(277 days)
Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.
The Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD) (K201422) demonstrates substantial equivalence to its predicate device (TEVADAPTOR® Closed Drug Reconstitution and Transfer System, K141448) based on a comprehensive set of non-clinical performance data.
1. Acceptance Criteria and Reported Device Performance:
The document provides a table of various tests conducted to support the substantial equivalence of the Arisure CSTD. The reported device performance is indicated by its compliance with the specified standards or by direct statements of outcome (e.g., "Non-pyrogenic," "Single use"). Where acceptance criteria are implicitly stated through comparison with standards, the device is reported to have met these. Explicit performance metrics are provided for certain aspects.
| Test Name | Acceptance Criteria (Implicit/Explicit from provided text) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5 compliant | Met |
| Hemocompatibility | ISO 10993-4 compliant | Met |
| Sensitization | ISO 10993-10 compliant | Met |
| Systemic Toxicity (Acute) | ISO 10993-11 compliant | Met |
| Irritation | ISO 10993-10 compliant | Met |
| Material-Mediated Pyrogenicity | ISO 10993-11 compliant | Met |
| LAL Endotoxin | ANSI/AAMI ST72:2002, USP 24<161> compliant | Met |
| Luer Access | ISO 594-2 compliant | Met |
| Liquid Leakage (back pressure) | ISO 594-2 compliant | Met |
| Liquid Leakage (connected pressure) | ISO 594-2 compliant | Met |
| Ease of Assembly | ISO 594-2 compliant | Met |
| Resistance to Overriding | ISO 594-2 compliant | Met |
| Stress Cracking | ISO 594-2 compliant | Met |
| Separation Force | ISO 594-2 compliant | Met |
| Gloved Hands | Usable with nitrile gloved hands | Usable with nitrile gloved hands |
| Valve Removal Torque and Bond Strength | >4.5 in-lbs | Met (>4.5 in-lbs) |
| Vial Pressure | (Not explicitly stated in provided document, but implicitly met for CSTD function) | Met |
| Attachment Force | <40 lbf | Met (<40 lbf) |
| Horizontal / Vertical Detachment | Remain attached with a 15N force for 15 seconds | Remained attached with a 15N force for 15 seconds |
| Misuse Leakage | No leakage with 7.5 PSI for 15 seconds | No leakage with 7.5 PSI for 15 seconds |
| Coring | Coring of the drug vial septum to have particulates does not occur | Coring of the drug vial septum to have particulates did not occur |
| Security of Attachment | Remain attached without leak with a 15N load for 15 seconds | Remained attached without leak with a 15N load for 15 seconds |
| Drug/Device Compatibility | (Implicitly demonstrated as suitable for hazardous drugs, no adverse interaction) | Met |
| Dry Disconnection | (Implicitly demonstrated as safe disconnection, no release of drug) | Met |
| Microbial Ingress | No introduction of microbial contaminants into the drug or fluid path | Met |
| Particulate | USP 788 compliant | Met |
| Vapor Study | CDC-2015-0075, NIOSH -288:2015 (draft) compliant (no release of drugs in vapor form) | Met |
| Chemical Characterization | ISO 10993-18 compliant | Met |
| Toxicological Risk Assessment | ISO 10993-17 compliant | Met |
| Sub-Acute Toxicity | ISO 10993-11 compliant | Met |
| Partial Simulation Performance Tests | ISTA P2A (2011) compliant | Met |
| Standard Practice for Performance Testing of Shipping Containers and Systems | ASTM D4169-14 compliant | Met |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ASTM F88M-09 compliant | Met |
| Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | ASTM F2096-11 compliant | Met |
| Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | ASTM F1886 compliant | Met |
| Flow Rate | ≥76 mL/min (subject device design to have flow rate of an 18-gauge needle) | ≥76 mL/min |
| Residual Fluid | <0.05mL for 13mm and 20mm, <1mL for 28mm | <0.05mL for 13mm and 20mm, <1mL for 28mm |
| Priming Volume | 0.12 mL for Dry Spike, 0.11mL for 13mm, 0.10mL for 20mm, 0.12mL for 28mm ACVA (less than predicate's 0.15mL) | Met |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each of the non-clinical performance tests. The provenance of the data is not detailed, but given the nature of the tests (biocompatibility, mechanical performance, packaging, etc.) and the regulatory context (510(k) submission), these would typically be internal laboratory tests conducted by the manufacturer or contracted to specialized testing facilities. The tests are non-clinical, meaning they do not involve human or animal subjects for clinical outcome assessment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The listed tests are objective, quantifiable, non-clinical engineering and biological performance evaluations. They do not rely on expert interpretation for "ground truth" in the way clinical diagnostic studies might. Compliance is determined by meeting pre-defined standards or objective measurements.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple experts assess the same cases and discrepancies need a resolution. The tests performed here are objective performance measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device, not a diagnostic algorithm that requires human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
This information is not applicable. The device is a physical medical device (Closed System Drug Transfer Device), not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used:
The ground truth for these non-clinical tests is established by:
- International Standards: Many tests refer to ISO, AAMI, ASTM, and USP standards (e.g., ISO 10993 for biocompatibility, ISO 594-2 for luer access). Compliance with these validated standards serves as the "ground truth" for acceptable performance.
- Pre-defined Engineering Specifications: For custom tests (e.g., Valve Removal Torque, Attachment Force, Misuse Leakage, Coring), the "ground truth" is defined by the specific, objective performance criteria set by the manufacturer to ensure the device meets its intended function and safety requirements (e.g., ">4.5 in-lbs", "<40 lbf", "no leakage").
- Functional Verification: For tests like "Gloved Hands" and "Dry Disconnection," the ground truth is simply the successful demonstration of the intended function.
8. The Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The device's design and manufacturing processes are validated, not "trained."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2021
Yukon Medical, LLC Pamela Mcnulty Sr. Director QA and Compliance 4021 Stirrup Creek Dr Ste 200 Durham, North Carolina 27703
Re: K201422
Trade/Device Name: Arisure Closed System Drug Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: November 25, 2020 Received: December 2, 2020
Dear Pamela Mcnulty:
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 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 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) K201422
Device Name Arisure Closed System Drug Transfer Device (CSTD)
Indications for Use (Describe)
Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
| 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 is a logo for Yukon Medical. The logo consists of a stylized figure in teal and gray, with the letters "Y" and "M" incorporated into the design. To the right of the figure is the word "YUKON" in dark gray, with the word "MEDICAL" in teal underneath.
510(k) Summary
I. SUBMITTER
Yukon Medical, LLC 4021 Stirrup Creek Drive, Suite 200 Durham, NC 27703 Phone: 919-595-8250 Fax: 919-595-8251 Contact Person: Pam McNulty Sr. Director QA and Compliance
Date Prepared: March 2nd, 2020
II. DEVICE
Name of Device: Arisure® Closed System Drug Transfer Device (CSTD) Common Name: Drug Reconstitution and Transfer System Classification Name: Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulatory Class: II Product Code: ONB
III. PREDICATE DEVICE
Name of Predicate: TEVADAPTOR® Closed Drug Reconstitution and Transfer System Predicate 510(k) Number: K141448 Regulation Number: 21 CFR 880.5440 Product Code: ONB This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
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IV. DEVICE DESCRIPTION
Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.
V. INDICATIONS FOR USE
Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A direct comparison of the indications for use and technical characteristics between the subject and predicate devices demonstrates equivalency. Minor differences between subject and predicate device characteristics do not introduce different questions of safety or effectiveness, the subject device is substantially equivalent to the predicate device.
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| Subject Device(K201422) | Predicate Device(K141448) | Discussion | |
|---|---|---|---|
| Indications forUse | Arisure® is a ClosedSystem Drug TransferDevice (CSTD) thatmechanically prohibitsthe release of drugs invapor, aerosol or liquidform during preparationand administration, andprevents the introductionof microbial and airbornecontaminants into thedrug or fluid path,allowing the system tominimize exposure ofindividuals, healthcarepersonnel, and theenvironment to hazardousdrugs. | TEVADAPTOR is aClosed System DrugTransfer Device (CSTD)that mechanicallyprohibits the release ofthe drug in vapor, aerosolor liquid form duringpreparation andadministration, andprevents the introductionof microbial and airbornecontaminants into thedrug or fluid path,allowing the system tominimize exposure ofindividuals, healthcarepersonnel, and theenvironment to hazardousdrugs | Same |
| Design | Designed using plasticand elastomeric materials,has normally closed fluidpath which closes offflow when the device isnot attached to matingcomponent. Includes anti-unwinding feature. | Designed using plastic,elastomeric, and metalmaterials, has normallyclosed fluid path whichcloses off flow when thedevice is not attached tomating component. | Minor differences in materialsdo not raise different questionsof safety or effectiveness as allmaterials contain inherentproperties to achieve theirintended use and have beendemonstrated to bebiocompatible. |
| ExternalDimensions(LxW) (inches) | Closed Male Luer: 1.1 x0.6Closed Vial Adapter: 2.5x 2.25Dry Spike: 4.0 x 0.5 | Syringe Adaptor: 2.2 x0.6Vial Adaptor: 2.2 x 0.9Spike Port Adaptor: 8.5x 0.8 | External dimensions have noimpact on performance and donot raise different questions ofsafety or effectiveness. |
| Packaging | Form, fill, seal packagingwith top web materialsealed to bottom webmaterial | Form, fill, seal packagingwith top web materialsealed to bottom webmaterial | Same |
| Sterilization | Gamma Irradiation | EO | Both sterilization methods areconsidered traditional by FDAand both achieve a SAL of 10-6,no different questions of safetyor effectiveness. |
| Latex | Not made with naturalrubber latex | Not made with naturalrubber latex | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Reuse | Single use | Single use | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Externallycommunicating Bloodcontact, indirectProlonged duration (>24hours to 30 d) | Externallycommunicating Bloodcontact, indirectProlonged duration (>24hours to 30 d) | Same |
| Flow Rate | ≥76 mL/min | 125 mL/min | This discrepancy is due to thefact that the subject device islimited by the CML which wasdesigned to have the flow rateof an 18-gauge needle. This wasbased upon clinical input priorto the device design and thisdifference is not anticipated tohave any impact on safety andefficacy. |
| Residual Fluid | <0.05mL for 13 mm and20mm<1mL for 28 mm | 0.37mL for 20mm | The residual fluid is less thanthe predicate, no differentquestions of safety oreffectiveness |
| Priming Volume | 0.12 mL for Dry Spike,0.11mL for 13mm,0.10mL for 20mm0.12mL for 28mm ACVA | 0.15mL | The priming volume is less thanthe predicate, no differentquestions of safety oreffectiveness |
| Subject Device(K201422)Closed Male Luer | Predicate Device(K141448)Syringe Adaptor | Discussion | |
| Connector Type | Luer Lock | Luer Lock | |
| Septum/Seal Type | Flat, Split Septum | Double Seal | |
| Upper Housing | Polycarbonate | ABS | |
| Lower Housing | Polycarbonate | Polycarbonate | |
| Cannula | Polycarbonate | Stainless Steel | |
| Anti-UnwindingHousing | Polycarbonate | N/A | Minor differences in materialsdue to different componentsachieving the same intendeduse. |
| Piston | Silicone | Stainless Steel | |
| Actuator | COC | N/A | |
| Lubrication | Fluorosilicone | N/A | |
| Adhesive | Acrylic Adhesive | Acrylic Adhesive | |
| Subject Device(K201422)Closed Vial Adapterwith Neutral Valve | Predicate Device(K141448)Vial Adaptor / LuerLock Adaptor | Discussion | |
| Vial Adapter | Terlux 2802 | ABS | |
| Bell Base | Cyrolite CG97 | N/A | |
| Bell LabyrinthRing | Cyrolite CG97 | N/A | |
| Bell Housing | Terlux 2822 | N/A | |
| Bell Membrane | Medalist MD145 | N/A | |
| Bell MembraneUV Tracer | SC-5 | N/A | |
| MembraneRetention Ring | Terlux 2802 | N/A | Minor differences in materials |
| Vent FilterMembrane | ePTFE Membrane withpolyester support | Charcoal | |
| Bell FilterMembrane | ePTFE Membrane withpolyester support | N/A | |
| Vent Check Valve | Elastosil LR3043 60 | N/A | due to different components |
| Bell Check Valve | Silicone | N/A | |
| Adhesive | Acrylic Adhesive | N/A | |
| Check ValveLubrication | Silicone | N/A | use. |
| NeutralValve/Luer LockAdaptor Housing | Polycarbonate | ABS | |
| NeutralValve/Luer LockAdaptor Piston | Silicone | Polyisoprene | |
| NeutralValve/Luer LockAdaptorRetention Ring | Polycarbonate | Polyisoprene | |
| NeutralValve/Luer LockAdaptorLubrication | Fluorosilicone,Trifluoroprophyl-methylsiloxane | N/A |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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| Test Name | Standard # |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Hemocompatibility | ISO 10993-4 |
| Sensitization | ISO 10993-10 |
| Systemic Toxicity (Acute) | ISO 10993-11 |
| Irritation | ISO 10993-10 |
| Material-Mediated Pyrogenicity | ISO 10993-11 |
| LAL Endotoxin | ANSI/AAMI ST72:2002, USP24<161> |
| Luer Access | ISO 594-2 |
| Liquid Leakage (back pressure) | ISO 594-2 |
| Liquid Leakage (connected pressure) | ISO 594-2 |
| Ease of Assembly | ISO 594-2 |
| Resistance to Overriding | ISO 594-2 |
| Stress Cracking | ISO 594-2 |
| Separation Force | ISO 594-2 |
| Gloved Hands | N/A, to verify the device is usablewith nitrile gloved hands |
| Valve Removal Torque and Bond Strength | N/A, >4.5 in-lbs |
| Vial Pressure | N/A |
| Attachment Force | N/A, <40 lbf |
| Horizontal / Vertical Detachment | N/A, remain attached with a 15Nforce attached for 15 seconds |
| Misuse Leakage | N/A, no leakage with 7.5PSI for 15seconds |
| Coring | N/A, coring of the drug vial septumto have particulates does not occur |
| Security of Attachment | N/A, remain attached without leakwith a 15N load for 15 seconds |
| Drug/Device Compatibility | N/A |
| Dry Disconnection | N/A |
| Microbial Ingress | N/A |
| Particulate | USP 788 |
| Vapor Study | CDC-2015-0075, NIOSH -288:2015(draft) |
| Chemical Characterization | ISO 10993-18 |
| Toxicological Risk Assessment | ISO 10993-17 |
| Sub-Acute Toxicity | ISO 10993-11 |
| Partial Simulation Performance Tests | ISTA P2A (2011) |
| Standard Practice for Performance Testing of Shipping Containers andSystems | ASTM D4169-14 |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ASTM F88M-09 |
| Standard Test Method for Detecting Gross Leaks in Packaging byInternal Pressurization (Bubble Test) | ASTM F2096-11 |
| Standard Test Method for Determining Integrity of Seals for FlexiblePackaging by Visual Inspection | ASTM F1886 |
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VIII. CONCLUSIONS
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device currently marketed with some minor differences. These differences do not impact the intended use or the fundamental scientific technology of the device. Through the comprehensive performance testing performed the subject device has demonstrated substantial equivalence to the predicate.
§ 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.