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

K113220 · Boston Scientific Corporation · LOX · Mar 22, 2012 · Cardiovascular

Device Facts

• Record ID: K113220
• Device Name: EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
• Applicant: Boston Scientific Corporation
• Product Code: LOX · Cardiovascular
• Decision Date: Mar 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Dilation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Device Story

Emerge PTCA Dilatation Catheter is a sterile, single-use intravascular device; available in Monorail (MR) and Over-The-Wire (OTW) configurations. Device consists of a catheter shaft with a distal inflatable balloon; radiopaque marker bands facilitate positioning. Used by physicians in clinical settings for coronary artery/bypass graft stenosis dilatation and post-stent expansion. Device is inserted into the vasculature; balloon is inflated to a specific diameter/length to dilate stenoses or expand stents. Benefits include improved myocardial perfusion and optimized stent apposition. No software or electronic components.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, reactivity, toxicity, pyrogenicity, hemolysis, coagulation, hemocompatibility, FTIR), and in-vitro performance (bond strength, tensile, crossing profile, inflation/deflation time, fatigue, burst pressure, compliance, and coating integrity).

Technological Characteristics

PTCA dilatation catheter; MR and OTW platforms. Features radiopaque marker bands and balloon/catheter coatings. Balloon diameters 2.00-4.00 mm; lengths 8-30 mm. Materials and design are substantially equivalent to predicate devices. Sterilization method not specified.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, and for post-delivery expansion of bare metal or drug-eluting 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

• Apex™ PTCA Dilatation Catheter (P860019/S208)
• Maverick2™ MR PTCA Dilatation Catheter (P860019/S179)
• Maverick™ OTW MR PTCA Dilatation Catheter (P860019/S162)

Submission Summary (Full Text)

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KI1322-0
1983

MAR 2 2 2012

# 510(k) Summary
per 21 CFR §807.92

| Submitter's<br>Name and<br>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<br>and<br>Information | Vicky L. Hagens<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | 21 March 2012 | | |
| Proprietary<br>Name | Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation<br>Catheter | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation<br>Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate<br>Devices | Apex™ PTCA Dilatation Catheter | P860019<br>/S208 | 07 November 2008 |
| | Maverick2™ MR PTCA Dilatation<br>Catheter | P860019<br>/S179 | 20 November 2002 |
| | Maverick™ OTW MR PTCA<br>Dilatation Catheter | P860019<br>/S162 | 05 October 2000 |
| Device<br>Description | The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile,<br>single-use, intravascular medical device. The catheter consists of a shaft<br>with a balloon near the distal tip. The balloon is designed to provide an<br>inflatable segment of known diameter and length at recommended<br>pressures. The Emerge™ PTCA Dilatation Catheter is offered in both<br>Monorail (MR) and Over-the-Wire (OTW) platforms. There are<br>radiopaque marker bands located under the balloon to aid in positioning<br>the system during the procedure. Coatings are applied to the balloon and<br>catheter to enhance insertion and withdrawal performance.<br>The Emerge™ PTCA Dilatation Catheter will be available with balloon<br>diameters 2.00 mm to 4.00 mm and balloon lengths 8 mm to 30 mm. | | |
| Intended Use<br>of Device | The Emerge™ PTCA Dilatation Catheter is intended for dilatation of<br>stenosis in coronary arteries or bypass grafts and for the post-delivery<br>expansion of bare metal and drug-eluting stents. | | |

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| Indications for<br>Use | The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation<br>Catheters are indicated for the balloon catheter dilatation of the stenotic<br>portion of a coronary artery or bypass graft stenosis for the purpose of<br>improving myocardial perfusion. Emerge Over-The-Wire and Emerge<br>Monorail PTCA Dilatation Catheters are also indicated for the post-<br>delivery expansion of balloon expandable stents (bare metal and drug-<br>eluting). |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The Emerge™ PTCA Dilatation Catheter incorporates substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process<br>and intended use as those featured in the Boston Scientific predicate<br>devices, Apex™ PTCA Dilatation Catheter P860019/S208 (approved<br>November 7, 2008), Maverick²™ MR PTCA Dilatation Catheter<br>(P860019/S179, approved November 20, 2002), and Maverick™ OTW<br>PTCA Dilatation Catheter (P860019/S162, approved October 05, 2000). |
| 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) | |

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The following in-vitro performance tests were completed on the Emerge™ 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 | Balloon Rated Burst Pressure in<br>Stent |
| | Balloon Fatigue (Repeat Inflations)<br>in Stent |

### Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Emerge™ PTCA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific predicate devices, Apex™, Maverick2TM MR, and Maverick™ OTW PTCA Dilatation Catheters.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.

#### Public Health Service

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

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

Re: K113220

Trade Name: Emerge™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheter Regulatory Class: Class II Product Code: LOX Dated: March 16, 2012 Received: March 19, 2012

Dear Ms. Hagens:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device 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 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 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

MAR 2 2 2012

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## 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/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 yours,

M. A. Hillemann

for 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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## Indications for Use

510(k) Number (if known):

Device Name: Emerge TM 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 Dilation Catheters are also indicated for the post-delivery 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)

M.S. Alleben

(Division Sign-Off) Division of Cardiovascular Devices

KII 3220 510(k) Number

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