(46 days)
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.
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.
This submission describes a medical device, the CombiPort Emergency Infusion Device, which is an I.V. fluid transfer set. However, the provided text does not contain any information regarding acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI/ML or diagnostic performance studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets them, nor can I provide information on sample sizes, ground truth, expert qualifications, or MRMC studies, as these concepts are not addressed in the provided document.
The document primarily focuses on:
- 510(k) Summary: A regulatory declaration for market clearance.
- Device Description: What the device is and its intended use (transferring fluids from a container to a patient's intravascular access catheter, with high flow rates for emergency trauma).
- Substantial Equivalence: Comparing it to a previously cleared device (IV Fluid Transfer Pin, K925401) by the same applicant.
- Material Safety: Stating that materials are tested according to ISO Standard 10993.
- Safety and Effectiveness (General Statement): Mentions that finished products are tested and must meet release specifications, including physical testing and visual examination, defined by Quality Control Test Procedure documents.
The "Safety And Effectiveness" section mentions "required release specifications" and "physical testing, visual examination." While these are indications of quality control, they are not presented as a formal study with specific acceptance criteria and detailed performance results that would be used to objectively "prove" clinical effectiveness or diagnostic accuracy in the way described in your prompt (which usually applies to software, AI/ML, or more complex diagnostic devices).
In summary, based only on the provided text, the requested information cannot be extracted.
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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) | ||
|---|---|---|
| K925401have 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
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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.
§ 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.