As indicated in 21 CFR 880.5200, to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

The ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ catheters provide a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the activation button is depressed by the clinician, the needle is withdrawn into the shield.

Device Description

The subject catheter is a short term, single use intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. The catheter unit is provided with a mechanism which allows the needle to be shielded following placement of the catheter.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) notification for a medical device (intravascular catheter) from Becton Dickinson, focusing on establishing substantial equivalence to a predicate device.

It primarily includes:

Submitter's information
Device name and classification
Identification of predicate device
Description of the device
Statement of intended use
Comparison of technological characteristics to the predicate device
FDA's response indicating substantial equivalence
Final indications for use statement

There are no details provided regarding:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
Number or qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for a training set was established.

This document serves as a regulatory clearance document based on substantial equivalence, not a detailed technical report of a performance study against specific acceptance criteria.

Summary

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4/9/99
BECTON DICKINSON AND COMPANY

BECTON
DICKINSON

K984059

Becton Dickinson Infusion Therapy 9450 South State Street Sandy, Utah 84070 Tel (801) 565-2535 Fax (801) 565-2749

510(k) NOTIFICATION

SUMMARY OF SAFETY AND EFFICACY

A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417-1880. Contact: C. J. Welle, Becton Dickinson Infusion Therapy, 9450 South State Street, Sandy, UT 84070. Telephone: 801-565-2535. Prepared: November 9, 1998.
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Intravascular Catheter Brand: ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ catheters Common Name: Intravascular Catheter Classification Name: Intravascular Catheter (80 FOZ)
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Infusion Therapy Systems ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ brand catheters.
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a short term, single use intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. The catheter unit is provided with a mechanism which allows the needle to be shielded following placement of the catheter.
E. Statement of intended use of the device.
As provided at 21 CFR 880.5200, the intended use is to provide access to the vascular system to sample blood, monitor blood pressure, or administer fluids intravenously.

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510(k) NOTIFICATION

F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed catheter differs from the ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ brand catheters in that the mechanism by which the needle is withdrawn into the shield has been modified.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 9 1999

Mr. Charles J. Welle Becton Dickinson & Company 9450 South State Street Sandy, Utah 84070

Re : K984059 ANGIOCATH® AUTOGUARD® Catheter, INSYTE® Trade Name: AUTOGUARD® Catheter Requlatory Class: II Product Code: FOZ January 28, 1999 Dated: Received: February 1, 1999

Dear Mr. Welle:

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 requlation 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. Welle

This letter will allow you to begin marketing your device as Inis recei will arrow your your market notification. The FDA described in your 510 (x) promazioe of your device to a legally rinding of substancial equivalence of polyclication for your marketed predicate device robated in oproceed to the market.

If you desire specific advice for your device on our labeling i II you debire operial 801 and additionally 809.10 for in regulation (21 on rares), please contact the Office of Villo draghosere ac (301) 594-4692. Additionally, for questions on Compilance at (501) 537 537 537 device, please contact the Dfomocion and adversibling of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entifical Hibbidhang 7 / Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Division or (301) 638-2041 or (301) 443-6597 or at its to at Its Coll-free namber (000)- 300 fdafgov/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) NOTIFICATION

March 29, 1998

INDICATIONS FOR USE

510(k) Number: K984059

Device Name: ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ Catheters

Indications for Use: As indicated in 21 CFR 880.5200, to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109)

Over-The -Counter Use:

Patricia Cascede
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K984059

vortech13.docvortech13.doc

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).