flow Test | ISO 8536-12:2007+A1:2013, Clause 6.5 |
| 7 | Blocking Performance Test | ISO 8536-12:2007+A1:2013, Clause 6.7 |
| 8 | Opening Pressure | Opening Pressure > 14.7 kPa |
| 9 | Blood Filter Tests (Uniform Pore Size DimensionalCompliance Test) | ISO 1135-5, Clause 6.6 |
| 10 | Blood Filter Tests (Particle Retention Test) | ISO 1135-5, Clause 6.6 |
| 11 | Chamber Squeezing Test | Force required to squeeze ≤ 91 N |
| 12 | ISO Spike Tests (Dimensional Compliance Test) | ISO 8536-4:2013+A1:2013, Section 6.4 |
| 13 | ISO Spike Tests (Spike Secure Connection Test) | ISO 1135-5, Clause 6.4.No water leakage after spike to containerconnection of 5 hours |
| 14 | ISO Spike Tests (Spike Coring test) | ISO 1135-5, Clause 6.4 |
| 15 | ISO Spike Tests (Spike to Blood Bag Traction Test) | ISO 1135-5, Clause 6.4.3 |
Table 5. Performance Data
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| LineItem# | Test | Acceptance Criteria |
|---|---|---|
| 16 | ISO Spike Tests (Spike to Blood Bag Leak Test) | ISO 1135-5, Clause 6.4.4 |
| 17 | Clearlink LAV Tests (Clearlink LAV Leak Test - Post100 Actuations) | No leakage when subjected to 200kPa for 15sec after 100 actuations |
| 18 | Particulate Matter Test | USP <788> |
| 19 | Non-DEHP Claim Verification (<0.1% DEHP m/m) | <0.1% DEHP m/m |
| 20 | ISO 1135-5 Blood Component Compatibility Test | ISO 1135-5, Clause 8.6 and 8.7; ISO 1135-4,Clause 7.6 and 7.7 |
| 21 | Shelf Life Microbial Ingress Testing of the ClearlinkLuer Activated Valve (LAV) During SimulatedClinical Use | ANSI/AAMI CN27:2021; Annex E |
| 22 | Functional Performance Testing after SimulatedShipping/Transportation | No damaged product, including but notlimited to, cracked or broken components,separated tip protectors, wall to wall kinkedtubing. |
Table 5. Performance Data
All tests met the acceptance criteria.
Biocompatibility:
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices and FDA-2013-D-0350 Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," as recommended in the Intravascular Administration Sets guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]." Biocompatibility assessments were conducted on final, finished devices to meet an ISO 10993-1 categorization of external communicating device, indirect blood path, prolonged contact duration. The following tests were conducted as part of the biocompatibility assessment for the proposed device:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10 ●
- Acute Systemic Toxicity ISO 10993-11
- 30 Day Systemic Repeat Dose Toxicity Study ISO 10993-11
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- Material Mediated Pvrogen ISO 10993-11
- Hemocompatibility ISO 10993-4
Based upon the results, the data supports an ISO 10993-1 categorization of external communicating device, indirect blood path, prolonged contact duration. The proposed device is biocompatible and appropriate for its intended use.
Sterility:
The proposed device is sterilized with gamma radiation. The product is in the bioburden (sub) category "General Sets Labeled Sterile". The Minimum Sterilizing Dose (MSD) required to provide a 106 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products – Radiation-Part 2: Establishing the sterilization dose." The dose setting method used includes, but is not limited to, Method 1 or VDmax. Generally, the MSDs are between 14.2 – 25.0 kGy. The continued validity of the MSD for this (sub) category is confirmed via periodic dose audit studies. Bacterial endotoxins tests were conducted in conformance to USP <85>. The endotoxin limit is 20 EU/device per USP <161>. In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category. The sterilization process for the proposed device was established in accordance with ANSVAAMI/ISO 11137-1, "Sterilization of health care products-Radiation-Part 1; Requirements for development, validation and routine control of a sterilization process for medical devices."
Shelf-Life:
Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
Microbial Ingress Testing:
Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed device. The potential microbial entry points consist of the Clearlink Luer Activated Valve (LAV), the male Luer connector site, and the spike interface. Microbial ingress testing was conducted on the Clearlink LAV following section 8 of FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008. The male Luer connector site was tested following Baxter's test method (as previously cleared under K180739) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. The spike interface was tested following Baxter's test method (as previously cleared under K180739) of challenging the
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interface during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. All test results met their acceptance criteria and support that the proposed device is appropriately designed for its intended use.
CONCLUSION:
The differences between the predicate and the subject device do not raise any new or different questions of safety and effectiveness. The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is legally marketed for the same intended use.
§ 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.