(243 days)
No
The device description and performance studies focus on the physical components and functional performance of a standard IV administration set, with no mention of AI or ML.
No
The device is used for the delivery of fluids, which itself is not a treatment, but a means for administering substances that may or may not be therapeutic. It facilitates an action, rather than performing a therapeutic function directly.
No
The device description and intended use clearly state that these administration sets are for "delivery of fluids from a container into a patient's vascular system." There is no mention of diagnostic functions or collecting data for analysis. It is purely for fluid delivery.
No
The device description clearly outlines physical components like insertion spike, drip chamber, tubing, and clamps, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of fluids from a container into a patient's vascular system." This is a direct interaction with the patient's body for therapeutic purposes (delivering medication or fluids).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. They do not directly interact with the patient's body in the way this device does.
- Device Description: The description details components like insertion spikes, tubing, and luer connections, all of which are designed for connecting to and delivering substances into the patient's vascular system.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
This device is a medical device used for administering fluids intravenously, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was completed with the proposed IV Administration Sets to demonstrate that the sets perform as intended. The test results demonstrated that the proposed device complies with the following standards:
ISO 8536-4:2010/Amd. 1: 2013, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"
ISO 80369-7:2016, "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"
ISO 10993-1:2009(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Biocompatibility testing included cvtotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility testing
ISO 11135:2014. "Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"
In addition, the following functional and performance tests were successfully completed to demonstrate that the IV Administration Sets perform as intended.
- Tubing-Slide Clamp Compatibility
- Chemical resistance testing
- Occlusion
- Dynamic tensile strength
- Leakage - negative pressure test
Microbial ingress data for the needleless luer access devices and injection sites was referenced to the previously cleared 510(k)'s K031923, K931377, K083723, and K140311 for these components.
Results of the testing demonstrate that the proposed device can be used according to its intended use. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031923, K931377, K083723, K140311
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
June 26, 2018
B.Braun Medical Inc. Nancy Skocypec Associate Director, Regulatory Affairs 901 Marcon Blvd Allentown, Pennsylvania 18109
Re: K173361
Trade/Device Name: IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 21, 2018 Received: May 22, 2018
Dear Nancy Skocypec:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Alan M. Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Stevens - S - 0.9.2342.19200300.100.1.1=130 0.9.2342.19200300.100.1.1=1300 Date: 2018.06.26 15:15:00 -04'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173361
Device Name IV Administration Set
Indications for Use (Describe)
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
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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B. Braun Medical Inc. 510(k) Premarket Notification, Traditional 510(k) IV Administration Sets
K173361 510(k) SUMMARY
| DATE: | June 26, 2018 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| Contact: Nancy Skocypec | |
| Phone: (610) 596-2798 | |
| Fax: (610) 266-4962 | |
| E-mail: nancy.skocypec@bbraun.com | |
| DEVICE NAME: | IV Administration Set |
| COMMON NAME: | IV Administration Set |
| CLASSIFICATION: | Class II, Product Code FPA, 21 CFR 880.5440 General Hospital |
| PREDICATE DEVICE: | U & U Intravascular Administration Set, U & U Medical |
| Technology Co., Ltd., K151151, Class II, FPA, 21 CFR 880.5440 | |
| General Hospital |
Description
IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.
Indication for Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Substantial Equivalence
The IV Administration Sets are substantially equivalent to the predicate device, U&U IV Administration Sets cleared with K151151.
Technological Characteristics
The IV Administration Sets presented in this submission have similar indications for use, the same intended use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of similar component types, and meet the same relevant performance specifications as the predicate devices. Both sets are comprised
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of similar industry standard materials. The tubing material utilized with both sets is PVC. The proposed device tubing material contains hydrogenated castor oil within its formulation.
Successful completion of biocompatibility testing and chemical characterization testing per ISO 10993 confirmed that this difference in materials did not impact the biological or chemical safety of the IV Administration Sets. Additionally, performance testing was performed to ensure that this formulation did not impact the substantial equivalence of the device.
A table summarizing the comparison between the B. Braun IV Administration sets and the predicate device is provided below.
| Feature | Proposed Device
IV Administration Sets | Predicate Device (K151151)
U & U Intravascular Administration Set |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Delivery of fluids from a container into a patient's vascular system | Delivery of fluids from a container into a patient's vascular system |
| Indications for Use | The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. | The device is intended to administration fluids from a container into a patient's vascular system through a needle or catheter inserted into the vein. |
| Mode of Fluid Delivery | Gravity | Gravity |
| Materials | Tubing – PVC w/ DEHT and HCO
Spike – ABS
Back check valve - MABS
Roller clamp - ABS
Luer connections - MABS/PC
Drip chamber – PVC
Injection site - Acryllic/Polyisoprene
Needleless Y-site - PC | Tubing - PVC
Spike – ABS
Back check valve - ABS
Roller Clamp – ABS
Male Lure Lock - ABS
Drip Chamber – unknown
Needleless Y-Site - unknown |
| Summary of nonclinical tests for determination of substantial equivalence | ISO 8536-4 Physical Requirements Particulate contamination index ≤ 90 Leakage Flow Rate Tensile Strength Closure-piercing device Air-inlet device Tubing Drip chamber Flow Regulator Male Conical Fitting Protective Caps | ISO 8536-4 Physical Requirements Particulate Leakage Flow rate Tensile strength Closure-piercing device Air-inlet device Tubing Drip chamber |
| Feature | Proposed Device
IV Administration Sets | Predicate Device (K151151)
U & U Intravascular Administration Set |
| Patient Contact
category /
duration | Externally communicating blood path
indirect prolonged contact | unknown |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Pyrogenicity |