The SCHNEIDER GUIDER® guiding catheter is manufactured in four French sizes (6 through 9 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.

AI/ML Overview

The submission for the SCHNEIDER GUIDER® Softip® guiding catheter (K981413) does not describe an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML is not applicable.

The submission is for a conventional medical device, a guiding catheter, and focuses on demonstrating substantial equivalence to a predicate device through comparison of design and verification of materials.

Here's an analysis based on the provided text, focusing on what is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Not explicitly stated	Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies compliance with biocompatibility standards, though specific data not provided in summary).
Tip Tensile Pull	Not explicitly stated	Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting tensile strength requirements, though specific data not provided in summary).
Pressure Injection Leak Test	Not explicitly stated	Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting leak integrity requirements, though specific data not provided in summary).
Shape Recovery	Not explicitly stated	Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting shape recovery requirements, though specific data not provided in summary).
Overall Equivalence for Intended Use	Device is safe and effective for intended use, substantially equivalent to predicate.	"The results of design control activities indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters and are, therefore, safe for the intended use." This statement summarizes the outcome of all testing demonstrating substantial equivalence.

Missing Information (as per AI/ML prompt, but not applicable to this submission):

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device submission involving physical testing, not a dataset for AI/ML.
3. 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. Ground truth for AI/ML algorithms is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Study Description (for the conventional device):

The study was a design control activity to demonstrate the equivalence of the modified SCHNEIDER GUIDER® Softip® guiding catheter (with new stem material) to the original, currently marketed predicate device. The "study" involved a series of engineering and material performance tests.

Tests Conducted: Biocompatibility, tip tensile pull, pressure injection leak test, and shape recovery.
Objective: To verify that the change in stem material did not adversely affect the safety and effectiveness of the device, thereby proving its substantial equivalence to the predicate device.
Conclusion: The tests indicated that the modified catheters are equivalent to the currently marketed ones and are safe for the intended use.

Summary

{0}------------------------------------------------

K981413

MAY | 3 1998

510(k) Summary for SCHNEIDER GUIDER® Softip® guiding catheter

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is __________________________________________________________________________________________________

Date Prepared:	April 15, 1996
Sponsor:	Schneider (USA) Inc5905 Nathan LanePlymouth, MN 55442Phone: (612)550-5500
Contact:	Maria BrittleSr. Regulatory Affairs Specialist
Trade/Proprietary Name:	SCHNEIDER GUIDER® Softip® guiding catheters
Classification:	Class II
Equivalent Devices	SCHNEIDER GUIDER® Softip® guiding catheters

Device Description

Intended Use

The SCHNEIDER GUIDER® Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

Technological Characteristics

The equivalence of the SCHNEIDER GUIDER® Softip® guiding catheter with new stem material was demonstrated through comparison of design with the original and summary of the design control activities undertaken to verify equivalence of the added material. Testing included biocompatibility, tip tensile pull, pressure injection leak test and shape recovery.

The results of design control activities indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters and are, therefore, safe for the intended use.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1998

Ms. Marie Brittle Sr. Regulatory Affairs Specialist Schneider (USA) Inc. Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442

Re: K981413 Trade Name: SCHNEIDER GUIDER® Softip® Guiding Catheters Requlatory Class: II Product Code: DOY Dated: April 17, 1998 Received: April 20, 1998

Dear Ms. Brittle:

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 qeneral 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

{2}------------------------------------------------

Page 2 - Ms. Maria Brittle

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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Division o Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

SCHNEIDER GUIDER Softip™ Guiding Catherer

Page of

510(k) Number (if known):

Device Name:

SCHNEIDER GUIDER Softip® Guiding Catheter

Indications for Use:

The SCHNEIDER GUIDER Softip® Guiding Catheter is designed for the intravascular introduction of interventional devices.

Taca A. Re

JIVISION 64-6 Division of Cardiovascular, Respiratory, nd Neurological Devices : ロツk) Numbs: …… 1198/413

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 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).