STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012

K083727 · Bridgepoint Medical · DQX · Feb 20, 2009 · Cardiovascular

Device Facts

• Record ID: K083727
• Device Name: STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
• Applicant: Bridgepoint Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray Guidewires are not to be used in cerebral blood vessels.

Device Story

Stingray™ Guidewire is a 0.014" diameter, single-use, disposable percutaneous guidewire. Device features stainless steel shaft with proximal PTFE coating; distal portion is taper-ground for flexibility. Distal tip includes platinum/tungsten coil for fluoroscopic visibility, fixed with silver alloy solder, and hydrophilic coating. Angled distal tip transitions to rounded tip with short monolithic core wire extension. Used by physicians in clinical settings to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA/PTA procedures. Radiopaque distal tip allows for precise placement under fluoroscopy. Lubricious surface facilitates smooth delivery of interventional devices.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on intended use, device description, and performance evaluation (bench testing).

Technological Characteristics

0.014" diameter guidewire; stainless steel core wire; platinum/tungsten distal coil; silver alloy solder; PTFE proximal coating; hydrophilic distal coating. Radiopaque distal tip. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring placement of balloon dilatation catheters or other intravascular devices. Contraindicated for use in cerebral blood vessels.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Stingray™ Guidewire (f.k.a. Entera™ Percutaneous Coronary Guidewire) (K081187)
• Confianza Pro Asahi PTCA Guidewire (K041531)
• Triumph™ PTCA Guidewire (K970396)

Submission Summary (Full Text)

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

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: K083727

Applicant Information:

FEB 2 0 2009

Date Prepared: December 12, 2008

Name: Address: BridgePoint Medical 2800 Campus Drive, #50 Plymouth, MN 55441 Phone: [phone] Fax: [phone]

| Contact Person: | Jill Munsinger |
|-----------------|------------------------------------------|
| Phone Number: | Office: 763-225-8510 / Cell 651-270-0572 |
| E-mail: | [e-mail] |

### Device Information:

| Classification: | Class II Percutaneous Guidewire |
|----------------------|---------------------------------|
| Trade Name: | Stingray™ Guidewire |
| Common Name: | Percutaneous Guidewire |
| Classification Name: | Percutaneous Guidewire |

## Predicate Devices:

The BridgePoint Medical stiff model Stingray™ Guidewire is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices:

K081187 - standard model Stingray™ Guidewire (f.k.a. Entera™ Percutaneous Coronary Guidewire)

K041531 - Confianza Pro Asahi PTCA Guidewire

K970396 - Triumph™ PTCA Guidewire

## Device Description:

The Stingray™ Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"

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

(which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.

## Intended Use:

The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in cerebral blood vessels.

## Comparison to Predicate Devices:

The BridgePoint stiff model Stingray™ Guidewire is substantially equivalent to the standard model Stingray™ Guidewire, K081187, the Confianza Pro Asahi PTCA Guidewire, K041531, and the Triumph™ PTCA Guidewire, K970396 in that they are all designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA.

The BridgePoint Medical stiff model Stingray™ Guidewire is not just substantially equivalent, but is exactly the same as the K081187 - standard model StingrayTM Guidewire, with the only exceptions being the length of the grind/tapers required to produce the desired wire flexibility/support and the removal of the outer distal coil from the distal tip of the wire. The stiff and standard model Stingray™ Guidewires are manufactured using the same processes. The stiff and standard models are produced using the same component materials (core wire, coil, coatings, solder etc.) and have similar physical attributes (flexibility, radiopacity, lubricity, extension wire compatibility, etc).

The distal tips of each device are radiopaque and can be seen with fluoroscopy for precise placement. Both devices are highly lubricious for smooth delivery of multiple devices. They both have stainless steel core wires.

#### Summary:

Based upon the intended use, description information, and performance evaluation provided in this pre-market notification, the BridgePoint Medical stiff model Stingray™ Guidewires have been shown to be substantially equivalent to currently marketed predicate devices.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BridgePoint Medical c/o Ms. Jill Munsinger Regulatory Affairs 2800 Campus Drive, Suite 50 Plymouth MN. 55441

FEB 2 0 2009

Re: K083727

. Trade/Device Name: Stingray™ Guidewire, Stiff Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Dated: January 16, 2009 Received: January 21, 2009

Dear Ms. Munsinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booken o s (1) p= device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that prior to may 20, 1970, and cordance 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 therefore, market the act include requirements for annual registration, listing of devices, good connotic pro receive a 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 n your de rio 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 I least be advisod that 1 Dr. I betermination that your device complies with other requirements of the Act or that 1 Drin has made a determinations 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); an the Act 3 requirements, unstacturing practice requirements as set forth in the quality iabeling (21 CFR Part 807), CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Jill Munsinger

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 yours.

R. Vachner

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

{4}------------------------------------------------

# 8. INDICATIONS FOR USE STATEMENT

510(k) Number: (FBA) K083727

BridgePoint Medical Stingray™ Guidewire Device Name:

Indications For Use:

The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray Guidewires are not to be used in cerebral blood vessels. 1 - 12 - 12 - 11 - 11 -:

Prescription Use Over-The-Counter Use AND/OR X (Part 2) CFR 801 Subpart D) (21 CFR 807 Subpari C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

urray R. Van Ness

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_K6832227