ARTIMES BALLOON DILATATION CATHETER

K141025 · Brosmed Medical · LOX · Sep 12, 2014 · Cardiovascular

Device Facts

• Record ID: K141025
• Device Name: ARTIMES BALLOON DILATATION CATHETER
• Applicant: Brosmed Medical
• Product Code: LOX · Cardiovascular
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Artimes PTCA catheter is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

Device Story

Artimes Balloon Dilatation Catheter is a rapid-exchange (Rx) coronary dilatation catheter; 140cm working length; 0.014-inch guidewire compatible. Used by interventional cardiologists in cath labs for percutaneous transluminal coronary angioplasty (PTCA). Device features semi-compliant Pebax balloon (1.5mm-4.0mm diameter); PTFE-coated stainless steel proximal shaft; Pebax/nylon distal shaft; platinum/iridium radiopaque marker bands. Physician advances catheter over guidewire to stenotic site; inflates balloon to dilate artery/graft; improves myocardial perfusion. Radiopaque markers assist in fluoroscopic positioning. No lumen for dye injection or pressure measurement. Benefits include restoration of blood flow in ischemic or infarcted vessels.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kinking, torque strength, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma). All results met acceptance criteria.

Technological Characteristics

Rapid-exchange PTCA catheter; 140cm length. Materials: Pebax (balloon/distal shaft), PTFE-coated stainless steel (proximal shaft), nylon (distal shaft), platinum/iridium (marker bands). Rated burst pressure: 14 atm. Lubricious distal coating. Compatible with 0.014-inch guidewires. Mechanical operation via manual inflation/deflation. Sterilization method not specified.

Indications for Use

Indicated for patients with coronary ischemia requiring balloon dilatation of stenotic coronary arteries or bypass grafts, and for patients with acute myocardial infarction requiring balloon dilatation of coronary artery occlusions.

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

• Sprinter Legend RX (P790017 S096)
• Voyager RX (P810046 S216)
• Maverick (P860019 S160)
• Apex (P860019 S208)
• Fire Star (P880003 S090)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

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

September 12, 2014

BrosMed Medical Co., Ltd % Stephen Lee Deputy General Manager 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan 523808 CHINA

Re: K141025

Trade/Device Name: Artimes Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: August 15, 2014 Received: August 18, 2014

Dear Mr. Lee,

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

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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 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.

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 yours,

M.A. Hillebrenner

for

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K141025

Device Name

Artimes Balloon Dilatation Catheter

Indications for Use (Describe) The Artimes Balloon Dilatation Catheter is indicated for:

1. Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients coronary ischemia for the purpose of improving myocardial perfusion

2. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

| Submitter: | BrosMed Medical Co., Ltd<br>15th building, SMEs Venture Park<br>SongShan Lake Hi-Tech Industrial Development Zone<br>Dongguan 523808, China<br>Office: [phone]<br>Fax: [phone] |
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| Contact Person:<br>Date Prepared<br>Trade Name: | Stephen Lee<br>April, 06th, 2014<br>Artimes Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR<br>870.5100(a), Product Code LOX) |
| Predicate Devices: | Sprinter Legend RX (P790017 S096; cleared October 31, 2008)<br>Voyager RX (P810046 S216; cleared June 18, 2004)<br>Maverick (P860019 S160; cleared September 27, 2000)<br>Apex (P860019 S208; cleared November 7, 2008)<br>Fire Star (P880003 S090; cleared August 31, 2007) |
| Device Description: | The Artimes1 (Rx type) device is a coronary dilatation catheter<br>designed for easy guidewire exchange. The catheter working length is<br>140cm. Lubricious coatings are applied to the distal section. Balloon<br>diameters range from Ø1.5mm to Ø4.0mm. The balloon material is<br>made of a semi-compliant Pebax material for diameter 1.5mm to<br>4.0mm with a rated burst pressure of 14 atmospheres. The proximal<br>shaft of the catheter is composed of a female luer connector bonded to<br>a PTFE coated stainless steel tube with a wire. The proximal shaft<br>joins with a smooth transition to a distal shaft composed of an outer<br>tube of pebax/nylon and a tri-extrusion inner tube with a balloon laser<br>welded to both tubes at the distal tip. Two radiopaque platinum/iridium<br>marker bands are located within the balloon segment with the<br>exception of balloon diameters less than 2.0mm which incorporate a<br>centrally positioned single marker band. The inner tube accepts a<br>standard 0.014 inch PTCA guidewire. The guide wire enters the<br>catheter's tip and advances coaxially out the distal Rx port, thereby<br>allowing both coaxial guidance and rapid exchange of catheter with a<br>single standard length guide wire. Two marked sections of 5mm length<br>each located on the proximal shaft indicate catheter position relative to<br>the tip of either a brachial or femoral guiding catheter. The design of<br>this dilatation catheter does not incorporate a lumen for distal dye<br>injections or distal pressure measurements.<br>Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x<br>5-30mm configurations which are NOT intend for sales in the United States<br>(US) but rest of world (ROW) based upon availability of regulatory approvals.<br>Separate Catalog numbers have been assigned to the Artimes US product<br>(801-DDLLU, reference section 11.0) for the Ø1.5-4.0mm x 5-30mm<br>configurations with its IFU and label, compared with Artimes ROW product<br>(801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510k<br>Artimes PTCA<br>Page 1 of 2 |
| | or relevant (e.g. IDE or PMA) submission will be executed if BrosMed<br>Medical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) in<br>the United States. |
| Intended Use: | The Artimes PTCA catheter is indicated for:<br>balloon dilatation of the stenotic portion of a coronary artery<br>or bypass graft stenosis in patients evidencing coronary<br>ischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for the<br>treatment of acute myocardial infarction |
| Technological Characteristics: | Comparisons of the new and predicate devices show that the<br>technological characteristics such as product performance, design, and<br>intended use are substantially equivalent to the currently marketed<br>predicate devices. |
| Performance Data: | Both in vitro performance tests, such as dimensional verification,<br>balloon preparation, deployment, and retraction, balloon rated burst<br>pressure, balloon fatigue, balloon compliance, balloon inflation and<br>deflation time, catheter bond strength, tip pull strength, flexibility and<br>kinking, torque strength, radiopacity, coating integrity, and particulate<br>evaluation, and also biocompatibility tests, such as cytotoxicity,<br>sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity,<br>intracutaneous reactivity and genototocity (bacterial mutagenicity and<br>in vitro mouse lymphoma) were conducted on the Artimes PTCA<br>catheter. The test results met all acceptance criteria, were similar to<br>predicate devices, and ensure that the Artimes PTCA catheter design<br>and construction are suitable for its intended use as recommended by<br>the Class II Special Controls Guidance Document for Certain<br>Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters<br>(FDA; September 8, 2010). |
| Conclusion: | This information supports as determination of substantial equivalence<br>between the Artimes PTCA catheter and the predicate devices<br>described above. |

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510(k) Notification (21CFR 807.90(e))