BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES

K080987 · Bridgepoint Medical · DQY · Feb 6, 2009 · Cardiovascular

Device Facts

• Record ID: K080987
• Device Name: BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
• Applicant: Bridgepoint Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The BridgePoint Medical Stingray™ Orienting Balloon Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.

Device Story

Stingray Orienting Balloon Catheter is a single-use, over-the-wire, percutaneous catheter. Distal end features two small-caliber inflatable Pebax balloons flanking a central guidewire lumen. When inflated with radiopaque contrast media, balloons create a planar geometry (2.5 mm width, 2.5x height) providing stability and visual orientation within vasculature. Distal portion includes two oppositely facing lateral ports communicating with the guidewire lumen, allowing operator to direct guidewire at a 45° angle to the catheter shaft. Radiographic markers assist physician in determining catheter orientation. Distal portion is hydrophilic coated for lubricity. Used by physicians in clinical settings to access coronary and peripheral vasculature; device provides stability and steering control for guidewires, facilitating navigation through complex vascular anatomy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, over-the-wire percutaneous catheter. Materials: Pebax balloons, Pebax/PTFE guidewire lumen. Distal portion hydrophilic coated. Radiopaque markers for orientation. Inflatable element geometry: 2.5 mm width. Energy source: Manual inflation with radiopaque contrast media.

Indications for Use

Indicated for patients requiring guidewire access to discrete regions of the coronary and peripheral vasculature.

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)
• Venture Wire Control Catheter Model WCC (K061843)
• Kerberos Occluding Guide Catheter and Accessories (K041151)

Submission Summary (Full Text)

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# 3. 510(k) Summary

FEB - 6 2009

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: | TBD K 080987 |
|------------------------|-------------------------------------------|
| Applicant Information: | |
| Date Prepared: | April 5, 2008 |
| Name: | BridgePoint Medical |
| Address: | 2800 Campus Drive, #50 Plymouth, MN 55441 |
| Phone: | 763-225-8500 |
| Fax: | 763-225-8718 |

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

Email: [e-mail]

## Device Information:

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

## Predicate Devices:

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

- K011562 LuMend Percutaneous Catheter K061843 - Venture Wire Control Catheter Model WCC K041151 - Kerberos Occluding Guide Catheter and Accessories
### Device Description:

The Stingray Orienting Balloon Catheter is a single use, over the wire, disposable percutaneous catheter consisting of a distal inflatable element, that when inflated with radiopaque contrast media provides visibility and intra-arterial stability. The catheter also includes a proximal shaft that provides flexibility and push and includes a guidewire lumen. The distal inflatable element consists of two small caliber inflatable Pebax® balloons positioned adjacent to a Pebax® and PTFE guide wire lumen. When inflated, these small caliber balloons along with the guidewire lumen define a planar geometry where the width of the construction (2.5 mm) is approximately 2.5 times its height.

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Within the inflatable element, the distal portion of the catheter includes two oppositely facing lateral ports that communicate with the central guide wire lumen. These ports allow the operator to direct a guidewire from the wire lumen outward at an angle (approximately 45°) to the catheter shaft. The Stingray Orienting Balloon Catheter has radiographic marks that allow the physician to determine the orientation of the catheter with respect to the vasculature. The distal portion of the Stingray Orienting Balloon Catheter is hydrophilic coated to enhance lubricity.

#### Intended Use:

The BridgePoint Medical Stingray™ Orienting Balloon Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.

## Comparison to Predicate Device(s):

The design of the BridgePoint Medical Stingray Orienting Balloon Catheter is similar to the predicates listed, the LuMend Percutaneous Catheter (K011562) and the Venture Wire Control Catheter Model WCC (K061843) in that they are all devices designed to access discrete regions of the coronary and peripheral vasculature. The mechanism of operation, of the non-therapeutic inflatable balloon elements at the distal tip, is technically similar to the Kerberos Occluding Guide Catheter and facilitates stability, visual orientation and placement of the central guidewire.

#### Summary:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BridgePoint Medical c/o Mr. Michael A. Daniel Acting Vice President, Regulatory and Clinical Affairs Daniel & Daniel Consulting 8 Snowberry Court Orinda, CA 94563

Re: K080987

> Trade/Device Name: Stingray™ Orienting Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: January 27, 2009 Received: January 29, 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 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.

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

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## Page 2 - Mr. Michael A. Daniel

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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

Sram 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 STATEMENT 8.

510(k) Number: (TBA)

BridgePoint Medical Stingray™ Orienting Balloon Catheter Device Name:

Indications For Use:

The BridgePoint Medical Stingray™ Orienting Balloon Catheters are indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.

Prescription Use

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danner R. V. Ames

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Division of Cardiovascular Devices

510(k) Number K080987

**CONFIDENTIAL ***