(80 days)
The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.
The neria™ guard Infusion Set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.
This document describes the premarket notification (510(k)) for the neria™ guard Infusion Set. Since this is an infusion set and not an AI/ML powered device, several of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI/ML study design are not applicable.
Here's the information extracted from the provided text regarding the acceptance criteria and the studies conducted for the neria™ guard Infusion Set:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various non-clinical performance tests conducted to demonstrate the safety and effectiveness of the neria™ guard Infusion Set and its substantial equivalence to the predicate device. The general acceptance criterion is that the device "meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design inputs and specifications for the device." Specific quantitative acceptance criteria or precise performance metrics are not detailed in this summary for each functional test, but rather that the device "met the requirements" of the relevant standards and internal tests.
| Test Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | The sterility of the device is assured using a validated sterilization method in accordance with ISO 11135:2014. |
| Biocompatibility | ISO 10993-1:2009 (Biological Evaluation of Medical Devices) & FDA Guidance (June 16, 2016) | The biological safety was demonstrated through testing including: Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute and 14-day Systemic toxicity, Material Mediated Pyrogenicity, Hemolysis, Particulate Testing, Chemical Characterization, Genotoxicity (AMES and MLA). The device complies with ISO 10993-1. |
| Shelf Life | ASTM F1980:2011 (Accelerated Aging of Sterile Barrier Systems) | A maximum shelf life of 3 years was determined. |
| Functional Testing | Placement Introducer Needle before and after activation, Tensile Test Base-Connector, Functional Test Adhesive Liner, Contents in Blister Package, Functional Test Serter, Tensile Test Needle Hub, Soft Cannula Tensile Test, Base-Adhesive Patch Peel Test, Packaging, Disassemble fluid part from base, Disassemble base from cylinder, Serter Activation Force, Leak Test, Flow Test, Distance Introducer Needle bevel to Soft Cannula tip, Distance Soft Cannula tip to bottom fluid part, Visual Test of IFU, Blister Lid and Inner and Outer box label, Disassemble Cylinder from Cover, Drug Compatibility Testing, Tensile Strength Packaging and Labelling tests. | The neria™ guard Infusion Set met the requirements for these internal performance tests. |
| Packaging | ISO 11607-1:2009, ISO 11607-2:2006, ASTM D4169-16 | Packaging tests were conducted and met requirements. |
| Risk Management | ISO 14971:2012 | Application of risk management principles per standard. |
2. Sample size used for the test set and the data provenance
The document indicates that "a number of non-clinical performance tests" were completed. However, specific sample sizes for each test are not provided in this summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these were non-clinical, in-vitro/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is an infusion set, not an AI/ML powered device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and the functional performance against engineering specifications and international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the device is an infusion set, not an AI/ML powered device. Adjudication methods are typically relevant for human review of AI/ML performance.
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 question is not applicable as the device is an infusion set, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is an infusion set, not an AI/ML powered device. The "standalone" performance here refers to the device's functional performance as described in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device (infusion set), the "ground truth" is established by:
- International Standards: e.g., ISO, ASTM standards for sterilization, biocompatibility, packaging, and functional performance.
- Engineering Specifications: Internal requirements that define the performance characteristics and design criteria of the device.
- Predetermined Benchmarks: Performance of the predicate device (Unomedical Inset™ Subcutaneous Infusion Set) serves as a benchmark for comparison.
It's not an expert consensus or pathology-based ground truth as would be used for diagnostic image analysis.
8. The sample size for the training set
This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set and associated ground truth.
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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.
December 13, 2019
Unomedical a/s % Deirdre Barrow Senior Consultant. Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K192647
Trade/Device Name: neria™ guard Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 23, 2019 Received: September 24, 2019
Dear Deirdre Barrow:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
for Geeta Pamidimukkala 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) K192647
Device Name neria™ guard infusion set
Indications for Use (Describe)
The neria™ guard infusion set is indicated for subcutaneous infusion of medication administered by an external pump.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k)Summary
K192647
1. Submission Sponsor
Unomedical a/s
Aaholmvej 1-3, Osted
DK-4320 Lejre,
Denmark
Contact: Mette Henningsen
Title: Regulatory Affairs Specialist
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Deirdre Barrow
Title: Senior Consultant, RA
3. Date Prepared
Dec-11-2019
4. Device Identification
Trade/Proprietary Name: neria™ guard Infusion Set
Common/Usual Name: Set, Administration, Intravascular
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| Classification Name: | Intravascular administration set |
|---|---|
| Regulation Number: | 880.5440 |
| Product Code: | FPA, Intravascular administration set |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate Device(s)
Table 5A: Legally Marketed Predicate Device
| DeviceName | 510(k) No. | Product Code | ClassificationRegulation | ClassificationName | Sponsor |
|---|---|---|---|---|---|
| UnomedicalInset™SubcutaneousInfusion Set(formerlyknown astheUnomedicalMonicaInfusion Set) | K032854 | FPA | 880.5440 | Intravascularadministrationset | Unomedical |
6. Indication for Use Statement
The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.
7. Device Description
The neria™ guard Infusion Set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication.
The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.
8. Substantial Equivalence Discussion
The following table compares the neria™ guard Infusion Set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.
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It should be noted that the cannula from the subject device and the predicate are identical (same materials from the same suppliers, same manufacturing process, same intended use). Differences between the subject device and predicate device include difference in the insertion method, needle retraction mechanism, additional available lengths, and material differences.
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| Manufacturer | Unomedical | Unomedical | Device Comparison |
|---|---|---|---|
| Trade Name | neriaTM guard Infusion Set | Unomedical InsetTM SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| 510(k) Number | K192647 | K032854 | N/A |
| Product Code | FPA | FPA | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set | Same |
| Indications for Use | The neriaTM guard Infusion Set isindicated for subcutaneous infusion ofmedication administered by anexternal pump. | The Unomedical InsetTM SubcutaneousInfusion Sets are indicated for thesubcutaneous infusion of medicationfrom an external pump. | Similar- Difference in the name of thesubject device. Does not impact safetyor effectiveness |
| Mechanism of Action | The neriaTM guard Infusion Set is aninfusion administration set, connectingto a reservoir/infusion pump andinserted in the subcutaneous tissue ofa user. | The Unomedical InsetTM SubcutaneousInfusion Set is an infusionadministration set, connecting to areservoir/infusion pump and insertedin the subcutaneous tissue of a user. | Same |
| TechnologyOverview | Serter:• Subcutaneous insertion of softcannula by introducer needlesituated inside soft cannula at a 90°insertion angle. | Serter:• Subcutaneous insertion of softcannula by introducer needlesituated inside soft cannula at a 90°insertion angle. | Serter:• Same angle of insertion and useof introducer needle and cannula |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| • insertion of soft cannula: 2 usersteps for insertion: removeprotective cap for base and pressrelease button | • insertion of soft cannula: 3 manualuser steps for insertion: loading,inserting and retraction. | • Both devices use an insertiondevice to insert the soft cannula,the proposed device has aninsertion mechanism preloadedand ready for insertion by simplypressing the activation buttonafter removing the safeguard. Thistechnical difference is notclinically significant as while thisadditional safety feature doeshave a minor impact upon themethod of operation of the deviceit does not introduce any newquestions of safety oreffectiveness. | |
| • The Base Set in neria™ guardInfusion Set is made of twocomponents, the Fluid Part and theBase Part | • The Base Set used in Unomedicalinset™ is moulded as one | • The fluid part of the neria™ guardInfusion Set assembly is insertedinto the base assembly (on body).This step is not required for theUnomedical inset™ Infusion Set.This technical difference is notclinically significant as theadditional required step for theproposed device does notsignificantly impact the method of | |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| • The neria™ guard Infusion Set isdelivered ready to use in a pre-loaded insertion device withautomatic needle retraction. Thenewly developed mechanism allowsthe needle to be hidden from theuser and/or caregiver before andafter insertion. | • The Unomedical Inset™Subcutaneous Infusion Set does nothave a mechanism for automaticneedle retraction and the needle isvisible to the user. | • The insertion needle and softcannula of neria™ guard InfusionSet are hidden from the userbefore, during and after insertionof the soft cannula. This featurehelps prevent needle stick injuries.This technical difference does notintroduce any new questionsregarding safety and effectivenessof the device. The additionalsafety feature does not impact themethod of operation of thedevice. | |
| Administration Set:The administration set attaches to thereservoir by means of a "tubingconnector", and subcutaneously in tothe user through an indwellingcatheter made ofpolytetrafluoroethylene (PTFE). Thetubing is made of two layers: the innerlayer is polyethylene; the outer ispolyurethane. The indwelling catheteris introduced into the subcutaneous | Administration Set:The administration set attaches to thereservoir by means of a "tubingconnector", and subcutaneously in tothe user through an indwellingcatheter made ofpolytetrafluoroethylene (PTFE). Thetubing is made of two layers: the innerlayer is polyethylene; the outer ispolyurethane. The indwelling catheteris introduced into the subcutaneous | Same technology used in bothdevices for the administration set. Itshould be noted that the cannulafrom the subject device and thepredicate are identical (samematerials from the same suppliers,same manufacturing process, samesterilization, same intended use). | |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neriaTM guard Infusion Set | Unomedical InsetTM SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| tissue by a removable 27 gaugeintroducer needle (cannula) made ofAISI 304 stainless steel. | tissue by a removable 27 gaugeintroducer needle (cannula) made ofAISI 304 stainless steel. | ||
| Anatomical Location | Standard recommended sites forsubcutaneous infusion of medicationi.e. subcutaneous sites are selectedbased on the presence of adequateadipose tissue. The choice of insertionsite depends on treatment and patientspecific factors as recommended byHCP. Preference is given to sites thatdo not affect the patient's mobility,the insertion site has to be free of skinirritation and inflammation such asredness, scar tissue and bleeding.Site selection: the abdomen, in aroughly semicircular area around andbelow the umbilicus is preferred as anapplication site. Other insertion sitesinclude the upper leg, upper buttocks,hips, upper arms and lower back andoccasionally the chest when otherssites have edema. | Standard recommended sites forsubcutaneous infusion of medicationi.e. subcutaneous sites are selectedbased on the presence of adequateadipose tissue. The choice of insertionsite depends on treatment and patientspecific factors as recommended byHCP. Preference is given to sites thatdo not affect the patient's mobility,the insertion site has to be free of skinirritation and inflammation such asredness, scar tissue and bleeding.Site selection: the abdomen, in aroughly semicircular area around andbelow the umbilicus is preferred as anapplication site. Other insertion sitesinclude the upper leg, upper buttocks,hips, upper arms and lower back andoccasionally the chest when otherssites have edema. | Same |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| particularly important in patients withmany years use, since the overuse ofskin sites has an influence onabsorption variability. | particularly important in patients withmany years use, since the overuse ofskin sites has an influence onabsorption variability. | ||
| Material | Materials include:Polypropylene, polyoxymethylene,stainless steel,polytetraflouroethylene, nonwovenpolyester/polyacrylate,polyethylene, silicone, MethylMethacrylate Acrylonitrile ButadieneStyrene(MABS), Terlux 2802 HD,transp., medical grade paper,polycarbonate | Materials include:Polypropylene, Stainless Steel,Polyethylene, Polyurethane, Silicone,Polycarbonate,Polytetrafluoroethylene, MethylMethacrylate Acrylonitrile ButadieneStyrene(MABS), Terlux 2802 HD,transp., Medical Grade Paper, UV-cured Glue, Colour Pigments | Differences in material wereevaluated with the appropriatebiocompatibility testing per ISO10993-1. |
| Sterile | Yes – EO – SAL 10-6 | Yes – EO – SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Complies with ISO10993-1 | Yes | Yes | Same |
| Soft Cannula Length | 6 and 9mm | 6 and 9mm | Same |
| Tubing:IDOD | 0.385 mm,1.50 mm | 0.385 mm,1.50 mm | Same |
| Soft Cannula OD | 0.68 mm | 0.68 mm | Same |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neriaTM guard Infusion Set | Unomedical InsetTM SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set) | |
| Needle Gauge | 27 gauge | 27 gauge | Same |
| Tubing Length | 12 cm, 30 cm, 60 cm, 80 cm and 110cm | 60 and 110 cm | Additional tubing lengths of 12, 30and 80 cm have been made availablefor the proposed device. Does notimpact safety or effectiveness. |
| Angle of Insertion | 90 degrees, perpendicular | 90 degrees, perpendicular | Same |
| Insertion Method | Pre—loaded insertion device withautomatic needle retraction. Theinsertion needle and soft cannula arehidden from the user before, duringand after insertion of the soft cannula. | Insertion device, which enables theuser not to place the soft cannula inthe tissue manually | Similar in that both devices allow forthe patient to not have to insert thedevice in the tissue manually - theproposed device includes anadditional mechanism so that thepatient does not need to see theneedle or cannula at any stage of theprocess and has an automatic needleretraction to help ensure needlesafety |
| Time of Use | Up to 72 hours | Up to 72 hours | Same |
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Non-Clinical Performance Data 9.
As part of demonstrating safety and effectiveness of neria™ guard Infusion Set and in showing substantial equivalence to the predicate device, Unomedical completed a number of non-clinical performance tests. The neria™ guard Infusion Set meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design inputs and specifications for the device.
The neria™ guard Infusion Set has met the requirements for testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
• Sterilization Testing
The sterility of the neria™ guard Infusion Set is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014.
Biocompatibility testing .
The biological safety of the neria™ guard Infusion Set was demonstrated by testing in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016.
The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity/Irritation
- Acute and 14-day Systemic toxicity
- Material Mediated Pyrogenicity ●
- Hemolysis
- Particulate Testing
- Chemical Characterization ●
- Genotoxicity (AMES and MLA)
. Shelf Life Determination
A maximum shelf life of 3 years was determined based on an assessment of the seal integrity of the sterile barrier packaging and functional testing of the device in accordance with ASTM F1980:2011.
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● Functional Testing
Placement Introducer Needle before and after activation Tensile Test Base-Connector Functional Test Adhesive Liner Contents in Blister Package Functional Test Serter Tensile Test Needle Hub Tensile Test Soft Cannula Tensile Test Base-Adhesive Patch Peel Test Packaging Disassemble fluid part from base Disassemble base from cylinder Serter Activation Force Leak Test Flow Test Distance Introducer Needle bevel to Soft Cannula tip Distance Soft Cannula tip to bottom fluid part Visual Test of IFU, Blister Lid and Inner and Outer box label Disassemble Cylinder from Cover Drug Compatibility Testing Tensile Strength Packaging and Labelling tests
Standards used:
ISO 11135:2014; Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices ASTM F1980:2011; Standard Guide or Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 11607-1:2009; Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 10993-1:2009; Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14971:2012; Medical devices. Application of risk management to medical devices
ISO 10993-11:2006; Biological evaluation of medical devices -- Part 11: Tests for systemic cytotoxicity
ISO 11607-2:2006; Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
ASTM D4169-16; Standard Practice for Performance Testing of Shipping Containers and Systems
10. Conclusion
The neria™ guard Infusion Set, as designed and manufactured, is determined to be substantially equivalent to the predicate device.
§ 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.