(125 days)
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.
The proposed set consists of non-DEHP PVC (< 0.1% DEHP) tubing, a notch clamp, a female Luer lock, a non-vented cap for a female Luer lock, a male Luer lock, and a filter vented cap for a male Luer lock.
The provided text describes the regulatory filing for a medical device called a "Blood Administration Set" (K210335) by Baxter Healthcare Corporation. It details the device's indications for use, technological characteristics, and substantial equivalence to a predicate device, as well as a list of nonclinical tests performed to support its safety and effectiveness.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 | Met acceptance criteria (all tests). |
| ISO 80369-7 Luer Tests on female 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 | Met acceptance criteria (all tests). |
| Tensile Strength Test | ISO 1135-4:2015, Clause 5.3 | Met acceptance criteria. |
| Leak Test (Pressure Test) | ISO 1135-4:2015, Annex A.2 | Met acceptance criteria. |
| Notch Clamp Activation Force Test | Activation force ≤50N | Met acceptance criteria. |
| Notch Clamp Shut-Off Test | No liquid or air leakage when subjected to 50kPa for 15 sec | Met acceptance criteria. |
| Non-DEHP Claim Verification | <0.1% DEHP | Met acceptance criteria. |
| Particulate Matter Test | USP <788> | Met acceptance criteria. |
| Flow Rate Testing | ISO 1135-4:2015, Section 5.9 | Met acceptance criteria. |
| ISO 1135-4 Blood Component Compatibility Test | ISO 1135-4, Clause 7.6 and 7.7 | Met acceptance criteria. |
Biocompatibility Tests:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Supported biocompatibility. |
| Sensitization | ISO 10993-10 | Supported biocompatibility. |
| Intracutaneous (Irritation) Reactivity | ISO 10993-10 | Supported biocompatibility. |
| Acute Systemic Toxicity | ISO 10993-11 | Supported biocompatibility. |
| 30 Day Systemic Repeat Dose Toxicity Study | ISO 10993-11 | Supported biocompatibility. |
| Material Mediated Pyrogen | ISO 10993-11 | Supported biocompatibility. |
| Hemocompatibility | ISO 10993-4 | Supported biocompatibility. |
Sterility Tests:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility | 10⁻⁶ Sterility Assurance Level (SAL) per ANSI/AAMI/ISO 11137-2, with MSDs between 14.2 - 25.0 kGy. Confirmed by periodic dose audit studies. | Met SAL. |
| Bacterial Endotoxins | Endotoxin limit of 20 EU/device per USP <161>. | In conformance to USP <85>. |
| Pre-sterilization Bioburden | Routine periodic testing performed. | Performed. |
Shelf-Life:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life | 3 (three) years | Supported. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each of the nonclinical tests. It refers to "risk analyses and design verification tests" and "bench tests" conducted by Baxter Healthcare Corporation. The data provenance is internal to Baxter Healthcare Corporation, indicated by "Baxter Healthcare Corporation conducts risk analyses and design verification tests". There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective, as these are nonclinical bench tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the studies described are nonclinical (bench) tests on the device's physical and functional properties, not clinical studies involving human patients or expert interpretation of medical data. Therefore, no "ground truth" was established by experts in a healthcare context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where human interpretation or expert consensus is required for complex outcomes.
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 section is not applicable as the device is a "Blood Administration Set," a physical medical device, not an AI software/algorithm requiring human reader evaluation. There is no mention of AI or human reading in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical tests, the "ground truth" or reference standards are the specified international and national standards (e.g., ISO 80369-7, ISO 1135-4, USP <788>, USP <85>, USP <161>, ISO 10993 series, ANSI/AAMI/ISO 11137 series) that the device must comply with. These standards define the acceptable performance parameters.
8. The sample size for the training set
This section is not applicable. The context is the regulatory filing for a physical medical device, not a machine learning model. There is no concept of a "training set" for the type of nonclinical tests performed for this device.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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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 Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2021
Baxter Healthcare Corporation James Vangeisen Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K210335
Trade/Device Name: Blood Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ Dated: May 4, 2021 Received: May 11, 2021
Dear James Vangeisen:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
Payal Patel 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210335
Device Name Blood Administration Set
Indications for Use (Describe)
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
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 slightly italicized, giving the word a sense of movement. The word is the logo for the company Baxter International, a global healthcare company.
510(k) Summary
K210335
June 10, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
James Vangeisen Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 3308 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Blood Administration Set Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ
| Code # | 2N3383 |
|---|---|
| Device Description | Blood Extension Set, 59" (150 cm), Vol. 4.7 mL |
| 1. | Non-Vented Cap for Female Luer Lock |
| 2. | Female Luer Lock |
| 3. | Notch Clamp |
| 4. | Tube |
| 5. | Male Luer Lock |
| 6. | Filter Vented Cap for Male Luer Lock |
Table 1. Proposed Set Configuration
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PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Blood AdministrationSets | Baxter HealthcareCorporation | K993120 | November 17, 1999 |
Table 2. Predicate Device
REASON FOR SUBMISSION:
The basis for this premarket notification is the intent to market an Intravascular (IV) Administration Set (Blood Administration Set). The proposed device in this submission is a single-use, 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:
The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.
The proposed set consists of non-DEHP PVC (< 0.1% DEHP) tubing, a notch clamp, a female Luer lock, a non-vented cap for a female Luer lock, a 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 most common use of this proposed set would be for syringe pump administration as a primary set and as an extension set. This proposed set can also be used as an extension set in combination with gravity and large volume infusion pump blood administration sets (primarily to add length). See Figure 1, Figure 2, and Figure 3 for the clinical use set ups for the proposed device.
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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 presented in a simple, clean design.
Figure 1. Clinical Use Set Up of Proposed Device when used directly with a Syringe as a Primary Syringe Set
Image /page/5/Figure/2 description: This image shows a medical setup with various components labeled. A "Male Luer Lock" is connected to a patient's vascular access device. A "Female Luer Lock" is connected to a syringe, which is labeled as a "Syringe (Container)". A "Shut Off Clamp" is positioned in the middle of the tube.
Figure 2. Clinical Use Set Up of Proposed Device when used as an Extension to a Primary Syringe Set
Image /page/5/Figure/4 description: This image shows a medical setup for administering fluids or medication to a patient. The setup includes a syringe connected to a primary syringe set, which is then connected to an extension set. A male luer lock connects to the patient's vascular access device, while a female luer lock connects to the syringe. A shut-off clamp is also included in the setup.
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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly slanted to the right. The word is likely a logo or brand name.
Image /page/6/Figure/1 description: The image shows a diagram of an intravenous (IV) infusion setup. The setup includes a solution container at the top, connected to a primary administration set. Further down, a female Luer lock connects the primary administration set to an extension set, which is then connected to a male Luer lock that is inserted into the patient's arm.
Figure 3. Clinical Use Set Up of Proposed Device when used as an Extension to a Primary Administration Set
INDICATIONS FOR USE:
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device is substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K993120 on November 17, 1999. The intended use and function of the proposed device is equivalent to the predicate device.
Table 3 is a device comparison table outlining the differences between the predicate and proposed devices.
| Features | Predicate DeviceK993120 | Proposed DeviceK210335 | Assessment of Differences |
|---|---|---|---|
| Intended Use | For the administration offluids from a container intothe patient's vascularsystem through a vascularaccess device. | Same | N/A |
| Indication for Use | For the administration ofblood, blood components orsolutions from a containerinto the patient's vascularsystem through a vascularaccess device. | Same | N/A |
| Regulation Number | 21 CFR 880.5440 | Same | N/A |
| Product Code | BRZ | Same | N/A |
| Sterile | Gamma radiation | Same | N/A |
| Sterility AssuranceLevel (SAL) | 10⁻⁶ | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 112" (2.8 m)(2C8750) | 59" (150 cm)(2N3383) | The predicate device iscomparatively longer than theproposed device.Design control activities have beenconducted and confirmed, throughclinical studies, that the length of theproposed device ensures a safedelivery without excessivemanipulation of the set and patientdiscomfort. |
| Features | Predicate DeviceK993120 | Proposed DeviceK210335 | Assessment of Differences |
| Fluid Path Components/Materials | The proposed device can also beused as an extension set that allowsthe clinician to extend the length ofthe primary set, when and if needed.A recommended clinical practice,when selecting the overall length ofthe set, is for the clinician to try andavoid using excessive lengths tominimize residual volumes andretain flow accuracy. From thisassessment it can be concluded thatthe proposed shorter set does notraise different questions of safetyand effectiveness when compared tothe predicate device. | ||
| Spike | Acrylonitrile ButadieneStyrene(2C8750) | N/A | The proposed device is an extensionset and does not contain a spike. |
| BloodChamber | Styrene-Butadiene BlendedCopolymer (Chamber andFilter Housing)Polyester -Filter membrane(Mesh)(2C8750) | N/A | The proposed device is an extensionset and does not contain a bloodchamber. |
| Tubing | Polyvinyl Chloride(2C8750) | Same | N/A |
| Injection Site | ClearlinkPolycarbonate (Inlet/OutletHousing)Silicone (Gland)Polycarbonate (Center Post)(2C8750) | N/A | The proposed device is an extensionset and does not contain an injectionsite. |
| Female LuerLock | N/A | Polymethylmethacrylate(Acrylic) | The predicate device does not have afemale Luer Lock. Design controlactivities have been conducted andhave confirmed that the different |
| Features | Predicate DeviceK993120 | Proposed DeviceK210335 | Assessment of Differences |
| technological characteristics of the proposed devices do not raise different questions of safety and effectiveness. | |||
| Male LuerLock | Acrylonitrile ButadieneStyrene(2C8750) | Same | N/A |
Table 3. Device Comparison
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be a corporate logo. The word is horizontally oriented and takes up most of the image space.
Table 3. Device Comparison
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Table 3. 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 4) were conducted to evaluate the functional performance of the proposed devices:
| Test | Acceptance Criteria |
|---|---|
| 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 |
| ISO 80369-7 Luer Tests on female 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 |
| Tensile Strength Test | ISO 1135-4:2015, Clause 5.3 |
| Leak Test (Pressure Test) | ISO 1135-4:2015, Annex A.2 |
| Notch Clamp Activation Force Test | Activation force ≤50N |
| Notch Clamp Shut-Off Test | No liquid or air leakage when subjected to50kPa for 15 sec |
| Non-DEHP Claim Verification | <0.1% DEHP |
| Particulate Matter Test | USP <788> |
| Flow Rate Testing | ISO 1135-4:2015, Section 5.9 |
| ISO 1135-4 Blood Component Compatibility Test | ISO 1135-4, Clause 7.6 and 7.7 |
Table 4. Performance Data
All tests met the acceptance criteria.
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Biocompatibility:
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path 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, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]." Biocompatibility assessments were conducted on a worst case/representative final, finished device for all fluid path materials of the proposed device. 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
- Material Mediated Pyrogen 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
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Image /page/12/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.
device was established in accordance with ANSI/AAMI/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.
CONCLUSION:
The non-clinical data demonstrate that the subject device is substantially equivalent and performed 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.