MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

K103110 · Abbott Vascular-Cardiac Therapies · LOX · Jan 10, 2011 · Cardiovascular

Device Facts

• Record ID: K103110
• Device Name: MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
• Applicant: Abbott Vascular-Cardiac Therapies
• Product Code: LOX · Cardiovascular
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters are indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

Device Story

TREK and MINI TREK are coronary dilatation catheters (RX and OTW designs) used for PTCA procedures. Devices feature distal balloon for stenosis dilation and radiopaque markers for positioning. RX models use rapid exchange co-axial design; OTW models use over-the-wire co-axial design. Inner lumen accommodates guide wire; outer lumen allows inflation/deflation with contrast fluid via external inflation device. Used by physicians in clinical settings to dilate stenotic coronary arteries, bypass grafts, or stents. Output is mechanical expansion of balloon to restore blood flow. Benefits include improved myocardial perfusion and flow restoration in STEMI patients.

Clinical Evidence

No clinical data. Evidence consists of in vitro bench testing per FDA Class II Special Controls for PTCA Catheters (Sept 2010). Tests included catheter preparation, profile, inflation/deflation, fatigue, rupture, compliance, bond tensile strength, coating particulate, kink/flexibility, torque, and radiopacity. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation. All acceptance criteria met.

Technological Characteristics

Co-axial catheter design with distal balloon. Materials include tubular inner/outer members, radiopaque markers. Features include brachial/femoral markers, inflation/guide wire lumens. Sterilization and specific material standards not detailed. Mechanical sensing/actuation via hydraulic inflation. No software or electronic components.

Indications for Use

Indicated for patients requiring balloon dilatation of coronary artery or bypass graft stenoses to improve myocardial perfusion, patients with ST-segment elevation myocardial infarction requiring restoration of coronary flow, and post-stent implantation dilatation (for 2.0-5.0 mm models).

Regulatory Classification

Identification

Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.

Special Controls

*Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b) *Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.

Predicate Devices

• VOYAGER® RX Coronary Dilatation Catheter
• VOYAGER® NC Coronary Dilatation Catheter
• VOYAGER® OTW Coronary Dilatation Catheter

Submission Summary (Full Text)

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

/C10 3110

# JAN 1 0 2011

1

## 510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

.

| 1. SUBMITTER'S NAME | Abbott Vascular Inc. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. SUBMITTER'S ADDRESS | 26531 Ynez Road, Temecula, CA 92591 |
| 3. TELEPHONE | [phone] |
| 4. FAX | [phone] |
| 5. CONTACT PERSON | Suzanne Redman |
| 6. DATE PREPARED | November 9, 2010 |
| 7. DEVICE TRADE NAME | TREK™ RX Coronary Dilatation Catheter<br>MINI TREK™ RX Coronary Dilatation Catheter<br>TREK™ OTW Coronary Dilatation Catheter<br>MINI TREK™ OTW Coronary Dilatation<br>Catheter |
| 8. DEVICE COMMON NAME | • Coronary Dilatation Catheter<br>• Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheter |
| 9. DEVICE CLASSIFICATION<br>NAME | PTCA Catheter (LOX) |
| 10. PREDICATE DEVICE NAME | VOYAGER® RX Coronary Dilatation Catheter<br>VOYAGER® NC Coronary Dilatation Catheter<br>VOYAGER® OTW Coronary Dilatation Catheter |

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

### 11. DEVICE DESCRIPTION

#### TREK RX and MINI TREK RX Coronary Dilatation Catheter 11.1

The TREK RX and MINI TREK RX Coronary Dilatation Catheters are a rapid exchange co-axial design with a balloon at the distal tip. Table 1 provides a matrix of the balloon diameters and lengths available.

| Balloon<br>Diameter<br>(mm) | Balloon Length | | | | | | |
|-----------------------------|----------------|-----|------|------|------|------|------|
| | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm |
| | MINI TREK RX | | | | | | |
| 1.50 | X | X | X | X | X | | |
| 2.00 | X | X | X | X | X | X | X |
| | TREK RX | | | | | | |
| 2.25 | X | X | X | X | X | X | X |
| 2.50 | X | X | X | X | X | X | X |
| 2.75 | X | X | X | X | X | X | X |
| 3.00 | X | X | X | X | X | X | X |
| 3.25 | X | X | X | X | X | X | X |
| 3.50 | X | X | X | X | X | X | X |
| 3.75 | X | X | X | X | X | X | X |
| 4.00 | X | X | X | X | X | X | X |
| 4.50 | X | X | X | X | | | |
| 5.00 | | | X | X | | | |

Table 1 TREK RX and MINI TREK RX Balloon Sizes

The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.

#### TREK OTW and MINI TREK OTW Coronary Dilatation Catheter 11.2

The TREK OTW and MINI TREK OTW Coronary Dilatation Catheters are an over-thewire co-axial design with a balloon at the distal tip. Table 2 provides a matrix of the balloon diameters and lengths available.

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

| Table 2 | TREK OTW and MINI TREK OTW Balloon Sizes | | | | | | |
|-----------------------------|------------------------------------------|-----|------|------|------|------|------|
| Balloon<br>Diameter<br>(mm) | Balloon Length | | | | | | |
| | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm |
| MINI TREK OTW | | | | | | | |
| 1.50 | X | X | X | X | X | | |
| 2.00 | X | X | X | X | X | X | X |
| TREK OTW | | | | | | | |
| 2.25 | X | X | X | X | X | X | X |
| 2.50 | X | X | X | X | X | X | X |
| 2.75 | X | X | X | X | X | X | X |
| 3.00 | X | X | X | X | X | X | X |
| 3.25 | X | X | X | X | X | X | X |
| 3.50 | X | X | X | X | X | X | X |
| 3.75 | X | X | X | X | X | X | X |
| 4.00 | X | X | X | X | X | X | X |
| 4.50 | | | X | X | | | |
| 5.00 | | | X | X | | | |

The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

### 12. INDICATIONS FOR USE

The TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW are indicated for:

a) balloon dilatation of the stentotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;

b) balloon dilatation of a coronary artery occlusion of the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;

c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

#### TECHNOLOGICAL CHARACTERISTICS 13.

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

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.

### PERFORMANCE DATA 14.

The TREK RX, MINI TREK RX, TREK OTW and MINI TREK OTW Coronary Dilatation Catheters were subjected to the following in vitro bench tests according to the requirements of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010:

- ◆ Catheter Preparation
- Catheter Profile (crossing and refolded) .
- Balloon Inflation and Deflation �
- Balloon Fatigue and Balloon Fatigue Within a Stent .
- Balloon Rupture and Balloon Rupture Within a Stent ●
- Balloon Compliance .
- ◆ Catheter Bond Tensile Strength
- . Catheter Coating Particulate
- . Kink and Flexibility
- . Torque
- . Radiopacity

Biocompatibility testing included cyctotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation.

These in vitro bench and biocompatibility tests demonstrated that the TREK RX, MINI TREK RX, TREK OTW and MINI TREK OTW Coronary Dilatation Catheters met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, these devices may be considered substantially equivalent to the predicate devices.

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

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three lines extending upwards, possibly representing growth or progress.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Abbott Vascular, Inc c/o Ms. Suzanne Redman Principal regulatory Affairs Associates 26531 Ynez Road Temecula, CA 92591

# JAN 1 0 2011

Re: K103110

Trade/Device Name: TREK™ RX Coronary Dilatation Catheter MINI TREK™ RX Coronary Dilatation Catheter TREKTM OTW Coronary Dilatation Catheter MINI TREKTM OTW Coronary Dilatation Clatheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheters Regulatory Class: Class II (two) Product Code: LOX Dated: December 29, 2010 Received: December 30, 2010

Dear Ms. Redman:

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 enactnent date of the Medical Device Amendinents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do trequire approval of a provisions of the Federal Food, Drug,
You may, therefore, market the douise of i 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 misting 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.

:

and the contraction of the comments of the comments of

{5}------------------------------------------------

Page 2 – Ms. Suzanne Redman

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

una R. Vi. Vanes

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

Enclosure

{6}------------------------------------------------

JAN 1 0 2011

### INDICATIONS FOR USE

| 510(k) Number (if known): | K103110 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Names: | TREKTM RX Coronary Dilatation Catheter<br>MINI TREKTM RX Coronary Dilatation Catheter<br>TREKTM OTW Coronary Dilatation Catheter<br>MINI TREKTM OTW Coronary Dilatation Catheter |
| Indications<br>for Use: | The TREKTM RX, MINI TREKTM RX, TREKTM OTW, and MINI<br>TREKTM OTW Coronary Dilatation Catheters are indicated for: a)<br>balloon dilatation of the stenotic portion of a coronary artery or<br>bypass graft stenosis for the purpose of improving myocardial<br>perfusion;<br>b) balloon dilatation of a coronary artery occlusion for the purpose of<br>restoring coronary flow in patients with ST-segement elevation<br>myocardial infarction;<br>c) balloon dilatation of a stent after implantation (balloon models 2.0<br>mm - 5.0 mm only) |

X Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter_ (Optional Format 1-1-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

smmaR.L.hmes4

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices Page _ of ___

510(k) Number_k 10 310(k) Number