The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.

Device Description

The 4 French SELECTOR™ diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device rather than a study for an AI/ML powered device. The information provided describes a diagnostic catheter and its equivalence to predicate devices, not an AI system.

Therefore, many of the requested categories are not applicable to the provided text.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Bond strength tests	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Flexural rigidity	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Bodystock force decay	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Shape recovery	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Flow rate	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Dynamic pressure	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)
Output/input torque to failure testing	Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The general phrasing "The following tests were performed... on the 4 French SELECTOR™ diagnostic catheter and on the predicate device" does not provide specific sample quantities for each test.
- Data Provenance: Not specified. It's a physical device P510(k) submission, so "data provenance" in the AI sense isn't directly applicable here. The tests were likely conducted by the manufacturer, Schneider (USA) Inc.
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. This document describes performance testing of a physical medical device (a catheter) against a predicate device, not an AI/ML algorithm requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this pertains to expert consensus on AI outputs, which is not relevant for this device.
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 a hardware device. No human-in-the-loop study with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device. No algorithm performs a standalone function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this physical device, "ground truth" would refer to established engineering standards or physical properties measured in a lab, not clinical expert consensus, pathology, or outcomes data in the context of an AI model's performance. The "ground truth" for the equivalence claim is the performance of the legally marketed predicate devices.
The sample size for the training set
- Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.

Summary of the Study (as described in the document):

The "study" conducted for the 4 French SELECTOR™ diagnostic catheter was a series of physical and mechanical tests designed to demonstrate its substantial equivalence to a previously approved predicate device. The technological characteristics evaluated included: bond strength tests, flexural rigidity, bodystock force decay, shape recovery, flow rate, dynamic pressure, and output/input torque to failure testing. The results of these tests indicated that the new device was equivalent to the predicate, thus deeming it safe for its intended use as a conduit for contrast medium delivery and other diagnostic/therapeutic procedures during angiography. This is a standard approach for 510(k) submissions for physical medical devices of this nature.

Summary

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K98207

AUG | | 1998

Schneider (USA) Inc Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442 Tel 612 550 5500 Fax 612 550 5771

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510(K) SUMMAR

Image /page/0/Picture/5 description: The image contains the word "SUMMARY" in large, bold font on the left side. To the right of the word "SUMMARY" is a logo with the word "SCHNEIDER" stacked on top of the word "WORLDWIDE". The letters in "WORLDWIDE" are spaced out.

5 French and 6 French SELECTOR™ diagnostic catheters

4 French SUPER TORQUE and SUPERTORQUEPLUS™

(March 3, 1993: K925522/March 29, 1996: K960801)

diagnostic catheter (April 2, 1996: K960975).

Date Prepared:

Sponsor:

June 12, 1998

Schneider (USA) Inc 5905 Nathan Lane Plymouth, MN 55442 Phone: (612)550-5500

Contact:

Janell A. Colley Regulatory Affairs Specialist

Trade/Proprietary Name: 4 French SELECTOR™ diagnostic catheter

Class II

Classification:

Equivalent Devices

Device Description

The 4 French SELECTOR™ diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.

The 4 French SELECTOR" is designed to deliver contrast Intended Use medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.

Technological Characteristics

The following tests were performed on the 4 French SELECTOR™ diagnostic catheter and on the predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force decay, shape recovery, flow rate, dynamic pressure, and output/input torque to failure testing.

The results of these tests indicate that the 4 French SELECTOR" diagnostic catheter is equivalent to the previously approved predicate device and is therefore safe for its intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG / 1 1998

Ms. Janell A. Colley Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442

Re: K982077 4 French SELECTOR™ Diagnostic Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: June 12, 1998 Received: June 12, 1998

Dear Ms. Colley:

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 requlations 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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Page 2 - Ms. Janell A. Colley

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) 594-4648. 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J V 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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emarket Notification 510(k) for the French SELECTORTM Diagnostic Cathete

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

4 French SELECTOR™ diagnostic catheter

Indications for Use:

The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tara A. Ry

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

Prescription Use (Per 21 CRF 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).