BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER

K081130 · Bridgepoint Medical · DQY · May 14, 2009 · Cardiovascular

Device Facts

• Record ID: K081130
• Device Name: BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
• Applicant: Bridgepoint Medical
• Product Code: DQY · Cardiovascular
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.

Device Story

The CrossBoss Catheter is a single-use, over-the-wire percutaneous catheter designed for vascular access. It features a full-length coiled stainless steel shaft with a polyester and polyurethane exterior, providing torque and pushability. The distal end transitions to an enlarged (1mm) rounded stainless steel tip, which is radiopaque and designed to be atraumatic to arterial tissue. The catheter is hydrophilic-coated for lubricity. A coaxially positioned torque device on the proximal shaft allows for manual manipulation by a physician; this torque device includes a torsion release safety mechanism to prevent exceeding the torsional operating strength of the shaft. The device is used in clinical settings to navigate the coronary or peripheral vasculature, facilitating the placement of guidewires and subsequent interventional devices. By providing a stable, steerable platform, it assists clinicians in accessing challenging vascular regions, potentially improving procedural success in interventional cardiovascular applications.

Clinical Evidence

The manufacturer provided a variety of in vitro and in vivo information to demonstrate substantial equivalence. No specific clinical trial results, sample sizes, or statistical metrics (e.g., sensitivity, specificity) were detailed in the provided summary.

Technological Characteristics

Materials: stainless steel (coiled shaft and distal tip), polyester, polyurethane. Features: 1mm diameter rounded distal tip, hydrophilic coating, proximal torque device with torsion release safety mechanism. Connectivity: None (mechanical device). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for use in patients requiring access to discrete regions of the coronary or peripheral vasculature to facilitate the placement of guidewires and other interventional devices.

Regulatory Classification

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.

Predicate Devices

• LuMend Percutaneous Catheter (K011562)
• Asahi Tornus Support Catheter (K051772)
• Magnum-Meier Recanalization Guidewire (K911547)

Submission Summary (Full Text)

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BridgePoint Medical CrossBoss Catheter K081130/S5

# MAY 1 4 2009

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K081130

## Applicant Information:

| Date Prepared: | April 18, 2008 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name:<br>Address: | BridgePoint Medical<br>2800 Campus Drive, #50<br>Plymouth, MN 55441<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

| Contact Person: | Michael A. Daniel |
|-------------------|------------------------------------------|
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | [phone] |

#### Device Information:

| Classification: | Class II Percutaneous Catheter |
|----------------------|-------------------------------------------------|
| Trade Name: | BridgePoint Medical CrossBoss™ Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

## Predicate Devices:

The BridgePoint Medical CrossBoss Catheter is substantially equivalent in intended use, method of operation and technical aspects to a combination of the following predicale devices:

K011562 - LuMend Percutaneous Catheter K051772 - Asahi Tornus Support Catheter K911547 - Magnum-Meier Recanalization Guidewire

## Device Description:

The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethanc exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced

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risk of arterial tissue engagement while providing radiopaque visibility. The distal risk of arterial those Catheter is hydrophilic coated to enhance lubricity. The portion of the OrossDoos Canieternal stainless steel hypotube stiffener that provides the additional tolerance to push. A torque device, coaxially positioned over the proximal additional the CrossBoss Catheter, provides a comfortable user interface for device manipulation. The CrossDose (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.

## Intended Use:

The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with I he Bridger unit freaturess discrete regions of the coronary or peripheral vasculature. 11 a guidention to facilitate placement of guidewires and other interventional devices.

## Comparison to Predicate Device(s):

The design of the BridgePoint Medical CrossBoss™ Catheter is similar to the predicates listed, the LuMend Percutaneous Catheter (K011562) and the Asahi Tornus Support Catheter (K051772) in that they are all devices designed to access discrete regions of the corners and peripheral vasculature. The enlarged (1mm diameter) rounded distal tip is technically similar to the Magnum-Meier Recanalization Guidewire (K911547).

## Device Evaluation Information Provided:

A variety of in vitro and in vivo information has been provided demonstrating substantial cquivalence.

## Summary:

Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the BridgePoint CrossBoss Catheter has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Bridegepoint Medical c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 2800 Campus Drive #50 Plymouth, MN 55441

Re: K081130

BridgePoint Medical CrossBoss™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 24, 2009 Received: April 27, 2009

Dear Mr. Daniel:

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 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. Michael A. Daniel

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

una R. Vachner

Branch
Director

- 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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BridgePoint Medical CrossBoss Catheter K081130/S5

# Indications for Use

510(k) Number: K081130

#### BridgePoint Medical CrossBoss™ Catheter Device Name:

### Indications For Use:

The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices

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)

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imma P. Jones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number KO81130

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