The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intra-luminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

Device Description

The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the original CrossPoint TransAccess Catheter (K013363).

AI/ML Overview

This device is a medical catheter and not an AI/ML device. Therefore, the requested information regarding AI/ML device performance metrics, such as ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies, is not applicable. The provided text is a 510(k) summary for a medical device called the CrossPoint® TransAccess® Catheter. This document asserts the device's substantial equivalence to a predicate device and reports on in-vitro testing.

Here's the breakdown of the information relevant to the device as presented in the document:

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

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (to allow placement and positioning of catheters within the peripheral vasculature and provide intraluminal, cross-sectional ultrasound imaging)	"Results of in-vitro testing demonstrate that the modified design of the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature."
Substantial Equivalence to (K013363)	"Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices."

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

Sample Size for Test Set: Not specified in the provided document. The document only mentions "in-vitro testing."
Data Provenance: Not specified. The testing was "in-vitro," meaning conducted in a controlled environment outside of a living organism, but no details on where or how these tests specifically were conducted are provided.

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)

This information is not applicable to the provided document. The device's performance was assessed through in-vitro testing, not against expert ground truth derived from clinical images or patient data.

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

This information is not applicable. The evaluation was based on in-vitro testing outcomes, not on subjective assessments requiring expert adjudication.

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

This information is not applicable. The device is a physical catheter, not an AI or imaging interpretation software. No MRMC study was conducted or mentioned in this context.

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

This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

The concept of "ground truth" as typically used for AI/ML performance evaluation (e.g., expert consensus interpretations, pathology results for imagery) is not directly applicable here. The "ground truth" for this device's performance would be engineering specifications and functional benchmarks met during in-vitro testing to demonstrate its ability to facilitate catheter placement and provide ultrasound images.

8. The sample size for the training set

This information is not applicable. The device is a physical catheter, not an AI/ML model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

Summary

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

K031920

JUL 2 8 2003

510(k) Safety and Effectiveness Information Summary

This summary of 510(k) Safety and Effectiveness Information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

June 20, 2003. Date Prepared:

510(k) Number:

Contact Person: Applicant Information:

TransVascular, Incorporated 1505-D Adams Drive Menlo Park, CA 94025-1439

Richard E. Anderson Phone: (650) 473-4500 X124 Fax: (650) 473-4545 Email: randerson@transvascular.com

Classification: Class II

Device Information:

Trade Name: CrossPoint® TransAccess® Catheter

Classification Name: Percutaneous Catheter (21 CFR 870.1250) and Diagnostic Ultrasound Transducer (21 CFR 892.1570)

Equivalent Device:

The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the original CrossPoint TransAccess Catheter (K013363).

Intended Use:

The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

Test Results:

Results of in-vitro testing demonstrate that the modified design of the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature.

Summary:

Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. 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

JUL 2 3 2003

TransVascular, Inc. c/o Mr. Richard E. Anderson 1505-D Adams Drive Menlo Park, CA 94025-1439

Re: K031920

CrossPoint® TransAccess® Catheter Regulation Number: 21 CFR 870.1250, 892.1570 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: ITX, DQY Dated: June 20, 2003 Received: June 23, 2003

Dear Mr. Anderson:

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. Iisting 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 - Mr. Richard E. Anderson

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) 594-4692. 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 vours.

J. Bram D. Zuckerman, M.D.

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

Enclosure

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

TransVascular, Inc.

Special 510(k)

This application

Indications for Use

510(k) Number (if known):

Device Name:

CrossPoint TransAccess Catheter

Indications for Use: The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intra-luminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

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)

N. Qatun

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K03192

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.