The Introcan Safety I.V. Catheter which is a passive antineedle stick device. The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

AI/ML Overview

Based on the provided text, the device in question is the Introcan Safety I.V. Catheter, which is a passive anti-needle stick device. The document is a 510(k) summary indicating its substantial equivalence to a previously cleared device, the "Microcath"™ Intravenous Catheter Placement Unit and Catheter (K801941).

Here's the analysis of acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility	Composed of materials tested in accordance with ISO Standard 10993 and determined to be suitable for intended use.
Functional Integrity (General)	"All finished products are tested and must meet all required release specifications before distribution."
Physical Testing	"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 specific parameters or numerical results are provided in this summary.)
Visual Examination	"Visual examination (in process and finished product)" is performed. (No specific criteria or results are provided.)
Substantial Equivalence	The device is similar in materials, form, and intended use to the predicate device (Microcath™) and raises no new issues of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for any specific test set or clinical study. The testing described appears to be manufacturing quality control and component testing rather than a clinical trial or performance study against pre-defined acceptance criteria with clinical endpoints.

The data provenance is implied to be internal testing by B. Braun Medical, Inc., rather than external clinical data or country-specific data. It's retrospective in the sense that it refers to internal testing of finished products, not a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. The "ground truth" for the internal quality control tests would be the established product design specifications and testing procedures, not expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study is more common for diagnostic imaging devices or software. The device here is an I.V. catheter.

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

The device is a physical medical device (an I.V. catheter), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The described testing (physical, visual) is standalone performance for the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the described testing appears to be:

Established engineering/design specifications: For physical testing.
ISO Standard 10993 requirements: For biocompatibility.
cGMP (Current Good Manufacturing Practices) for quality control: For manufacturing and release procedures.

There is no mention of pathology, outcomes data, or expert consensus as a ground truth for this specific device's performance. The comparison is to a predicate device for "substantial equivalence" based on materials, form, and intended use, implying that its safety and effectiveness are derived from its similarity to an already approved device.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a physical I.V. catheter, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this physical device.

Summary

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K98.2805

August 4, 1998

JAN 1 4 1999

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

Mark S. Alsberge, Regulatory Affairs Director Contact:

Introcan Safety I.V. Catheter Product Name:

Trade Name: Catheter, Intravascular, Short Term

Classification name:

Hospital Class II, 80FOZ 21 CFR 880.5200

SUBSTANTIAL EQUIVALENCE1 TO:

510(k) number	Name	Applicant
K801941	"Microcath" ™ IntravenousCatheter Placement Unit andCatheter	Burron 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 Introcan Safety I.V. Catheter which is a passive antineedle stick device. The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

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 Introcan Safety I.V 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 Safety I. V. Catheter is similar in materials, form and intended use to the Microcath™ cleared by B. Braun Medical Inc. formally known as Burron Medical. There are no new issues of safety or effectiveness raised by The Safety I.V. 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 cGMP"s.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Mr. Mark S. Alsberge Requlatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue Bethlehem, Pennsylvania 18018-0027

K982805 Re : Trade Name: Introcan Safety I.V. Catheter Regulatory Class: II Product Code: FOZ Dated: November 9, 1998 Received: November 12, 1998

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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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): I.V. Ca the fer afety strocan Device Name: anti-needle Stick device to be Indications For Use: Dassive antify frem.
Specipheral vein for the infusion of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Snucenik

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 49782805

Prescription Use
(Per 21 CFR 801.109)

。

Over-The-Counter Use

(Optional Forrazt 1-2-96)

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).