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.

Device Description

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity or specificity thresholds). Instead, the performance claims are qualitative and relate to the device's intended function and safety.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality: Facilitate placement and positioning of catheters within the peripheral vasculature.	"Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature."
Imaging: Provide an intraluminal, cross-sectional ultrasound image of the area of interest.	"The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest." (This is a statement of capability, not a performance metric like image quality or resolution.)
Biocompatibility: Materials must be safe for use in the body.	"The materials used in the manufacture of the CrossPoint TransAccesss Catheter have been shown to be biocompatible when tested in accordance with ISO 10993-1 requirements."
Safety: Device must be safe for its intended use.	"Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective..."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing and animal studies." It only refers to "results of in-vitro testing and animal studies."
Data Provenance: The studies mentioned are "in-vitro testing" and "animal studies." No country of origin is specified, and the studies are inherently prospective in nature (designed and conducted to gather specific data).

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. Given the nature of "in-vitro testing and animal studies," ground truth would likely be established through direct observation, physiological measurements, or histological analysis, rather than by human expert interpretation in the same way it would be for a diagnostic AI.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of medical images where disagreements need to be resolved. For in-vitro and animal studies, objective measurements or observations form the "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The device described (CrossPoint TransAccess Catheter) is a physical medical device (catheter with ultrasound imaging capability), not an AI algorithm intended for diagnostic interpretation to be used with or without human assistance. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. As noted above, this device is not an AI algorithm. Its performance is related to its physical function and the quality of the ultrasound images it provides, not algorithmic interpretation.

7. The Type of Ground Truth Used

Based on the description of "in-vitro testing and animal studies," the ground truth would likely be established through:

Direct Observation: For catheter placement and manipulation.
Physiological Measurements: To assess efficacy and safety in animal models.
Histological Analysis or Other Pathology: For evaluating tissue effects or confirming findings in animal studies.
Engineering Measurements/Specifications: For in-vitro performance (e.g., image resolution, catheter flexibility).

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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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.

Date Prepared: August 1, 2001

510(k) Number: 9 Be Determined

Applicant Information:

Contact Person:

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

Steve Jwanouskos Vice President, Clinical & Regulatory Affairs

Phone: (650) 473-4500 x105 Fax: (650) 473-4545

Device Information:

Classification: Class II

Trade Name: CrossPoint™ TransAccess® Catheter

(013365

Classification Name: Percutaneous Catheter (21 CFR 870.1250)

Equivalent Device:

The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the Perclose Outback Catheter (K001577) and Endosonics' devices, Visions 2.9F Ultrasonic Imaging Catheter and Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter.

Intended Use:

Test Results:

Performance

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

Biocompatibility

The materials used in the manufacture of the CrossPoint TransAccesss Catheter have been shown to be biocompatible when tested in accordance with ISO 10993-1 requirements.

Summary:

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

CONFIDENTIAL

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:

(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)

Prescription Use
(Per 21 CFR 801.109)

F-3

Division of Cardiovascular & Respiratory Devices
510(k) Number K013365

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trans Vascular Incorporated C/o Mr. Mark Job TUV Product Service, Inc. 1775 Old Highway 8 New Brighton, MN 55112

APR 0 2 2002

Re: K013363

Trade Name: Crosspoint Transaccess Catheter Regulation Number: 21 CFR 892.1570 and 21 CFR 870.1250 Regulation Name: Diagnostic Ultrasonic Transducer and Percutaneous Catheter Regulatory Class: II (two) Product Code: ITX and DQY Dated: February 28, 2002 Received: March 1, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket 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.

This determination of substantial equivalence applies to the following transducer intended for use with the Crosspoint Transaccess Catheter, as described in your premarket notification:

Transducer Model Number 0.014" Guidewire Compatible; 6.2 French

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 - Mr. Mark Job

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 (08) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Mr. Mark Job

If you have any questions regarding the content of this letter, please contact Elisa Harvey at (301) 443-8262 extension 167.

Sincerely yours,

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

Enclosure

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Center for Devices and Radiological Health Premarket Notification [510(k)] Indications for Use Statement

0133663
K

Date Prepared: August 1, 2001

Device Trade Name:

CrossPoint TransAccess Catheter

Indications for Use:

The CrossPoint TransAccess Catheter is latended to facilitate the placement and positioning of catheters within the periphers wascellature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the ares of interest. The CrossPoint TrausAccess Catheter is not indicated for use in the coronary or cerchral vasculature.

TransVascular, Inc.

CONFIDENTIAL

Prescription Use
(21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013363

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.