In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Midclavicular Catheter.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Midclavicular Catheter" or "Cavafix." It outlines the device's description, materials, and substantial equivalence to previously cleared devices. However, this document does not contain the type of information requested about acceptance criteria, detailed study design, or performance evaluation from a clinical or technical perspective.

Specifically, the document focuses on:

Device identification: Product name, trade name, classification.
Substantial equivalence: Comparing the device to existing predicate devices (K861479 Cavafix and SoloPICC).
Material compatibility: Stating materials were tested according to ISO Standard 10993.
Safety and effectiveness (general statement): Mentioning that finished products are tested to meet release specifications, including physical testing and visual examination, as per Quality Control Test Procedure documents and GMPs.

This information is typical for a 510(k) submission seeking clearance based on substantial equivalence, rather than a de novo approval or clinical trial report that would detail specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information:

A table of acceptance criteria and the reported device performance: This information is not present. The document only broadly states "All finished products are tested and must meet all required release specifications."
Sample size used for the test set and the data provenance: Not mentioned. The "testing" referred to appears to be internal manufacturing quality control, not a clinical or performance study of a defined "test set."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such study is described.
Adjudication method: Not applicable.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable, as no external "ground truth" performance study is detailed. The ground truth for internal quality control would be the device specification itself.
The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

971999
May 28, 1997 Nov. 24, 1997

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400

Mark S. Alsberge, Director, Regulatory Affairs Contact:

Product Name: Midclavicular Catheter

Trade Name: Cavafix

Classification name:

Cardiovascular Class II, 80FOZ 21 CFR 880.5200

SUBSTANTIAL EQUIVALENCE1 TO:

510(k) number	Name	Applicant
K861479	Cavafix	B. Braun Medical Inc.
UNKNOWN	SoloPICC	SoloPak

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 a Midclavicular Catheter.

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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 applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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Material:

The Midclavicular Catheter is composed of materials that have been tested in accordance with and the ISO Standard 10993 for this category. The materials have been determined to be suitable for the intended use of this product.

Substantial equivalence:

The Peripherally Inserted Central Catheter is similar in materials, form, and intended use to the Cavafix cleared by B. Braun Medical Inc. and the SoloPICC manufactured for SoloPak. There are no new issues of safety or effectiveness raised by Midclavicular Catheter.

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.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1997

Mr. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Incorporated 824 Twelfth Avenue P.O. Box 4027 18018-0027 Bethlehem, Pennsylvania

Re : K971999 Accuguide® Midclavicular Catheter Trade Name: Unclassified Requlatory Class: Product Code: LJS Dated: September 11, 1997 Received: September 12, 1997

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Alsberge

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Sincerely yours,

Timothy A. Ulatowski

Director Director
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Division of Demital Devices vision of Dencarious Devices
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Enclosure

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510(k) Number (if known): Kall 1 1999

Device Name: MID LAWICHLAR CATHERER

Indications For Use:

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THE DEDICE IS DESIGNED TO DE INSELTED INTO THE PERIORERAL DENDES SYSTEM FOR THE INFOSION OF SOUTHOUS INTO THE CENTRAL varies system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Caccavale

Division Sign-Off Division of Dental, and General He 510(k) Number

Prescription Use V (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”