(46 days)
Not Found
No
The description focuses on the physical function of the device (fluid transfer) and high flow rates, with no mention of AI, ML, image processing, or data-driven decision making.
No
The device is used to transfer fluids, which supports a patient's physiological function but does not directly treat a disease or condition. Therefore, it is not a therapeutic device.
No
Explanation: The device is described as an IV set used to transfer fluids, and there is no indication that it is used for diagnosis.
No
The device description explicitly states it is a physical device ("equivalent to an IV set") used to transfer fluids, indicating it is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transfer fluids from a container to a patient's intravascular access catheter." This describes a device used for administering fluids directly to a patient, which is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description reinforces the intended use, stating it's "equivalent to an IV set" and used for "transfer[ring] fluids."
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for fluid delivery.
N/A
Intended Use / Indications for Use
utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.
Product codes
80LHI
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce The CombiPort Emergency Infusion Device. This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
B. Braun Medical. Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
January 27, 1997
MAR 1 8 1997
Mark S. Alsberge, Regulatory Affairs Manager Contact:
CombiPort Emergency Infusion Device Product Name:
I.V. Fluid Transfer Set Trade Name:
Classification name:
Hospital Class II, 80LHI 21 CFR 880.5440
SUBSTANTIAL EQUIVALENCE1 TO:
| -510(k) number - 1 (c) - 1 (c) Name - 1 (c) - 1 ) - (Applicant - 1 (canting - 1 (c) - 1 - 1 (c) | ||
|---|---|---|
| K925401 | ||
| have a more and the many of the comments of the comments of the comments of the comments of | IV Fluid Transfer Pin | B. Braun Medical Inc. |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce The CombiPort Emergency Infusion Device. This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not
1
applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
Material:
11
The CombiPort Emergency Infusion Device is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The CombiPort Emergency Infesion Device is similar in materials, form, and intended use to I.V. Fluid Transfer Pin cleared by B. Braun Medical Inc. There are no new issues of safety or effectiveness raised by The Emergency Infusion Device.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.