EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)

K121196 · Boston Scientific Corp · LOX · Aug 31, 2012 · Cardiovascular

Device Facts

• Record ID: K121196
• Device Name: EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
• Applicant: Boston Scientific Corp
• Product Code: LOX · Cardiovascular
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge™ PTCA Dilatation Catheter (1.50 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts.

Device Story

The Emerge™ PTCA Dilatation Catheter is a sterile, single-use intravascular device used by physicians in clinical settings for coronary angioplasty. It consists of a catheter shaft with an inflatable balloon at the distal tip, available in Monorail (MR) and Over-the-Wire (OTW) configurations. Radiopaque marker bands under the balloon assist in fluoroscopic positioning. The device is inserted into the coronary vasculature to dilate stenotic lesions or expand stents. Coatings on the balloon and catheter facilitate insertion and withdrawal. By inflating the balloon to a specific diameter and length at recommended pressures, the device restores or improves blood flow (myocardial perfusion) or ensures proper stent apposition. The device is operated by a physician during interventional procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, sensitization, reactivity, toxicity, pyrogenicity, hemocompatibility, FTIR analysis) and in-vitro performance (balloon inflation/deflation, crossing profile, bond strength, flexibility, kink resistance, torque, burst pressure, fatigue, compliance, and coating integrity).

Technological Characteristics

Intravascular PTCA dilatation catheter; Monorail and Over-the-Wire platforms. Features radiopaque marker bands and lubricious coatings. Materials and design are consistent with predicate devices. Sterilization method is standard for this device class. No software or electronic components.

Indications for Use

Indicated for balloon catheter dilatation of stenotic coronary artery or bypass graft segments to improve myocardial perfusion. Models 2.00-4.00 mm are also indicated for post-delivery expansion of bare metal and drug-eluting balloon-expandable stents.

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

• Emerge™ PTCA Dilatation Catheter (K113220)
• Apex™ PTCA Dilatation Catheter (P860019/S208)

Submission Summary (Full Text)

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

## K121196

. .

AUG 3 1 2012

# 510(k) Summary
per 21 CFR §807.92

.

| Submitter's Name and Address | Boston Scientific Corporation<br>Cardiovascular, Rhythm & Vascular Division<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: [phone]<br>Fax: [phone] | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact Name and Information | Vicky L. Hagens<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Prepared | 16 April 2012 | |
| Proprietary Name | Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter | |
| Product Code | LOX | |
| Classification | Class II, 21 CFR Part 870.5100 | |
| Predicate Devices | Emerge™ PTCA Dilatation Catheter K113220 22 March 2012<br>Apex™ PTCA Dilatation Catheter P860019 /S208 07 November 2008 | |
| Device Description | The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-the-Wire (OTW) platforms. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheter will be available with balloon diameters of 1.50 mm and balloon lengths 8 mm to 20 mm. | |
| Intended Use of Device | The Emerge™ PTCA Dilatation Catheter (1.50 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts. | |
| Indications for Use | The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). | |
| Comparison of<br>Technological<br>Characteristics | The Emerge™ PTCA Dilatation Catheter (1.50 mm diameter) incorporates<br>substantially equivalent device materials and design, packaging materials<br>and design, fundamental technology, manufacturing processes,<br>sterilization process and intended use as those featured in the Boston<br>Scientific predicate devices, Emerge™ PTCA Dilatation Catheter<br>K113220 (cleared March 22, 2012) and Apex™ PTCA Dilatation Catheter<br>P860019/S208 (approved November 7, 2008) | |
| Performance<br>Data | The Emerge™ PTCA Dilatation Catheter was subjected to testing<br>according to the requirements of Guidance for Industry and FDA Staff -<br>Class II Special Controls for Certain Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and<br>biocompatibility testing were performed to support a determination of<br>substantial equivalence. The results of these tests provide reasonable<br>assurance that the proposed device has been designed and tested to<br>assure conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the testing and,<br>therefore, these devices may be considered substantially equivalent to the<br>predicate devices. | |
| | The following biocompatibility and chemical characterization tests were<br>completed on the Emerge™ PTCA Dilatation Catheter: | |
| | Cytotoxicity | Hemolysis (Direct Contact) |
| | Sensitization | Hemolysis (Extract Method) |
| | Intracutaneous Reactivity | Complement Activation |
| | Acute Systemic Toxicity | Coagulation |
| | Materials Mediated Pyrogenicity | In Vitro Hemocompatibility |
| | USP Physicochemical | FTIR Analysis |
| | (Additional Characterization Tests - residual NPGDA analysis) | |
| | The following in-vitro performance tests were completed on the Emerge™<br>PTCA Dilatation Catheter: | |
| | Effective Length | Balloon Inflation/Deflation Time |
| | Shaft Inner and Outer Diameter | Catheter Bond Strength Tensile |
| | Balloon Crossing Profile | Tip Pull Test |
| | Balloon Preparation, Deployment,<br>and Retraction | Flexibility and Kink |
| | Withdrawal into a Guide Catheter | Torque Strength |
| | Shaft and Bond Burst Pressure | Radiopacity |
| | Balloon Rated Burst Pressure | Coating Integrity |
| | Balloon Fatigue (Repeat Inflations) | Particulate Evaluation |
| | Balloon Compliance | |
| Conclusion | Based on the indications for use, technological characteristics, and safety<br>and performance testing, the Emerge™ PTCA Dilatation Catheter has<br>been shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the Boston Scientific predicate devices. | |

:

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

:

. . .

Emerge™ and Apex™ PTCA Dilatation Catheters.

:

,

·

:

:

.

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

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

AUG 3 1 2012

Boston Scientific Corporation c/o Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K121196

Trade Name: Emerge™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Standard PTCA Catheter Regulatory Class: Class II Product Code: LOX Dated: August 16, 2012 Received: August 17, 2012

Dear Ms. Hagens:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocares in 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 encreate) ve the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that do novice, subject to the general controls provisions of the Act. The r ou may, dierelors, manus are act include requirements for annual registration, listing of general controls provisions of the I 100 labeling, and prohibitions against misbranding and devices, good manimatianing praction in exaluate information related to contract liability adulteration. Tease note: CDICP does not evaluate labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 acove). Existing major regulations affecting your device can be may be subject to additional combiness, 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 Please be advised hat I DA s issualted or a sualies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a decornmancir as administered by other Federal agencies. You must of any Federal statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not section (consec comply with an the Act 3 requirements, including in the reporting (reporting of medical

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

Page 2 - Ms. Vicky Hagens

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/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 yours,

Mig Heller

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

Enclosure

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

### Indications for Use

510(k) Number (if known):

Device Name: Emerge ™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter

Indications for Use:

The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tm.g. Hillman

ision Sign-Off) Division of Cardiovascular Devices

510(k) Number