As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . 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 catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Device Description

The subject catheter is a short term, single use, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.

AI/ML Overview

This device is a Diagnostic Intravascular Catheter (INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ Catheters) intended to provide access to the vascular system for monitoring blood pressure, sampling blood, or introducing substances into the heart and vessels. The key modification for this 510(k) submission is the explicit clarification that the catheters are suitable for use with power injectors, with a maximum rated pressure of 300 psi.

Based on the provided information, there is no acceptance criteria or study that proves the device meets specific performance metrics in the context of AI/ML or diagnostic accuracy. This document is a 510(k) premarket notification for a medical device (intravascular catheter) where the primary assertion is substantial equivalence to a predicate device, with an added clarification regarding use with power injectors.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable or not present:

A table of acceptance criteria and the reported device performance

There are no specific quantitative acceptance criteria or reported device performance metrics provided in the document related to diagnostic accuracy or AI/ML performance. The basis for clearance is substantial equivalence to a predicate device, with the addition of a clarified intended use with power injectors.

The "performance" referred to in the "Summary of Safety and Efficacy" relates to the inherent function of the catheter, not a diagnostic output. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate device	Cleared as substantially equivalent to the Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters.
Suitability for intended use with power injectors (300 psi max)	Labeling clarified to include use with power injectors up to 300 psi.
Safety and Efficacy	Assumed through substantial equivalence determination and compliance with general controls.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) for a physical medical device (catheter), not an AI/ML diagnostic software. There is no "test set" in the context of an AI/ML algorithm's performance evaluation mentioned in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As this is not an AI/ML diagnostic submission, there is no mention of experts establishing a ground truth for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is mentioned.
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

Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. There is no AI algorithm being submitted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no AI algorithm requiring ground truth data.
The sample size for the training set

Not applicable. There is no AI algorithm that requires a training set mentioned in this document.
How the ground truth for the training set was established

Not applicable. There is no AI algorithm or training set discussed.

Summary

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DEC 2 4 1997

SUMMARY OF SAFETY AND EFFICACY

A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared:April 10, 1997.
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Diagnostic Intravascular Catheter Brand: INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ II Catheters Common Name: I.V. Catheter Classification Name: Diagnostic Intravascular Catheter (74DQQ)
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, 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, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.
E. Statement of intended use of the device.
The intended use is to provide access to the vascular system to monitor blood pressure, to sample blood or introduce substances into the heart and vessels.. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
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 INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters currently marketed in that the labeling clarifies the suitability of the catheters for use with power injectors.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, stacked on top of each other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Mr. Charles J. Welle Manager, Regulatory Affairs Manager, Rogano Vascular Access, Incorporated 9450 South State Street Sandy, Utah 84070

K971339 Re: INSYTE®, INSYTE-W® and INSYTE® AUTOGUARD™ Trade Name: Catheters II Requlatory Class: Product Code: FOZ Dated: September 22, 1997 Received: September 30, 1997

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 Regulations, Title 21, Parts 800 to 895. A 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 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

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Page 2 - Mr. Welle

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 requlations.

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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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

Ulatows Timothy A. 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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April 10, 1997-

INDICATIONS FOR USE

510(k) Number: K 97|339

Device Name: INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ Catheters

Indications for Use: As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . 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 catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use: (Per 21 CFR 801.109)	X
OR	Over-The -Counter Use:

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
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510(k) Number	K971339
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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).