(90 days)
Not Found
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/ML technologies or related data analysis.
No
The device delivers fluids but does not provide therapeutic treatment itself. It's a delivery mechanism for a separate therapeutic agent.
No
The primary purpose of the device is for the delivery of fluids, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like insertion spikes, tubing, and clamps, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of fluids from a container into a patient's vascular system." This is a direct therapeutic or supportive function within the patient's body.
- Device Description: The description details components for fluid delivery (spikes, tubing, clamps, etc.), not for analyzing samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical and functional aspects of fluid delivery and compliance with standards related to administration sets, not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is purely for administering fluids, which falls under the category of medical devices used for treatment or support, not diagnosis.
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, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. 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)
Bench testing was performed on IV Administration Sets to demonstrate that the device performs as intended. No clinical testing was performed. The test results demonstrated that the proposed device complies with ISO 8536-4, ISO 8536-8, ISO 10993-1, ISO 10993-7, ISO 11135, ISO 80369-7, and ISO 80369-20. Internal testing included Microbial Ingress, Particulate Testing per USP (788), Stress Cracking, Roller Clamp function, Joint testing, Simulated use Testing, and Lipid Compatibility.
Results of the functional and performance testing conducted on the proposed devices demonstrate that the IV Administration Set is equivalent to the predicate device. The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness.
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.
Not Found
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.
0
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March 3, 2022
B.Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K213778
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: November 24, 2021 Received: December 3, 2021
Dear Tracy Larish:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gang Peng for Payal Patel 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
2
Indications for Use
510(k) Number (if known) K213778
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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3
K213778 510(k) SUMMARY
SUBMITTER INFORMATION:
| Name: | B. Braun Medical Inc. |
|---|---|
| Address: | 901 Marcon Boulevard |
| Allentown, PA 18109-9341 | |
| Telephone Number: | 610-266-0500, ext. 2966 |
| Contact Person: | Tracy Larish, Sr. Regulatory Affairs Specialist |
| Telephone Number: | (610) 596-2941 |
| Fax Number: | (610) 849-9286 |
| Email: | tracy.larish@bbraunusa.com |
| Date Prepared: | February 3, 2021 |
DEVICE NAME:
| Device Trade Name: | IV Administration Set |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular administration set, 21 CFR §880.5440 |
| Class II, Product code FPA |
PREDICATE DEVICES:
- · K173361 IV Administration Set, B. Braun Medical Inc.
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, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.
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.
TECHNOLOGICAL CHARACTERISTICS:
The IV Administration Set is substantially equivalent to the B. Braun Medical Inc. IV Administration Set (K173361). The predicate device used for comparison to the IV Administration Set was utilized to demonstrate the substantial equivalence in Indications for Use, intended use, and design between the proposed device and the predicate devices.
The IV Administration Set has the same intended use, the same principle of operation, the same fundamental scientific technology and Indications for Use as the predicate device. It comprised of similar component types and meet the same relevant performance specifications as the predicate devices.
4
The fundamental technology of the proposed set is unchanged when compared to the predicate device. The differences between the proposed IV Administration Set and predicate device are listed below. These differences do not raise new issues of safety and effectiveness.
- The Spin lock Luer connector with primestop cap has been modified to be a fixed male luer lock and the material of construction have been changed.
- The roller clamp design has been modified to include a docking location for the insertion spike and the materials of construction have been changed.
- An in-line filter was added to the set. ●
A table summarizing the comparison between the IV Administration Sets and the predicate devices is provided below:
| | Proposed IV Administration Set
(K213778) | Predicate Device (K173361) IV
Administration Set with HCO tubing | Differences |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 | Same |
| 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. | Same |
| Mode of Fluid
Delivery | Gravity | Gravity | Same |
| Administration
Set Components/
materials | Drip chamber PVC
Insertion spike-ABS
Roller Clamp-ABS
Tubing- PVC w/ DEHT and HCO
Luer connection- MABS/PP
In line filters-MABS/ABS
PPSU/PVP/PTFE | Drip chamber-PVC
Insertion spike-ABS
Roller clamp-ABS
Tubing -PVC w/ DEHT and HCO
Luer connections-MABS/PC
Injection site-Acryllic/Polyisoprene
Needleless Y-site - PC
Back check valve- MABS | Design and material
change to the roller clamp
and luer connector.
Addition of in-line filter.
Biocompatibility and
performance testing were
performed to demonstrate
substantial equivalence
(see below). |
| Summary of
nonclinical tests
for determination
of substantial
equivalence | ISO 8536-4 Physical Requirements
● Particulate
● Leakage
● Flow Rate
● Tensile Strength
● Closure-piercing device
● Air-inlet device
● Tubing
● Drip chamber
● Flow Regulator
● Male Conical Fitting
● Protective Caps
ISO 8536-8
ISO 80369-7:2016
ISO 80369-20:2015
Internal Testing
● Microbial Ingress
● Particulate Testing per USP
● Stress Cracking
● Roller Clamp function
● Joint testing
● Simulated use Testing
● Lipid Compatibility | ISO 8536-4 Physical Requirements
● Particulate
● Leakage
● Flow Rate
● Tensile Strength
● Closure-piercing device
● Air-inlet device
● Tubing
● Drip chamber
● Flow Regulator
● Male Conical Fitting
● Protective Caps | Additional tests performed
to confirm substantial
equivalence |
| Patient Contact
category/
Duration | Externally Communicating, Blood
Path Indirect prolonged exposure | Externally Communicating, Blood Path
Indirect prolonged exposure | Same |
| | Proposed IV Administration Set
(K213778) | Predicate Device (K173361) IV
Administration Set with HCO tubing | Differences |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Same |
| Pyrogenicity | Pyrogenicity