CROSSPOINT TRANSACCESS CATHETER

K013363 · Trans Vascular Incorporated · ITX · Apr 2, 2002 · Radiology

Device Facts

• Record ID: K013363
• Device Name: CROSSPOINT TRANSACCESS CATHETER
• Applicant: Trans Vascular Incorporated
• Product Code: ITX · Radiology
• Decision Date: Apr 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

CrossPoint TransAccess Catheter functions as a percutaneous catheter for peripheral vascular access; integrates intraluminal ultrasound imaging. Device inputs include acoustic signals processed to generate cross-sectional ultrasound images of the area of interest. Operated by clinicians in a clinical setting to assist in catheter placement and positioning. Output provides real-time visual feedback to the physician, aiding navigation and clinical decision-making during peripheral vascular interventions. Benefits include improved accuracy in catheter placement and visualization of the vascular environment. Device is 6.2 French and compatible with 0.014" guidewires.

Clinical Evidence

Bench testing and animal studies only. No human clinical trial data provided. Biocompatibility testing performed in accordance with ISO 10993-1.

Technological Characteristics

6.2 French percutaneous catheter; 0.014" guidewire compatible. Integrated ultrasound transducer for intraluminal imaging. Materials tested for biocompatibility per ISO 10993-1. Operates as a diagnostic ultrasonic transducer (21 CFR 892.1570) and percutaneous catheter (21 CFR 870.1250).

Indications for Use

Indicated for facilitating placement and positioning of catheters within the peripheral vasculature in patients requiring peripheral vascular procedures. Not indicated for use in coronary or cerebral vasculature.

Regulatory Classification

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.

Predicate Devices

• Perclose Outback Catheter (K001577)
• Visions 2.9F Ultrasonic Imaging Catheter
• Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter

Submission Summary (Full Text)

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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: [phone] x105 Fax: [phone]

### 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:

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:

#### 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

54

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone] 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