The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition ;- I.V. fluids or drugs.

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 Soft Tip Multi- Lumen Central Venous Catheter . A Soft Tip Multi- Lumen Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.

AI/ML Overview

This document is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes a "Soft Tip Multi-Lumen Central Venous Catheter" and claims substantial equivalence to a previously cleared device. Due to the nature and date of the provided document, much of the requested information about device performance studies and AI-related details is not present and cannot be inferred. This document predates the widespread use of advanced AI in medical devices and the specific reporting requirements for such studies.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Materials tested to ISO Standard 10993 and determined suitable for intended use.	"The Soft Tlp Multi-Lumen Central Venous Catheter 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."
Must meet all required release specifications (physical testing, visual examination).	"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)."
Physical testing defined by Quality Control Test Procedure documents, conforming to product design specifications.	"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."
No new issues of safety or effectiveness raised compared to the predicate device.	"There are no new issues of safety or effectiveness raised by The Soft Tip Multi-Lumen Central Venous Catheter."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "all finished products are tested" for release, implying manufacturing quality control, but not a specific sample size for a statistically robust pre-market test set.
Data Provenance: Not specified. The testing appears to be internal quality control ("All finished products are tested," "physical testing is defined by Quality Control Test Procedure documents").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The "ground truth" for the device seems to be compliance with internal specifications and physical testing parameters, rather than expert consensus on a clinical outcome.

4. Adjudication method for the test set

Not applicable/Not specified. The document describes internal testing and visual examination for product release, which typically follows predefined standards and does not involve adjudication by multiple experts in the sense of clinical study data interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document describes a physical medical device (catheter) from 1997. MRMC studies, especially those involving AI assistance, are not applicable to this type of product and were not prevalent at the time of this filing.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This document describes a physical medical device (catheter) from 1997. Standalone algorithm performance studies are not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purposes of this 510(k) submission, the "ground truth" for the device's acceptable performance seems to be its adherence to internal product design specifications, ISO standards (10993 for materials), and established Quality Control Test Procedures for physical testing and visual examination. There is no mention of clinical outcomes data, pathology, or expert consensus on clinical diagnostic performance.

8. The sample size for the training set

Not applicable/Not specified. This document does not describe a machine learning or AI-driven device that requires a training set. The mentioned "testing" refers to manufacturing quality control.

9. How the ground truth for the training set was established

Not applicable/Not specified. As there is no training set for an AI model, this information is not relevant to the provided text.

Summary

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

K971085
June 2, 1997

March 7, 1997

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

Contact:	Mark S. Alsberge, Regulatory Affairs Manager
Product Name:	Soft Tip Multi-Lumen Central Venous Catheter
Trade Name:	Catheter, Percutaneous Intravascular, Long term

Classification name:

Hospital Unclassified, 80LJS 21 CFR

SUBSTANTIAL EQUIVALENCE' TO:

K834473A	Accuguide Multi-LumenCentral Venous Catheter Kit	B. Braun Medical Inc.
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Device Description:

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 Soft Tlp Multi-Lumen Central Venous Catheter 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 Soft Tip Multi-Lumen Central Venous Catheter is similar in materials, form, and intended use to the Accuguide Multi-Lumen Central Venous Catheter Kit cleared by B. Braun Medical Inc. There are no new issues of safety or effectiveness raised by The Soft Tip Multi-Lumen Central Venous 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 consists of a stylized eagle with three curved lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Mark S. Alsberge Manager, Regulatory Affairs B. Braun Medical, Incorporated 824 Twelfth Avenue Bethlehem, Pennsylvania 18018

JUN - 2 1997

K971085 Re : Soft Tip Multi-Lumen Central Venous Trade Name: Catheter Unclassified Regulatory Class: Product Code: LJS Dated: March 11, 1997 March 25, 1997 Received:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP)

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Page 2 - Mr. Alsberge

解: 详!!

regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:

The labeling, packaging and method of sterilization of 1. the suture cannot be changed without prior notification, review and clearance by FDA.
The supplier of the sutures used in your device cannot be 2. changed without prior notification, review and clearance by FDA.

In addition, we have determined that your device kit contains a 5 ml. ampul of lidocaine and povidone iodine ointment which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4618. advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041/for at (301) 443-6597.

Sincerely yours,

Tim K. R. Wlatowski

Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K971085
Device Name:	Soft Tip Multi-Lumen Central Venous Catheter
Indications For Use:	The soft Tip Multi-Lumen Catheteris a device that is inserted intothe venous system for the administrationof blood products, parenteral nutrition ;-I.V. fluids or drugs.

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

Compliance of CDRH, Office of Device Evaluation (ODE)

(Division	Patrician Conti
Division of	Infection Control,
and General Hospital Devices
510(k) Number	K971085

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(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.”