The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The TransXchange Support Catheter is designed to perform the following functions during percutaneous intravascular procedures:

Support a 0.014" guidewire during introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter is designed to assist in the introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter acts to fill the annular space between the smaller guidewire and larger catheter lumen.
Allow for the exchange of guidewires through its lumen
Infusion of fluids such as saline or diagnostic contrast agents through its lumen into the vascular system using pressures up to 150 psi

The TransXchange Support Catheter in constructed of 5 components: a single lumen high density polyethylene tubing with a tapered distal tip, a proximal female luer hub, a two piece strain relief constructed of polyolefin, a distal platinum iridium marker band, and Loctite 4304 Cyanoacrylate Adhesive.

AI/ML Overview

This document describes a 510(k) premarket notification for the "TransXchange Support Catheter" by Medtronic Vascular. This type of submission focuses on proving "substantial equivalence" to a predicate device, rather than independent performance acceptance criteria and a detailed clinical study for novel devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table for this device. The focus is on demonstrating "substantial equivalence" to a predicate device, the Spectranetics Support Catheter (K991059).

Instead of specific numerical targets, the acceptance criteria for this 510(k) submission are inferred to be:

Ability to perform intended functions:
- Support a 0.014" guidewire during the introduction of larger catheters.
- Allow for the exchange of guidewires.
- Infuse fluids (saline or contrast agents) at pressures up to 150 psi.
Safety and Effectiveness: Demonstrated through biocompatibility and non-clinical (preclinical) testing.
Sterility: The device must be provided sterile and not intended for reuse or resterilization.
Substantial Equivalence: The primary "acceptance criterion" of a 510(k) is to prove that the device is as safe and effective as a legally marketed predicate device.

The reported device performance is described qualitatively as:

"The subject and predicate stents are identical technology and are intended to support a guidewire during access of the vasculature, to allow for the exchange of guidewires, and to infuse saline or diagnostic contrast agent."
"The subject device offers a smaller catheter diameter." (This is a design difference, not a performance metric per se, but it implies a performance characteristic in terms of access).
"Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." (No specific results are provided).
"The TransXchange Support Catheter... meets clinical needs of the physicians."

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

The document does not mention a "test set" in the context of human clinical data or a specific sample size for such a set. The "testing" referred to is "Nonclinical testing" to confirm "safe and effective performance" and "biocompatibility." These are typically bench tests or in vitro/ex vivo studies, not clinical trials with human subjects. Therefore, details like data provenance or retrospective/prospective nature are not applicable here.

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)

No information is provided about experts used to establish ground truth because there is no mention of a human clinical test set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is mentioned as there is no human clinical test set described.

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

No such study was conducted or mentioned. This device is a physical catheter, not an AI-powered diagnostic tool, so MRMC studies and AI assistance metrics are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device and the submission (510(k) for substantial equivalence based primarily on non-clinical testing), the "ground truth" or validation would come from:

Engineering specifications and standards: Confirming the catheter's physical properties, material compatibility, and functional performance (e.g., ability to support a guidewire, flow rates at specific pressures, burst pressure, fatigue resistance).
Biocompatibility testing results: Adherence to established standards for biological safety.
Comparison to the predicate device: The predicate device itself (Spectranetics Support Catheter K991059) represents a "ground truth" of a legally marketed and presumably safe and effective device. The "truth" for the new device is that it performs "substantially equivalently" to this predicate.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

Summary

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MAY 25 2004

510(k) Summary

1. Sponsor's Information

Sponsor's Name and Address:

Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403

Sponsor's Phone/ Fax Number:

(707) 525-0111 (707) 591-7406

Contact Person:

Leisa Martinez Regulatory Affairs Associate Phone: (707) 541-3259 Fax: (707) 591-7406 E-mail: leisa.martinez@medtronic.com

Submitted:

April 30, 2004

2. Device Information

Name: TransXchange Support Catheter

Trade Name: N/A

Classification:

Common Name: Intravascular Catheter Classification Name: Percutaneous Catheter (21 CFR 870-1250)

3. Predicate Device Information:

Name:	Spectranetics Support Catheter
Manufacturer:	Spectranetics
510(k) Number:	K991059
Clearance Date:	October 19, 1999

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Device Description 4.

The TransXchange Support Catheter is designed to perform the following functions during percutaneous intravascular procedures:

1. Support a 0.014" guidewire during introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter is designed to assist in the introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter acts to fill the annular space between the smaller guidewire and larger catheter lumen.
1. Allow for the exchange of guidewires through its lumen
1. Infusion of fluids such as saline or diagnostic contrast agents through its lumen into the vascular system using pressures up to 150 psi

ડ. Intended Use of Device

6. Technological Characteristics:

Comparison of Technological Characteristics A.

The TransXchange Support Catheter is substantially equivalent to the currently cleared Spectranetics Support Catheter (K0991059). The subject and predicate stents are identical technology and are intended to support a guidewire during access of the vasculature, to allow for the exchange of guidewires, and to infuse saline or diagnostic contrast agent. The subject device offers a smaller catheter diameter. The subject and predicate stents are both intended to meet clinical needs. The difference between the subject and predicate devices are minor and are not relevant to the ability of the subject device to perform as intended.

B. Nonclinical testing

Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device.

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C. Sterilization

The TransXchange Support Catheter is provided sterile. The device is not intended for reuse or resterilization.

Conclusion D.

The TransXchange Support Catheter is substantially equivalent to the currently cleared Spectranetics Support Catheter (K991059) and meets clinical needs of the physicians.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

Medtronic Vascular c/o Ms. Leisa Martinez 3576 Unocal Pl. Santa Rosa, CA 95403

Re: K033540

Trade/Device Name: TransXchange Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 8, 2003 Received: November 10, 2003

Dear Ms. Martinez:

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.

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Page 2 - Ms. Leisa Martinez

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 Or It 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) 594-4648. 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,

Dina P. Vochner

(g/ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033540

Device Name: TransXchange Support Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dima R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510/k) Number_K033540

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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).