Emerge PTCA Dilatation Catheter

K163174 · Boston Scientific Corporation · LOX · Dec 14, 2016 · Cardiovascular

Device Facts

• Record ID: K163174
• Device Name: Emerge PTCA Dilatation Catheter
• Applicant: Boston Scientific Corporation
• Product Code: LOX · Cardiovascular
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis). The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) 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. The 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).

Device Story

Emerge PTCA Dilatation Catheter is a sterile, single-use intravascular device for coronary angioplasty. It features a dual-lumen polymeric shaft with a distal inflatable balloon and an inner lumen for guidewire advancement. Radiopaque marker bands under the balloon facilitate positioning; proximal shaft marks indicate exit from the guide catheter. Hydrophilic and hydrophobic coatings enhance insertion/withdrawal. Used in clinical settings by physicians to dilate stenotic coronary arteries or bypass grafts and expand stents. The device provides mechanical dilatation of vessels, improving myocardial perfusion and ensuring proper stent apposition. It is a mechanical tool; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Performance testing included corrosion resistance, proximal mark abrasion resistance, proximal shaft marks, repeat inflation, midshaft bond tensile, and shaft/bond burst pressure. Biocompatibility and chemical characterization included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, materials-mediated pyrogenicity, mutagenicity, hemolysis, PTT, in vitro hemocompatibility, complement activation, USP physicochemical, latex assay, nonvolatile residue, and SEM analysis.

Technological Characteristics

Dual-lumen polymeric shaft catheter with distal balloon; Monorail (MR) and Over-The-Wire (OTW) configurations. Materials include polymers, radiopaque marker bands, and hydrophilic/hydrophobic coatings. Sterilization via Ethylene Oxide (EO). Mechanical sensing/actuation via manual inflation/deflation. No software or electronic components.

Indications for Use

Indicated for patients requiring pre-dilatation of stenotic coronary arteries or bypass grafts (≥70% stenosis), balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, or 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

• Emerge PTCA Dilatation Catheter (K113220)
• Emerge PTCA Dilatation Catheter (K121196)
• Emerge PTCA Dilatation Catheter (K130391)

Reference Devices

• NC Emerge PTCA Dilatation Catheter (K141236)

Submission Summary (Full Text)

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

December 14, 2016

Boston Scientific Corporation Jane Horan Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K163174

Trade/Device Name: Emerge PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 10, 2016 Received: November 14, 2016

Dear Jane Horan:

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Brian D. Pullin -S

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) K163174

Device Name Emerge PTCA Dilatation Catheter

#### Indications for Use (Describe)

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) 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.

The 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).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510k Summary

# Per 21 CFR §807.92

| Common or<br>Usual Name | PTCA Dilatation Catheter |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Emerge™ Monorail PTCA Dilatation Catheter<br>Emerge™ Push Monorail PTCA Dilatation Catheter<br>Emerge™ Over-The-Wire Monorail PTCA Dilatation Catheter<br>Emerge™ Push Over-The-Wire Monorail PTCA Dilatation Catheter |
| Product Code | LOX - Percutaneous Transluminal Coronary Angioplasty<br>(PTCA) Catheter |
| Classification of<br>Device | Class II, 21 CFR 870.5100 |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Three Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name<br>and Information | Jane Horan<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 7 Dec. 2016 |
| Section 514 of the<br>Act Performance<br>Standards | No performance standards have been established under<br>Section 514 of the Food, Drug and Cosmetic Act for<br>percutaneous catheters. |

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| Establishment<br>Registration<br>Numbers | Owner<br>/Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 |
|------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturing<br>Facility: | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 |
| | Sterilization<br>Facilities: | Boston Scientific Corporation –<br>Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>ERN: 1000121056 |
| | | STERIS Isomedix Services<br>3459 South Clinton Avenue<br>South Plainfield, NJ 07080<br>ERN: 2246552 |
| | | Synergy Health Ireland Ltd.<br>(Tullamore)<br>IDA Business & Technology Park<br>Tullamore, County Offaly<br>Ireland<br>ERN: 3002807314 |
| | | Synergy Health AST, SRL<br>B13. 1 Street 4, Avenue 1<br>El Coyol Free Zone<br>El Coyol, Alajeula 20102<br>Costa Rica<br>ERN: 3010273872 |
| | | Synergy Health Venlo<br>Faunalaan 38<br>Venlo Limburg, Netherlands<br>5928 RZ<br>ERN: 3009337401 |

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| Predicate Devices | Emerge™ PTCA Dilatation Catheter, K113220, cleared 22<br>March 2012. |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Emerge™ PTCA Dilatation Catheter, K121196, cleared 31<br>August 2012. |
| | Emerge™ PTCA Dilatation Catheter, K130391, cleared 10<br>July 2013. |
| Reference<br>Device | NC Emerge™ PTCA Dilatation Catheter, K141236,<br>cleared 7 August 2014 |
| Device<br>Description | The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. 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. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm. |
| Intended Use/<br>Indications for<br>Use | The Emerge Over-The-Wire and Emerge Monorail PTCA<br>Dilatation Catheters (1.20 mm balloon models) are<br>indicated as pre-dilatation catheters in the stenotic portion<br>of a coronary artery or bypass graft stenosis (≥ 70%<br>stenosis). |
| | The Emerge Over-The-Wire and Emerge Monorail PTCA<br>Dilatation Catheters (balloon models 1.50-4.00 mm) are<br>indicated for the balloon catheter dilatation of the stenotic<br>portion of a coronary artery or bypass graft stenosis for<br>the purpose of improving myocardial perfusion. |
| | The Emerge Over-The-Wire and Emerge Monorail PTCA<br>Dilatation Catheters (balloon models 2.00 - 4.00 mm) are<br>also indicated for the post-delivery expansion of balloon<br>expandable stents (bare metal and drug-eluting). |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Emerge™ PTCA Dilatation Catheter<br>incorporates substantially equivalent device materials and<br>design, packaging materials and design, fundamental<br>technology, manufacturing processes, sterilization<br>process and intended use as those featured in the Boston<br>Scientific predicate devices, Emerge™ PTCA Dilatation<br>Catheter K113220 (cleared March 22, 2012); Emerge™<br>PTCA Dilatation Catheter K121196 (cleared August 31,<br>2012); and Emerge™ PTCA Dilatation Catheter K130391<br>(cleared July 10, 2013). |
| | The proposed and predicate devices share the following<br>technological characteristics: |
| | Fundamental catheter design and intended use Shaft, balloon, marker band, and coating materials Packaging materials and design Sterilization method Fundamental manufacturing processes |
| | The proposed and predicate devices differ in the following<br>technological characteristic: |
| | Method of making proximal marks on the shaft |

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| Summary of Non-Clinical Test Summary | Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. | | | | | | | | | | | | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------|----------------------|----------------------------|---------------------------|-------------------------------|--------------------------|---------------------|---------------------------------|-------------|--------------|---------------------|-----------|-----|
| | The following performance tests were completed on the Emerge™ PTCA Dilatation Catheter: | | | | | | | | | | | | | | |
| | <table><tr><td>Corrosion Resistance</td><td>Proximal Mark Abrasion Resistance</td></tr><tr><td>Proximal Shaft Marks</td><td>Repeat Inflation</td></tr><tr><td>Midshaft Bond Tensile</td><td>Shaft and Bond Burst Pressure</td></tr></table> | Corrosion Resistance | Proximal Mark Abrasion Resistance | Proximal Shaft Marks | Repeat Inflation | Midshaft Bond Tensile | Shaft and Bond Burst Pressure | | | | | | | | |
| Corrosion Resistance | Proximal Mark Abrasion Resistance | | | | | | | | | | | | | | |
| Proximal Shaft Marks | Repeat Inflation | | | | | | | | | | | | | | |
| Midshaft Bond Tensile | Shaft and Bond Burst Pressure | | | | | | | | | | | | | | |
| | The following biocompatibility and chemical characterization tests were completed on the Emerge™ PTCA Dilatation Catheter: | | | | | | | | | | | | | | |
| | <table><tr><td>Cytotoxicity</td><td>Partial Thromboplastin Time</td></tr><tr><td>Sensitization</td><td>In Vitro Hemocompatibility</td></tr><tr><td>Intracutaneous Reactivity</td><td>Complement Activation</td></tr><tr><td>Acute Systemic Injection</td><td>USP Physicochemical</td></tr><tr><td>Materials Mediated Pyrogenicity</td><td>Latex Assay</td></tr><tr><td>Mutagenicity</td><td>Nonvolatile Residue</td></tr><tr><td>Hemolysis</td><td>SEM</td></tr></table> | Cytotoxicity | Partial Thromboplastin Time | Sensitization | In Vitro Hemocompatibility | Intracutaneous Reactivity | Complement Activation | Acute Systemic Injection | USP Physicochemical | Materials Mediated Pyrogenicity | Latex Assay | Mutagenicity | Nonvolatile Residue | Hemolysis | SEM |
| Cytotoxicity | Partial Thromboplastin Time | | | | | | | | | | | | | | |
| Sensitization | In Vitro Hemocompatibility | | | | | | | | | | | | | | |
| Intracutaneous Reactivity | Complement Activation | | | | | | | | | | | | | | |
| Acute Systemic Injection | USP Physicochemical | | | | | | | | | | | | | | |
| Materials Mediated Pyrogenicity | Latex Assay | | | | | | | | | | | | | | |
| Mutagenicity | Nonvolatile Residue | | | | | | | | | | | | | | |
| Hemolysis | SEM | | | | | | | | | | | | | | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Emerge™ PTCA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to Emerge™ PTCA Dilatation Catheter (K113220), (K121196) and (K130391). | | | | | | | | | | | | | | |