K Number
K961147
Device Name
CLOSED FLUID COLLECTION SYSTEM
Date Cleared
1996-05-31

(71 days)

Product Code
Regulation Number
878.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.
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 Closed Fluid Collection System. The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage. The Closed Fluid Collection System is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
More Information

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Not Found

No
The summary describes a physical fluid collection system with no mention of software, algorithms, or any technology related to AI or ML.

Yes

The device is used for drainage of abscesses, pleura, and chest, which are therapeutic interventions aimed at alleviating medical conditions.

No
The provided text describes a "Closed Fluid Collection System" used for drainage, not for diagnosis. There is no mention of the device being used to identify or analyze a condition.

No

The device description explicitly states it is "composed of materials" and describes physical testing, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for collecting fluid from the body (abscess, pleura, chest drainage). This is a procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
  • Device Description: The description focuses on the materials and function of a fluid collection system used for drainage. It doesn't mention any components or processes related to analyzing biological samples.
  • Lack of IVD Indicators: There is no mention of:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing diagnostic information based on sample analysis
    • Any of the typical characteristics of an IVD device.

The device is clearly designed for a therapeutic or procedural purpose (draining fluid) rather than a diagnostic purpose (analyzing samples to diagnose a condition).

N/A

Intended Use / Indications for Use

The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.

Product codes

80 FPK

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 Closed Fluid Collection System. The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

0

196114

MAY 3 | 1996

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

March 19, 1996

CONTACT : Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Closed Fluid Collection System

TRADE NAME : Fluid Delivery Tubing

CLASSIFICATION NAME:

General Hospital Class II, 80 FPK, Fluid Delivery Tubing 21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE' TO:

510(k) numberNameApplicant
Collection
Protection StationNAMIC
Disposal DepotMerit Medical

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 Closed Fluid Collection System. The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.

MATERIAL:

' The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory 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. products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

1

The Closed Fluid Collection System is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

SUBSTANTIAL EQUIVALENCE:

The Closed Fluid Collection System is equivalent in materials, form, and intended use to Closed Fluid Collection Systems currently marketed by Merit Medical and NAMIC. There are no new issues of safety or effectiveness raised by the Closed Fluid Collection System.

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.