TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER

K121222 · Abbott Vascular · LOX · Jun 22, 2012 · Cardiovascular

Device Facts

• Record ID: K121222
• Device Name: TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
• Applicant: Abbott Vascular
• Product Code: LOX · Cardiovascular
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MINI TREKTM OTW and TREKTM OTW Coronary Dilatatoin 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). The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery bypass stent graft (≥ 70% stenosis).

Device Story

Over-the-wire co-axial coronary dilatation catheter with distal balloon; used for PTCA procedures. Input: guide wire for catheter advancement; contrast fluid for balloon inflation/deflation. Operation: physician advances catheter through guiding catheter to stenosis; inflates balloon to expand vessel/stent. Radiopaque markers aid positioning. Output: mechanical dilatation of stenotic coronary artery or bypass graft. Used in clinical settings (e.g., cath lab) by interventional cardiologists. Benefits: improved myocardial perfusion, restored coronary flow, and optimized stent apposition.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included catheter preparation, balloon inflation/deflation, shaft fatigue, shaft rupture, tensile strength, inner member collapse, kink/flexibility, and torque. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation. All tests met acceptance criteria.

Technological Characteristics

Co-axial catheter design with distal balloon and radiopaque markers. Materials include tubular inner and outer members. Energy source: manual inflation device (contrast fluid). Connectivity: none. Sterilization: not specified. Software: none. Complies with Class II Special Controls for PTCA Catheters (September 8, 2010).

Indications for Use

Indicated for patients requiring balloon dilatation of coronary artery or bypass graft stenoses to improve myocardial perfusion, restore flow in ST-segment elevation myocardial infarction, or post-stent dilatation. 1.20 mm model indicated for initial dilatation of coronary artery bypass stent grafts with ≥ 70% stenosis.

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

• TREKTM OTW Coronary Dilatation Catheter (K121222)
• MINI TREKTM OTW Coronary Dilatation Catheter (K121222)

Submission Summary (Full Text)

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K121222
Page 1 of 3

### SECTION 2 - 510(k) SUMMARY

JUN 2 2 2 2012

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 |
|----------------------------------|-------------------------------------------------------------------------------------------------------|
| 2. SUBMITTER'S ADDRESS | 26531 Ynez Road, Temecula, CA 92591 |
| 3. TELEPHONE | [phone] |
| 4. FAX | [phone] |
| 5. CONTACT PERSON | Suzanne Redman |
| 6. DATE PREPARED | April 20, 2011 |
| 7. DEVICE TRADE NAME | TREKTM OTW Coronary Dilatation Catheter<br>MINI TREKTM 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, Class II<br>21 CFR 870.5100 |
| 10. PREDICATE DEVICE NAME | TREKTM OTW Coronary Dilatation Catheter<br>MINI TREKTM OTW Coronary Dilatation<br>Catheter |

#### DEVICE DESCRIPTION 11.

The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter are an over-the-wire co-axial design with a balloon at the distal tip. Table 1 provides a matrix of the balloon diameters and lengths available.

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K121222

Page 2 of 3

| Table 2-1 | TREK OTW and MINI TREK OTW Size Matrix | | | | | | |
|--------------------------------------------|----------------------------------------|-----|------|------|------|------|------|
| Balloon<br>Diameter<br>(mm) | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm |
| MINI TREK OTW Coronary Dilatation Catheter | | | | | | | |
| 1.20 | X | X | X | X | X | | |
| 1.50 | X | X | X | X | X | | |
| 2.00 | X | X | X | X | X | X | X |
| TREK OTW Coronary Dilatation Catheter | | | | | | | |
| 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 | | | |

| Table 2-1 TREK OTW and MINI TREK OTW Size Matrix | | | | | | | | |
|--------------------------------------------------|----------------|--|--|--|--|--|--|--|
| Balloon Diameter | Balloon Length | | | | | | | |

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 co-axial 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 OTW and MINI TREK OTW Coronary Dilatation Catheters (1.50 mm - 5.00 mm) 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).

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K1212222
Page 3 of 3

The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery bypass graft stenosis (≥ 70% stenosis).

#### TECHNOLOGICAL CHARACTERISTICS 13.

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.

#### 14. PERFORMANCE DATA

The modified 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 .
- Balloon Inflation / Balloon Deflation .
- . Catheter Shaft Fatigue
- Catheter Shaft Rupture .
- . Distal Catheter Tensile Strength
- Proximal Adaption Tensile Strength .
- . Inner Member Collapse
- . Kink and Flexibility
- Torque .

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

These in vitro bench and biocompatibility tests demonstrated that the 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.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

### Public Health Service

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

JUN 2 2 2012

Abbott Vascular, Inc. Ms. Suzanne Redman Regulatory Affairs 26531 Ynez Road Temecula, CA 92591

Re: K121222

Trade/Device Name: TREK OTW Coronary Dilatation Catheter and MINI TREK OTW Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheter Regulatory Class: Class II Product Code: LOX Dated: May 23, 2012 Received: May 24, 2012

Dear Ms. Redman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prices to May 20, 1978, are exactions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costiete Act (71ct) that ao not required to the general controls provisions of the Act. The 1 ou may, mercerere, manel as act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and ucvices, good manufacturing praction in the mot evaluate information related to contract liability adulteration. Tease note: ODIC access not ever labeling must be truthful and not misleading.

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## Page 2 – Ms. Suzanne Redman

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc acribed that I Drimination that your device complies with other requirements of the Act that 1 27 Planal statutes and regulations administered by other Federal agencies. You must or uny I casual statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of ice rated 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 rord in and ation 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 n you desire specific ad 1700 sor you/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 note the regalation manied 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

[phone] 01 (50 (50 (50 corcesfor You/Industry/default.htm.

Sincerely yours,

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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### SECTION 1 - INDICATIONS FOR USE

# 510(k) Number (if known):

| Device Names: | TREKTM OTW Coronary Dilatation Catheter<br>MINI TREKTM OTW Coronary Dilatation Catheter |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use: | Balloon diameters 1.50 mm - 5.00 mm<br>The MINI TREKTM OTW and TREKTM OTW Coronary Dilatatoin<br>Catheters are indicated for:<br>a) 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-segment elevation<br>myocardial infarction;<br>c) balloon dilatation of a stent after implantation (balloon models 2.0<br>mm - 5.0 mm only).<br>Balloon diameter 1.20 mm<br>The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is |

indicated for initial balloon dilatation of the stenotic portion of a coronary artery bypass stent graft (≥ 70% stenosis).

Prescription Use______________________________________________________________________________________________________________________________________________________________ X = (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) | |
|--------------------------------------------------------|---------------|
| (Division Sign-Off) | Page __ of __ |
| Division of Cardiovascular Devices | |
| 510(k) Number | K121222 |

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