The Xtrak Support catheter shaft consists of a flexible, distal section made of closely-wound coils, and a stiffer and more torqueable mid-section coupled to a proximal handle through a short length of spiraled strain relief. The distal and mid-shaft sections, and the strain relief are constructed from a continuous length of stainless steel wire to maximize catheter integrity. The catheter is provided in various sizes to accommodate .014" and .018" quidewires.

AI/ML Overview

This 510(k) premarket notification for the Xtrak Support Catheter does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance. The provided document details a traditional medical device submission, focusing on mechanical and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested categories related to AI/ML performance, ground truth, expert opinions, and sample sizes for AI training and testing, cannot be extracted from this document.

Here's a breakdown of the information that can be extracted and an explanation for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Type	Acceptance Criteria (from document)	Reported Device Performance (from document)
Material Safety	Materials suitable for intended use, commonly used in cleared products.	"All materials used...are suitable for their intended use and are used commonly in the manufacture of previously cleared products."
Mechanical Performance	Compliance with specifications.	"Test results demonstrate conformance...to their specification requirements."
Biocompatibility	Compliance with specifications.	"Test results demonstrate conformance...to their specification requirements."
Overall Safety & Effectiveness	"as safe and effective as the legally marketed predicated devices."	"Test results...that the Xtrak Support catheter is as safe and effective as the legally marketed predicated devices."

2. Sample Size for the Test Set and Data Provenance

Not Applicable / Not Provided: The document discusses mechanical and biocompatibility testing. These tests typically involve a defined number of physical samples of the device and its components, not data from a "test set" in the context of an AI/ML study. The document does not specify the number of units tested.
Data Provenance: Not applicable in the context of device performance testing of a physical medical device.

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

Not Applicable: This device is a physical medical device (catheter), not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" in the AI/ML sense, established by medical experts for a dataset, is not relevant to this submission.

4. Adjudication Method for the Test Set

Not Applicable: As there is no "test set" in the AI/ML context, there is no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: The document does not mention any MRMC study. This type of study is typically performed for imaging or diagnostic tools where human readers are involved in interpreting results, which is not the case for a support catheter.
Effect Size of Human Readers with/without AI: Not applicable, as no AI component is described.

6. Standalone (Algorithm Only) Performance Study

No: This device is a physical medical instrument. There is no AI algorithm to be evaluated in a standalone manner.

7. Type of Ground Truth Used

Product Specifications / Industry Standards: For mechanical and biocompatibility testing, the "ground truth" is typically defined by the device's own engineering specifications, relevant ISO standards, and FDA guidance documents for medical devices of this type. It's about meeting pre-defined physical and biological criteria, not clinical outcomes or expert consensus on image interpretation.

8. Sample Size for the Training Set

Not Applicable: There is no AI/ML component, and therefore no "training set."

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

Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.

Summary

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

032660

Xtrak Support Catheter Pre-Market Notification [510(k)]

OCT 2 9 2003

510(k) Summary

General Information Classification:

Class II (per 21 CFR 870.1250)

Trade Name:

Sponsor:

Xtrak Support Catheter

Xtrak Medical, Inc. 26H Keewaydin, Dr. Salem. NH 03079 (603) 896-6416 Tel: Fax: (603) 893-7708 Gary Boseck, Ph.D.

Contact:

Identification of Predicate or Legally Marketed Devices: ILT Safe Cross Support Catheter (K030984) manufactured by Intraluminal Therapeutics, Inc.

Intended Use:

The Xtrak Support catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.

Device Description:

Materials:

All materials used in the manufacture of the Xtrak Support catheter are suitable for their intended use and are used commonly in the manufacture of previously cleared products.

Performance Testing:

The Xtrak Support catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:

. Mechanical Strength Testing
Biocompatibility Testing .

Test results demonstrate conformance of the Xtrak Support catheter components to their specification requirements, and that the Xtrak Support catheter is as safe and effective as the legally marketed predicated devices.

Summary of Substantial Equivalence:

Xtrak Medical believes that the Xtrak Support catheter is substantially equivalent to the legally marketed predicate devices. This claim of equivalence is supported by the identical intended use of the devices and their common technological characteristics.

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

Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with three lines representing the body and wings. The image is simple and clean, with a focus on the text and the bird symbol.

OCT 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Xtrak® Medical, Inc. c/o Ms. Debbie Iampietro ORC Consulting 26H Keewaydin Dr. Salem, NH 03079

Re: K032660

Trade Name: Xtrak® Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 26, 2003 Received: September 3, 2003

Dear Ms. Iampietro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 - Ms. Debbie Iampietro

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Jhosa D. Alay for

Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Xtrak Support Catheter Pre-Market Notification [510(k)]

Ver/ 3 - 4/24/96

production and and station starting the may

Applicant: XTRAK MEDICAL, INC.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Xtrak Support Catheter

Indications For Use:

The Xtrak Support Catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
(Per 21 CFR 801.109)	Division of Cardiovascular Devices
(Optional Format 1-2-96)	510(k) Number K032660
	Prescription Use

X 10/28/03

(Per 21 CFR 801.109)

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).