The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

Device Description

The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.

AI/ML Overview

The provided text describes a 510(k) summary for the SCHNEIDER GUIDER Softip® Guiding Catheters. This submission focuses on demonstrating substantial equivalence to predicate devices based on design and indications for use, rather than conducting a detailed performance study with specific acceptance criteria as you would find for a novel device or AI/software.

Therefore, much of the requested information about acceptance criteria, study design, and ground truth is not explicitly present or applicable to this type of regulatory submission. The document emphasizes mechanical testing in simulated environments to ensure the device's functionality, not clinical performance metrics.

Here is an attempt to address your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Force needed for insertion is acceptable (in simulated anatomy).	"These have been tested in simulated aortic and carotid anatomy with appropriate interventional devices to test that the force needed for insertion is acceptable."
Design (e.g., French sizes, distal stem configurations, lengths) is consistent with predicate.	"The design of the SCHNEIDER GUIDER Softip® Guiding Catheter remains the same as for the previous cleared devices."
Indications for Use are substantially equivalent to predicate devices.	"Schneider (USA) Inc has demonstrated that the SCHNEIDER GUIDER Softip® Guiding Catheters are substantially equivalent based on design, test results, and indications for use to the predicate devices."

Explanation: In a 510(k) for a medical device like this catheter, acceptance criteria are often implied by comparison to a legally marketed predicate device. The primary "study" is a demonstration of substantial equivalence through design comparison and mechanical testing, rather than a clinical trial with performance metrics like sensitivity, specificity, or accuracy.

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

Sample Size: Not specified. The description mentions "simulated aortic and carotid anatomy with appropriate interventional devices," but does not explicitly state the number of catheters tested or the number of simulated procedures performed.
Data Provenance: The origin of the simulated anatomy data is not specified (e.g., country of origin). The testing was an internal evaluation by the manufacturer, not a clinical study on human subjects, so the terms "retrospective" or "prospective" do not directly apply to patient data.

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

This information is not provided. Given that the testing was mechanical in simulated anatomy, "experts" in the sense of clinical reviewers establishing ground truth for disease states or outcomes are not applicable. The "ground truth" here would be the physical properties and functionality of the catheter itself, assessed by engineers or technical personnel.

4. Adjudication Method for the Test Set

Not applicable. There's no indication of independent review or adjudication for the mechanical testing results beyond the manufacturer's own internal reports.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. This device is a physical medical instrument (guiding catheter), not an AI or software algorithm. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. As stated above, this is not an AI/algorithm device.

7. The Type of Ground Truth Used

The "ground truth" was based on mechanical performance and design equivalence to predicate devices. Specifically, it involved whether the "force needed for insertion is acceptable" in simulated anatomical models and whether the design features matched the predicate. It did not involve expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of data used to train an algorithm. Any "training" would refer to the historical data and design principles used to develop the catheter, which is not quantified.

9. How the Ground Truth for the Training Set was Established

Not applicable. Since there's no training set for an AI algorithm, this question doesn't apply.

Summary

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1980453

AUG 1 1 1998

510(k) Summary

Date Prepared

August 7, 1998

Submitter

Address:

Schneider (USA) Inc 5905 Nathan Lane Minneapolis, MN 55442

Phone:	(612) 550-5500
Fax:	(612) 550-5771

Contact Person

Ronald W. Bennett Senior Regulatory Affairs Specialist

Device Name and Classification

Trade Name	SCHNEIDER GUIDER Softip® Guiding Catheters
Classification	Class II
Predicate Devices	SCHNEIDER GUIDER Softip® Guiding Catheters(K961999)Cordis Vista brite tip™ guiding catheter

Device Description

Indication

SCHNEIDER GUIDER Softip® Guiding Catheters are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

Technological Characteristics

The design of the SCHNEIDER GUIDER Softip® Guiding Catheter remains the same as for the previous cleared devices. These have been tested in simulated aortic and carolid anatomy with appropriate interventional devices to test that the force needed for insertion is acceptable.

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Summary

In summary Schneider (USA) Inc has demonstrated that the SCHNEIDER GUIDER Softip® Guiding Catheters are substantially equivalent based on design, test results, and indications for use to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with overlapping lines creating a sense of depth.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 1998

Mr. Ronald W. Bennett Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442

Re: K980453 SCHNEIDER GUIDER Softip® Guiding Catheter Requlatory Class: II (two) Product Code: 74 DQY Dated: May 26, 1998 Received: May 28, 1998

Dear Mr. Bennett:

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 legally marketed predicate 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 of the Act. 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 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 requirements, 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Ronald W. Bennett

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):

Device Name: SCHNEIDER GUIDER Softip® Guiding Catheter

Indications for Use:

Tara A. Re

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 980453 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).